Request History

• Restore to current request
• applications/index/sort:study_title/direction:desc/page:4/trial_therapeutic_use:1
• applications/index/page:20/sort:study_title/direction:desc/trial_therapeutic_use:1
• applications/index/sort:protocol_no/direction:asc/page:6/trial_therapeutic_use:1
• applications/index/sort:protocol_no/direction:asc/page:8/trial_therapeutic_use:1

Session

• Config(array)
  • userAgent9c3d2c89526db53b7b69e8c9faa06145
  • time1763883682
  • countdown10

Request

Cake Params

• plugin(null)
• controllerapplications
• actionindex
• named(array)
  • page18
  • sortstudy_title
  • directiondesc
  • trial_therapeutic_use1
• pass(empty)
• isAjax(false)
• paging(array)
  • Application(array)
    • page18
    • current5
    • count115
    • prevPage(true)
    • nextPage(true)
    • pageCount23
    • order(array)
      • Application.study_titledesc
    • limit5
    • options(array)
      • page18
      • order(array)
        • Application.study_titledesc
      • sortstudy_title
      • directiondesc
    • paramTypenamed

Post data

• Application(array)
  • trial_therapeutic_use1

Query string

No querystring data.

Cookie

To view Cookies, add CookieComponent to Controller

Current Route

• keys(array)
  • 0controller
  • 1action
• options(empty)
• defaults(array)
  • plugin(null)
• template/:controller/:action/*

Sql Logs

Logs

View Variables

• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id376
      • user_id255
      • trial_status_id6
      • abstract_of_study<p>\n <strong><u> SYNOPSIS</u></strong><br />\n Study title<br />\n An observational pilot study to characterize the immune response<br />\n induced by the commercial Varicella Zoster Virus vaccine<br />\n Zostavax® (Merck) in healthy adult females in Nairobi, Kenya.<br />\n Clinical Phase IV<br />\n Trial Design Immediate vs delayed study<br />\n <u>Study Population</u><br />\n HIV-1/2 negative, females at low risk of HIV aged 18-50 years of<br />\n age.<br />\n Planned Sample Size 44<br />\n Planned Trial Period 13 months after recruitment<br />\n Primary Outcome To measure cervical mucosal immune activation after VZVvaccination<br />\n in the context of VZV-effector responses.<br />\n <u>Secondary Objective</u><br />\n To measure the effector VZV-specific CD8+ T cells at the rectal<br />\n mucosa after VZV vaccination;<br />\n To compare the immune activation observed in mucosal tissues<br />\n and in blood.<br />\n <u>Primary Endpoint</u><br />\n The co-primary endpoints are the measurement of the percentage<br />\n of cervical CD38+CD4+T cells and the measurement of interleukin<br />\n 6 (IL-6) and interleukin 1β (IL-1β) in vaginal secretion at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. Changes in these parameters must be<br />\n significantly different from the changes observed in the same<br />\n period for the delayed group in order to be considered associated<br />\n to vaccination.<br />\n <u>Secondary endpoints</u><br />\n An increase in the percentage of VZV-specific CD8+T cells at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. This increase must be significantly different<br />\n from the change observed in the same period for the delayed group<br />\n in order to be considered associated to vaccination.<br />\n To compare the expression of co-receptors and activation markers<br />\n such as CCR5, α4β7, CD38, CD69 and HLA-DR in blood and<br />\n cervical CD4+T cells at 3 months after immunization with<br />\n varicella vaccine.<br />\n Investigational<br />\n Medicinal Product<br />\n Zostavax®<br />\n KAVI-VZV-001 Version 2.0 (01 September 2014) Page 9 of 49<br />\n Dose Zostavax® >19,400 PFU (Z)<br />\n Route Subcutaneous needle injection<br />\n <u>Study Design</u><br />\n Vaccination Period<br />\n Group No. Wk 0 Wk 12<br />\n Immediate 22 Z -<br />\n Delayed 22 - Z<br />\n <u>Follow-Up Duration</u><br />\n After the vaccination with Zostavax®, the delayed groups will be<br />\n followed-up for 9 months and the immediate groups for 12<br />\n months.<br />\n Trial Sponsor University of Toronto, Canada</p>\n
      • study_title<p style=\"text-align: justify;\">\n <br />\n <u><strong>Study title</strong></u><br />\n An observational pilot study to characterize the immune response<br />\n induced by the commercial Varicella Zoster Virus vaccine<br />\n Zostavax® (Merck) in healthy adult females in Nairobi, Kenya.<br />\n Clinical Phase IV<br />\n  </p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/15/01/02
      • version_noVersion No: 2.0 (01 September 2014)
      • date_of_protocol01-09-2014
      • study_drugVaricella Zoster Virus vaccine Zostavax® (Merck)
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameZostavax®
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressEmutisya@kaviuon.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantKAVI-Institute of Clinical Research (KAVI-ICR) University of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya
      • declaration_date115-01-2015
      • declaration_principal_investigatorProfessor Walter Jaoko, MB, ChB, MTropMed, PhD, Site Principal Investigator
      • declaration_date215-01-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n 1. Healthy females, as assessed by a medical history, physical examination and<br />\n laboratory tests, with no chronic medical condition;<br />\n 2. Aged at least 18 years on the day of screening and no greater than 50 years on the day<br />\n of the first vaccination.<br />\n 3. VZV-seropositive, as assessed by the VIDAS assay.4. Ability to comply with the study requirements and available for follow-up for the<br />\n planned duration of the study.<br />\n 5. In the opinion of the Principal Investigator or designee, the volunteer has understood<br />\n the information provided and signed the consent document.<br />\n 6. Willing to undergo HIV testing, HIV counselling and receive HIV test results.<br />\n 7. For women with potential to become pregnant, willing to use effective contraception<br />\n or barrier methods to avoid pregnancy during the study (spermicides or chemicals are<br />\n not allowed).<br />\n  </p>\n
      • principal_exclusion_criteria<p>\n Any relevant abnormality on history or examination including history of tuberculosis,<br />\n immunodeficiency or autoimmune disease, or use of systemic corticosteroids,<br />\n immunosuppressive, antiviral, anticancer or other medication that, in the opinion of the<br />\n Principal Investigator or designee, is clinically significant. (Note: use of inhaled steroids for<br />\n asthma or use of topical steroids for localized skin conditions will not exclude a volunteer<br />\n from participation) and/or:<br />\n 1. A high risk for HIV-acquisition defined by the experience of any of the follow<br />\n situations:<br />\n a) Had unprotected vaginal or anal sex with a known HIV-1-infected person, a<br />\n person known to be at high risk for HIV or a casual partner (i.e., no continuing,<br />\n established relationship) within the previous 6 months;<br />\n b) Engaged in sex work for money or drugs within the previous 6 months;<br />\n c) Used injection drugs;<br />\n d) Abuse of illicit or prescribed drugs, including alcohol;<br />\n e) Acquired one of the following sexually transmitted infection: chlamydia,<br />\n gonorrhoea and syphilis in the last 12 months;<br />\n f) More than 1 sexual partner within the last 6 months;<br />\n g) New sexual partner within the last 3 months.<br />\n 2. Persistent or recurrent bacterial vaginosis or vaginal candidiasis unresponsive to<br />\n therapy (2 consecutive attempts by study team).<br />\n 3. Confirmed HIV-1 or HIV-2 infection.<br />\n 4. Any clinically significant acute or chronic medical condition that is considered<br />\n progressive or, in the opinion of the Principal Investigator or designee, would make<br />\n the volunteer unsuitable for the study (active or underlying diabetes, gastrointestinal,<br />\n cardiovascular, malignancy, neurological, psychiatric, metabolic, renal, hepatic,<br />\n respiratory, auto-immune diseases, psoriasis, primary and acquired immunodeficiency<br />\n KAVI-VZV-</p>\n<p>\n status and rectal problems).<br />\n 5. Any of the following abnormal laboratory parameters except that one abnormal<br />\n laboratory test may be repeated once if thought to be due to a temporary condition:<br />\n Haematology<br />\n a) Haemoglobin < 9.0 g/dl<br />\n b) Platelets ≤100,000 /mm3, ≥ 550,000 /mm3 (≤ 100 /l, ≥ 550 /l)<br />\n Coagulation<br />\n - INR <1.0 or >1.5<br />\n 6. Evidence of coagulopathy demonstrated by a reduced level of platelets or a history of<br />\n 3 or more episodes of uncontrolled bleeding from their mouth, nose or other mucous<br />\n membrane (marked by excessive bleeding of more than 30 min).<br />\n 7. A positive pregnancy test or breast-feeding at screening; for the participants with<br />\n reproductive potential, unwilling to use an effective method of preventing pregnancy<br />\n during the study.<br />\n 8. Receipt of vaccine within the previous 2 months or planned receipt at any time until 6<br />\n months after vaccination with Zostavax®.<br />\n 9. Receipt of blood transfusion or blood products within the previous 6 months.<br />\n 10. Participation in another clinical trial currently or within the previous 3 months.<br />\n 11. History of severe or very severe local or systemic reactogenicity events after<br />\n vaccination, or history of severe or very severe allergic reactions.<br />\n 12. History of toxic shock syndrome.<br />\n 13. Confirmed diagnosis of acute or chronic hepatitis B virus infection (spontaneous<br />\n clearance leading to natural immunity, indicated by antibodies to core + antigens, is<br />\n not an exclusion criterion); confirmed diagnosis of hepatitis C virus infection.<br />\n 14. Immunosuppressive medications 30 days before or during the study period.<br />\n 15. History of anaphylactic/anaphylactoid reaction to neomycin (each dose of<br />\n reconstituted vaccine contains trace quantities of neomycin).<br />\n 16. Major psychiatric illness including any history of schizophrenia or severe psychosis,<br />\n bipolar disorder, suicidal attempt or ideation in the previous 3 years.<br />\n 17. Contra-indication for undergoing a biopsy due to bleeding diathesis, haemorrhoids,<br />\n mucosal infection at the biopsy site, medication that interfere with clotting (e.g.<br />\n warfarin or heparin) – both clinical and laboratory.<br />\n 18. Any other reason as determined by the Principal Investigator</p>\n
      • primary_end_points<p>\n The co-primary endpoints are the measurement of the percentage<br />\n of cervical CD38+CD4+T cells and the measurement of interleukin<br />\n 6 (IL-6) and interleukin 1β (IL-1β) in vaginal secretion at 3<br />\n months after immunization with varicella vaccine when compared<br />\n to their own baseline. Changes in these parameters must be<br />\n significantly different from the changes observed in the same<br />\n period for the delayed group in order to be considered associated<br />\n to vaccination.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifycharacterization of mucosal immune response.
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td>\n <p>\n Name</p>\n </td>\n <td>\n <p>\n Designation</p>\n </td>\n <td>\n <p>\n Qualifications</p>\n </td>\n <td>\n <p>\n Years in research</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Omu Anzala</p>\n </td>\n <td>\n <p>\n Co-Investigator</p>\n </td>\n <td>\n <p>\n MBChB, diploma epidemiology, PhD medical microbiology and infectious disease, post doc fellow molecular immunology group institute of molecular medicine oxford university</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Walter Jaoko</p>\n </td>\n <td>\n <p>\n Principal Investigator</p>\n </td>\n <td>\n <p>\n MBChB, MSc tropical medicine, diploma research methodology, PhD medical mirobiology</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Prof. Kirana Bhatt</p>\n </td>\n <td>\n <p>\n Consultant Physician</p>\n </td>\n <td>\n <p>\n MBChB, MMed internal medicine, MSc clinical tropical medicine, PhD</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Gina Ouattara</p>\n </td>\n <td>\n <p>\n Co-investigator</p>\n </td>\n <td>\n <p>\n MBChB</p>\n </td>\n <td>\n <p>\n 5.5</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Gaudensia Mutua</p>\n </td>\n <td>\n <p>\n Co-investigator</p>\n </td>\n <td>\n <p>\n MBChB, MPH</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Emmanuel Museve</p>\n </td>\n <td>\n <p>\n Study clinician</p>\n </td>\n <td>\n <p>\n Diploma clinical medicine and surgery</p>\n </td>\n <td>\n <p>\n 1</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Jacquelyn Nyange</p>\n </td>\n <td>\n <p>\n Study coordinator - regulatory</p>\n </td>\n <td>\n <p>\n KRN, BA psychology, MSc clinical psychology</p>\n </td>\n <td>\n <p>\n 11</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Elizabeth Mutisya</p>\n </td>\n <td>\n <p>\n Study coordinator – clinic level</p>\n </td>\n <td>\n <p>\n KRCHN, BA psychology and sociology</p>\n </td>\n <td>\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Hilda Ogutu</p>\n </td>\n <td>\n <p>\n Senior study nurse</p>\n </td>\n <td>\n <p>\n KRM, KRCHN, BScN</p>\n </td>\n <td>\n <p>\n 13</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Rose Ndambuki</p>\n </td>\n <td>\n <p>\n Study nurse</p>\n </td>\n <td>\n <p>\n KRCHN, HND counseling, BA psychology</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Roselyne Malogo</p>\n </td>\n <td>\n <p>\n Community coordinator</p>\n </td>\n <td>\n <p>\n KRCHN, certificate in conflict resolution, BA community development</p>\n </td>\n <td>\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Rose Mahira</p>\n </td>\n <td>\n <p>\n Community coordinator</p>\n </td>\n <td>\n <p>\n ECN, diploma in counseling, BA psychology</p>\n </td>\n <td>\n <p>\n 10</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Bashir Farah</p>\n </td>\n <td>\n <p>\n Laboratory manager</p>\n </td>\n <td>\n <p>\n HND virology, MSc Virology</p>\n </td>\n <td>\n <p>\n 18</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Jackton Indagasi</p>\n </td>\n <td>\n <p>\n Laboratory quality assurance manager</p>\n </td>\n <td>\n <p>\n PGD infectious disease, MSc infectious disease</p>\n </td>\n <td>\n <p>\n 12</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Robert Langat</p>\n </td>\n <td>\n <p>\n Laboratory and site Safety officer</p>\n </td>\n <td>\n <p>\n BSc medical laboratory technology</p>\n </td>\n <td>\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Simon Ogolla</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n HND microbiology</p>\n </td>\n <td>\n <p>\n 12</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Irene Mwangi</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n Diploma laboratory technology, BSc laboratory technology</p>\n </td>\n <td>\n <p>\n 4</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Ruth Chirchir</p>\n </td>\n <td>\n <p>\n Laboratory technician</p>\n </td>\n <td>\n <p>\n BSc biological sciences</p>\n </td>\n <td>\n <p>\n 9</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Moses Muriuki</p>\n </td>\n <td>\n <p>\n Data/IT Manager</p>\n </td>\n <td>\n <p>\n BSc software engineering</p>\n </td>\n <td>\n <p>\n 7</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Laura Lusike</p>\n </td>\n <td>\n <p>\n Data assistant</p>\n </td>\n <td>\n <p>\n BA home economics</p>\n </td>\n <td>\n <p>\n 14</p>\n </td>\n </tr>\n <tr>\n <td>\n <p>\n Other staff:</p>\n <p>\n Administrative, Finance and support staff</p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n <td>\n <p>\n  </p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n Site facilities:<br />\n - Reception<br />\n - Waiting room for volunteers<br />\n - Counseling rooms - 2<br />\n - Patient examination rooms – 3<br />\n - Study records filing room – limited access using swipe card<br />\n - Laboratories – swipe access<br />\n o safety laboratory<br />\n o immunology laboratory<br />\n - Data room – limited access with swipe card<br />\n o Pre – archive room – swipe card access<br />\n o Data entry computers – 4<br />\n o Online and offline data entry capabilities<br />\n o Data faxing<br />\n o Internet – upload and download bandwidth of 1MB/second and backup modems from mobile service providers<br />\n o Backup UPS of 4 – 6 hours and backup generator<br />\n - Kitchenette – for staff and volunteer refreshments<br />\n - Meeting room<br />\n Emergency facilities:<br />\n - One of the patient examination rooms is equipped as an emergency room with oxygen tank and mask, suction pump machine with suction tubes, defibrillator, nebulizer, laryngoscope, endotracheal tubes, airway, adult ambu bag and mask, giving sets.<br />\n - Emergency stretcher<br />\n - Emergency drugs in stock –<br />\n o Parenteral - hydrocortisone, adrenaline, paracetamol, hyosine, atropine, lidocaine, lignocaine, aminophylline, sodium bicarbonate, metoclopramide, diazepam, chlorpheniramine, calcium gluconate,<br />\n o Salbutamol nebulizer solution<br />\n o IV fluids – 5% dextrose, 50% dextrose, normal saline<br />\n o Post exposure prophylaxis – combivir and kaletra<br />\n - Patients can then be transferred to Kenyatta National Hospital emergency department or admitted to the wards for further care.</p>\n
      • other_details_explanation<p>\n In this trial we ai to investigate the potentail of using varicella-zoster virus (VZV) as a vector for an hiv-vaccine by first characterising the mucosal immune response induced by VZV vaccination. As we intend to conduct the future VZV-HIV phase 1 clinical trial ( with VZV carrying HIV genes) in kenya it is important that the study that sets the basis for this future be also conducted in Kenya.</p>\n
      • other_details_regulatory_notapproved<p>\n University of Toronto research ethics committee, !st Dec 2014.</p>\n
      • other_details_regulatory_approved<p>\n KNH/UON Ethics research committee.</p>\n<p>\n Approval date:23rd oct 2014.</p>\n<p>\n Sites: KAVI-ICR, Nairobi Kenya.</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration13 months after enrollment.
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKAVI-INSTITUTE OF CLINICAL RESEARCH (KAVI-ICR)
      • single_site_physical_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya.
      • single_site_contact_personProfessor Walter Jaoko,
      • single_site_telephone+254-2-2717694/+254727555254
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listKENYA\nCANADA
      • data_monitoring_committeeNo
      • total_enrolment_per_siteN/A
      • total_participants_worldwide44
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameProf Walter Jaoko
      • investigator1_middle_name
      • investigator1_family_name Jaoko
      • investigator1_qualificationMB, ChB, MTropMed, PhD, Site Principal Investigator
      • investigator1_professional_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya .
      • investigator1_telephone+254-2-2717694/+254727555254
      • investigator1_emailwjaoko@kaviuon.org
      • organisations_transferred_Yes
      • number_participants44
      • notification<p>\n none.</p>\n
      • approval_date10-03-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted15-01-2015
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study has been approved
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2017-04-26 16:23:36
      • created2015-01-15 09:38:39
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id256
        • application_id376
        • given_nameProf Walter Jaoko
        • middle_name
        • family_nameJaoko
        • qualificationMB, ChB, MTropMed, PhD, Site Principal Investigator
        • professional_addressUniversity of Nairobi PO Box 19676-00202 Off Ngong Road, Nairobi Kenya .
        • telephone+254-2-2717694/+254727555254
        • emailwjaoko@kaviuon.org
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
    • SiteDetail(array)
      • 0(array)
        • id307
        • application_id376
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id194
        • application_id376
        • sponsorUniversity of Toronto
        • sponsor_type(null)
        • contact_personDr. Kelly S. MacDonald, MD, FRCPC, Chief Investigator
        • addressDepartment of Medicine and Immunology University of Toronto 1 King’s College Circle Medical Sciences Building, Room 6360 Toronto ON, M5S 1A8 Canada.
        • telephone_number(416) 946-3733
        • fax_number(416) 978-8765
        • cell_number(416) 946-3733
        • email_addresskelly.macdonald@utoronto.ca
        • created2015-01-15 09:57:12
        • modified2015-01-15 12:52:21
  • 1(array)
    • Application(array)
      • id833
      • user_id567
      • trial_status_id5
      • abstract_of_study<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n <span style=\"-webkit-font-kerning: none;\"><b>Background</b>:  Kenya has the 4th largest HIV burden in the world with about 1.6 million people living with HIV.  Of these, just over 1 million are on antiretroviral therapy.  Current national guidelines recommend a first line regimen composed of 2 nucleoside reverse transcriptase inhibitors (NRTI) plus an integrase strand transfer inhibitor (INSTI) or a non-nucleoside reverse transcriptase inhibitor(NNRTI).  Second line regimens are composed of 2 NRTI plus a ritonavir boosted protease inhibitor(PIr).  This is based on evidence showing good clinical outcomes on this regimen.  Protease inhibitors are associated with multiple side effects including an increase is cardiovascular disease risk and, have significant drug to drug interactions that complicate management of other conditions such as tuberculosis.  INSTIs have been shown in one study to be an alternative to PIr in second line regimens when combined with fully active NRTIs.  It is not clear if this would still be the case if the activity of the NRTIs was not known.  We will evaluate the efficacy of switching from a PIr to a dolutegravir based second line ART regimen.</span></p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0); min-height: 14px;\">\n  </p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n <span style=\"-webkit-font-kerning: none;\"><b>Hypothesis</b>: switching virologically suppressed patients from a PIr based second line to a dolutegravir based second line is non-inferior to continuing on a PIr based second line.</span></p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0); min-height: 14px;\">\n  </p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n <span style=\"-webkit-font-kerning: none;\"><b>Objectives</b>: The primary objective will be to evaluate the non-inferiority of switching to a DTG containing regimen relative to maintaining a PI/r containing second-line regimen in virologically suppressed, INSTI-naive HIV-1 positive adults (≥ 18 years old) as determined by having HIV-1 RNA ≥ 50 copies/ml at week 48.  Secondary objectives will be to assess the impact of such a switch on CD4 counts, safety and tolerability.</span></p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0); min-height: 14px;\">\n  </p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n <span style=\"-webkit-font-kerning: none;\"><b>Methods</b>: Open-label, randomized, non-inferiority, multisite trial over 48 weeks, describing the efficacy and safety of switching from a second-line ARV regimen containing a ritonavir-boosted protease inhibitor (PI/r) plus 2 NRTIs to DTG plus 2 NRTIs in patients having achieved virological suppression (HIV-1 RNA < 50 copies/ml) for at least 12 weeks and with no prior INSTI exposure.  Adult consenting participants will be randomized at baseline to remain on their pre-enrollment PI/r or switch to DTG.  Participants will continue the NRTIs from their pre-enrollment regimen in both arms.  A total of 766 participants (388 in each arm) will be recruited from 4 sites - Kenyatta National Hospital, Kiambu County Hospital, Thika County Hospital and Jaramogi Oginga Odinga Teaching and Referral Hospital.</span></p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0); min-height: 13px;\">\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p style=\"-webkit-text-stroke-width: initial; margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n <span style=\"-webkit-font-kerning: none;\"><b>Conclusion:</b> This study seeks to inform the guidelines around the efficacy and safety of alternative second line regimens.</span></p>\n
      • study_title<p style=\"margin: 0px; text-align: center; font-stretch: normal; line-height: normal; font-family: "Trebuchet MS"; -webkit-text-stroke-width: initial; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n <span style=\"font-kerning: none\"><b>Switching Treatment-Experienced, Integrase Inhibitor-Naïve, Virally Suppressed HIV-1 Infected Adults from Ritonavir boosted Protease Inhibitors to Dolutegravir: An Open-Label Randomized Controlled Trial</b></span></p>\n<p style=\"margin: 0px; text-align: center; font-stretch: normal; line-height: normal; font-family: "Trebuchet MS"; -webkit-text-stroke-width: initial; -webkit-text-stroke-color: rgb(0, 0, 0); min-height: 14px;\">\n  </p>\n<p style=\"margin: 0px; text-align: center; font-stretch: normal; line-height: normal; font-family: "Trebuchet MS"; -webkit-text-stroke-width: initial; -webkit-text-stroke-color: rgb(0, 0, 0);\">\n  </p>\n<div>\n  </div>\n
      • laymans_summary<p>\n <strong>Background</strong></p>\n<p>\n People living with HIV are given medication to reduce (suppress) the amount of the virus in their blood called antiretroviral drugs (ARVs). Suppressing the virus results in improved immunity, reduction in sickness and reduced chances of transmission of the virus. However, these ARVs have to be taken for life to maintain suppression. However, in some cases, the first set of ARVs given may become ineffective in suppressing the virus necessitating a change to another option of drugs which is referred to as second line therapy. Just like any other medication, ARVs have side effects with some of the drugs used in second line therapy having more side effects than those used in the nationally recommended first-line therapy.</p>\n<p>\n Over time, newer safer and easier to take ARVs have been made. The purpose of this study is to determine whether patients who are currently on the standard national second line therapy can be safely switched to a regimen containing one of the newer ARVs called dolutegravir. This is important because some studies have shown us that dolutegravir may achieve the same or better rates of viral suppression, may have less harmful effects to the body including improving cholesterol and may be simpler to take.</p>\n<p>\n Dolutegravir is not a new drug, it has been used in this country for the last 4 years and is the recommended drug for first line HIV treatment (this is the very first regimen or HIV treatment one uses after a diagnosis of HIV).  It has not routinely been used for second line treatment in Kenya yet. Dolutegravir is a tablet that is swallowed. It can either be combined with other drugs in to one pill or be provided as a separate pill.</p>\n<p>\n <strong>What questions are we trying to answer?</strong></p>\n<p>\n Sometimes we do not always know which drugs work best for different patients. To find out, we need to make comparisons between the different treatments. We put people into groups and give each group a different treatment; the results are compared to see if one is better. The areas we will assess at the end of this study are:</p>\n<ul>\n <li>\n Whether viral load will continue to be suppressed or will increase</li>\n <li>\n Change in CD4 count</li>\n <li>\n Change in lipid (cholesterol) levels</li>\n <li>\n Change in blood glucose</li>\n <li>\n Change in weight, body-mass index, waist-hip ratio and, waist circumference</li>\n <li>\n Whether any side effects are experienced</li>\n <li>\n How satisfied participants are with their treatment</li>\n <li>\n If the viral load is not suppressed, whether the virus develops any resistance</li>\n</ul>\n<p>\n At the end of the study, we will determine whether these areas are equal in the study arms or whether one arm is better or worse than the other. This will help inform our knowledge and guidelines on management of second line antiretroviral therapy.</p>\n<p>\n <strong>Where will the study be done?</strong></p>\n<p>\n This study will take place at Kenyatta National Hospital, Thika Level V Hospital, Kiambu County Hospital and Jaramogi Oginga Odinga Teaching and Referral Hospital.</p>\n<p>\n <strong>How will the study be conducted?</strong></p>\n<p>\n Those currently on care at the study sites who are on second line treatment will be invited for a screening visit to review whether they can participate in the study. This will involve review of their medical history and laboratory tests. Those who are eligible for the study will either be given a new treatment combination containing dolutegravir or continue their treatment regimen without any change. For this study, the chances of being enrolled into one or the other arm is 1 in 2. To try to make sure the groups are the same to start with, each patient is put into a group by chance (randomly, this is what we call randomisation). 766 people living with HIV will be recruited in this study. Each participant will be followed up for up to 1 year, during which there will be at least five additional clinic visits on weeks 4, 12, 24, 36 and 48 from the enrollment visit. The results for the two groups will then compared. </p>\n<p>\n We expect that it will take about 18 months for all the 766 participants to go through 1 year of follow-up.</p>\n<p>\n  </p>\n
      • short_titleSecond line switch to Dolutegravir (2SD) study
      • protocol_noECCT/19/11/04
      • version_no2.3
      • date_of_protocol18-11-2019
      • study_drugDolutegravir
      • disease_conditionHIV
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameDolutegravir
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameBoosted Atazanavir and Lopinavir
      • comparator_registeredYes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressloisea@uonbi.ac.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Loice Achieng
      • declaration_date118-11-2019
      • declaration_principal_investigatorDr. Loice Achieng
      • declaration_date218-11-2019
      • placebo_presentNo
      • study_objectives<p>\n Primary Objective</p>\n<ul>\n <li>\n To evaluate the non-inferiority of switching to a DTG containing regimen relative to maintaining a PI/r containing second-line regimen in virologically suppressed, INSTI-naive HIV-1 positive adults (≥ 18 years old) as determined by having HIV-1 RNA ≥ 50 copies/ml at week 48.</li>\n</ul>\n<p>\n Secondary Objectives</p>\n<ul>\n <li>\n To assess the impact of switching to DTG on development of virological failure at week 24</li>\n <li>\n To assess the impact of switching to DTG on maintenance of virological suppression at weeks 24 and 48</li>\n <li>\n To assess the impact of switching to DTG on change in CD4 count at weeks 24 and 48</li>\n <li>\n To assess the impact of switching to DTG on change in cardiovascular risk as determined by change in lipid values (total cholesterol, LDL, HDL, triglycerides and TC:HDL ratio) at weeks 24 and 48 and change in fasting blood glucose at weeks 24 and 48</li>\n <li>\n To investigate the impact of switching to DTG on change in anthropometric measurements (weight, body-mass index, waist-hip ratio, waist circumference)</li>\n <li>\n To investigate the impact of switching to DTG on safety and tolerability</li>\n <li>\n To investigate the impact of switching to DTG on patient satisfaction, as determined by the HIV Treatment Satisfaction Questionnaire (HIVTSQ)</li>\n <li>\n To investigate if outcomes differ based on the PI/r used (LPV/r, ATV/r, or DRV/r)</li>\n <li>\n To investigate if outcomes differ based on the NRTI used (TDF, ABC, or AZT)</li>\n <li>\n To investigate if outcomes differ for patients who switch NRTIs for clinical reasons during the study relative to patients who do not switch NRTIs during the study</li>\n <li>\n To investigate if outcomes differ based on if the NRTIs were changed from first-line to second-line</li>\n <li>\n To describe the genotypic resistance patterns for participants meeting protocol-defined virological failure</li>\n</ul>\n
      • principal_inclusion_criteria<p style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \">\n <span style=\"font-kerning: none\">Participants must satisfy all of the following criteria to be enrolled in the study:</span></p>\n<ul>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Able and willing to understand and comply with the protocol requirements, instructions and restrictions</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Able and willing to give informed consent</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Age 18 years or above</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Documented HIV-1 infection as confirmed by HIV-antibody testing as per the Kenya National Guidelines</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Has been receiving a second-line ARV regimen containing a PI/r (DRV/r, ATV/r or LPV/r) and 2 NRTIs for at least 24 weeks</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Documented HIV-1 RNA viral load < 50 copies/ml at least 12 weeks prior to enrollment and no viral rebound between the first viral load < 50 copies/ml and the screening viral load</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">HIV-1 RNA viral load < 50 copies/ml at screening (within 28 days prior to enrollment)</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">If female and of childbearing potential, is using effective contraception and is willing to continue using effective contraception throughout the study period (as defined in Appendix 5). Note: Non-childbearing potential is defined as either post-menopausal (12 months of spontaneous amenorrhoea and age of 45 years or above) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy</span></li>\n</ul>\n
      • principal_exclusion_criteria<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Potential participants who meet any of the following criteria will be excluded from participating in the study:</span></p>\n<ul>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Any prior integrase inhibitor exposure</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Documented HIV-2 infection</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Using any concomitant therapy disallowed as per the reference safety information and product labeling for the study drugs</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Has AST and/or ALT at least 5-times greater than the upper limit of normal in conjunction with hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV). Note: patients can enter the study with chronic HBV or HCV if AST and ALT are less than 5-times greater than the upper limit of normal and, in the investigators opinion, their medical status will not interfere with assessments or completion of the study</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Is both HBsAg positive and has a CrCl below 50 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Advanced renal insufficiency requiring dialysis</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">If female, currently pregnant or breastfeeding, or intending to become pregnant during the study period</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Documented opportunistic infection within 4 weeks prior to the study enrolment</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Investigator opinion that the patient should switch from PI/r to DTG immediately for clinical reasons</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the study</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">History or presence of allergy to the study drugs or their components</span></li>\n</ul>\n
      • primary_end_points<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\"><b>Primary Endpoint:</b></span></p>\n<ul>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Proportion of participants with HIV-1 RNA ≥ 50 copies/ml at week 48 (by US Food and Drug Administration snapshot algorithm, modified to allow for changes in NRTIs for clinical reasons)</span></li>\n</ul>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" min-height:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n  </p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\"><b>Secondary Endpoints:</b></span></p>\n<p>\n  </p>\n<ul>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Proportion of participants with HIV-1 RNA ≥ 50 copies/ml at week 24</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Proportion of participants able to maintain virological suppression (HIV-1 RNA < 50 copies/ml with no discontinuation of the study treatment) at weeks 24 and 48</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Change in CD4 count from baseline to weeks 24 and 48</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Change in fasting blood sugar and lipid values (total cholesterol, LDL, HDL, triglycerides and TC:HDL ratio) from baseline to weeks 24 and 48</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Change in anthropometric measurements (weight, body-mass index, waist-hip ratio, waist circumference) from baseline to weeks 24 and 48</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Safety (clinical and laboratory adverse events) at weeks 24 and 48</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Patient satisfaction (HIVTSQ) at weeks 24 and 48</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Genotypic resistance mutations for participants with protocol-defined virological failure</span></li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\"><b>CAPABILITY STATEMENT FOR KNH COMPREHENSIVE CARE CENTRE TO CONDUCT CLINICAL RESEARCH</b></span></p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Kenyatta National Hospital Comprehensive Care Centre was established in December 2002 as the pioneer care and treatment Centre for HIV/AIDS. The Centre was established with the support of the USAID/FHI/KNH cooperative agreement with the main objective of mitigating the effects of HIV/AIDS nationally by participating in the national HIV/AIDS response. Since 2005, services and expansion of the Centre have been supported by Center for Disease Prevention and Control (CDC) through the University of Nairobi, AIDS Care and Treatment Services (ACTS),Partnership for Advanced Care and Treatment – Centre of Excellence (PACT - CoE) and Centers’ of Excellence - HIV Medicine (CoEHM) Programs respectively. It has evolved over time to be a Centre of excellence for ambulatory HIV medicine in the country dealing with both complicated referral patients and stable patients.  </span></p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" min-height:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n  </p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">The comprehensive care centre offers a one stop shop approach in the management of HIV/AIDS. In order to achieve this goal, a multidisciplinary team with different specializations in HIV/AIDS management runs the centre. This team consists of Consultants, Medical Specialists, Medical Officers, Registered Clinical Officers, Pharmacists and Pharmaceutical Technologists, Counsellors, Laboratory Staff, Nursing Officers, Nutritionists and social workers among others.</span></p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" min-height:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n  </p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">The services offered at the Comprehensive Care Centre include the following:</span></p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" min-height:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n  </p>\n<ol>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Diagnosis and Treatment of opportunistic infections and other HIV/AIDS related co- morbidities.</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Anti-Retroviral Therapy both 1</span><span style=\"font-stretch: normal; font-size: 7.3px; line-height: normal; -webkit-font-kerning: none;\">^st</span><span style=\"font-kerning: none\"> line; 2</span><span style=\"font-stretch: normal; font-size: 7.3px; line-height: normal; -webkit-font-kerning: none;\">^nd</span><span style=\"font-kerning: none\"> line and 3</span><span style=\"font-stretch: normal; font-size: 7.3px; line-height: normal; -webkit-font-kerning: none;\">^rd</span><span style=\"font-kerning: none\"> line regimens as per the WHO guidelines.</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Laboratory monitoring and evaluation of the patients- The Centre has an ISO 15189:2012 standard accredited laboratory which has equipment that can do the following analytical procedures:</span></li>\n</ol>\n<ul>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Flow Cytometry </span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Hematology </span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Chemistry </span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">TB Diagnosis </span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">HIV EID </span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">HIV Viral Load </span></li>\n</ul>\n<ol>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Research: Since its inception the Centre has actively been involved in research which has informed HIV/AIDS National policy. Some of the research conducted in the facility by both the University of Nairobi and Kenyatta National Hospital in collaboration with International partners include: </span></li>\n</ol>\n<ul>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Effectiveness of Non-nucleoside Reverse-Transcriptase Inhibitor-Based Antiretroviral Therapy in Women Previously Exposed to a Single Intrapartum Dose of Nevirapine:  A Multi-country, Prospective Cohort Study</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Optimizing Pediatric HAART Study</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Evaluation of the Kenya ARV scale-up program:  Surveillance for emergence of antiretroviral resistant genotypes among treatment experienced patients</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Treatment outcomes of HIV infected adolescents attending a National Referral Hospital in Kenya:</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Trends, treatment outcomes and determinants of attrition among adult patients in care in a large tertiary HIV clinic in Nairobi Kenya</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Predicted HIV-1 co receptor usage among Kenya patients shows a high tendency for subtype d to be cxcr4 tropic</span></li>\n</ul>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" min-height:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n  </p>\n<ol>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Training of undergraduate and  post graduate students in the departments of Medicine and Pediatrics from the University of Nairobi</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Adherence Counseling</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Nutritional Counseling</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Social Work Support</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Physiotherapy services</span></li>\n <li -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">Supportive Counseling.</span></li>\n</ol>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" min-height:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n  </p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">The CCC currently serves an average of 150-200 patients per day. Currently, adult patients on ART are 9400 with 8,150 on 1</span><span style=\"font-stretch: normal; font-size: 7.3px; line-height: normal; -webkit-font-kerning: none;\">^st</span><span style=\"font-kerning: none\"> line regimens and 1,230 on 2</span><span style=\"font-stretch: normal; font-size: 7.3px; line-height: normal; -webkit-font-kerning: none;\">^nd</span><span style=\"font-kerning: none\"> line regimen and 20 patients on 3</span><span style=\"font-stretch: normal; font-size: 7.3px; line-height: normal; -webkit-font-kerning: none;\">^rd</span><span style=\"font-kerning: none\"> line regimen.</span></p>\n<p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" style=\"margin: 0px 0px 10px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: \" trebuchet=\"\">\n <span style=\"font-kerning: none\">With the experience of the staff working in the CCC and the high number of patients, the KNH Comprehensive Care Centre is best suited to undertake any kind of research </span></p>\n<p>\n  </p>\n<div>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-stretch: normal; line-height: normal; font-family: Times; -webkit-font-kerning: none;\">Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH), </span><span style=\"font-kerning: none\">formerly known as New Nyanza Provincial General Hospital or Russia was built in 1965 by the Russian Government (then Soviet Union) through the Government of Kenya. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The hospital has been named Jaramogi Oginga Odinga in honour of one of the founding fathers of this Nation, Jaramogi Oginga Odinga who played a pivotal role in convincing the Russian Government to fund and build the facility. Henceforth, the hospital will be known as Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH). </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">JOOTRH has been in operation since 1969. It is located in Kisumu city on acreage of 22.6 hectares along Kisumu - Kakamega highway. It is the main referral centre to 10 counties in western Kenya and rift valley with a population of more than 7 million people. It has a bed capacity of 530. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The main mandate of JOOTRH is to provide curative, preventive, promotive and rehabilitative health services. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">It provides specialized clinical services in the areas of renal medicine, critical care, oncology, orthopaedic surgery, paediatric surgery and specialized diagnostic services—both radiological and laboratory services. It serves as a centre for research activities, medical training for midlevel health workers and medical students for Maseno University and Uzima university. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The hospital has a total of 640 staff consisting of 486 regular staff, 154 donor-supported staff (for HIV care services) as at 1st June 2019.</span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">JOOTRH CCC was started in the year 2002 and has ever enrolled approximately 28000 clients. Current active on care is 6842 by the end of June 2019. Total number of clients on 1</span><span style=\"font-stretch: normal; line-height: normal; -webkit-font-kerning: none;\">^st</span><span style=\"font-kerning: none\"> line are 6203 , on 2</span><span style=\"font-stretch: normal; line-height: normal; -webkit-font-kerning: none;\">^nd</span><span style=\"font-kerning: none\"> line are 600, and 11 clients are on 3</span><span style=\"font-stretch: normal; line-height: normal; -webkit-font-kerning: none;\">^rd</span><span style=\"font-kerning: none\"> line. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">Out of The 154 staff employed by ICAP who is the implementing partner, 39 are stationed at the CCC and 6 are MOH staff.. 1 Medical officer, 1 pharmacist, 8 nurses,7 clinical officers ,3 Pharmacy technicians, 2 social workers,4 adherence councilors, 8 peer educators, 3 HRIOs, 5 data clerks, 1 nutritionist and 1 lab technician.</span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The daily workload of the clinic is between 250- 300 (MON, TUE, FRI), adults (35 yrs and above), 180 – 250 clients seen on Wednesday (youth day age 20- 35 yrs), 70 – 150 clients on Thursdays (adolescents day)</span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The CCC also runs a viremia clinics for patient with high viral loads on 1</span><span style=\"font-stretch: normal; line-height: normal; -webkit-font-kerning: none;\">^st</span><span style=\"font-kerning: none\"> line every Wednesday and Fridays for clients failing second line treatment.</span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The medical officer is the in charge of the clinic and works closely with the Matron and the pharmacist in charge. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">The clinic has been integrated and most of the services are offered within CCC which includes, clinical, nursing, adherence counseling, nutrition, community and linkage to OVC, cervical cancer screening amongst others. </span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-kerning: none\">JOOTRH is also the HUB center for Nyanza western technical working group meetings held every 2</span><span style=\"font-stretch: normal; line-height: normal; -webkit-font-kerning: none;\">^nd</span><span style=\"font-kerning: none\"> Monday of the month. We are also the spokes hub for ECHO sessions held every Thursday at 3pm.</span></span></p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n  </p>\n <p style=\"margin: 0px; font-stretch: normal; line-height: normal; font-family: Helvetica; min-height: 14px;\">\n  </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n <span style=\"font-stretch: normal; font-size: 12px; line-height: normal;\"> </span><b>Kiambu Level 5 and Thika Level 5 Hospital Profiles </b></p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Kiambu Level 5 Hospital is located within the outskirts of Nairobi, at Kiambu town which is approximately 18km from the capital city. It was established in 1920 and due to its proximity to Nairobi County, the hospital is frequently the first point of service for populations from the sub-counties within Nairobi County that are contiguous with Kiambu County, particularly the parts that are impoverished and marginal. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n The catchment population of Kiambu Level 5 Hospital (KL5H) is currently placed at about 120,000 persons – a figure estimated from the National Census of 2009. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n KL5H has a higher share of emergencies because of its location between the main national trunk roads traversing the County of Kiambu to the Western and Northern parts of the country. These factors make KL5H easily accessible to residents of Kiambu and Nairobi counties, as well as those that experience road traffic emergencies along the national trunk roads. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n The hospital sits on a 10 acres piece of land. It has a bed capacity of 324 beds with bed occupancy of an approximate 154%. The hospital has 1 medical ward (72 beds), 1 surgical ward (72 beds), 1 maternity ward (74 beds), 1 new born unit (53 beds), 1 pediatric ward (57 beds), 2 operating theaters, casualty area, outpatient departments that include a Comprehensive Care Centre, eye clinic unit, dental clinic unit, Ear Nose and Throat (ENT) clinic unit, Central Sterile Supplies Department (CSSD) unit, pharmacy, laboratory, psychiatric clinic unit, physiotherapy unit, occupational therapy unit, radiology department, registry and records unit, kitchen and laundry, maintenance department, administration offices and mortuary. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n During 2016 – 2018, Kiambu Level 5 Hospital received a total of 610,902 outpatient attendances, Additionally, during 2016 – 2018, Kiambu Level 5 Hospital conducted a total of 27,331 deliveries. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n <b>Comprehensive Care Centre </b></p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Kiambu level 5 hospital started its HIV comprehensive Care Centre in August 2005 with a total of 3 patients. The client numbers have grown over the years to a cumulative number of <b>10,732 </b>clients ever enrolled. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Kiambu L5H is currently supported by UON-CRISS+ project in implementation of HIV services. The facility underwent major renovations in 2015, through the support of the implementing partner., The following units were set up within the CCC; Chest clinic, 3 consultation rooms, VCT room, Nutrition room, Health records room, adherence counselling room, Pharmacy, 2 HTS rooms and a cervical cancer screening room. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n The current number of clients on follow up is <b>3,190 </b>and is distributed as follows; </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 330 PMTCT mothers with 258 HEI’s on follow up. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 67 males and 48 females less than 15years. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 1008 males and 2067 females above 15years. </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; min-height: 13px;\">\n  </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n The following staff are supported by CRISSP+ at the CCC; </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 3 Clinicians </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 1 adherence nurse </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 1 psychologist </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 8 HTS providers </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 1 pharmaceutical technologist </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; min-height: 13px;\">\n  </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; min-height: 13px;\">\n  </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 1 lab technician </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 2 HRIO’s </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n • 3 LCN’s </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica; min-height: 13px;\">\n  </p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n <b>Human Resource </b></p>\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n As at 31<span style=\"font-stretch: normal; font-size: 7px; line-height: normal;\">st </span>Dec 2018, KL5H had a total of 453 working staff including 93 intern medical officers, pharmacists, nurses, clinical officers and community oral health officers) as seen in Table 1. Another 24 workers were on training leave. Thus, KL5H had only a total of 360 qualified workers against a total of 1,469 workers (24.5%) in accordance with the KEPH Level 5 hospital staffing norms. During 2016 – 2018, KL5H saw a total of 610,902 patients translating to an average 4 times as many patients per health worker as compared to the KEPH Level 5 staffing norms. </p>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n  </p>\n <table cellpadding=\"0\" cellspacing=\"0\" style=\"border-collapse: collapse\">\n <tbody>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n <i>Table 1: KL5H Staff Profile As 31st Dec 2018 </i>Consultants 19 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Medical Officers 15 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n General & Specialized Dental Officers 2 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n General and Specialized Pharmacists & Allied Staff 9 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n General & Specialized Nurses </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 169 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n General and Specialized Clinical Officers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 23 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Diagnostic & Imaging Staff </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 6 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Rehabilitative Staff </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 14 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Medical Laboratory Scientists </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 10 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Dental Technologists </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 1 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Community Oral Health </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 2 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Plaster Technicians </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 4 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Medical Social Workers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 3 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Nutritionists & Nutrition Staff </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 6 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Clinical Cytologist </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 1 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Clinical Psychologists (counsellor) </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 1 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Health Promotion Officer </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 1 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Health Administration Officers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 2 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Accountant/Finance Officer </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 2 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Clerical Officers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 10 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Office Administrative Assistant </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 2 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Telephone Operators </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 5 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Supportive Staff </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 10 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Cooks </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 4 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Health Records Information Officers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 5 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Med. Engineering </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 7 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Artisans </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 1 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Drivers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 5 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Procurement Officers Incl. Assistants </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 4 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Public Health Officers </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 16 </p>\n </td>\n </tr>\n <tr>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n Data Clerk </p>\n </td>\n <td style=\"padding: 0.0px 5.0px 0.0px 5.0px\" valign=\"top\">\n <p style=\"margin: 0px; font-stretch: normal; font-size: 11px; line-height: normal; font-family: Helvetica;\">\n 1 </p>\n </td>\n </tr>\n </tbody>\n </table>\n <p -webkit-text-stroke-color:=\"\" -webkit-text-stroke-width:=\"\" new=\"\" style=\"margin: 0px 0px 12px; font-stretch: normal; font-size: 16px; line-height: normal; font-family: \" times=\"\">\n  </p>\n <div>\n  </div>\n</div>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Study is sposored by the University of Nairobi and conducted fully in Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n KNH-UoN ERC</p>\n<p>\n JOOTRH ethics committee</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration18 months from time of first patient enrolled to last patient follow-up. Each patient is followed up for 48 weeks
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorCurrent Ritonavir boosted
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites4
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site766
      • total_participants_worldwide766
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenUnclear
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLoice
      • investigator1_middle_name
      • investigator1_family_nameAchieng
      • investigator1_qualificationMBChB, MMED Internal Medicine, MSC Infectious Diseases
      • investigator1_professional_addressP.O Box 2304-00202, Nairobi
      • investigator1_telephone+254722576984
      • investigator1_emailloisea@uonbi.ac.ke
      • organisations_transferred_No
      • number_participants766
      • notification
      • approval_date23-12-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-06-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-21 10:13:53
      • created2019-11-13 12:12:39
      • total_sites(null)
      • ecitizen_invoice362878
    • InvestigatorContact(array)
      • 0(array)
        • id515
        • application_id833
        • given_nameLoice
        • middle_name
        • family_nameAchieng
        • qualificationMBChB, MMED Internal Medicine, MSC Infectious diseases
        • professional_addressP.O Box 2304-00202, Nairobi
        • telephone+254722576984
        • emailloisea@uonbi.ac.ke
        • created2019-11-13 12:22:32
        • modified2020-06-08 13:05:19
    • SiteDetail(array)
      • 0(array)
        • id674
        • application_id833
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressNgong road
        • contact_detailsP.O Box 19676-00202
        • contact_personDr. Loice Achieng
        • site_capacity(null)
        • misc(null)
        • created2019-11-13 12:22:32
        • modified2020-06-08 13:05:19
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id675
        • application_id833
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressKisumu
        • contact_detailsP.O Box 849-40100
        • contact_personDr. Florentius Ndinya
        • site_capacity(null)
        • misc(null)
        • created2019-11-13 12:22:32
        • modified2020-06-08 13:05:19
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id676
        • application_id833
        • county_id22
        • site_nameThika Level 5 Hospital
        • physical_addressThika Town
        • contact_details0722842741
        • contact_personDr. Jared Mecha
        • site_capacity(null)
        • misc(null)
        • created2019-11-13 12:39:29
        • modified2020-06-08 13:05:19
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 3(array)
        • id677
        • application_id833
        • county_id22
        • site_nameKiambu Level 5 Hospital
        • physical_addressKiambu Town
        • contact_details0722842741
        • contact_personDr. Jared Mecha
        • site_capacity(null)
        • misc(null)
        • created2019-11-13 12:39:29
        • modified2020-06-08 13:05:19
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
    • Sponsor(array)
      • 0(array)
        • id403
        • application_id833
        • sponsorUniversity of Nairobi
        • sponsor_typeOthers
        • contact_personProf. T. M Munyao, Chair, Department of Clinical Medicine and Therapeutics
        • addressP.O Box 19676-00202, Nairobi
        • telephone_number020 4915041
        • fax_number
        • cell_number+254 718703330
        • email_addresstitus.munyao@uonbi.ac.ke
        • created2019-11-13 12:22:32
        • modified2020-06-08 13:05:19
  • 2(array)
    • Application(array)
      • id1096
      • user_id38
      • trial_status_id4
      • abstract_of_study<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Iron Deficiency Anaemia is a condition whereby iron store depletion is associated with low blood volume in the body, <em>i.e</em>. a haemoglobin (Hb) concentration below an established cut-off value, consequently impairing the capacity of the blood to transport oxygen around the body. According to the World Health Organisation (WHO) about 30% of the world’s population suffers from anaemia.</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Oral iron supplements are considered as safe, cheap, and effective in restoring iron balance. Side effects associated with iron supplementation are mostly gastrointestinal side effects including abdominal discomfort, nausea, vomiting, constipation, and dark colored stools.</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n With more than five decades of international use, the efficacy and the safety of Tot'héma® in the curative and prophylactic treatment of IDA has been well established. Several clinical trials conducted in different populations have supported the efficacy of Tot'héma® in IDA, showing normalization of biological parameters such as Hb and ferritin blood levels after treatment with Tot'héma®.</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Iron supplementation has long been proven to be effective for the treatment of IDA and iron treatment is recommended by many international organizations (WHO) and national learned societies (UK, US, India).</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n However, only few studies have demonstrated an increase in the Hb level and in biological parameters associated with IDA at early stages of treatment by iron supplementation.  A significant increase in Hb level was already observed after 1 week of iron supplementation in a study conducted on women with severe postpartum anaemia. In a study conducted on chronic kidney disease patients with IDA, the increase in Hb level was significant after 3 weeks of iron treatment. An analysis of pooled data from 5 randomized trials identified patients with an increase of Hb ≥ 1 g/dL at 14 days of treatment as responders to iron supplementation.</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n The purpose of this study is to obtain data on the biological parameters associated with IDA at the very early stages of treatment (3<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; top: -0.5em;\">rd</span>, 5<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; top: -0.5em;\">th</span>, 7<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; top: -0.5em;\">th</span> days) to assess the Onset-of-Action of an Iron gluconate liquid formulation (Tot'héma®). The efficacy and the safety of Tot'héma®, administered according to the summary of product characteristics (SmPC) recommendations, will also be evaluated regularly during the scheduled 12 weeks of treatment for the study.</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <u>Primary objective</u></p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n To assess, in patients with moderate IDA, the Onset-of-Action of a daily treatment with Tot'héma®. The onset of action is defined as the time required for a mean increase of at least 0.5 g/dL from baseline in the haemoglobin level.</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <u>Secondary objectives</u></p>\n<ol style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <li style=\"line-height: 20px;\">\n Assessment, in patients with moderate IDA, of the Onset-of-Action of a daily treatment with Tot'héma® separately within each of the 2 geographic zones. The onset of action is defined as the time required for a mean increase of at least 0.5 g/dL from baseline in haemoglobin level.</li>\n <li style=\"line-height: 20px;\">\n Assessment, in patients with moderate IDA, of the Onset-of-Action of a daily treatment with Tot'héma®, defined as the time required for a mean increase of at least 2 g/dL from baseline in the haemoglobin level.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the proportion of patients with moderate IDA treated with Tot'héma® achieving different levels of improvement and, ultimately, a normalization of haemoglobin level over time.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the time course of the increase and, ultimately, the normalization of haemoglobin level in patients with moderate IDA treated with Tot'héma®.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the evolution of biological markers of anaemia in patients with moderate IDA treated with Tot’héma®.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the evolution of the mean level of C-Reactive Protein (CRP) in patients with moderate IDA treated with Tot'héma®.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the evolution of fatigue in patients with moderate IDA treated with Tot'héma®.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the evolution of quality of life of patients with moderate IDA treated with Tot'héma®.</li>\n <li style=\"line-height: 20px;\">\n Performance of conjunctival pallor for detecting anaemia and its evolution during treatment.</li>\n <li style=\"line-height: 20px;\">\n Assessment of patient compliance with treatment.</li>\n <li style=\"line-height: 20px;\">\n Assessment of treatment safety.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the overall level of investigators satisfaction with the treatment.</li>\n</ol>\n
      • study_title<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Assessments of the EFficacy, the onset-of-Action and the Safety of Tot'héma® in adults with moderate iron deficiency anaemia</p>\n
      • laymans_summary<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Iron Deficiency Anaemia is a condition whereby iron store depletion is associated with low blood volume in the body, <em>i.e</em>. a haemoglobin (Hb) concentration below an established cut-off value, consequently impairing the capacity of the blood to transport oxygen around the body. According to the World Health Organisation (WHO) about 30% of the world’s population suffers from anaemia.</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Oral iron supplements are considered as safe, cheap, and effective in restoring iron balance. Side effects associated with iron supplementation are mostly gastrointestinal side effects including abdominal discomfort, nausea, vomiting, constipation, and dark colored stools.</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n With more than five decades of international use, the efficacy and the safety of Tot'héma® in the curative and prophylactic treatment of IDA has been well established. Several clinical trials conducted in different populations have supported the efficacy of Tot'héma® in IDA, showing normalization of biological parameters such as Hb and ferritin blood levels after treatment with Tot'héma®.</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Iron supplementation has long been proven to be effective for the treatment of IDA and iron treatment is recommended by many international organizations (WHO) and national learned societies (UK, US, India).</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n However, only few studies have demonstrated an increase in the Hb level and in biological parameters associated with IDA at early stages of treatment by iron supplementation.  A significant increase in Hb level was already observed after 1 week of iron supplementation in a study conducted on women with severe postpartum anaemia. In a study conducted on chronic kidney disease patients with IDA, the increase in Hb level was significant after 3 weeks of iron treatment. An analysis of pooled data from 5 randomized trials identified patients with an increase of Hb ≥ 1 g/dL at 14 days of treatment as responders to iron supplementation.</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n The purpose of this study is to obtain data on the biological parameters associated with IDA at the very early stages of treatment (3<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; top: -0.5em;\">rd</span>, 5<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; top: -0.5em;\">th</span>, 7<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; top: -0.5em;\">th</span> days) to assess the Onset-of-Action of an Iron gluconate liquid formulation (Tot'héma®). The efficacy and the safety of Tot'héma®, administered according to the summary of product characteristics (SmPC) recommendations, will also be evaluated regularly during the scheduled 12 weeks of treatment for the study.</p>\n<p style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <span style=\"font-family: Calibri, sans-serif; font-size: 14.6667px;\">The IP is registered in kenya. Registration number in Kenya is n°H2009/19801/578</span></p>\n
      • short_titleFAST Study
      • protocol_noECCT/21/12/04
      • version_no1.0
      • date_of_protocol31-03-2020
      • study_drugTot\'héma®
      • disease_conditionIron Deficiency Anaemia
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvowira@aceresearchafrica.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantElizabeth Nzuu
      • declaration_date117-12-2021
      • declaration_principal_investigatorDr. Francis Odawa
      • declaration_date217-12-2021
      • placebo_presentNo
      • study_objectives<p font-size:=\"\" style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u>Primary objective</u></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n To assess, in patients with moderate IDA, the Onset-of-Action of a daily treatment with Tot'héma®. The onset of action is defined as the time required for a mean increase of at least 0.5 g/dL from baseline in the haemoglobin level.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u>Secondary objectives</u></p>\n<ol font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Assessment, in patients with moderate IDA, of the Onset-of-Action of a daily treatment with Tot'héma® separately within each of the 2 geographic zones. The onset of action is defined as the time required for a mean increase of at least 0.5 g/dL from baseline in haemoglobin level.</li>\n <li style=\"line-height: 20px;\">\n Assessment, in patients with moderate IDA, of the Onset-of-Action of a daily treatment with Tot'héma®, defined as the time required for a mean increase of at least 2 g/dL from baseline in the haemoglobin level.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the proportion of patients with moderate IDA treated with Tot'héma® achieving different levels of improvement and, ultimately, a normalization of haemoglobin level over time.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the time course of the increase and, ultimately, the normalization of haemoglobin level in patients with moderate IDA treated with Tot'héma®.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the evolution of biological markers of anaemia in patients with moderate IDA treated with Tot’héma®.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the evolution of the mean level of C-Reactive Protein (CRP) in patients with moderate IDA treated with Tot'héma®.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the evolution of fatigue in patients with moderate IDA treated with Tot'héma®.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the evolution of quality of life of patients with moderate IDA treated with Tot'héma®.</li>\n <li style=\"line-height: 20px;\">\n Performance of conjunctival pallor for detecting anaemia and its evolution during treatment.</li>\n <li style=\"line-height: 20px;\">\n Assessment of patient compliance with treatment.</li>\n <li style=\"line-height: 20px;\">\n Assessment of treatment safety.</li>\n <li style=\"line-height: 20px;\">\n Assessment of the overall level of investigators satisfaction with the treatment.</li>\n</ol>\n
      • principal_inclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Potential participants must meet all of the following criteria to be eligible for inclusion in the study:</p>\n<ol font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Adult men and women (≥18 years)</li>\n <li style=\"line-height: 20px;\">\n Patient with a confirmation of moderate anaemia defined as haemoglobin level of 8.0 g/dL to 9.0 g/dL (all values inclusive) on the last haematological test performed within 7 days before inclusion visit</li>\n <li style=\"line-height: 20px;\">\n Patient with ferritin blood level < lower limit of laboratory standard for this biological parameter on the last hematological test performed within 7 days before inclusion visit</li>\n <li style=\"line-height: 20px;\">\n Patient who has read, understood, dated and signed the informed consent form</li>\n <li style=\"line-height: 20px;\">\n Patient agreeing to comply with protocol requirements, including visits and blood samples at specifically defined dates</li>\n</ol>\n
      • principal_exclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Participants are excluded from the study if any of the following criteria apply:</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 1.       Patient for whom an oral iron supplementation is not indicated or not recommended according to Investigator’s opinion</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 2.       C-Reactive Protein > 10 mg/L on the last haematological test performed within 7 days before inclusion visit</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 3.       Patient with confirmed benign or malignant neoplastic tumour</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 4.       Patient presenting gastrointestinal disorders incompatible with study treatment compliance</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 5.       Pregnant or breastfeeding woman</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 6.       Woman with childbearing potential who does not agree to use an accepted highly effective method of contraception – per investigator’s judgment</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 7.       Patient with surgery scheduled to occur during the treatment period</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 8.       Patient allergic or hypersensitive to any of the components of Tot’héma® ampoule</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 9.       Patient with chronic inflammatory disease, including chronic inflammatory bowel syndrome and/or chronic heart failure and/or chronic renal failure and/or inflammatory rheumatism</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 10.   Patient with active digestive bleeding (such as digestive ulcer)</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 11.   Patient having taken iron supplementation, iron-based IV therapy, or mineral supplementation with iron within the 15 days prior to the inclusion visit (V2)</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 12.   Patient with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 13.   Patient with acute malaria within 15 days prior to inclusion</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 14.   Patient with a positive Faecal Occult Blood Test (FOBT)</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 15.   Patient with confirmed HIV infection</p>\n<p align=\"left\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 16.   Unreliable patients, including non-observant patients, patients with known alcoholism or drug abuse, or with a history of a serious psychiatric disorder, as well as patients who are reluctant to give informed consent or to comply with protocol requirement</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 0.25in; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 17.   Patient with a family relationship to a person at the investigator’s site or at the Sponsor or at the CRO</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Participant involved in another interventional or observational clinical trial or who participated in another interventional clinical trial within four weeks before inclusion </p>\n
      • primary_end_points<p font-size:=\"\" style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <u>Primary endpoint</u></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n EFFICACY</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 1.65pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n First time (in days) associated with a mean increase in the haemoglobin level of at least 0.5 g/dL (versus mean haemoglobin level at D0). This primary endpoint will be assessed by modelling the evolution during the treatment of the mean haemoglobin level between Day 0 and Week 12.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\">MTRH clinical research site (CRS) is based at Chandaria Cancer and Chronic Disease Center, within MTRH, Eldoret, Kenya. The CRS has 5 rooms; an examination room, data room, site coordinator's office, pharmacy room and Supplies & GeneXpert room. The pharmacy has two study fridges, a dispensing area.CRS has a total of 5 Investigators, data manager (1), pharmacist (1), back –up-pharmacist (1), site coordinator(1), study nurse (2), recruitment officers (1) and research assistant (1).</span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\">The study site in Kisumu is the UNIM Research and Training Centre (URTC), run by Nyanza Reproductive Health Society (NRHS). NRHS has established a Community Advisory Board (CAB) in Kisumu, and study staff will consult with these groups in meetings both before and during the study. The study clinic will be the URTC while additional satellite sites for enrolment may be utilized, mainly in Kisumu and its environs where the organization has a strong presence. Along with posting recruitment flyers, active recruitment will be done at the primary care health clinics, family planning clinics, HIV testing facilities, gynaecology clinics, institutions of higher learning, community based youth centres, schools, and other community-based organizations. Enrolment and follow up visits will be conducted at the URTC. Research capacity 3 Investigators, data manager (2), pharmacist (1), back –up-pharmacist (1), site coordinator(1), study nurse (10), recruitment officers (4) and research assistant (3).</span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\">Kenyatta national site is based at the Kenyatta national Hospital with research capacity of 3 Investigators, data manager (2), pharmacist (2), site coordinator(1), study nurse (3), recruitment officers (2) and research assistant (2).</span></p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The study is also being conducted in the sponsors country</span></p>\n
      • other_details_regulatory_notapproved<p>\n Not Applicable</p>\n
      • other_details_regulatory_approved<p>\n <span class=\"TextRun Highlight SCXW134812158 BCX0\" data-contrast=\"auto\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; outline: transparent solid 1px; font-weight: bold; font-size: 12pt; font-family: Arial, Arial_EmbeddedFont, Arial_MSFontService, sans-serif; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\"><span class=\"NormalTextRun SCXW134812158 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent;\">France:</span></span><span class=\"TextRun Highlight SCXW134812158 BCX0\" data-contrast=\"auto\" lang=\"EN-US\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent; outline: transparent solid 1px; font-size: 12pt; font-family: Arial, Arial_EmbeddedFont, Arial_MSFontService, sans-serif; line-height: 20.5042px; font-variant-ligatures: none !important;\" xml:lang=\"EN-US\"><span class=\"NormalTextRun SCXW134812158 BCX0\" style=\"margin: 0px; padding: 0px; user-select: text; -webkit-user-drag: none; -webkit-tap-highlight-color: transparent;\"> Competent Authority (ANSM) and Ethics Committee (CPP Ouest III) submitted on 6 April 2020. Approval granted 11 May 2020</span></span></p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_durationStudy period is 84 days per participant
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states3
      • number_of_sites3
      • multi_country_listFrance, Bulgaria, Kenya
      • data_monitoring_committeeNo
      • total_enrolment_per_site50 Although recruitment is competitive therefore sites should be able to recruit >50 participants
      • total_participants_worldwide270
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameNaftali
      • investigator1_middle_name
      • investigator1_family_nameBusakhala
      • investigator1_qualificationMedical Doctor, Internal Medicine, Pharmacologist
      • investigator1_professional_addressMoi University School of Medicine, P.O. Box 4606, Postal Code 30100, Eldoret, Kenya
      • investigator1_telephone+254722496933
      • investigator1_emailnbusakhala@yahoo.com
      • organisations_transferred_Yes
      • number_participants135
      • notification
      • approval_date18-03-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted16-02-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe queries raised by the reviewers have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-02-19 21:49:04
      • created2021-12-09 11:23:12
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id760
        • application_id1096
        • given_nameDr. Francis
        • middle_nameXavier Otieno
        • family_nameOdawa
        • qualificationMasters of medicine in Obstetrics and Gynaecology/ Bachelor of Medicine and Surgery
        • professional_addressKenyatta National Hospital P.O BOX 2500 -00202 Nairobi.
        • telephone+254 733-716097
        • emailodawafrancis11@gmail.com/ odawafrancis@yahoo.com
        • created2021-12-09 12:13:48
        • modified2022-02-16 20:06:35
    • SiteDetail(array)
      • 0(array)
        • id1200
        • application_id1096
        • county_id29
        • site_nameMOI University Teaching and Referral Hospital
        • physical_addressMoi University, School of Medicine, Department of pharmacology and Therapeutics
        • contact_detailsP.O Box 4606
        • contact_personDr Naftali Busahala
        • site_capacity(null)
        • misc(null)
        • created2021-12-09 12:13:48
        • modified2022-02-16 20:06:35
        • County(array)
          • id29
          • county_nameNandi
          • created2012-06-15 10:25:33
          • modified2012-06-15 10:25:33
      • 1(array)
        • id1204
        • application_id1096
        • county_id42
        • site_nameUNIM Research and Training Centre
        • physical_addressNyanza Reproductive Health Society Lumumba County Hospital Compound, off Ondiek Highway
        • contact_detailsP. O. BOX 1764, KISUMU 40100
        • contact_personDr Fredrick Odhiambo Otieno
        • site_capacity(null)
        • misc(null)
        • created2021-12-09 12:48:12
        • modified2022-02-16 20:06:35
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1205
        • application_id1096
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressKenyatta National Hospital, Nairobi
        • contact_detailsP.O. Box 2500, Postal Code 00202, (KNH), Nairobi, Kenya. +254725737038
        • contact_personDr. Francis Odawa
        • site_capacity(null)
        • misc(null)
        • created2021-12-09 12:48:12
        • modified2022-02-16 20:06:35
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id564
        • application_id1096
        • sponsorLaboratoire INNOTECH INTERNATIONAL
        • sponsor_typeIndustry
        • contact_personDr François VERRIERE, Medical Affairs Director
        • addressLaboratoire INNOTECH INTERNATIONAL 22 avenue Aristide Briand BP 20032 94111 ARCUEIL CEDEX – France
        • telephone_number+33 1 46 15 18 83
        • fax_number
        • cell_number+33 1 46 15 18 83
        • email_addressfrancois.verriere@innothera.com
        • created2021-12-09 12:13:48
        • modified2022-02-16 20:06:35
  • 3(array)
    • Application(array)
      • id244
      • user_id107
      • trial_status_id6
      • abstract_of_study<p>\n In East Africa, ocular surface squamous neoplasia (OSSN) is a relatively common aggressive disease affecting younger adults. Treatment usually involves surgical excision, however, recurrent disease is quite common (up to 30-66% by 30 months afterwards) and there have been no randomised controlled trials to investigate how to reduce this. For a long time topical 5-fluorouracil (5FU) has been widely used as adjuvant therapy following surgical excision, with many case reports and series in the literature. However, it has not been formally tested in a randomised controlled trial and so we currently do not know if it is effective in preventing recurrent tumours, particularly in the context where more expensive adjuvants or surgical equipment are not readily available. A Cochrane review shows there have been no randomised controlled trials of the various alternatives in clinical practice to investigate how to reduce recurrence.</p>\n<p>\n We propose to conduct a randomised controlled trial to determine whether OSSN recurrence can be reduced by adjuvant topical 5FU chemotherapy following excision. One month after surgical excision of histopathologically confirmed OSSN when the operation site has healed, participants will be randomised to either 5FU eyedrops, or placebo drops to be taken four times a day for 1 month. Patients will be followed for one year to assess the effect. The primary outcome measure is histopathologically confirmed recurrent OSSN.</p>\n
      • study_title<p style=\"margin-left:21.3pt;\">\n A double-masked randomised placebo-controlled trial of adjuvant topical 5-fluorouracil (5FU) treatment following surgical excision of ocular surface squamous neoplasia.</p>\n<p>\n  </p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/12/04/01
      • version_no1
      • date_of_protocol05-04-2012
      • study_drug5-fluorouracil
      • disease_conditionOcular surface squamous neoplasia (OSSN)
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_name5-FU
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresssgichuhi@uonbi.ac.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Stephen Gichuhi
      • declaration_date116-12-2013
      • declaration_principal_investigatorDr. Stephen Gichuhi (national PI)
      • declaration_date216-12-2013
      • placebo_presentYes
      • study_objectives(null)
      • principal_inclusion_criteria<ol style=\"list-style-type:lower-roman;\">\n <li>\n Histologically proven ocular surface squamous neoplasia (OSSN)</li>\n <li>\n Healed excision site.</li>\n <li>\n At least 18 years of age.</li>\n</ol>\n
      • principal_exclusion_criteria<ol style=\"list-style-type:lower-roman;\">\n <li>\n If the tumour is a recurrence from prior excision.</li>\n <li>\n Prior treatment with topical antimetabolite drugs such as 5FU, Mitomycin C (MMC) to the same eye or systemic cytotoxic drugs.  </li>\n <li>\n Patients who may need more radical surgery than a simple excision eg. intraocular extension or features suggestive of metastasis such as fornix or regional lymph node involvement.</li>\n <li>\n Pregnant or breastfeeding mothers.</li>\n</ol>\n
      • primary_end_points<p>\n The primary end-point in this trial will be the development of histopathologically confirmed recurrent OSSN at any point during the first year after the primary surgery. During follow-up, if the outcome assessor notices a possible recurrence, it will be re-excised and sent for histopathology. We will compare the proportion of recurrences at one year in the two intervention arms. Intention-to-treat analysis will be used. The measure of effect will be the odds ratio with 95% confidence intervals. Kaplan-Meier analysis will be used to plot the survival curves for both arms up to the final visit at one year. Participants with “clinical recurrence” (clinician sees recurrence but participant declines re-excision) will be excluded from the primary analysis of the primary end point and go into secondary analysis.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Sites involved in the study</p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:659px;\" width=\"659\">\n <tbody>\n <tr>\n <td style=\"width:206px;\">\n <p>\n Site</p>\n </td>\n <td style=\"width:454px;\">\n <p>\n Staff, qualifications & experience</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:206px;\">\n <p>\n Kenyatta National Hospital</p>\n </td>\n <td style=\"width:454px;\">\n <p>\n Consultant Ophthalmologists</p>\n <p>\n Dr. Stephen Gichuhi, MBChB  MMed MBA MSc (epid) -  15 years</p>\n <p>\n Dr. Rhoda Munene, MBChB  MMed  Oculoplastics Fellowship – 12 years</p>\n <p>\n Dr. Joseph Wachira, MBChB  MMed  Oculoplastics Fellowship – 10 years</p>\n <p>\n  </p>\n <p>\n Research Assistant (data management)</p>\n <p>\n John Maina, Dip IT</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:206px;\">\n <p>\n PCEA Kikuyu Eye Unit</p>\n </td>\n <td style=\"width:454px;\">\n <p>\n Consultant Ophthalmologists</p>\n <p>\n Dr. Joy Kabiru, MBChB  MMed  Oculoplastics Fellowship – 12 years</p>\n <p>\n Dr. M’Bongo Zindamoyen, MBChB  MMed – 12 years</p>\n <p>\n  </p>\n <p>\n Ophthalmic Clinical Officer</p>\n <p>\n Mr. Ephantus Macharia, Dip Clin Ophth, HND eye surgery – 10 years</p>\n <p>\n  </p>\n <p>\n *Dr S. Gichuhi oversees work here 2 days a week</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:206px;\">\n <p>\n Sabatia Eye Hospital</p>\n </td>\n <td style=\"width:454px;\">\n <p>\n Consultant Ophthalmologists</p>\n <p>\n Dr. Ernest Olando, MBChB  MMed  Paed Ophth Fellowship – 5 years</p>\n <p>\n  </p>\n <p>\n Ophthalmic Clinical Officer</p>\n <p>\n Mr. Leonard Wanyama, Dip Clin Ophth, HND eye surgery – 17 years</p>\n <p>\n  </p>\n <p>\n Study Nurse</p>\n <p>\n Sr. Mercy, KRCHN – 10 years</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:206px;\">\n <p>\n Kitale District Hospital Eye Unit</p>\n </td>\n <td style=\"width:454px;\">\n <p>\n Consultant Ophthalmologists</p>\n <p>\n Dr. Hilary Rono, MBChB  MMed  MSc (public eye health) – 8 years</p>\n <p>\n  </p>\n <p>\n Ophthalmic Clinical Officer</p>\n <p>\n William, Dip Clin Ophth, HND eye surgery – 7 years</p>\n <p>\n  </p>\n <p>\n Study Nurse</p>\n <p>\n Sr. Grace Wachira, KRN – 8 years</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:206px;\">\n <p>\n Homa Bay District Hospital Eye Unit</p>\n </td>\n <td style=\"width:454px;\">\n <p>\n Consultant Ophthalmologists</p>\n <p>\n Dr. Ochieng, MBChB, MMed – 5 years</p>\n <p>\n  </p>\n <p>\n *SITE NOT ACTIVATED YET</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n All the sites have the following facilities</p>\n<ol>\n <li>\n Fully equipped eye clinic – with slit lamps and all accessories needed for a comprehensive eye examination</li>\n <li>\n Fully equipped eye operating theatre – with resuscitation equipment</li>\n <li>\n HIV comprehensive clinic – to provide support for HIV infected participants</li>\n <li>\n Laboratory – conduct HIV and CD4 testing except Sabatia Eye Hospital where we have made arrangements with the nearby Vihiga District hospital.</li>\n</ol>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The host country of the sponsor is the UK. This study is being conducted in Kenya because  ocular surface squamous neoplasia is a rare disease in the temperate climates. We recently published a systematic review in which we found that the peak incidence is at latitude 16⁰ South. The mean age standardised rate (ASR) worldwide is 0.18 and 0.08 cases/year/100 000 among males and females, respectively but the highest incidence is found in Africa (1.38 and 1.18 cases/year/100,000).</p>\n<p>\n Gichuhi S, Sagoo MS, Weiss HA, Burton MJ. Epidemiology of ocular surface squamous neoplasia in Africa. <strong>Trop Med Int Health</strong><strong>. 2013 Dec;18(12):1424-43</strong></p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n 1. Kenyatta National Hospital/University of Nairobi Ethics and Research Committee</p>\n<p>\n 2. London School of Hygiene & Tropical Medicine Ethics committee</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration24 months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo - artificial tear
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites4 active, 1 not activated (Homa Bay)
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteKikuyu max 350\nOthers max 154
      • total_participants_worldwide504
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameStephen
      • investigator1_middle_name
      • investigator1_family_nameGichuhi
      • investigator1_qualificationMBChB, M.Med (Ophth), MBA, MSc (Epidemiology)
      • investigator1_professional_addressUniversity of Nairobi, Dept of Ophthalmology, Kenyatta National Hospital campus
      • investigator1_telephoneOffice 020-2726300 ext. 43776, mobile 0722873059
      • investigator1_emailsgichuhi@uonbi.ac.ke
      • organisations_transferred_No
      • number_participants504
      • notification<p>\n I will send a copy of the receipt I obtained after paying $1000 once I get it from London.</p>\n<p>\n I attach a copy of the approval letter obtained after the initial application</p>\n
      • approval_date15-03-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-12-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2014-11-24 04:28:40
      • created2013-12-16 14:14:17
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id175
        • application_id244
        • given_nameStephen
        • middle_name
        • family_nameGichuhi
        • qualificationMBChB, M.Med (Ophth), MBA, MSc (Epidemiology)
        • professional_addressUniversity of Nairobi, Dept of Ophthalmology, Kenyatta National Hospital campus
        • telephoneOffice 020-2726300 ext. 43776, mobile 0722873059
        • emailsgichuhi@uonbi.ac.ke
        • created2013-12-16 17:08:14
        • modified2013-12-17 17:35:19
    • SiteDetail(array)
      • 0(array)
        • id219
        • application_id244
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressHospital Road,Upper Hill,Nairobi 00202, Kenya
        • contact_detailsTel 2726300
        • contact_personDr. Stephen Gichuhi, Consultant Ophthalmologist,
        • site_capacity(null)
        • misc(null)
        • created2013-12-16 17:08:14
        • modified2013-12-17 17:35:19
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id220
        • application_id244
        • county_id22
        • site_namePCEA Kikuyu Eye Unit
        • physical_addressPCEA Kikuyu Hospital, Kikuyu Road,Kenya
        • contact_detailsP.O Box 1021, Kikuyu, Kenya
        • contact_personDr. Joy Kabiru, Consultant Ophthalmologist
        • site_capacity(null)
        • misc(null)
        • created2013-12-16 18:09:20
        • modified2013-12-17 17:35:19
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 2(array)
        • id221
        • application_id244
        • county_id37
        • site_nameSabatia Eye Hospital
        • physical_addressVihiga District
        • contact_detailsP.O. Box 214-50311 Wodanga
        • contact_personDr. Ernest Ollando, Director & Consultant Ophthalmologist
        • site_capacity(null)
        • misc(null)
        • created2013-12-16 18:09:20
        • modified2013-12-17 17:35:19
        • County(array)
          • id37
          • county_nameKakamega
          • created2012-06-15 10:26:29
          • modified2012-06-15 10:26:29
      • 3(array)
        • id222
        • application_id244
        • county_id26
        • site_nameKitale District Hospital, Eye Unit
        • physical_addressKitale
        • contact_detailsP.O. Box 98 - 30200, Kitale
        • contact_personDr. Hilary Rono, Consultant Ophthalmologist in charge
        • site_capacity(null)
        • misc(null)
        • created2013-12-16 18:09:20
        • modified2013-12-17 17:35:19
        • County(array)
          • id26
          • county_nameTrans Nzoia
          • created2012-06-15 10:25:05
          • modified2012-06-15 10:25:05
      • 4(array)
        • id223
        • application_id244
        • county_id43
        • site_nameHoma Bay District Hospital, Eye Unit
        • physical_addressHoma Bay
        • contact_detailsP.O Box 52 - 40300, Homa Bay
        • contact_personDr. Ochieng, Consultant Ophthalmologist
        • site_capacity(null)
        • misc(null)
        • created2013-12-16 18:09:20
        • modified2013-12-17 17:35:19
        • County(array)
          • id43
          • county_nameHoma Bay
          • created2012-06-15 10:27:10
          • modified2012-06-15 10:27:10
    • Sponsor(array)
      • 0(array)
        • id141
        • application_id244
        • sponsorLondon School of Hygiene & Tropical Medicine
        • sponsor_type(null)
        • contact_personPatricia Henley
        • addressKeppel Street, London, WC1E 7HT
        • telephone_number+44 (0) 20 7927 2626
        • fax_number+44 (0) 20 7580 5636
        • cell_number+44 (0) 20 7927 2626
        • email_addresspatricia.henley@lshtm.ac.uk
        • created2013-12-16 17:08:14
        • modified2013-12-17 17:35:19
  • 4(array)
    • Application(array)
      • id1195
      • user_id667
      • trial_status_id7
      • abstract_of_study<p>\n <strong>Background:  </strong>People Living with HIV (PLHIV) who use tobacco experience an excess of tobacco-attributable morbidity and mortality. An analysis of tobacco use among PLHIV in 28 LMIC found that HIV positive men were 40% more likely to use tobacco than HIV negative men. For women, the increase in risk of tobacco use was 36%. As the use of, and adherence to, anti-retroviral therapy (ART) increases, PLHIV who use tobacco become at higher risk for a range of diseases caused or aggravated by tobacco use, such as cancer, including lung, head and neck, cervical and anal cancers, hypertension and heart disease, diabetes, and lung diseases.   In addition, PLHIV who use tobacco are at an increased risk of pneumonia, tuberculosis and other infections. There is paucity of studies on cessation in Africa and few cessation services in Kenya. This study will evaluate the implementation of cross cutting national recommendations on Tobacco use cessation among PLHIV.</p>\n<p>\n <strong>Broad Objectives: </strong>The primary objective is to compare the effectiveness of a tobacco use cessation intervention focusing on breadth (brief intervention) or depth (intensive intervention) in supporting Kenyans living with HIV to quit tobacco use.</p>\n<p>\n <strong>Implementation site(s):</strong> The project will be implemented in Kisumu County, within 20 HIV care and treatment clinics in Kisumu County-Kenya.</p>\n<p>\n <strong>Key Methods</strong>: The study will conduct a cluster randomized controlled trial at 20 HIV care and treatment clinics to compare the effectiveness of two levels of evidence-based tobacco use cessation strategies: 1) The intensive intervention (12 counseling sessions in-person or telemedicine; provision of a Quitline number, NRT and bupropion); 2) The brief intervention (one-time counseling plus the Quitline number). After 12 months the study will offer the intensive intervention to patients in the brief intervention group who continue to use tobacco. We will evaluate the cost of both interventions by biochemically verified abstinence at 12 months using standard costing methods and in the last year of the project, we will conduct qualitative studies to evaluate adopters at the clinic and health provider levels, assessing barriers to and facilitators of adoption, implementation, and factors associated with scalability/sustainability.</p>\n<p>\n <strong>Expected Application of findings: </strong>Results from this study will provide pivotal information to understand the needs for tobacco use cessation of PLHIV and the most effective strategies to integrate tobacco dependence treatment within HIV care.</p>\n
      • study_title<p style=\"margin-left:1.0pt;\">\n <strong>Integrating Tobacco use cessation into HIV care and Treatment Clinics in Ministry of Health Facilities in Kisumu County, Kenya</strong></p>\n
      • laymans_summary<div>\n Tobacco use among people living with HIV (PLHIV) urgently needs to be addressed, particularly in low- and middle-income countries (LMIC) where the burden of double epidemics, tobacco and HIV, could overwhelm the health system, public health finances and be a barrier to reaching the Sustainable Development Goals (SDG)(1). Countries in sub- Saharan Africa remain the HIV epidemic epicenter (2) while experiencing significant growth in tobacco consumption (3-5). PLHIV who use tobacco experience an excess of tobacco- attributable morbidity and mortality. In high income countries, it is estimated that PLHIV are two or three times more likely to use tobacco than the general population (6-7). An analysis of tobacco use among PLHIV in 28 LMIC found that HIV positive men were 40% more likely to use tobacco than HIV negative men. For women, the increase in risk of tobacco use was 36% (8). As the use of, and adherence to, anti-retroviral therapy (ART) increases, PLHIV who use tobacco become at higher risk for a range of diseases caused or aggravated by tobacco use, such as cancer, including lung, head and neck, cervical and anal cancers, hypertension and heart disease, diabetes, and lung diseases (6). In addition, PLHIV who use tobacco are at an increased risk of pneumonia, tuberculosis and other infections (1). There is a paucity of studies on cessation in Africa (9) and few cessation services in Kenya. Approximately half of tobacco users made a quit attempt in the previous 12 months, and 80% were thinking about quitting, indicating that there might be a growing interest in cessation amongst Kenyans. However, only 34.1% of tobacco users who saw a healthcare provider received advice to quit. Most (70%) quit attempts in Kenya are without any support (10). In 2017 Kenya’s MOH launched the National Guidelines for Tobacco Dependence Treatment and Cessation (11) (hereafter, Guidelines). It supports the implementation of tobacco use cessation programs within health care services, based on the 5As approach (Ask, Advice, Assess, Assist and Arrange) and is a tool to reach the country’s goals of reducing non-communicable diseases burden.</div>\n<div>\n The Ministry of Health in Kenya launched the National Guidelines for Tobacco Dependence Treatment and Cessation in 2017 that is mirrored on the World Health Organization guidelines and several systematic reviews demonstrating that pharmacotherapy supports tobacco use cessation and increase quit rates when compared   with placebo or no intervention (or trying to quit without support). Evidence indicates that combination Nicotine Replacement Therapy (NRT) (a slow + a fast-acting agent, such as patch and lozenge), with Bupropion, and behavioral support to be the most effective (9,13). Evidence also support the use of Varenicline alone or in combination with NRT, this medication is not available in Kenya.</div>\n<div>\n Therefore, there is a need to enhance support for tobacco cessation services in Kenya (10, 12) and to evaluate strategies to implement the Guidelines in routine clinical practice. This is the first study to implement the Guidelines in an HIV community healthcare setting. This project will evaluate the implementation of cross cutting national recommendations. </div>\n
      • short_titleHIV & Tobacco Cessation Study
      • protocol_noECCT/22/12/01
      • version_no2
      • date_of_protocol05-08-2022
      • study_drugBupropion 150mg
      • disease_conditionNictine additcion
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameBupropion hydrochloride
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressrgreshon@kemri-rctp.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantGreshon Rota
      • declaration_date101-12-2022
      • declaration_principal_investigatorElizabeth Bukusi
      • declaration_date201-12-2022
      • placebo_presentNo
      • study_objectives<p style=\"margin-left: 40px;\">\n <strong>Primary Objective</strong></p>\n<p style=\"margin-left:15.0pt;\">\n The primary objective is to compare the efficacy of a brief versus an intensive intervention in supporting PLHIV in quitting tobacco use. The time frame is 12 months.</p>\n<p style=\"margin-left:15.0pt;\">\n <strong>Secondary Objectives</strong></p>\n<p style=\"margin-left:15.0pt;\">\n The secondary objectives are to compare cessation status by brief versus intensive intervention at 1, 3 and 6 months.</p>\n<p style=\"margin-left:15.0pt;\">\n Other secondary objectives include:</p>\n<p style=\"margin-left:15.0pt;\">\n -  Changes in providers self-reported tobacco dependence treatment interventions overtime and between groups</p>\n<p style=\"margin-left:21.95pt;\">\n -  Assess cost-effectiveness of the brief versus intensive interventions</p>\n
      • principal_inclusion_criteria<p style=\"margin-left:15.0pt;\">\n <em>Non-clinical component (HCW capacity building and qualitative evaluation):</em></p>\n<p style=\"margin-left:15.0pt;\">\n All HIV care providers will be eligible for the capacity building</p>\n<p style=\"margin-left:15.0pt;\">\n Clinic administrators / providers engaged in the delivery of the interventions   </p>\n<p style=\"margin-left:15.0pt;\">\n <em>Clinical Component (Randomized control Trial):</em></p>\n<p style=\"margin-left:15.0pt;\">\n <em>-           </em>age ≥18 years</p>\n<p style=\"margin-left:51.0pt;\">\n -                      HIV-seropositive</p>\n<p style=\"margin-left:51.0pt;\">\n -                      on or initiating ART</p>\n<p style=\"margin-left:15.0pt;\">\n -                      access to mobile phone for follow up scheduling (and for intensive intervention group, also for phone or text follow up visit)</p>\n<p style=\"margin-left:15.0pt;\">\n -                      Tobacco inclusion criteria: current tobacco users, i.e. used tobacco in the past 7 days; for smokers, smoked at least 100 cigarettes in lifetime, and at least 5 cigarettes per day, verified by expired Carbon Monoxide (CO)≥ 5-6 parts per million (ppm).</p>\n<p style=\"margin-left:15.0pt;\">\n Additional inclusion criteria for intensive intervention only:</p>\n<p style=\"margin-left:54.0pt;\">\n -                        not planning to move or travel within 12 weeks following entry in the study</p>\n<p style=\"margin-left:51.0pt;\">\n -                      able to read or be read SMS messages</p>\n
      • principal_exclusion_criteria<p style=\"margin-left:15.0pt;\">\n <em>Non-clinical component (HCW capacity building and qualitative evaluation:</em></p>\n<p style=\"margin-left:15.0pt;\">\n Providers who do not provide care to PLHIV;</p>\n<p style=\"margin-left:15.0pt;\">\n Clinic administrators / providers from clinics that were not included in the project PLHIV who did not participate in the study (see criteria below)</p>\n<p style=\"margin-left:15.0pt;\">\n <em>Clinical Component (Randomized control trial):</em></p>\n<p style=\"margin-left:51.0pt;\">\n -                      age < 18 years</p>\n<p style=\"margin-left:51.0pt;\">\n -                      HIV-seronegative</p>\n<p style=\"margin-left:51.0pt;\">\n -                      unable to provide verbal informed consent</p>\n<p style=\"margin-left:51.0pt;\">\n -                      unwilling to be contacted by clinic for follow up</p>\n<p style=\"margin-left:51.0pt;\">\n -                      Opioid users</p>\n<p style=\"margin-left:15.0pt;\">\n Additional exclusion criteria for intensive intervention only:</p>\n<p style=\"margin-left:51.0pt;\">\n -                      Myocardial Infarction in the 2 weeks prior to enrolling in the study</p>\n<p style=\"margin-left:51.0pt;\">\n -                      pregnant (as NRT and Bupropion might be contraindicated).</p>\n<p style=\"margin-left:51.0pt;\">\n -                      We will also exclude patients for whom Bupropion is contraindicated (e.g. history of seizures, recent use of MAO inhibitors, breastfeeding, and whose ART protocol present, as per prescription guidance, contraindications).</p>\n<p style=\"margin-left:51.0pt;\">\n -                      For those who share phones, prior disclosure of HIV status to the phone owner will be required to prevent inadvertent disclosure</p>\n
      • primary_end_points<p style=\"margin-left:15.0pt;\">\n 7-day Point Prevalence Abstinence at 12 months - We will assess effectiveness of the tobacco use cessation intervention as the proportion of patients considered to be non- tobacco users (cotinine strip level <16 ng/mL) in the intensive versus brief intervention arms at 12 months, comparing outcomes in the two groups.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <strong><u>FACILITY</u></strong></p>\n<p>\n  </p>\n<ol>\n <li>\n <strong>The main study site is:</strong></li>\n</ol>\n<p>\n KEMRI-RCTP</p>\n<p>\n KEMRI CIS Building</p>\n<p>\n Lumumba Sub-County Hospital</p>\n<p>\n Along Ondiek Highway</p>\n<p>\n P.O Box 614-40100</p>\n<p>\n Kisumu</p>\n<p>\n  </p>\n<p>\n The facility has</p>\n<ol>\n <li>\n Reception and waiting bay</li>\n <li>\n Six Clinic rooms</li>\n <li>\n Pharmacy</li>\n <li>\n Laboratory</li>\n <li>\n Data room</li>\n <li>\n Administration office</li>\n <li>\n Open Office</li>\n <li>\n Washrooms</li>\n</ol>\n<p>\n  </p>\n<p>\n All rooms are equipped with relevant furniture, equipment, and materials to facilitate the activities conducted in the rooms.</p>\n<p>\n  </p>\n<p>\n <strong><u>PERSONNEL </u></strong></p>\n<p>\n 1.      Dr. Elizabeth Anne Bukusi, Site Principal Investigator</p>\n<p>\n 2.      Dr. Linnet Ongeri, Co-Investigator</p>\n<p>\n 3.      Dr. Francesca Odhiambo, MBChB, Co-Investigator</p>\n<p>\n 4.      Dr. Zachary Kwena, PhD, Co-Investigator</p>\n<p>\n 5.      Rachel Mwakisha, Dr. Bukusi’s personal assistant</p>\n<p>\n 6.      Denis Ochola, Human Resource Manager</p>\n<p>\n 7.      Grace Waititu, Finance Manager</p>\n<p>\n 8.      Caroline Machuki, Administrator</p>\n<p>\n 9.      James Majeshi, Driver</p>\n<p>\n 10.  Study Manager</p>\n<p>\n 11.  Data Manager</p>\n<p>\n 12.  Programmer</p>\n<p>\n 13.  Everlyne Ombati, Regulatory Advisor.</p>\n<p>\n 14.  Qualitative Researcher (6),</p>\n<p>\n 15.  Research Assistants (5)</p>\n<ol>\n <li value=\"16\">\n Clinicians (10)</li>\n</ol>\n
      • other_details_explanation<p>\n The trial is an implementation science study designed for Kenya tobacco cessation interventions.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration4 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI-RCTP
      • single_site_physical_addressLumumba Sub-county Hospital
      • single_site_contact_personCirilus Ogolla
      • single_site_telephone0724717472
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site580
      • total_participants_worldwide580
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_name
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics)
      • investigator1_professional_addressCenter for Microbiology Research, KEMRI, Box 19464, post code 00202, Nairobi
      • investigator1_telephone+254733617503
      • investigator1_emailebukusi@rctp.or.ke
      • organisations_transferred_Yes
      • number_participants580
      • notification
      • approval_date16-03-2023
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-01-2023
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonResponses to reviewer comments have been reviewed and
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-13 01:05:03
      • created2022-12-04 06:09:18
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id869
        • application_id1195
        • given_nameElizabeth
        • middle_name
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics), MBE (Research Ethics)
        • professional_addressCenter for Microbiology Research, KEMRI, Box 19464, post code 00202, Nairobi
        • telephone+254733617503
        • emailebukusi@rctp.or.ke
        • created2022-12-04 06:46:00
        • modified2023-01-22 10:14:58
    • SiteDetail(array)
      • 0(array)
        • id1339
        • application_id1195
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2022-12-04 06:46:00
        • modified2023-01-22 10:14:58
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id618
        • application_id1195
        • sponsorNational Institutes of Health (NIH)
        • sponsor_typeResearch Institution
        • contact_personPhulip DeBiase
        • address10 Center Dr, Bethesda, MD 20814, United States
        • telephone_number+13014961993
        • fax_number
        • cell_number+13014961993
        • email_addressgrantsinfo@nih.gov
        • created2022-12-04 06:46:00
        • modified2023-01-22 10:14:58
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • trial_therapeutic_use1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
    • 2CORE/Cache/CacheEngine.php
  • Component(array)
    • 0CORE/Controller/Component/AclComponent.php
    • 1CORE/Controller/Component/Acl/DbAcl.php
    • 2CORE/Controller/Component/Acl/AclInterface.php
    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
    • 0CORE/Controller/Controller.php
    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
    • 0CORE/Model/Datasource/CakeSession.php
    • 1CORE/Model/Datasource/Database/Mysql.php
    • 2CORE/Model/Datasource/DboSource.php
    • 3CORE/Model/Datasource/DataSource.php
  • Error(array)
    • 0CORE/Error/exceptions.php
    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
    • 0CORE/Log/CakeLog.php
    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
    • 0CORE/bootstrap.php
    • 1CORE/basics.php
    • 2CORE/Core/App.php
    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
    • 5CORE/Event/CakeEventListener.php
    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
    • 0CORE/Routing/Dispatcher.php
    • 1CORE/Routing/Filter/AssetDispatcher.php
    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
    • 0APP/Controller/ApplicationsController.php
    • 1APP/Controller/AppController.php
  • Model(array)
    • 0APP/Model/AppModel.php
    • 1APP/Model/Application.php
    • 2APP/Model/User.php
    • 3APP/Model/TrialStatus.php
    • 4APP/Model/InvestigatorContact.php
    • 5APP/Model/Sponsor.php
    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
      • 0CakePdf/Config/bootstrap.php
      • 1CakePdf/Config/routes.php
  • CakeResque(array)
    • Config(array)
      • 0CakeResque/Config/bootstrap.php
    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
      • 2CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Event.php
      • 3CakeResque/vendor/kamisama/php-resque-ex/lib/Resque/Exception.php
  • DebugKit(array)
    • Component(array)
      • 0DebugKit/Controller/Component/ToolbarComponent.php
    • Plugin(array)
      • 0DebugKit/Lib/DebugMemory.php
      • 1DebugKit/Lib/Panel/HistoryPanel.php
      • 2DebugKit/Lib/DebugPanel.php
      • 3DebugKit/Lib/Panel/SessionPanel.php
      • 4DebugKit/Lib/Panel/RequestPanel.php
      • 5DebugKit/Lib/Panel/SqlLogPanel.php
      • 6DebugKit/Lib/Panel/TimerPanel.php
      • 7DebugKit/Lib/Panel/LogPanel.php
      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
      • 9DebugKit/Lib/Panel/VariablesPanel.php
      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
      • 11DebugKit/Lib/Panel/IncludePanel.php
      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
    • Config(array)
      • 0Media/Config/bootstrap.php
    • Plugin(array)
      • 0Media/Lib/mm/src/Mime/Type.php
      • 1Media/Lib/mm/src/Mime/Type/Magic/Adapter/Fileinfo.php
      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php