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• trial_statuses(array)
  • 1Recruiting
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• applications(array)
  • 0(array)
    • Application(array)
      • id938
      • user_id56
      • trial_status_id5
      • abstract_of_study<p>\n Maximizing access, minimizing costs of delivery, and reaching at-risk populations are key priorities for optimizing the public health impact of pre-exposure prophylaxis (PrEP) for HIV prevention. In Africa, PrEP is being added to an already-burdened public health infrastructure and the ability of the health systems to maximize PrEP access will necessitate finding novel delivery strategies. In feasibility evaluations of PrEP in Africa to date, major barriers to PrEP delivery include stigma, long waiting times, the costs of staffing, and healthcare providers’ unfamiliarity with delivering prevention interventions. In Kenya, retail pharmacies fill an important gap in the health care system, providing access to treatment of urgent conditions (e.g., evaluation and medication for STIs, upon presentation of a valid prescription), monitoring of chronic conditions (e.g., blood pressure testing), and preventative care (e.g., contraception). HIV testing is also now legally allowed at pharmacies through purchase of HIV self-tests or pharmacy provider-assisted HIV self-testing. Pharmacy-delivered care has many attributes that may be desirable for potential PrEP users, including convenience (as pharmacies outnumber clinics and have shorter waiting times), anonymity (compared to seeking PrEP at an HIV care center), and engagement (which may be greater for a preventative service at a pharmacy than at a clinic that prioritizes treating ill individuals). Pharmacies can offer free, subsidized, or fully fee-for-service care, and paying for a service could result in greater sustained consumer engagement. The core components of PrEP – including HIV testing, adherence and risk reduction counseling, assessment of side effects, and provision of refills – are within the scope of practice for pharmacists (including pharmaceutical technologists, common in sub-Saharan Africa), and one US model has demonstrated that PrEP can be provided by pharmacists, facilitated by oversight by a remote clinician.</p>\n
      • study_title<p>\n Pharmacy delivery to expand the reach of PrEP in Kenya: Pilot Study</p>\n
      • laymans_summary<p>\n Pre-Exposure Prophylaxis (PrEP) is a new HIV prevention method that works when taken as recommended. To take full advantage of public health benefit of PrEP for HIV prevention, there is need to prioritize access, minimize costs of delivery, and reach out to at-risk populations. In Africa, PrEP is being added to a public health infrastructure which is sometimes burdened by overcrowding and drug stock outs; the ability of health systems to maximize PrEP access necessitates finding novel delivery strategies. Additionally, there exist major barriers to PrEP delivery, which includes stigma, long waiting times, costs of staffing and healthcare providers’ unfamiliarity with delivering prevention interventions. In Kenya, and many other resource-limited countries, retail pharmacies (i.e., chemists) fill an important gap in the health care system providing first stop access to treatment, monitoring and preventive care of urgent and prolonged conditions. Potential PrEP users may desire pharmacy-delivered PrEP over facility-delivered PrEP for reasons including increased convenience, increased privacy and greater engagement compared to health facilities that focus on treating ill patients. Retail pharmacies can offer free, subsidized or affordable healthcare services. The core components of PrEP – including HIV testing, adherence and risk reduction counselling, assessment of side effects and provision of refills – are within the scope of practice for pharmaceutical technologists and pharmacists in Kenya. From prior formative qualitative research and a stakeholder meeting, we have developed a care pathway for pharmacy-based PrEP delivery (including initiation and refills), endorsed for piloting in a consultation meeting that included a wide spectrum of regulatory, professional, government, and community stakeholders in Kenya. We plan to pilot this care pathway in two retail pharmacies in Kisumu. Additionally, we plan to probe for potential weak points of pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs.</p>\n
      • short_titlePharmacy PrEP Delivery
      • protocol_noECCT/20/09/04
      • version_no1.0
      • date_of_protocol18-02-2020
      • study_drugEmtricitabine and Tenofovir disoproxil fumarate Tablets
      • 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_nameTruvada
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressaachoka@kemri-ucsf.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)
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      • applicant_impd1
      • applicant_prev_data1
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      • 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_applicantProffessor Elizabeth Bukusi
      • declaration_date110-09-2020
      • declaration_principal_investigatorProffessor Elizabeth Bukusi
      • declaration_date210-09-2020
      • placebo_presentNo
      • study_objectives<p>\n Study Objectives:</p>\n<p>\n 1. To test pathways for pharmacy-based PrEP delivery – both initiation and refill – through pilot studies.</p>\n<p>\n 2. To identify weak points for pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs.</p>\n
      • principal_inclusion_criteria<p>\n • >18 years</p>\n<p>\n • Interested in initiating PrEP at a pilot pharmacy</p>\n<p>\n • Meets all criteria (e.g., tests HIV-negative) for PrEP initiation on the checklist</p>\n<p>\n • Able & willing to provide written informed consent1</p>\n
      • principal_exclusion_criteria<p>\n Less than 18 years</p>\n<p>\n Not interested in pharmacy delivery</p>\n<p>\n HIV positive</p>\n<p>\n Not willing to provide informed consent form</p>\n
      • primary_end_points<p>\n • PrEP initiation. We will report the socio-demographic characteristics of participants who initiate PrEP at pharmacies (Aim 1a) and compare those with the sociodemographic characteristics of participants from our other studies who have initiated PrEP at healthcare facilities.</p>\n<p>\n • PrEP refills. We will report the socio-demographic characteristics of participants who refilled PrEP at a pharmacy and compare those with the sociodemographic characteristics of participants from our other studies who have refilled PrEP at healthcare</p>\n<p>\n  • PrEP discontinuation. For individuals who are in known HIV serodiscordant relationships, if a participant discontinues PrEP use because their HIV infected partner has initiated and sustained ART for >6 months (the Kenya standard for discontinuing PrEP), this participant will be considered PrEP-adherent. Similarly, if PrEP is discontinued for safety reasons (but not adherence reasons) as determined by the pharmacy providers and confirmed by the remote clinician, follow-up thereafter will be censored, since the subject will not be able to be assessed for adherence to PrEP.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • 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 Number of staff:</p>\n<p>\n 1. PI-1</p>\n<p>\n 2. Co-Investigators-3</p>\n<p>\n 3. Research Assistants-4</p>\n<p>\n 4. Pharmacist-1</p>\n<p>\n 5. Data -1</p>\n<p>\n 6. Admin-1</p>\n
      • other_details_explanation<p>\n This trial will be conducted in the Kenya  and not in other country</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n This protocol has been submitted to University of washington IRB and it was approved.</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</p>\n
      • estimated_duration2 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_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_sites2
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site100
      • total_participants_worldwide100
      • 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_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. Elizabeth
      • investigator1_middle_name
      • investigator1_family_name Bukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics).
      • investigator1_professional_addressBox 19464, post code 00202, Nairobi
      • investigator1_telephone254 733617503
      • investigator1_emailebukusi@rctp.or.ke
      • organisations_transferred_No
      • number_participants100
      • notification
      • approval_date27-10-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted19-09-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy approved by the Expert Committee
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-18 11:32:32
      • created2020-09-10 07:51:13
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id580
        • application_id938
        • given_nameProf. Elizabeth
        • middle_name
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics). MBE (Research Ethics).
        • professional_addressBox 19464, post code 00202, Nairobi
        • telephone254 733617503
        • emailebukusi@rctp.or.ke
        • created2020-09-10 08:05:21
        • modified2020-09-19 07:48:36
    • SiteDetail(array)
      • 0(array)
        • id808
        • application_id938
        • county_id22
        • site_namePHRDTHIKA
        • physical_addressTHIKA TOWN
        • contact_detailsP.O BOX 112
        • contact_personPeter Mogere
        • site_capacity(null)
        • misc(null)
        • created2020-09-10 08:05:21
        • modified2020-09-19 07:48:36
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 1(array)
        • id809
        • application_id938
        • county_id42
        • site_nameKisumu Site
        • physical_addressOndiek Street
        • contact_detailsP.O BOX 614-40100
        • contact_personKevin Kamolloh
        • site_capacity(null)
        • misc(null)
        • created2020-09-10 15:17:52
        • modified2020-09-19 07:48:36
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id453
        • application_id938
        • sponsorUniversity of Washington
        • sponsor_typeOthers
        • contact_person
        • address4333 Brooklyn Ave.NE, Box 359470 Seatle, WA 98195-9470
        • telephone_number206.543.0098
        • fax_number
        • cell_number206.543.0098
        • email_addresstnaluai@uw.edu
        • created2020-09-10 08:05:21
        • modified2020-09-19 07:48:36
  • 1(array)
    • Application(array)
      • id936
      • user_id613
      • trial_status_id5
      • abstract_of_study<div>\n <p>\n While vaccination is the cornerstone of prevention strategies for HBV, the response to current standard vaccination is suboptimal in those living with HIV. Hepatitis B vaccination response to standard regimens is suboptimal in persons living with HIV. A variety of modalities to improve response (primary or secondary series) have been utilized but none have gained universal acceptance. Recently, a new vaccine for HBV prevention was approved by the United States (US) Food and Drug Administration (FDA). The HEPLISAV-B® vaccine (Dynavax Technologies Corporation) is a 0.5 mL aqueous mixture of the HBsAg (20 mcg) combined with 3 mg of CpG1018, an adjuvant Toll-like receptor 9 (TLR9) agonist. It is given as an intramuscular (IM) injection at 0 and 1 months. In pivotal trials this regimen was superior to a three-dose vaccine series of ENGERIX-B, which has been licensed and used for many years in the US and worldwide. The proposed study will compare the efficacy and safety of HEPLISAV-B and ENGERIX- B in a population of HBV vaccine non-responders living with HIV. In Kenya, ENGERIX-B vaccine is the currently approved and registered Hepatitis B vaccine, while HEPLISAV-B is not yet registered. This is a is a phase III/IV, prospective, open-label, interventional, two group study being conducted at both US and non-US sites, with one group (Group A) consisting of a randomized, controlled trial with three study arms and the other group (Group B) consisting of a single arm. The study will involve adults living with HIV with a history of nonresponse to hepatitis B (HBV) vaccination (Group A HBV vaccine-experienced) and adults living with HIV with no known prior history of HBV vaccination (Group B HBV vaccine-naïve). Participants in Group A will be randomized 1:1:1 to receive HEPLISAV-B (Arms 1 [two doses] and 2 [three doses]) or ENGERIX-B (Arm 3 [three doses]). Participants in Group B will receive HEPLISAV-B. The study will compare the week 12 seroprotection of a two-dose regimen of HEPLISAV-B (Group A, Arm 1) versus the week 28  seroprotection of a standard three-dose regimen of ENGERIX- B (Group A, Arm 3) in hepatitis B virus (HBV) vaccine-experienced participants living with HIV (Group A).</p>\n</div>\n<p>\n <br clear=\"all\" />\n  </p>\n
      • study_title<p>\n  B-ENHANCEMENT OF HBV VACCINATIONIN PERSONS LIVING WITH HIV (BEe-HIVe) EVALUATION OF HEPLISAV-B,A5379</p>\n
      • laymans_summary<p>\n The best way to protect people from getting Hepatitis B virus (a virus that destroy the liver) is by injecting them with a vaccine that prevents against this virus. It is advisable to inject the vaccine to all people living with HIV. Unlike people who are not infected with HIV, those that are infected with HIV respond poorly to the vaccine that is currently approved for use. Despite using different methods to try to make the currently approved vaccine to work better among people living with HIV, it has not been possible. This study will be looking at a new vaccine called HEPLISAV-B® vaccine by Dynavax Technologies Corporation. This HEPLISAV-B® vaccine has been shown to be better than the currently approved Hepatitis Vaccine (ENGERIX-B) when used in people living with HIV. This HEPLISAV-B® vaccine is given as an injection to the muscle in two doses; the first as a start, then again after one month from the first injection. The study will involve adults living with HIV with a history of having been vaccinated but did not respond to hepatitis B vaccination (Group A HBV vaccine-experienced) and adults living with HIV with no known prior history of HBV vaccination (Group B HBV vaccine-naïve). Participants in Group A will be randomized 1:1:1 to receive HEPLISAV-B (Arms 1 [two doses] and 2 [three doses]) or ENGERIX-B (Arm 3 [three doses]). Participants in Group B will receive HEPLISAV-B. To carry out this study, the Kericho site will enroll up to 50 participants and the participants will be recruited from the hospitals that treat people that are infected with HIV in the region. The participants will be enrolled into one of the three groups in the study. The study will compare to see if the new vaccine is better in preventing people living with HIV from getting Hepatitis B virus that the one currently approved for use. The participants will be followed for 72 weeks from the time they have been enrolled into the study.</p>\n<p>\n  </p>\n<p>\n <br />\n  </p>\n<p>\n  </p>\n
      • short_titleBEe-HIVe
      • protocol_noECCT/20/09/02
      • version_no1.0
      • date_of_protocol11-10-2019
      • study_drugHEPLISAV-B
      • disease_conditionHEPATITIS B
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameENGERIX-B
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressKericho.DRS@usamru-k.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
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      • 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_applicantDR JOSPHAT KOSGEI
      • declaration_date103-09-2020
      • declaration_principal_investigatorDR JOSPHAT KOSGEI
      • declaration_date203-09-2020
      • placebo_presentNo
      • study_objectives<h3>\n 1.1.1To compare the week 12 SPR of a two-dose regimen of HEPLISAV-B (Group A, Arm 1) versus the week 28 SPR of a standard three-dose regimen of ENGERIX- B (Group A, Arm 3) in hepatitis B virus (HBV) vaccine-experienced participants living with HIV (Group A).</h3>\n<h3>\n 1.1.2To compare the week 28 SPR of a three-dose regimen of HEPLISAV-B (Group A, Arm 2) versus a standard three-dose regimen of ENGERIX-B (Group A, Arm3) in HBV vaccine-experienced participants living with HIV (Group A).</h3>\n<h3>\n 1.1.3To determine the week 28 SPR of a three-dose regimen of HEPLISAV-B in HBV vaccine-naïve participants living with HIV (Group B).</h3>\n<h3>\n 1.1.4To describe adverse events (AEs) reported in each study arm (Groups A and B, separately) over the duration of the study.</h3>\n
      • principal_inclusion_criteria<ul>\n <li>\n You have HIV-1 infection</li>\n <li>\n You should have been on ART for more than 56 days.</li>\n <li>\n You are a man or woman aged 18 to 70 years</li>\n <li>\n You received Hepatitis B vaccine more than 6 months ago with no protection (group A) or have not received hepatitis B vaccine (group B)</li>\n <li>\n You are not pregnant or not planning to get pregnant while on study.</li>\n <li>\n You have viral load of less than 1000 copies/mL within 180 days prior to study entry.</li>\n <li>\n You have CD4 of more than 100cells/mm³ within 180 days prior to study entry.</li>\n <li>\n Ability and willingness to provide informed consent.</li>\n <li>\n You are willing to be contacted by telephone while on study.</li>\n <li>\n Have acceptable laboratory values obtained within 45 days prior to study entry.</li>\n <li>\n If participating in sexual activity that could lead to pregnancy, you must agree that to use acceptable method of family planning.</li>\n</ul>\n
      • principal_exclusion_criteria<ul>\n <li>\n Serious illness.</li>\n <li>\n Known allergy/sensitivity.</li>\n <li>\n Active drug or alcohol use.</li>\n <li>\n Currently receiving medicines that are not allowed by study.</li>\n <li>\n Currently breastfeeding or planning to get pregnant during the study.</li>\n <li>\n Planning to discontinue ART during the study.</li>\n <li>\n Hepatitis B vaccination ≤168 days prior to study entry (group A)</li>\n <li>\n Received HEPLISAV-B vaccine at any time prior to study entry (group A)</li>\n <li>\n Infection or prior exposure to HBV any time prior to or at screening.</li>\n</ul>\n<p style=\"margin-left:58.0pt;\">\n  </p>\n<p style=\"margin-left:58.0pt;\">\n  </p>\n<p>\n  </p>\n<p style=\"margin-left:58.0pt;\">\n  </p>\n
      • primary_end_points<h3>\n 1.1.1To compare SPR and GMT at weeks 4, 8, 12, 24, 28, 32, 48, and 72 with HEPLISAV-B in HBV vaccine-experienced participants (Group A, Arm 2) to HBV vaccine-naïve participants living with HIV (Group B).</h3>\n<h3>\n 1.1.2To compare HBV surface antigen-specific B and T-cell responses, including cell function and phenotype, at baseline and at weeks 12 and 28 with three doses of HEPLISAV-B (Group A, Arm 2) to a standard three-dose regimen of ENGERIX-B (Group A, Arm 3) in HBV vaccine-experienced participants living with HIV (Group A).</h3>\n<h3>\n 1.1.3To compare innate immune soluble factors at baseline and approximately 24 hours after the first dose of HEPLISAV-B (Group A, Arm 2) and the first dose of ENGERIX-B (Group A, Arm 3) in HBV vaccine-experienced participants living with HIV (Group A).</h3>\n<h3>\n 1.1.4To identify specific genes/gene sets via RNA sequencing (RNA-Seq) at approximately 24 hours after vaccination that differ from baseline and adaptive cell phenotypes at weeks 12 and 24 that are associated with SPR and GMT with HEPLISAV-B (Group A, Arm 2) compared to ENGERIX-B (Group A, Arm 3) in HBV vaccine-experienced participants living with HIV (Group A).</h3>\n<h3>\n 1.1.5To analyze single-nucleotide polymorphisms (SNPs) in TLR-9 and assess their associations with baseline and vaccine-induced responses (Group A; Arms 2 and 3).</h3>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence1
      • 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_confirmatory1
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p style=\"margin-left:6.0pt;\">\n The U.S. Army Medical Research Directorate-Africa (USAMRD-A) is a Special Foreign Activity of the Walter Reed Army Institute of Research (WRAIR), Washington, DC. USAMRD- K is affiliated through a Cooperative Agreement with the Kenya Medical Research Institute (KEMRI). The unit was activated on a temporary basis in 1969 at the invitation of the Government of Kenya to study trypanosomiasis. The success of that initial venture led to the establishment of a permanent activity in 1973. Over the past 46 years, research has been conducted on malaria, polio, trypanosomiasis, leishmaniasis, entomology, HIV/AIDS, enteric diseases and arboviruses, with more than 250 manuscripts published.</p>\n<p style=\"margin-left:6.0pt;\">\n The Kericho CRC is equipped with two emergency rooms (one per floor) equipped with equipment and medications to provide immediate emergency care in the event of emergencies such as anaphylaxis during vaccinations. Additionally, the Kericho site has a standby, fully equipped ambulance for evacuation of participants for more specialized care when necessary. The study staff (clinicians/nurses) are trained on handling emergencies.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Has been done at the country of sponsor.</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 Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration72 weeks
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorENGERIX B
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_area KEMRI/KERICHO CLINIC RESEARCH CENTRE
      • single_site_physical_addressOFF HOSPITAL ROAD
      • single_site_contact_personDR. JOSPHAT KOSGEI
      • single_site_telephone0729110122
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states5
      • number_of_sites
      • multi_country_listKenya,Peru, Thailand, Uganda, and Zimbabwe.
      • data_monitoring_committeeYes
      • total_enrolment_per_siteonly one site that is KERICHO - 50
      • total_participants_worldwide634
      • 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_patientsNo
      • 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_othersYes
      • subjects_others_specifyHIV POSITIVE PARTICIPANTS
      • investigator1_given_nameJOSPHAT
      • investigator1_middle_name
      • investigator1_family_nameKOSGEI
      • investigator1_qualificationMBCHB, MSC, DLSHTM
      • investigator1_professional_addressKEMRI WRP KERICHO
      • investigator1_telephone254729110122
      • investigator1_emailjosphat.kosgei@usamru-k.org
      • organisations_transferred_No
      • number_participants50
      • notification
      • approval_date27-11-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-09-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy has been approved by the Expert committee members
      • final_report<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"702\">\n <tbody>\n <tr>\n <td style=\"width:702px;height:119px;\">\n <p>\n A5379 was a phase 3, open label, randomized clinical trial included people with HIV receiving antiretroviral therapy (CD4 cell count ≥100 cells/μL and HIV RNA <1000 copies/mL) without past or present serological evidence of having HBV or a response to hepatitis B vaccine. From December 2020 to February 2023, 561 adults were enrolled in the study at 41 sites in 10 countries in Africa, Asia, North America, and South America with follow-up for the primary outcome analysis through September 4, 2023.</p>\n <p>\n The objective was to compare the seroprotection response achieved with a 2-dose (noninferiority, 10% margin) and a 3-dose hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG vaccine) vs a conventional 3-dose hepatitis B vaccine with an aluminum hydroxide adjuvant (HepB-alum vaccine) in people with HIV and prior nonresponse to HepB-alum vaccine.</p>\n <p>\n Participants were randomly assigned to receive 2 doses of HepB-CpG vaccine administered intramuscularly at weeks 0 and 4; 3 doses of HepB-CpG vaccine administered intramuscularly at weeks 0, 4, and 24; or 3 doses of HepB-alum vaccine administered intramuscularly at weeks 0, 4, and 24.</p>\n <p>\n  The primary outcome was a seroprotection response to hepatitis B vaccine (defined as level of antibody titer against hepatitis B surface antigen [HBsAg] ≥10 mIU/mL) at week 12 for the 2-dose regimen (8 weeks after dose 2) and at week 28 for 3-dose regimens (4 weeks after dose 3). Key secondary outcomes included seroprotection response at additional time points, antibody titer against HBsAg, and adverse events within 4 weeks of hepatitis B vaccination.</p>\n <p>\n Of 561 participants included in the analysis (median age, 46 years [IQR, 31-56 years]); 64% were male; 17% of participants were Asian, 42% were Black, and 35% were White), a seroprotection response was achieved in 93.1% who received 2 doses of HepB-CpG vaccine (n = 174), in 99.4% who received 3 doses of HepB-CpG vaccine (n = 169), and in 80.6% who received 3 doses of HepB-alum vaccine (n = 165). The stratified difference in seroprotection response between the 2-dose HepB-CpG vaccine group and the 3-dose HepB-alum vaccine group was 12.5% (97.5% CI, 4.1%-20.9%), achieving noninferiority and indicating superiority. The 3-dose HepB-CpG vaccine regimen was superior to the 3-dose HepB-alum vaccine regimen (stratified difference in seroprotection response, 18.4% [repeated 97.5% CI, 10.4%-26.2%]). By week 12, more than 90% of participants who received HepB-CpG vaccine achieved a seroprotection response. The 3-dose regimen of HepB-CpG vaccine achieved a higher proportion of participants with antibody titer against HBsAg greater than 1000 mIU/mL (78.1%) vs the other 2 regimen groups (26.4% for 2 doses of HepB-CpG vaccine and 35.2% for 3 doses of HepB-alum vaccine). No unexpected safety issues were observed.</p>\n <p>\n Among people with HIV and nonresponse to prior hepatitis B vaccination, both the 2-dose and 3-dose regimens of HepB-CpG vaccine achieved a superior seroprotection response compared with 3 doses of HepB-alum vaccine.</p>\n <p>\n In conclusion, this study shows that vaccination with HepB-CpG achieves high seroprotection in PWH, which supports use of HepB-CpG as a primary vaccine series in this population. Two doses are highly immunogenic, and further study will show if 3 doses extends the durability of antibody titers.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • implication_results<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" width=\"702\">\n <tbody>\n <tr>\n <td style=\"width:702px;height:119px;\">\n <p>\n <strong>ACTG A5379 demonstrated that HepB-CpG (or Heplisav-B ® ) was superior in achieving a Sero protection response to conventional vaccine (brand name Engerix® ) for people with no prior response to HBV vaccine. It also found high levels of Sero protection in people who had not received HBV vaccine before.</strong></p>\n <p>\n A5379 was a phase 3, open label, randomized clinical trial included people with HIV receiving antiretroviral therapy (CD4 cell count ≥100 cells/μL and HIV RNA <1000 copies/mL) without past or present serological evidence of having HBV or a response to hepatitis B vaccine. From December 2020 to February 2023, 561 adults were enrolled in the study at 41 sites in 10 countries in Africa, Asia, North America, and South America with follow-up for the primary outcome analysis through September 4, 2023.</p>\n <p>\n The objective was to compare the seroprotection response achieved with a 2-dose (noninferiority, 10% margin) and a 3-dose hepatitis B vaccine with a cytosine phosphoguanine adjuvant (HepB-CpG vaccine) vs a conventional 3-dose hepatitis B vaccine with an aluminum hydroxide adjuvant (HepB-alum vaccine) in people with HIV and prior nonresponse to HepB-alum vaccine.</p>\n <p>\n Participants were randomly assigned to receive 2 doses of HepB-CpG vaccine administered intramuscularly at weeks 0 and 4; 3 doses of HepB-CpG vaccine administered intramuscularly at weeks 0, 4, and 24; or 3 doses of HepB-alum vaccine administered intramuscularly at weeks 0, 4, and 24.</p>\n <p>\n  The primary outcome was a seroprotection response to hepatitis B vaccine (defined as level of antibody titer against hepatitis B surface antigen [HBsAg] ≥10 mIU/mL) at week 12 for the 2-dose regimen (8 weeks after dose 2) and at week 28 for 3-dose regimens (4 weeks after dose 3). Key secondary outcomes included seroprotection response at additional time points, antibody titer against HBsAg, and adverse events within 4 weeks of hepatitis B vaccination.</p>\n <p>\n Of 561 participants included in the analysis (median age, 46 years [IQR, 31-56 years]); 64% were male; 17% of participants were Asian, 42% were Black, and 35% were White), a seroprotection response was achieved in 93.1% who received 2 doses of HepB-CpG vaccine (n = 174), in 99.4% who received 3 doses of HepB-CpG vaccine (n = 169), and in 80.6% who received 3 doses of HepB-alum vaccine (n = 165). The stratified difference in seroprotection response between the 2-dose HepB-CpG vaccine group and the 3-dose HepB-alum vaccine group was 12.5% (97.5% CI, 4.1%-20.9%), achieving noninferiority and indicating superiority. The 3-dose HepB-CpG vaccine regimen was superior to the 3-dose HepB-alum vaccine regimen (stratified difference in seroprotection response, 18.4% [repeated 97.5% CI, 10.4%-26.2%]). By week 12, more than 90% of participants who received HepB-CpG vaccine achieved a seroprotection response. The 3-dose regimen of HepB-CpG vaccine achieved a higher proportion of participants with antibody titer against HBsAg greater than 1000 mIU/mL (78.1%) vs the other 2 regimen groups (26.4% for 2 doses of HepB-CpG vaccine and 35.2% for 3 doses of HepB-alum vaccine). No unexpected safety issues were observed.</p>\n <p>\n Among people with HIV and nonresponse to prior hepatitis B vaccination, both the 2-dose and 3-dose regimens of HepB-CpG vaccine achieved a superior seroprotection response compared with 3 doses of HepB-alum vaccine.</p>\n <p>\n <strong>In conclusion, this study shows that vaccination with HepB-CpG achieves high seroprotection in PWH, which supports use of HepB-CpG as a primary vaccine series in this population. Two doses are highly immunogenic, and further study will show if 3 doses extends the durability of antibody titers.</strong></p>\n <p>\n <strong>ACTG A5379 demonstrated that HepB-CpG (or Heplisav-B ® ) was superior in achieving a Sero protection response to conventional vaccine (brand name Engerix® ) for people with no prior response to HBV vaccine. It also found high levels of Sero protection in people who had not received HBV vaccine before.</strong></p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • quantity_imported90 HEPLISAV-B 50 ENGERIX-B
      • quantity_dispensed50 HEPLISAV-B 16 ENGERIX-B
      • quantity_destroyed40 HEPLISAV-B 34 ENGERIX-B
      • quantity_exported0 HEPLISAV-B 0 ENGERIX-B
      • balance_site0 HEPLISAV-B 0 ENGERIX-B
      • final_date2025-07-15 10:09:56
      • modified2025-07-15 10:09:56
      • created2020-09-02 13:21:52
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id579
        • application_id936
        • given_nameJOSPHAT
        • middle_name
        • family_nameKOSGEI
        • qualificationMBCB MSC DLSHTM
        • professional_address1357 KERICHO
        • telephone0729110122
        • emailjosphat.kosgei@usamru-k.org
        • created2020-09-02 14:29:08
        • modified2020-09-03 21:33:03
    • SiteDetail(array)
      • 0(array)
        • id807
        • application_id936
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-09-02 14:29:08
        • modified2020-09-03 21:33:03
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id452
        • application_id936
        • sponsorNational Institute of Allergy and Infectious Diseases
        • sponsor_typeOthers
        • contact_person
        • addressBethesda
        • telephone_number301-761-7336
        • fax_number
        • cell_number301-761-7336
        • email_addresskenneth.sherman@uc.edu
        • created2020-09-02 14:29:08
        • modified2020-09-03 21:33:03
  • 2(array)
    • Application(array)
      • id933
      • user_id73
      • trial_status_id7
      • abstract_of_study<p>\n Pre-Exposure Prophylaxis (PrEP) is a new HIV prevention method that works when taken as recommended. To take full advantage of public health benefit of PrEP for HIV prevention, there is need to prioritize access, minimize costs of delivery, and reach out to at-risk populations. In Africa, PrEP is being added to a public health infrastructure which is sometimes burdened by overcrowding and drug stock outs; the ability of health systems to maximize PrEP access necessitates finding novel delivery strategies. Additionally, there exist major barriers to PrEP delivery, which includes stigma, long waiting times, costs of staffing and healthcare providers’ unfamiliarity with delivering prevention interventions. In Kenya, and many other resource-limited countries, retail pharmacies (i.e., chemists) fill an important gap in the health care system providing first stop access to treatment, monitoring and preventive care of urgent and prolonged conditions. Potential PrEP users may desire pharmacy-delivered PrEP over facility-delivered PrEP for reasons including increased convenience, increased privacy and greater engagement compared to health facilities that focus on treating ill patients. Retail pharmacies can offer free, subsidized or affordable healthcare services. The core components of PrEP – including HIV testing, adherence and risk reduction counselling, assessment of side effects and provision of refills – are within the scope of practice for pharmaceutical technologists and pharmacists in Kenya. From prior formative qualitative research and a stakeholder meeting, we have developed a care pathway for pharmacy-based PrEP delivery (including initiation and refills), endorsed for piloting in a consultation meeting that included a wide spectrum of regulatory, professional, government, and community stakeholders in Kenya. We plan to pilot this care pathway in four retail pharmacies in Thika, Kenya. Additionally, we plan to probe for potential weak points of pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs.</p>\n
      • study_title<p>\n <strong>Pharmacy delivery to expand the reach of PrEP in Kenya: </strong><strong><em>Pilot study</em></strong></p>\n<p>\n  </p>\n
      • laymans_summary<p>\n Pre-exposure prophylaxis (PrEP) is a powerful HIV prevention tool; PrEP delivery in low resource settings will require approaches that are time- and cost-efficient, for patients, care providers, and the health care system. In this highly innovative study, we propose a new delivery model for PrEP delivery that has never been explored in an African setting: pharmacy-based PrEP delivery (with remote physician oversight). Through formative research, we have developed a care pathway for pharmacy-based PrEP delivery than we plan on pilot testing in four Kenyan pharmacies. We hypothesize that pharmacy-based PrEP delivery will be acceptable and feasible in Kenya and that individuals who uptake PrEP in pharmacies will be retained in care.</p>\n<p>\n  </p>\n
      • short_titlePrEP in Pharmacy - PILOT STUDY
      • protocol_noECCT/20/09/01
      • version_no1.4
      • date_of_protocol23-07-2020
      • study_drugPrEP in Pharmacy - PILOT STUDY
      • 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_nameTDF/FTC
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@pipsthika.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_addendum0
      • 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_applicantPeter Mogere
      • declaration_date126-08-2020
      • declaration_principal_investigatorProf. Kenneth Ngure
      • declaration_date226-08-2020
      • placebo_presentNo
      • study_objectives<ol>\n <li>\n To test pathways for pharmacy-based PrEP delivery – both initiation and refill – through pilot studies.</li>\n <li>\n To identify weak points for pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs. </li>\n <li value=\"3\">\n To understand the potential impact of the COVID-19 pandemic on the uptake and continuation of pharmacy-based PrEP delivery.</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<h4>\n Eligibility for participants accessing PrEP in Retail Pharmacy:</h4>\n<ul>\n <li style=\"margin-left: 8.3pt;\">\n <u>></u>18 years</li>\n <li style=\"margin-left: 8.3pt;\">\n Interested in initiating PrEP at a pilot pharmacy</li>\n <li style=\"margin-left: 8.3pt;\">\n Meets all criteria (e.g., tests HIV-negative) for PrEP initiation on the checklist</li>\n <li style=\"margin-left: 8.3pt;\">\n Able & willing to provide written informed consent</li>\n</ul>\n<p style=\"margin-left: 8.3pt;\">\n Eligibility for pharmacy providers</p>\n<ul>\n <li style=\"margin-left: 8.3pt;\">\n <u>></u>18 years</li>\n <li style=\"margin-left: 8.3pt;\">\n Provides PrEP at a pilot pharmacy</li>\n <li style=\"margin-left: 8.3pt;\">\n Able & willing to provide consent</li>\n <li style=\"margin-left: 8.3pt;\">\n properly licensed with a fulltime licensed pharmacy provider</li>\n <li style=\"margin-left: 8.3pt;\">\n have a private counseling space where HIV testing and PrEP counseling can occur, and</li>\n <li style=\"margin-left: 8.3pt;\">\n must be already certified to provide provider-assisted HIV self-testing</li>\n</ul>\n<h4>\n Eligibility for participants accessing PrEP in CCC clinic:</h4>\n<ul>\n <li style=\"margin-left: 8.3pt;\">\n <u>></u>18 years</li>\n <li style=\"margin-left: 8.3pt;\">\n Initiated PrEP at a project-affiliated CCC</li>\n <li style=\"margin-left: 8.3pt;\">\n Meets all criteria (e.g., tests HIV-negative) for PrEP refill on the checklist</li>\n <li style=\"margin-left: 8.3pt;\">\n Able & willing to provide written informed consent</li>\n</ul>\n<p>\n <strong>Eligibility for Remote oversight clinicians</strong></p>\n<ul>\n <li style=\"margin-left: 8.3pt;\">\n <u>></u>18 years</li>\n <li style=\"margin-left: 8.3pt;\">\n PrEP clinician at a project-affiliated CCC who provides remote oversight to a pilot pharmacy</li>\n <li style=\"margin-left: 8.3pt;\">\n Able & willing to provide consent</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n Not meeting the principal inclusion criteria</p>\n
      • primary_end_points<ol>\n <li>\n PrEP Initiation : - Number of participants that initiated PrEP at Pilot pharmacies</li>\n <li>\n PrEP Retention : - % of participants who return to the pilot pharmacies (or CCC) for PrEP refills</li>\n <li>\n Selection of pharmacy-based PrEP : - % of participants who initiated PrEP at CCC and selected pharmacy-based PrEP refills</li>\n <li>\n PrEP Adherence: -</li>\n</ol>\n<ul>\n <li>\n % of participants that missed no pills in previous week</li>\n <li>\n % of participants that refill drugs at pharmacy</li>\n <li>\n % of DBS samples with drug concentrations indicating adherence</li>\n</ul>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • 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_specifyPROGRAMMATIC DELIVERY OF PrEP IN RETAIL PHARMACIES
      • 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:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n KEMRI-CCR Partners in Health & Research Development - PHRD Thika Project, has 64 full time clinical trial staff (including physicians, nurses, counsellors, pharmacist, pharmaceutical technologists, clinical officers, social scientists, administrative staff etc).</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Principal Investigator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Co - Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Co - Investigator:               Dr. Elizabeth Irungu MBChB, MPH</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Coordinator: Dr. Catherine Kiptinness, BPharm, MPH</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Study Coordinator/Regulatory - Peter Mogere, DPharm</p>\n
      • other_details_explanation<p>\n Maximizing access, minimizing costs of delivery, and reaching at-risk populations are key priorities for optimizing the public health impact of pre-exposure prophylaxis (PrEP) for HIV prevention. In Africa, PrEP is being added to an already-burdened public health infrastructure and the ability of the health systems to maximize PrEP access will necessitate finding novel delivery strategies. In feasibility evaluations of PrEP in Africa to date, major barriers to PrEP delivery include stigma, long waiting times, the costs of staffing, and healthcare providers’ unfamiliarity with delivering prevention interventions.</p>\n<p>\n In Kenya, retail pharmacies fill an important gap in the health care system, providing access to treatment of urgent conditions (e.g., evaluation and medication for STIs, upon presentation of a valid prescription), monitoring of chronic conditions (e.g., blood pressure testing), and preventative care (e.g., contraception). HIV testing is also now legally allowed at pharmacies through purchase of HIV self-tests or pharmacy provider-assisted HIV self-testing. Pharmacy-delivered care has many attributes that may be desirable for potential PrEP users, including convenience (as pharmacies outnumber clinics and have shorter waiting times), anonymity (compared to seeking PrEP at an HIV care center), and engagement (which may be greater for a preventative service at a pharmacy than at a clinic that prioritizes treating ill individuals). Pharmacies can offer free, subsidized, or fully fee-for-service care, and paying for a service could result in greater sustained consumer engagement. </p>\n
      • other_details_regulatory_notapproved<p>\n NACOSTI - 25th August 2020</p>\n
      • other_details_regulatory_approved<p>\n University of Washington IRB - Approved on 19th May 2020</p>\n<p>\n Two sites approved - Kisumu & Thika</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration2 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-CCR PHRD (THIKA) PROJECT
      • single_site_physical_addressOAU ROAD, THIKA SECTION 9
      • single_site_contact_personProf. Kenneth Ngure
      • single_site_telephone0722362219
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_siten/a
      • total_participants_worldwide300
      • 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_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameJared
      • investigator1_middle_nameMurray
      • investigator1_family_nameBaeten
      • investigator1_qualificationMD, PhD
      • investigator1_professional_addressUniversity of Washington, Box 359927; 325 Ninth Avenue, Seattle Washington 98104
      • investigator1_telephone206 520 3808
      • investigator1_emailjbaeten@uw.edu
      • organisations_transferred_Yes
      • number_participants300
      • notification
      • approval_date28-10-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted01-09-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy has been approved by the expert committee
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-03-25 09:09:39
      • created2020-08-25 11:32:49
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id577
        • application_id933
        • given_nameKenneth
        • middle_nameKairu
        • family_nameNgure
        • qualificationMSc. MPH, PhD
        • professional_address19865
        • telephone0722362219
        • emailk_ngure@hotmail.com
        • created2020-08-26 15:09:05
        • modified2020-09-01 12:32:41
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      • 0(array)
        • id805
        • application_id933
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        • misc(null)
        • created2020-08-26 15:09:05
        • modified2020-09-01 12:32:41
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id450
        • application_id933
        • sponsorUniversity of Washington
        • sponsor_typeResearch Institution
        • contact_personProf. Kenneth Ngure
        • address19865
        • telephone_number067 2222561
        • fax_number
        • cell_number0722362219
        • email_addressk_ngure@hotmail.com
        • created2020-08-26 15:09:05
        • modified2020-09-01 12:32:41
  • 3(array)
    • Application(array)
      • id934
      • user_id612
      • trial_status_id5
      • abstract_of_study<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Study description:</strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n <strong><u>Hypothesis:</u></strong> Low-dose radiation therapy (LDRT) improves clinical, radiographic, and immune outcomes in hospitalized patients with covid-19 pneumonia and severe acute respiratory syndrome.</p>\n <p>\n This study investigates LDRT as a selectively localized anti-inflammatory treatment to induce focal suppression of pulmonary immuno-toxicity within viral pneumonia infiltrates in hospitalized patients with COVID19.</p>\n <p>\n  </p>\n <p>\n <strong><u>Study: </u></strong>Administration of low dose whole lung radiotherapy (LDRT) for the treatment of severe COVID 19 pneumonia in patients on or requiring mechanical ventilation</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Objectives:</strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n To investigate safety and feasibility (primary endpoint) of low dose whole-lung radiation therapy (LDRT) in critically-ill patients with COVID-19 pneumonia, and to explore secondary efficacy endpoints: (1) clinical, (2) respiratory, and (3) outcome</p>\n <p>\n <strong><u>Primary Objective:</u></strong></p>\n <ol>\n <li>\n To assess the feasibility and safety of administering LDRT to patients with severe Covid 19 pneumonia</li>\n <li>\n To assess the toxicity of a single dose of LDRT administered to patients with severe Covid 19 pneumonia</li>\n </ol>\n <p>\n <strong><u>Secondary Objective:</u></strong></p>\n <ol>\n <li>\n Improvement in oxygen requirement at 3 days following LDRT</li>\n <li>\n Ability to come off mechanical (or avoid mechanical) ventilation within 7 days following LDRT</li>\n <li>\n Discharge by 14d and 28d following LDRT</li>\n <li>\n Death by 14d and 28d following LDRT</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Endpoints</strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n Primary</p>\n <ol>\n <li>\n Safety/Feasibility – ability to complete LDRT without treatment related SAE</li>\n <li>\n Toxicity – vital signs to assess clinical and respiratory status at 24h following LDRT</li>\n </ol>\n <p>\n Secondary</p>\n <ol>\n <li>\n Efficacy - ability to be weaned off pre-LDRT ventilatory or oxygen support at 3d post LDRT</li>\n <li>\n Efficacy – ability to come off (or avoid) ventilatory support at 7d post LDRT</li>\n </ol>\n <ol>\n <li value=\"3\">\n Efficacy - discharge or death by 14d / 28d post LDRT</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>SAMPLE SIZE</strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n Up to 20 participants will be enrolled on this study.</p>\n <ul>\n <li>\n Cohort 1 (pre-Vent): Up to 10 participants</li>\n <li>\n Cohort 2 (on-Vent): Up to 10 participants</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Study population</strong></p>\n </td>\n <td style=\"width:492px;\">\n <ol>\n <li>\n Patient with rtRTPC and Xray/CT proven Covid 19 pneumonia who have not responded to conventional therapy and:</li>\n </ol>\n <p style=\"margin-left:18.0pt;\">\n Cohort 1: would need mechanical ventilation if condition worsens (pre-Vent)</p>\n <p style=\"margin-left:18.0pt;\">\n Cohort 2: has been on mechanical ventilation, but for not more than 5 days (on-Vent)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Phase: </strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n Pilot Phase 1b/2 study</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Description of sites/facilities enrolling patients:</strong></p>\n </td>\n <td style=\"width:492px;\">\n <ol>\n <li>\n AKUHN – a collaborative effort of the Clinical Research Unit, dept. of hematology-oncology (radiation therapy section), infectious diseases, critical care</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Description of study intervention:</strong></p>\n </td>\n <td style=\"width:492px;\">\n <ol>\n <li>\n Single dose of 100 cGy LDRT administered to both lungs within 48h of determining eligibility</li>\n <li>\n Cohort 1 : 5 patients will be treated. If acute treatment related SAE is observed in ≤1 of 5 patients, additional 5 patients will be treated.</li>\n <li>\n Cohort 2 : 5 patients will be treated. If acute treatment related SAE is observed in ≤1 of 5 patients, additional 5 patients will be treated.</li>\n </ol>\n <p style=\"margin-left:18.0pt;\">\n If  > 1 of the initial 5 patients in either cohort experiences acute treatment related SAE, enrollment to that cohort will be halted.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Study Duration:</strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n 3 months</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Participant duration:</strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n 28d from enrollment</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • study_title<p>\n <strong>A pilot phase Ib/II study of whole-lung low dose radiation therapy (LDRT) in the treatment of severe Covid 19 pneumonia patients on (or requiring) mechanical ventilatory support</strong></p>\n
      • laymans_summary<p style=\"margin-left:50.2pt;\">\n This research study is designed to find out if low dose radiation therapy can be safely be administered to patient with severe Covid 19 pneumonia and if this can help improve outcomes in critically ill patients with COVID-19. It is believed radiation will help improve the excess inflammation in the lungs that occurs as a complication of COVID-19. The low dose radiation is much lower than is used in the treatment of other conditions and it is believed that it will  not have significant side effects, and the risk  will be much less than that of worsening Covid 19 pneumonia which can be life threatening. 20 subjects will participate in this study. Study site will be at Aga Khan University, Nairobi</p>\n
      • short_titleLOW DOSE RADIATION THERAPY
      • protocol_noECCT/20/08/04
      • version_no2
      • date_of_protocol24-08-2020
      • study_drugN/A
      • disease_conditionCOVID 19
      • 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_nameRadiotherapy
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressstacey.gondi@aku.edu
      • 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_countries(null)
      • applicant_addendum0
      • 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_applicantStacey Gondi
      • declaration_date131-08-2020
      • declaration_principal_investigatorProf Mansoor Saleh
      • declaration_date231-08-2020
      • placebo_presentNo
      • study_objectives<h1>\n <span style=\"font-size:12px;\"><strong>Primary Objective</strong></span></h1>\n<ol>\n <li>\n To assess the feasibility and safety of administered LDRT to patients with severe Covid 19 pneumonia</li>\n <li>\n To assess the toxicity of a single dose of LDRT administered to patients with severe Covid 19 pneumonia</li>\n</ol>\n<h1>\n <span style=\"font-size:12px;\"><strong>Secondary Objectives</strong></span></h1>\n<ol>\n <li>\n Improvement in Oxygen requirement at 3 days following LDRT</li>\n <li>\n Ability to come off mechanical ventilation within 7 days following LDRT</li>\n <li>\n Discharge by 14d and 28d following LDRT</li>\n <li>\n Death by 14d and 28d following LDRT</li>\n</ol>\n
      • principal_inclusion_criteria<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Be age 18 or over</li>\n <li>\n Have had a positive rtPCR test confirming the diagnosis of COVID-19 from nasopharyngeal swab, Sputum or lower respiratory tract sample</li>\n <li>\n Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrolment)</li>\n <li>\n Documented pO2 < 94% while on ambient air on admission, and requires supplemental oxygen to maintain pO2 ≥ 94%.</li>\n</ol>\n<ol>\n <li>\n Cohort 1: currently not on mechanical ventilation but would need mechanical ventilation if condition worsens (pre-Vent)</li>\n <li>\n Cohort 2: currently on mechanical ventilation for ≤ 5 days (on-Vent)</li>\n</ol>\n<ol style=\"list-style-type:lower-alpha;\">\n <li value=\"5\">\n Have visible consolidations/ground glass opacities on chest x-ray or computed tomography consisted with Covid 19 pneumonia.</li>\n <li value=\"6\">\n The patient, according to the treating physician, has received medical treatment considered best practice as per the institution’s guidelines, and does not show improvement</li>\n <li value=\"7\">\n Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions.</li>\n <li value=\"8\">\n Evidence of a signed informed consent/assent indicating that the subject is aware of the infectious nature of the disease and has been informed of the procedures to be followed, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.</li>\n</ol>\n
      • principal_exclusion_criteria<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Pre-existing lung comorbidity such as severe COPD, severe uncontrolled asthma or heart failure or concomitant active systemic infection.  </li>\n <li>\n Pre-existing dependency on supplemental oxygen prior to diagnosis of Covid 19 pneumonia</li>\n <li>\n Patients on mechanical ventilation requiring 100% FIO2 and > 8mm PEEP to maintain pO2 > 94% will not be eligible</li>\n <li>\n Unwilling or unable to following protocol procedures</li>\n <li>\n Pregnant and/or planned to be pregnant within in next 6 months</li>\n <li>\n Hemodynamic and Ventilatory instability precluding transfer to Radiation Oncology department</li>\n</ol>\n
      • primary_end_points<h1>\n  </h1>\n<ol>\n <li>\n Safety/Feasibility – % patients able to complete LDRT without treatment related SAE at 24h following LDRT</li>\n <li>\n Toxicity – % patients without worsening of vital signs to assess clinical and respiratory status at 24h following LDRT (CTCAE acute toxicity criteria)</li>\n</ol>\n<h1>\n  </h1>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">The Aga Khan University Hospital, Nairobi has a Clinical Research Unit (CRU) with specific focus in conducting ICH-GCP/FDA compliant Clinical Research. The CRU is well-staffed by trained personnel with expertise in the following research related tasks:</span></span></p>\n<ul>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Clinical Research Nursing: Make CRF entries/resolve queries; Collect medical information; Vital signs; Collect adverse events; Administer IP; Collect lab samples; Participant recruitment and retention</span></span></li>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Investigational Drug Services: Manage IP receipt/return; Prepare and dispense IP; Unblinding procedures</span></span></li>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Regulatory Affairs: Maintain essential documents; Manage submissions to ethics and regulatory authorities</span></span></li>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Contracts and Budgets: Maintain legal and financial documents; Ensure appropriate invoicing to the sponsor; Ensure appropriate processes for research covered procedures versus patients’ standard of care</span></span></li>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Data Management: Make CRF entries/resolve queries; Maintain the patients’ research documents</span></span></li>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Clinical Research operations: Oversight of AKU’s Clinical Research Unit’s studies and staff; support all research staff with their tasks</span></span></li>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Investigator: Obtain Informed Consent; Assess eligibility; Make CRF entries/resolve Queries; Medical decisions/review; Collect medical information; Vital signs; Assess Ordinal Scale; Collect/Assess Adverse Events; Administer IP; Conduct Physical Exam; Collect Lab Samples; Maintain Essential Documents; IP processes</span></span></li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\"><span class=\"ms-rtethemeforecolor-2-5\">The Aga Khan University Hospital, Nairobi is home to one of the most sophisticated radiology facilities in The Aga Khan University Hospital, Nairobi is home to one of the most sophisticated radiology facilities in East and Central Africa.<br />\n The Radiology Department provides a comprehensive range of imaging services, including both routine and specialized procedures.East and Central Africa.</span></span></span><span style=\"font-size:10.5pt;font-family:\"><o:p><span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\"> </span></span></o:p></span></li>\n</ul>\n<ul>\n <li>\n <p class=\"ms-rteelement-p\" style=\"margin: 0cm 0cm 7.5pt; text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial; box-sizing: content-box; outline: 0px;\">\n  </p>\n </li>\n</ul>\n
      • other_details_explanation<p>\n N/A</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_duration3 months
      • 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_areaAga Khan University Hospital, Nairobi
      • single_site_physical_addressAga Khan University Hospital Nairobi 3rd Parklands Avenue, off Limuru Road, P 0. Box 30270, GPO 00100, Nairobi, Kenya
      • single_site_contact_personProf. Mansoor Saleh
      • single_site_telephone+254 780 428 334
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteUP TO 20
      • total_participants_worldwideUP TO 20
      • 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_consentYes
      • subjects_specifyPatients who cannot give consent will have their next of kin consent for them
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailmansoor.saleh@aku.edu
      • organisations_transferred_No
      • number_participantsUP TO 20
      • notification
      • approval_date11-11-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted31-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApplication has been approved by the Expert Committee
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2022-08-01 11:18:35
      • created2020-08-30 21:21:47
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id578
        • application_id934
        • given_namePROF. MANSOOR
        • middle_name
        • family_nameSALEH
        • qualificationMD, Professor of Medicine and Pathology
        • professional_addressAga Khan University Hospital Nairobi 3rd Parklands Avenue, off Limuru Road, P 0. Box 30270, GPO 00100, Nairobi, Kenya
        • telephone0780428334
        • emailmansoor.saleh@aku.edu
        • created2020-08-30 21:45:11
        • modified2020-08-31 22:26:53
    • SiteDetail(array)
      • 0(array)
        • id806
        • application_id934
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-08-30 21:45:11
        • modified2020-08-31 22:26:53
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id451
        • application_id934
        • sponsorN/A
        • sponsor_typeResearch Institution
        • contact_person
        • addressN/A
        • telephone_numberN/A
        • fax_number
        • cell_numberN/A
        • email_addressmansoor.saleh@aku.edu
        • created2020-08-30 21:45:11
        • modified2020-08-31 22:26:53
  • 4(array)
    • Application(array)
      • id917
      • user_id639
      • trial_status_id7
      • abstract_of_study<p>\n  </p>\n<p>\n  </p>\n<p>\n The ultimate goal of this research is to develop a means to safely administer iron supplements to infants in settings with high infection burden. The hypothesis underlying this project is that promoting development of a beneficial, protective gut microbiota by co-administration of prebiotic galacto-oligosaccharides (GOS) and iron-sequestering bovine lactoferrin (bLF) during iron supplementation will prevent iron-induced increases of opportunistic enteropathogens that cause infection and inflammation. The proposed research will extend our established strategy of conjoining investigations <em>in vivo</em> [1-3]with intestinal fermentation and cellular models <em>in vitro </em>[4-9]. We will conduct a randomized clinical trial in 6-month-old Kenyan infants in conjunction with mechanistic microbiota studies using our established long-term continuous polyfermenter platform inoculated with immobilized fecal microbiota from Kenyan infants.</p>\n<p>\n The period from about 6-12 months of age is vital both for iron nutrition [10-13]and for the establishment of a healthy gut microbiome that promotes immune system development, local immune homeostasis and limits pathogen colonization [14-19]. Oral iron supplements are associated with a significant 15% increase in the rate of diarrhea in children in malaria-endemic areas. Our most recent studies have shown that prebiotic GOS can provide partial amelioration of the adverse effects (AEs) of iron-induced dysbiosis by enhancing the growth of barrier populations of bifidobacteria and lactobacilli [20].  We hypothesize that the combination of prebiotic GOS with bLF has iron sequestration, antimicrobial and immunomodulatory activities [21-26]and will provide virtually complete protection against the AEs of added iron on the intestinal microbiota. This research has two specific aims:</p>\n<ol>\n <li>\n To conduct a randomized, controlled double-blind 9-month clinical trial in 6-month old Kenyan infants comparing the effects on gut microbiome composition among groups receiving in-home fortification for 6 months with micronutrient powders (MNPs) containing 5 mg iron (as ferrous fumarate [FeFum]) and (i) GOS (7.5 g), (ii) bLF (1 g), (iii) GOS (7.5 g) and bLF (1 g), and (iv) no GOS or bLF. Each infant will then be followed for an additional 3 months to determine the longer-term effects of the treatments.</li>\n <li>\n To examine mechanisms of prebiotic GOS and bLF on microbiota composition, enteropathogen development, microbiota functions and metabolic activity, and inflammatory potential <em>in vitro</em> with treatments paralleling those in Specific Aim 1, using immobilized fecal microbiota from Kenyan infants to inoculate our established long-term continuous polyfermenter intestinal model (PolyFermS) to mimic Kenyan infant colon conditions, together with cellular studies. </li>\n</ol>\n<p>\n  </p>\n
      • study_title<p>\n  </p>\n<p>\n <span lang=\"EN-GB\" style=\"font-size:9.0pt;font-family:"Arial",sans-serif;\ncolor:#222222;background:white;mso-ansi-language:EN-GB\">Prebiotic galacto-oligosaccharides and lactoferrin for beneficial gut microbiota with iron supplements: an intervention trial in infants in Msambweni, Kwale County, southern coastal Kenya</span></p>\n<p>\n  </p>\n
      • laymans_summary<p>\n  </p>\n<p style=\"margin-left:1.45pt;\">\n Young children being breastfed and starting to eat solid foods are at risk of having diarrhea. In our digestive system (in adults but also in infants) live many bacteria that can be good or bad for health. In some cases, the good intestinal bacteria grow poorly and bad bacteria are more numerous. This can cause diarrhea.</p>\n<p style=\"margin-left:1.45pt;\">\n With this project, we want to study the effects of adding vitamins and minerals, plus a dietary fiber, called a prebiotic, and a small protein, which is found in breast milk, called lactoferrin, to maize porridge. We want to see if giving these nutrients can improve your child’s nutrition, in particular iron, which is essential for ‘good blood’ and healthy growth and development.</p>\n<p style=\"margin-left:1.45pt;\">\n In many countries, flours and cereals already have iron, zinc and vitamins added, and these have been shown to improve health and development in children taking the foods. We need to know if making these additions to food is helpful and whether they cause good or bad intestinal bacteria to grow, and whether they can reduce diarrhea. Therefore, we will be looking at whether feeding infants porridge with these nutrients will improve their health, and also reduce the risk for diarrhea.</p>\n<p style=\"margin-left:1.45pt;\">\n The study duration is 9 months, where the participants will be visited weekly and be delivered a micronutrient powder for 6 months, which contains the vitamins, minerals and nutrients, together with 2 kg maize flour for use in the preparation of all porridge fed to the infant. Some infants will receive vitamins and minerals (plus iron), another group will additionally receive the prebiotic, a third group will additionally receive the special lactoferrin protein and a fourth group will additionally receive both the prebiotic and the lactoferrin together. Neither the participants or their caregivers nor the team working in Msambweni will know which infants are in which group. However, a committee of scientists will be receiving health reports on the children and will know which children have received the additional nutrients. If there is any reason to believe that the nutrient powder is affecting the children badly they will stop the study. After the child receives the micronutrient powders for 6 months, he/she will be followed up for 3 months to determine the long-term effects.</p>\n<p style=\"margin-left:1.45pt;\">\n The child’s health will be checked at the start of the study and regularly during the study (weekly) and we also want to measure the child’s height/length and weight. At the beginning of the study (Day 1), after 1 month (Day 30), after 6 months (Day 180) (after the child finished taking the micronutrient powder) and at the end of the study (Day 270) (9 months), the child will be asked to give a small sample of blood (the amount in a small spoon) which will be used to see if the child has enough iron in his blood. Enough iron makes a child strong. We will also look at the bacteria in child’s intestine. Caregivers will be therefore asked to collect the child’s stool sample at the beginning (Day 1), after 1 month (Day 30), after 6 months (Day 180) and at the end of the study (Day 270). Caregivers will be shown how these samples have to be collected and stored in a container adding a sachet. These samples will be tested for which bacteria are present. This will help us to observe any changes caused by the nutrient powders.</p>\n<p>\n In some of the infants, we will collect a stool sample prior to study start (Day -1). This sample will be sent to the university in Zurich, Switzerland, where we will run tests on the bacteria.</p>\n<p>\n  </p>\n
      • short_titleNIH_PREFER
      • protocol_noECCT/20/08/03
      • version_no2
      • date_of_protocol13-02-2020
      • study_drugmicronutrient powder with 5 mg of iron (nutritional supplement)
      • disease_conditionnone
      • 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_namemicronutrient powder
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressnicole.stoffel@hest.ethz.ch
      • applicant_covering_letter1
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      • declaration_applicantProf. Simon Karanja
      • declaration_date120-08-2020
      • declaration_principal_investigatorProf. Simon Karanja
      • declaration_date220-08-2020
      • placebo_presentNo
      • study_objectives<p>\n  </p>\n<p style=\"text-align:justify;line-height:150%\">\n <span lang=\"EN-GB\" style=\"font-family:\">1. To compare the effects on gut microbiome composition among infants receiving in-home fortification for 6 months with micronutrient powders containing 5 mg iron  and (i) GOS; 7.5 g, (ii) bLF, 1.0 g, (iii) GOS (7.5 g) and bLF (1.0 g), and (iv) no GOS or Blf.</span></p>\n<p style=\"text-align:justify;line-height:150%\">\n <span lang=\"EN-GB\" style=\"font-family:\">2. To examine mechanisms of iron, prebiotic GOS and iron-sequestering bLF on microbiota composition, enteropathogen development, microbiota functions and metabolic activity, and inflammatory potential in vitro with treatments paralleling those in Specific Aim 1.</span></p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n  </p>\n<p>\n Inclusion criteria will be:</p>\n<p style=\"margin-left:18.0pt;\">\n (i) vaginal or cesarean delivery,</p>\n<p style=\"margin-left:18.0pt;\">\n (ii) an infant age of 6 months (±3 weeks),</p>\n<p style=\"margin-left:18.0pt;\">\n (iii) mother ≥15 years of age,</p>\n<p style=\"margin-left:18.0pt;\">\n (iv) infant still breastfeeding, and</p>\n<p style=\"margin-left:18.0pt;\">\n (v) anticipated residence in the area for the study duration.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n  </p>\n<p>\n Exclusion criteria will be:</p>\n<p style=\"margin-left:18.0pt;\">\n (i) inability to provide informed consent,</p>\n<p style=\"margin-left:18.0pt;\">\n (ii) hemoglobin < 70 g/L,</p>\n<p style=\"margin-left:18.0pt;\">\n (iii) Z scores for weight-for-age (WAZ) or weight-for-height (WHZ) <3,</p>\n<p style=\"margin-left:18.0pt;\">\n (iv) any maternal or infant chronic illness,</p>\n<p style=\"margin-left:18.0pt;\">\n (v) administration of any vitamin or mineral supplements for the past 2 months, and</p>\n<p style=\"margin-left:18.0pt;\">\n (vi) any history of antibiotic treatment in the past 7 days.</p>\n<p>\n  </p>\n
      • primary_end_points<p>\n  </p>\n<p>\n The primary outcome measure will be the ratio of the abundances of potentially harmful (enteropathogenic and/or enterotoxigenic <em>E. coli, C. difficile</em>, members of the <em>C. perfringens group, B. cereus, S. aureus</em>, sum of <em>Shigella</em> spp., and <em>Salmonella</em>) to beneficial (bifidobacteria and the group of La<em>ctobacillus/Leuconostoc/Pediococcus </em>spp.) bacterial genera at 1 month.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • 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_other1
      • trial_other_specifynutritional supplement efficacy trial
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n SITE CAPACITY</p>\n<p>\n Number of Staff: 17</p>\n<p>\n Study Manager: Mr. Francis Mwangome Katana</p>\n<p>\n Study coordinator: Suzane Nyilima (BSc. Environmental Health, MSc. Epidemiology Student). 3years working experience</p>\n<p>\n  </p>\n<p>\n Clinicians:</p>\n<p>\n Samuel Mwakai (Diploma in clinical Medicine and surgery) 7 Years working experience</p>\n<p>\n Monica Tallam (Diploma in clinical Medicine and surgery) 8 Years working experience</p>\n<p>\n Mwanaidi Waraka (Diploma in clinical Medicine and surgery) 6 Years working experience</p>\n<p>\n Hajjra Ruhinge (Diploma in clinical Medicine and surgery) 5 Years working experience</p>\n<p>\n  </p>\n<p>\n Study Team</p>\n<p>\n Team Leader: Hamadi Mambo: (BA Business Administration) 8 Years working experience.</p>\n<p>\n Team Leader: Ngome Mgaza (certificate in Project Management and leadership, Certificate in ICH good clinical Practice E6 (R2) 10 Years working experience.</p>\n<p>\n Naomi Koech (BSc. Community Health) 1 Year working experience.</p>\n<p>\n Munaa Lila (certificate in Research and Ethics, Certificate in ICH good clinical Practice E6 (R2)</p>\n<p>\n ) 12 Years working experience</p>\n<p>\n Anna Katana (Diploma in Community Health and Development) 4 Years working experience</p>\n<p>\n Yahya Said Makokha (BA Bachelor of Commerce) 1 Year working experience.</p>\n<p>\n Abdallah Rama Mwamkumba (Community Health Volunteer) 5 Years working experience</p>\n<p>\n Hemmed Hassan Ngere (Computer packages and driving Licence) 3 Years working experience</p>\n<p>\n Nasoro Salim (p1 certificate) 3 Years working experience</p>\n<p>\n Jumaa Mwapheku (community Health Volunteer) 10 Years working experience.</p>\n<p>\n  </p>\n<p>\n Study Team Designated Driver: Shee Salim Mkulu (Driving License) 25 Years working experience.</p>\n<p>\n SITE CAPACITY</p>\n<p>\n Number of Staff: 17</p>\n<p>\n Study Manager: Mr. Francis Mwangome Katana</p>\n<p>\n Study coordinator: Suzane Nyilima (BSc. Environmental Health, MSc. Epidemiology Student). 3years working experience</p>\n<p>\n  </p>\n<p>\n Clinicians:</p>\n<p>\n Samuel Mwakai (Diploma in clinical Medicine and surgery) 7 Years working experience</p>\n<p>\n Monica Tallam (Diploma in clinical Medicine and surgery) 8 Years working experience</p>\n<p>\n Mwanaidi Waraka (Diploma in clinical Medicine and surgery) 6 Years working experience</p>\n<p>\n Hajjra Ruhinge (Diploma in clinical Medicine and surgery) 5 Years working experience</p>\n<p>\n  </p>\n<p>\n Study Team</p>\n<p>\n Team Leader: Hamadi Mambo: (BA Business Administration) 8 Years working experience.</p>\n<p>\n Team Leader: Ngome Mgaza (certificate in Project Management and leadership, Certificate in ICH good clinical Practice E6 (R2) 10 Years working experience.</p>\n<p>\n Naomi Koech (BSc. Community Health) 1 Year working experience.</p>\n<p>\n Munaa Lila (certificate in Research and Ethics, Certificate in ICH good clinical Practice E6 (R2)</p>\n<p>\n ) 12 Years working experience</p>\n<p>\n Anna Katana (Diploma in Community Health and Development) 4 Years working experience</p>\n<p>\n Yahya Said Makokha (BA Bachelor of Commerce) 1 Year working experience.</p>\n<p>\n Abdallah Rama Mwamkumba (Community Health Volunteer) 5 Years working experience</p>\n<p>\n Hemmed Hassan Ngere (Computer packages and driving Licence) 3 Years working experience</p>\n<p>\n Nasoro Salim (p1 certificate) 3 Years working experience</p>\n<p>\n Jumaa Mwapheku (community Health Volunteer) 10 Years working experience.</p>\n<p>\n  </p>\n<p>\n Study Team Designated Driver: Shee Salim Mkulu (Driving License) 25 Years working experience.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The target population for the nutritional supplements we are using in this trial are anemic infants. The burden of anemia in infancy is high in Kenya. </p>\n<p>\n We have an extensive and successful collaboration with Jomo Kenyatta University for several years. </p>\n
      • other_details_regulatory_notapproved<p>\n none</p>\n
      • other_details_regulatory_approved<p>\n ETH Ethics Commmittee May 28th 2020</p>\n<p>\n IRB Columbia University Ethics Committee April 28th 2020</p>\n
      • other_details_regulatory_rejected<p>\n none</p>\n
      • other_details_regulatory_halted<p>\n none</p>\n
      • estimated_duration5 years
      • 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_comparatorMNPs with no GOS and bLf
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaMsambweni County Referral Hospital
      • single_site_physical_addressUkunda-Ramisi Road Ramisi Kwale Kenya
      • single_site_contact_personDr. Edith Mwasi
      • single_site_telephone+254721237653
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site288
      • total_participants_worldwide288
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenNo
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • 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
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      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameSimon
      • investigator1_middle_name
      • investigator1_family_nameKaranja
      • investigator1_qualificationAssociate Professor JKUAT
      • investigator1_professional_addressSchool of Public Health Kenyatta University P. O. Box 43844 – 00100, Nairobi- Kenya
      • investigator1_telephone+254 726424669
      • investigator1_emailskaranja@jkuat.ac.ke
      • organisations_transferred_Yes
      • number_participants288
      • notification
      • approval_date21-02-2021
      • submitted1
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      • deleted_date(null)
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      • date_submitted08-10-2020
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      • modified2022-08-05 14:09:32
      • created2020-07-01 10:29:03
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        • given_nameGary
        • middle_name
        • family_nameBrittenham
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        • professional_addressNewYork-Presbyterian Morgan Stanley Children\'s Hospital 3959 Broadway New York, NY 10032
        • telephone(212) 305-7005
        • emailgmb31@cumc.columbia.edu
        • created2020-07-01 10:38:37
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        • sponsorThe National Institute of Diabetes and Digestive and Kidney Diseases-NIH
        • sponsor_typeResearch Institution
        • contact_person
        • address9000 Rockville Pike, Bethesda, Maryland 20892
        • telephone_number1-866-569-1162
        • fax_number
        • cell_number1-800-860-8747
        • email_addresshealthinfo@niddk.nih.gov
        • created2020-07-01 10:38:37
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      • 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