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  • 1Recruiting
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• applications(array)
  • 0(array)
    • Application(array)
      • id32
      • user_id38
      • trial_status_id8
      • abstract_of_study<p>\n ACTs are effective and today are considered by World Health Organization to be the best anti-malarials in terms of efficacy and a lower propensity to resistance. However, resistance to the recommended anti-malarial drugs has become a challenge and is a public health problem. Efforts are required to secure new therapies (single or in combination), which could be an alternative to standard treatment.</p>\n<p>\n The combination of AS and MQ, whether in loose or fixed combination, was the first of the artemisinin-based combinations, used extensively in Asia and Latin America, however there is very limited data on its efficacy and safety in young children in Africa.  ASMQ has a simple schedule of administration with single daily doses of one to two tablets per day according to an age-based categories, rather than weight. It is available on paediatric formulation and field-adapted packaging with 3 years of stability.</p>\n<p>\n  The proposed study will evaluate a new product, Farmanguinhos Artesunate-Mefloquine, a fixed-dosed combination of Artesunate-Mefloquine in the treatment of uncomplicated P. falciparum malaria and will also add to the scarce knowledge on efficacy, safety and pharmacokinetics of the combination in young children in Africa.  The target population in the study is under-5 children, the primary victims of malaria in the continent, with the highest burden of the disease, and which had been documented to have increased rates of vomiting with mefloquine monotherapy</p>\n
      • study_title<p>\n Efficacy, Safety and Population-Pharmacokinetics of Artesunate-Mefloquine Combination for the Treatment of Uncomplicated Falciparum Malaria in African Children versus Artemether-Lumefantrine</p>\n
      • laymans_summary(null)
      • short_titleASMQ Study
      • protocol_noECCT/10/11/03
      • version_noAmendment Version 2
      • date_of_protocol10-06-2011
      • study_drugASMQ
      • disease_conditionMalaria
      • 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_nameartesunate-mefloquine
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvictorine.owira@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_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
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      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
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      • applicant_pan_african(null)
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      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicant+254722299438
      • declaration_date113-02-2013
      • declaration_principal_investigator+254733966065
      • declaration_date213-02-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<ol>\n <li>\n <ol>\n <li>\n Age between 6 to 59 months.</li>\n <li>\n Presence of acute uncomplicated <em>P. falciparum</em> mono-infection confirmed by:</li>\n </ol>\n <ol style=\"list-style-type: lower-alpha;\">\n <li>\n Axillary temperature ³37.5° C <strong>and,</strong></li>\n <li>\n Positive microscopy of <em>P. falciparum</em> with parasite density between 2,000 and 200,000 asexual parasites/µl</li>\n </ol>\n <ol>\n <li value=\"3\">\n Written informed consent from parent/guardian</li>\n </ol>\n </li>\n</ol>\n
      • principal_exclusion_criteria<ul>\n <li>\n Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000</li>\n <li>\n Weight < 5kg</li>\n <li>\n Inability to tolerate oral medication (presence of any of the following danger signs: unable to drink or breastfeed, severe vomiting, recent history of convulsions, lethargic or unconscious state, unable to sit or stand up)</li>\n <li>\n Mixed Plasmodium infection.</li>\n <li>\n Presence of febrile conditions caused by diseases other than malaria.</li>\n <li>\n Known history of hypersensitivity, allergic or serious adverse reactions to Mefloquine, Quinine, Quinidine, Artesunate or other Artemisinins.</li>\n <li>\n History of use of any anti-malarial agent within 2 weeks prior to start of the study (except mefloquine and piperaquine within 4 weeks).</li>\n <li>\n Prior participation to a therapeutic trial within 3 months.</li>\n</ul>\n
      • primary_end_points<ul>\n <li>\n Cure Rate as determined by PCR-corrected adequate clinical and parasitological response (ACPR) on Day 63.</li>\n</ul>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • 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_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n 1 Medical Doctor</p>\n<p>\n 1 Pharmacist</p>\n<p>\n 1 pharm technicians</p>\n<p>\n 3 Laboratory technicians</p>\n<p>\n 1 Clinical Research Coordinator</p>\n<p>\n 4 Nurses</p>\n<p>\n 1 Clinical Officers/Physician Assistants</p>\n<p>\n 3 Field Officers</p>\n
      • other_details_explanation<p>\n As stated in the study title, the objective of this study is to<span new=\"\" style=\"line-height: 115%; font-family: ;\" times=\"\"><font color=\"#000000\"> compare the efficacy and safety of the fixed-dose combination of ASMQ with AM-LM in under 5 children with uncomplicated falciparum malaria in <st1:place w:st=\"on\">Africa.</st1:place></font></span></p>\n<p>\n <span new=\"\" style=\"line-height: 115%; font-family: ;\" times=\"\"><font color=\"#000000\">This is an efficacy and safety study of uncomplicated Malaria treatment. There is no Malaria in the host country so it not possible to do such a study in the host country</font></span></p>\n
      • other_details_regulatory_notapproved<p>\n 0</p>\n
      • other_details_regulatory_approved<p>\n 0</p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration63 days for each participant
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorArtemether-Lumefantrine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaThe Kenya Medical Research Institute (KEMRI), Kisumu, Kenya
      • single_site_physical_addressAlong Kisumu Nairobi Road adjacent Ahero Town
      • single_site_contact_personDr Bernhards Ogutu
      • single_site_telephone+254733812613
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states4
      • number_of_sites
      • multi_country_listGhana\nKenya\nTanzania\nBukina Faso
      • data_monitoring_committeeYes
      • total_enrolment_per_site300
      • total_participants_worldwide940
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_nameOgutu
      • investigator1_family_nameRagama
      • investigator1_qualificationMBChB, MMed(Peds), PhD
      • investigator1_professional_address54-40100 Kisumu
      • investigator1_telephone+254733812613
      • investigator1_emailbogutu@wrp-ksm.org
      • organisations_transferred_No
      • number_participants400
      • notification
      • approval_date07-02-2011
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-11-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2016-02-10 00:29:27
      • created2013-02-13 13:15:44
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id22
        • application_id32
        • given_nameBearnhards
        • middle_nameOgutu
        • family_nameRagama
        • qualificationMBChB, MMed(Peds), PhD
        • professional_address54-40100 Kisumu
        • telephone+254733812613
        • emailbogutu@wrp-ksm.org
        • created2013-02-13 13:43:26
        • modified2013-11-03 19:04:28
    • SiteDetail(array)
      • 0(array)
        • id33
        • application_id32
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-02-13 13:43:26
        • modified2013-11-03 19:04:28
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id16
        • application_id32
        • sponsorDNDi, 15 Chemin Louis Dunant.
        • sponsor_type(null)
        • contact_personGwenaelle CARN
        • address1202 GENEVA Switzerland
        • telephone_number+41 22 906 9230
        • fax_number
        • cell_number+41 22 906 9230
        • email_addressgcarn@dndi.org
        • created2013-02-13 13:43:26
        • modified2013-11-03 19:04:28
  • 1(array)
    • Application(array)
      • id1389
      • user_id567
      • trial_status_id6
      • abstract_of_study<p>\n <strong>Background</strong></p>\n<p>\n Three drug regimens for the treatment of HIV are widely used and successful in achieving viral suppression. However, they are associated with various adverse events including renal and bone disease, anemia, mitochondrial toxicity, and possible association with increased cardiovascular events. Data from the ongoing BFTAF Elderly Switch Study has demonstrated high rates of renal insufficiency and osteoporosis in people living with HIV aged 60 years or more, hence the need for safe treatment options. Two drug regimens (2DR) have demonstrated non-inferiority to three drug regimens in patients who are treatment naïve as well as in those who are virally suppressed on a first-line regimen and potentially have lower toxicity, fewer adverse drug events and a lower drug burden.</p>\n<p>\n <strong>Objectives</strong></p>\n<p>\n To assess the efficacy and safety of switch to dolutegravir and lamivudine (DTG/3TC) single tablet regimen from bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) in persons living with HIV aged 60 years old or more.</p>\n<p>\n <strong>Methods</strong></p>\n<p>\n This is a phase 3b, multi-center, open-label, single arm clinical trial over 96 weeks. The study will take place at two sites in Kenya: Kenyatta National Hospital (KNH) and Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). Study visits will take place at screening, baseline, and weeks 4, 12, 24, 36, 48, 60, 72, 84, and 96 (with a 6-week extension as required for confirming HIV-1 RNA levels). A target of 240 participants from the ongoing BFTAF Elderly Switch Study will be enrolled. Eligible participants will be switched from B/F/TAF to DTG/3TC at enrollment and followed up for 96 weeks. The primary endpoint will be the proportion of participants with plasma HIV-1 RNA ≥ 50 copies/mL (Snapshot algorithm) at Week 48. Analysis of the primary endpoint will be performed for the ITT-E population using the FDA snapshot method.</p>\n<p>\n Data Management: The collection and processing of personal data from s enrolled in this study will be limited to those data that are necessary to investigate the primary and secondary objectives. These data will be collected using electronic Case Report Forms and processed with adequate precautions to ensure confidentiality and compliance with data privacy and protection laws and regulations</p>\n<p>\n <strong>Study Utility</strong></p>\n<p>\n The Kenyan national HIV program currently recommends tenofovir disoproxil fumarate (TDF) as the preferred nucleoside reverse transcriptase inhibitor (NRTI). TDF is associated with both renal and bone toxicity and in the absence of safer tenofovir pro-drugs such as tenofovir alafenamide (TAF), it is important to consider regimens that exclude the toxic NTRIs such as the two-drug regimen of lamivudine and dolutegravir, especially in populations that are at risk of multiple comorbidities. This will provide useful data to inform policy and programming.</p>\n
      • study_title<p>\n Efficacy, Safety and Tolerability of Switching to DTG/3TC Single Tablet Regimen from B/F/TAF in Older Persons Living with HIV in Kenya</p>\n
      • laymans_summary<p align=\"center\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: center; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Efficacy, Safety and Tolerability of Switching to DTG/3TC Single Tablet Regimen from B/F/TAF in Older Persons Living with HIV in Kenya</span></strong><span style=\"font-size: 9.5pt; font-family: "Trebuchet MS", sans-serif; color: rgb(51, 51, 51);\"><o:p></o:p></span></p>\n<p style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 9.5pt; font-family: "Trebuchet MS", sans-serif; color: rgb(51, 51, 51);\"> <o:p></o:p></span></p>\n<p style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Background: </span></strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">The standard treatment for HIV comprises three or four drugs in order to achieve viral suppression. However, the use of some of these drugs may affect the kidneys, bone and other body systems. For example, an ongoing study in Kenya has demonstrated high rates of kidney and bone disease in older persons living with HIV aged 60 years old or more.<o:p></o:p></span></p>\n<p style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Recent studies have shown that two-drug regimens such as a combination of dolutegravir (DTG) and lamivudine (3TC) may achieve the same rates of viral suppression after switching from other treatment regimens containing three drugs. The use of a two-drug regimen means that there will be a lower drug burden that may have less harmful effects including improving bone health and kidney function.</span><span style=\"font-size: 9.5pt; font-family: "Trebuchet MS", sans-serif; color: rgb(51, 51, 51);\"> </span><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\"><o:p></o:p></span></p>\n<p style=\"margin-right: 0cm; margin-left: 0cm; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Objective: </span></strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">The purpose of the study is to determine whether older persons living with HIV (60 years old or above) who are currently virally suppressed on their first line antiretroviral regimen containing bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) can safely be switched to a two-drug regimen of dolutegravir (DTG) and lamivudine (3TC).<o:p></o:p></span></p>\n<p style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: "Times New Roman", serif; color: rgb(0, 0, 0); text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial;\">\n <strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">Participants and Methods: </span></strong><span style=\"font-size: 10.5pt; font-family: Arial, sans-serif; color: rgb(51, 51, 51);\">We will enroll 240 participants in two sites in Kenya: Kenyatta National Hospital in Nairobi and Jaramogi Oginga Odinga Teaching and Referral Hospital in Kisumu. After providing written informed consent, participants will be evaluated for eligibility. Those who are enrlled will have their treatment regimen changed to a combined pill containing DTG and 3TC taken once daily for the duration of the study. Thereafter, each person will be followed up for 96 weeks (about two years). All participants will have scheduled visits at weeks 4, 12, 24, 36, 48, 60, 72, 84 and 96. During follow-up, the amount of HIV virus in blood will be checked alongside other laboratory and radiological tests assessing for safety.<o:p></o:p></span></p>\n
      • short_titleB/F/TAF to DTG/3TC Switch Stud
      • protocol_noECCT/24/04/01
      • version_no1.2
      • date_of_protocol07-03-2024
      • study_drugDolutegravir (DTG) and Lamivudine (3TC)
      • 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_nameAvridela
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressloisea@uonbi.ac.ke
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_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_applicantDr Loice Achieng Ombajo
      • declaration_date103-04-2024
      • declaration_principal_investigatorDr Loice Achieng Ombajo
      • declaration_date203-04-2024
      • placebo_presentNo
      • study_objectives<p border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><b><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">Primary Objective</span></b></span><b><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></b></p>\n<p border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate the maintenance of virologic suppression of DTG/3TC at Week 48 post-switch from BIC/FTC/TAF</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></p>\n<p border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"None\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"> </span></span></p>\n<p border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><b><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">Secondary Objectives</span></b></span><b><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></b></p>\n<ul>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate the antiviral activity, immunologic effects, and incidence of disease progression (HIV-associated conditions, AIDS and death) of DTG/3TC over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To assess viral resistance in participants experiencing protocol-defined virologic failure over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate the safety and tolerability of DTG/3TC over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate the efficacy and immunologic response of DTG/3TC by participant characteristics subgroups (e.g., demographic factors, Baseline CD4, CD4 nadir) and pre-specified target population (≥65 years old, CV risk, women, co-medication) over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate renal (in urine and blood) biomarkers over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate cardiovascular risk over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate fasting lipids over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To evaluate weight and body morphology evolution over time</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To assess health-related quality of life</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n <li border:=\"\" class=\"BodyBA\" color:=\"\" new=\"\" style=\"margin: 0cm; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span class=\"NoneA\"><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\">To assess patient treatment satisfaction</span></span><span lang=\"EN-US\" style=\"font-family: Calibri, sans-serif;\"><o:p></o:p></span></li>\n</ul>\n
      • principal_inclusion_criteria<ol>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Able and willing to understand and comply with the protocol requirements, instructions and restrictions</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Able and willing to give informed consent</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Have been randomised to the B/F/TAF arm and completed the B/F/TAF-elderly study.  Participant should be on B/F/TAF until day 1 of entry into the current study</span></span></p>\n </li>\n <li>\n <p>\n <span style=\"font-size:14px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">HIV-1 RNA viral load < 50 copies/ml at screening (within 28 days prior to enrollment)</span></span></p>\n </li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Confirmed treatment failure as defined by two consecutive HIV-1 RNA viral loads ≥ 50 copies/ml separated by at least 2 weeks, after at least 6 months on ART or after a documented HIV-1 RNA viral load < 50 copies/ml</li>\n <li>\n Using any protocol-defined prohibited medicine where the participant is unwilling or unable to switch to an alternative (see Section 5.2. under Prohibited medications and non-drug therapies)</li>\n <li>\n Evidence of hepatitis B virus (HBV) infection based on the results of testing at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antibody (anti-HBs) and HBV DNA as follows:\n <ul>\n <li>\n a) Participants positive for HBsAg are excluded;</li>\n <li>\n b) Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status), whether negative or positive for HBV DNA, are excluded;</li>\n <li>\n c) Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded.</li>\n </ul>\n </li>\n <li>\n Has AST and/or ALT at least 5-times greater than the upper limit of normal</li>\n <li>\n Severe hepatic impairment (Class C) as determined by Child-Pugh classification</li>\n <li>\n Has a CrCl below 30 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)</li>\n <li>\n Documented opportunistic infection within 4 weeks prior to the study enrolment</li>\n <li>\n Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the study</li>\n <li>\n Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible.</li>\n <li>\n History or presence of allergy or intolerance to the study treatment or their components or drugs of their class or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.</li>\n <li>\n Ongoing malignancy other than cutaneous Kaposi’s sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.</li>\n <li>\n Participants who in the investigator’s judgment, poses a significant suicidality risk. Participant’s history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk</li>\n <li>\n Any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major INSTI resistance associated mutation</li>\n</ol>\n<div>\n  </div>\n
      • primary_end_points<p>\n Participants with plasma HIV-1 RNA ≥ 50 copies/mL (snapshot algorithm) at week 48</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" times=\"\">\n <strong><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">CAPABILITY STATEMENT FOR KNH COMPREHENSIVE CARE CENTRE TO CONDUCT CLINICAL RESEARCH</span></strong><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"><o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Kenyatta National Hospital Comprehensive Care Centre (CCC) was established in December 2002 as the pioneer care and treatment centre for HIV/AIDS. The Centre was established with the support of the USAID/FHI/KNH cooperative agreement with the main objective of mitigating the effects of HIV/AIDS nationally by participating in the national HIV/AIDS response. Since 2005, services and expansion of the Centre have been supported by Center for Disease Prevention and Control (CDC) through the University of Nairobi, AIDS Care and Treatment Services (ACTS), Partnership for Advanced Care and Treatment – Centre of Excellence (PACT - CoE) and Centers’ of Excellence - HIV Medicine (CoEHM) Programs, and the Center for International Health, Education, and Biosecurity (CIHEB) - Kenya. It has evolved over time to be a centre of excellence for ambulatory HIV medicine in the country dealing with both complicated referral patients and stable patients.  <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The CCC offers a one-stop-shop approach in the management of HIV/AIDS. In order to achieve this goal, a multidisciplinary team with different specializations in HIV/AIDS management runs the centre. This team consists of Consultants, Medical Specialists, Medical Officers, Registered Clinical Officers, Pharmacists and Pharmaceutical Technologists, Counsellors, Laboratory Staff, Nursing Officers, Nutritionists and social workers among others.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"> The services offered at the Comprehensive Care Centre include the following:<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">1.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Diagnosis and Treatment of opportunistic infections and other HIV/AIDS related co-morbidities<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">2.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Anti-Retroviral Therapy both 1^st line; 2^nd line and 3^rd line regimens as per the WHO guidelines<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">3.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Laboratory monitoring and evaluation of the patients - The centre has an ISO 15189:2012 standard accredited laboratory which has equipment that can do the following analytical procedures:<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">a.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Flow Cytometry <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">b.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Hematology <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">c.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">      </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Chemistry <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">d.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">TB Diagnosis <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">e.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">HIV EID <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">f.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">      </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">HIV Viral Load <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">4.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Research: Since its inception the centre has actively been involved in research which has informed HIV/AIDS national policy. Some of the research conducted in the facility by both the University of Nairobi and Kenyatta National Hospital in collaboration with international partners include: <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">a.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">A clinical trial with almost 400 participants at the site to determine the efficacy of a switch to DTG-based ART from the standard PI/r-based ART for PLHIV on second-line ART<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">b.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">A clinical trial with over 300 participants evaluating the effectiveness of switching older PLHIV on first-line ART to bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF)<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">c.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">      </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Effectiveness of Non-nucleoside Reverse-Transcriptase Inhibitor-Based Antiretroviral Therapy in Women Previously Exposed to a Single Intrapartum Dose of Nevirapine:  A Multi-country, Prospective Cohort Study<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">d.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Optimizing Pediatric HAART Study<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">e.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Evaluation of the Kenya ARV scale-up program:  Surveillance for emergence of antiretroviral resistant genotypes among treatment experienced patients<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">f.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">      </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Treatment outcomes of HIV infected adolescents attending a National Referral Hospital in Kenya:<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">g.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Trends, treatment outcomes and determinants of attrition among adult patients in care in a large tertiary HIV clinic in Nairobi Kenya<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 72pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">h.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">     </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Predicted HIV-1 co receptor usage among Kenya patients shows a high tendency for subtype d to be cxcr4 tropic<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">5.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Training of undergraduate and postgraduate students in the departments of Clinical Medicine and Therapeutics and Pediatrics and Child Health at the University of Nairobi<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">6.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Adherence Counseling<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">7.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Nutritional Counseling<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">8.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Social Work Support<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">9.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">       </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Physiotherapy services<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 0cm 58.75pt; font-size: 12pt; font-family: \" text-align:=\"\" text-indent:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">10.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-variant-alternates: normal; font-kerning: auto; font-optical-sizing: auto; font-feature-settings: normal; font-variation-settings: normal; font-variant-position: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">    </span></span><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Supportive Counseling<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"> <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The CCC currently serves an average of 150-200 patients per day. Currently, adult patients on ART are 9,400 with 8,150 on first-line regimens and 1,230 on second-line regimens and 20 patients on third-line regimens. There are 4 co-investigators in the B/F/TAF to 2DR Switch Study who are based at the site and 2 site-based study staff (study nurse/counsellor and study clinical officer) have been engaged and are currently working at the CCC. The site currently has 138 PWH aged 60 years or older on B/F/TAF.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"> </span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <strong><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">CAPABILITY STATEMENT FOR JOOTRH TO CONDUCT CLINICAL RESEARCH</span></strong><span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\"><o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH), formerly known as New Nyanza Provincial General Hospital or Russia was built in 1965 by the Russian Government (then Soviet Union) through the Government of Kenya. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The hospital has been named Jaramogi Oginga Odinga in honour of one of the founding fathers of this Nation, Jaramogi Oginga Odinga who played a pivotal role in convincing the Russian Government to fund and build the facility. Henceforth, the hospital will be known as Jaramogi Oginga Odinga Teaching & Referral Hospital (JOOTRH). <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">JOOTRH has been in operation since 1969. It is located in Kisumu city on acreage of 22.6 hectares along Kisumu - Kakamega highway. It is the main referral centre to 10 counties in western Kenya and Rift Valley with a population of more than 7 million people. It has a bed capacity of 530. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The main mandate of JOOTRH is to provide curative, preventive, promotive and rehabilitative health services. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">It provides specialized clinical services in the areas of renal medicine, critical care, oncology, orthopaedic surgery, paediatric surgery and specialized diagnostic services—both radiological and laboratory services. It serves as a centre for research activities, medical training for midlevel health workers and medical students for Maseno University and Uzima university. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The hospital has a total of 640 staff consisting of 486 regular staff, 154 donor-supported staff (for HIV care services) as on 1st June 2019.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">JOOTRH Patient Support Centre (PSC) was started in the year 2002 and has ever enrolled approximately 28,000 clients. Current active on care is 6,842 by the end of June 2019. Total number of clients on first-line are 6,203, on second-line are 600, and 11 clients are on third-line. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">Out of the 154 staff employed by the CDC-funded implementing partner at the site, 39 are stationed at the PSC and 6 are MOH staff. There is 1 medical officer, 1 pharmacist, 8 nurses, 7 clinical officers, 3 pharmaceutical technologists, 2 social workers, 4 adherence councilors, 8 peer educators, 3 health records information officers, 5 data clerks, 1 nutritionist and 1 laboratory technician. There are 3 co-investigators in the IMPALA Study who are based at the site and 2 site-based study staff (study nurse/counsellor and study clinical officer) have been engaged and are currently working at the PSC.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The daily workload of the clinic is between 250 to 300 per regular clinic day (Monday, Tuesday and Friday) comprising adults 35 years old and above. 180 to 250 youths are seen on Wednesday (youth day age 20- 35 yrs) and 70 to 150 adolescents are seen on Thursdays.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The CCC also runs viremia clinics for patient with high viral loads on first-line therapy every Wednesday while Fridays are reserved for clients failing second-line treatment.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The medical officer is the in-charge of the clinic and works closely with the matron and the pharmacist in charge of the PSC Pharmacy. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">The clinic has been integrated and most of the services are offered within CCC which includes, clinical, nursing, adherence counseling, nutrition, community and linkage to OVC, cervical cancer screening amongst others. <o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">JOOTRH is also the hub center for the regional Nyanza-Western technical working group meetings held every 2^nd Monday of the month. It is also the spokes hub for ECHO sessions held every Thursday at 3pm.<o:p></o:p></span></p>\n<p background-attachment:=\"\" background-clip:=\"\" background-image:=\"\" background-origin:=\"\" background-position:=\"\" background-repeat:=\"\" background-size:=\"\" color:=\"\" new=\"\" style=\"margin: 0cm 0cm 7.5pt; font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"font-size: 11pt; font-family: Calibri, sans-serif; color: rgb(51, 51, 51);\">There are 4 co-investigators in the B/F/TAF to 2DR Switch Study who are based at the site and 3 site-based study staff (2 study nurse/counsellors and a study clinical officer) have been engaged and are currently working at the CCC. The site currently has 105 PWH aged 60 years or older on B/F/TAF.<o:p></o:p></span></p>\n
      • other_details_explanation<p>\n Not applicable</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n Not applicable</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration2.5 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_committeeYes
      • total_enrolment_per_site105 at JOOTRH and 135 in KNH
      • total_participants_worldwide240
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameLoice
      • investigator1_middle_nameAchieng
      • investigator1_family_nameOmbajo
      • investigator1_qualificationMBChB, MMED Internal Medicine, MSc Infectious Diseases
      • investigator1_professional_addressMBChB, MMED Internal Medicine, MSc Infectious Diseases
      • investigator1_telephone+254722576984
      • investigator1_emailloisea@uonbi.ac.ke
      • organisations_transferred_No
      • number_participants240
      • notification
      • approval_date02-06-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-04-2024
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed adequately.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-10-25 10:53:09
      • created2024-03-14 10:26:11
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id1049
        • application_id1389
        • given_nameLoice
        • middle_nameAchieng
        • family_nameOmbajo
        • qualificationMBChB, MMED Internal Medicine, MSc Infectious Diseases
        • professional_addressP.O. Box 2304 - 00202 Nairobi, Kenya
        • telephone+254722576984
        • emailloisea@uonbi.ac.ke
        • created2024-03-14 10:42:12
        • modified2024-04-03 13:18:57
    • SiteDetail(array)
      • 0(array)
        • id1685
        • application_id1389
        • county_id42
        • site_nameJaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressPatient Support Centre, Jomo Kenyatta Highway, Kaloleni, Kisumu
        • contact_detailsP.O. Box 849 - 40100, Kisumu
        • contact_personDr Florentius Ndinya
        • site_capacity(null)
        • misc(null)
        • created2024-03-14 10:42:12
        • modified2024-04-03 13:18:57
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id1686
        • application_id1389
        • county_id47
        • site_nameKenyatta National Hospital
        • physical_addressComprehensive Care Centre, Hospital Road, Nairobi
        • contact_detailsP.O. Box 20723 - 00202, Nairobi
        • contact_personDr Loice Achieng Ombajo
        • site_capacity(null)
        • misc(null)
        • created2024-03-14 11:48:06
        • modified2024-04-03 13:18:57
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id733
        • application_id1389
        • sponsorUniversity of Niarobi
        • sponsor_typeResearch Institution
        • contact_personProf Erastus Amayo
        • addressP.O. Box 19676 - 00202 Nairobi, Kenya
        • telephone_number+254204915041
        • fax_number
        • cell_number+254733611557
        • email_addresserastus.amayo@uonbi.ac.ke
        • created2024-03-14 10:42:12
        • modified2024-04-03 13:18:57
  • 2(array)
    • Application(array)
      • id278
      • user_id127
      • trial_status_id5
      • abstract_of_study<p>\n <strong>Background:</strong> According to KDHS 2008/9 the under 5-mortality rate has dropped from 115 per 1000 in 2003 KDHS, to 74 per 1000 in 2008, this represents an annual decline rate of 0.9%. Unless this rate is accelerated to at least 4.5%, Kenya is unlikely to meet MDG 4 by 2015. Integrated community case management (iCCM) coupled together with the administration of vitamin A supplements (VAS), is an important and viable option of reducing the mortality of children under the age of five <em>due to pneumonia, malaria and diarrhea</em>. Implementation of the iCCM in Kenya still remains inadequate. The main challenges to implementation include: inadequate training among the CHWs including little follow up post training in iCCM.</p>\n<p>\n <strong>The main objective</strong> is to determine whether trained, supervised and well supplied community health workers in hard to reach areas such as Homabay County can administer Vitamin A Supplements (VAS) and correctly perform iCCM and increase the proportion of children under five years receiving antibiotics for pneumonia, artementher-lumefantrine for malaria and zinc and oral rehydration therapy for diarrhoea by 20% compared to the baseline. On the other hand, despite efforts to improve vitamin A status among children through supplementation, advocacy for dietary diversification, bio fortification, industrial and home fortification of essential food commodities, VAD still remains a major public health problem in Kenya.  Studies have shown that about 42% of children under the age of five years in Sub Saharan Africa are at risk of VAD with Kenya at 76%. Achievement of Millennium Development Goal 4 of reducing under five mortality by two third by 2015, requires addressing or enhancing factors that contribute to child survival and development. Such factors include vitamin A supplementation and the integration of iCCM which will go a long way in reducing both maternal and child deaths.</p>\n<p>\n <strong>Methodology: </strong>The study will employ a pre and post design to compare iCCM and VAS health and process outcomes in Homabay County in Nyanza Province, Kenya during the intervention period, with those during a pre-intervention period. We will implement iCCM and VAS in a stepwise manner using a four-prong approach. The four prongs are 1) Sensitization of national, district, health center and community teams on iCCM and VAS 2) Training of the Community Health Extension Workers (CHEWS), CHWs and health care workers 3) Supervision and motivation of CHWs and 4) Commodity provision and accountability.</p>\n
      • study_title<p>\n Evaluating integrated community case management of pneumonia, malaria and diarrhoea among children under 5 years in Homabay County, Kenya.</p>\n
      • laymans_summary(null)
      • short_title Integrated community case management
      • protocol_noECCT/14/02/02
      • version_no1.4
      • date_of_protocol19-12-2013
      • study_drugAmoxicillin dispersible tablets [New formulation]
      • disease_conditionPneumonia
      • 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_nameAmoxicillin dispersible tablets
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressmaricianah@yahoo.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantPO BOX 614-40100 Kisumu, Tel No. +254 732 390 992 email: maricianah@yahoo.com
      • declaration_date123-02-2014
      • declaration_principal_investigatorDr. Onono Maricianah - Principal Investigator
      • declaration_date223-02-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n -Children aged 2months- 5 years<br />\n -Children suffering from Pneumonia, Diarrhoea and Malaria</p>\n
      • principal_exclusion_criteria<p>\n -Adults<br />\n -Children less than 2 months or over 5 years</p>\n<p>\n Children not suffering from Pneumonia, Diarrhoea and Malaria</p>\n
      • primary_end_points<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"732\">\n <tbody>\n <tr>\n <td style=\"width:160px;height:14px;\">\n <p>\n <strong>Primary outcome</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;\">\n <p>\n Proportion of children under 5 years with pneumonia who receive appropriate antibiotic treatment, compared to baseline</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:70px;\">\n <p>\n Proportion of CHWs who are able to rationally use antibiotics for treatment of pneumonia</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:83px;\">\n <p>\n Proportion of CHWs who appropriately account for supplied commodities</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of CHWs who are able to rationally use antimalarials</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of CHWs who are able to rationally use ORS and zinc</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of mothers of children under 5 years who have symptoms of pneumonia or malaria who seek care from an appropriate provider</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of children aged 6 to 59 months who received VAS on a semi-annual basis.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of CHWs who are able to correctly administer VAS, defined as giving vitamin A supplementation to children aged 6 to 59 months on a semi-annual basis in the County</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n <strong>Secondary outcome</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:160px;height:59px;\">\n <p>\n Proportion of children treated for pneumonia who do not respond to treatment (experience treatment failure or relapse</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n <br />\n  </p>\n
      • scope_diagnosis1
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <strong>Dr. Onono Maricianah:</strong> M.B.Ch.B, MSc Clinical Research  Global Health Fellowship- Principal Investigator<br />\n <strong>Dr. Bukusi Elizabeth:</strong> MBChB, M.Med (ObGyn), MPH, PhD , PGD(Research Ethics) - Co-Investigator<br />\n <strong>Akama Eliud:</strong> BSc, Diploma Community Health Nursing - Co-Investigator<br />\n <strong>Owuor Kevin</strong>: MSc Research Methods, BSc. Statistics - Co-Investigator/Statistician</p>\n<p>\n  </p>\n<p>\n <strong>Strength of the research team and f</strong><strong>easibility of project completion: </strong>The researchers in the study are part of the Kenya Medical Research Institute (KEMRI). Kenya Medical Research Institute (KEMRI) is a state corporation responsible for carrying out health research in Kenya. Since it's inception, KEMRI has developed a critical mass of scientists and technical personnel, to enable it mount a competitive research infrastructure to rank as a leading centre of excellence in health research both in Africa as well as globally. The researchers on this project have experience working in Nyanza province, specifically the Mbita district, in collaboration with the Ministries of Health in implementing a large scale HIV/AIDS program – the Family AIDS Care and Education Services (FACES). KEMRI will build on its experience and institutional knowledge gained from working in Homabay County. In Homabay County, KEMRI has over the years: 1) spearheaded community mobilization and built community linkages in alignment with the Government of Kenya (GoK) Community Strategy; 2) achieved rapid decentralization of services in underserved communities through family-based comprehensive HIV service provision; 3) improved the health system capacity in Mbita through training, mentorship, ongoing supervision, lab and pharmacy support, and logistics development; 4) successfully conducted clinical research including Microbicide research in partnership with the International Partnership for Microbicides (IPM); 5) established partnerships with GoK and other local institutions working in the area; and 6) attracted philanthropic support to help fund projects in the area e.g. the construction of the Comprehensive Care Clinic in Sindo District hospital (Steinberg building) and the Kar Geno Centre, Suba.7) Established the Fishermen hotline that allows the fishermen to dial in to be referred to the nearest health facilities providing antiretroviral therapy and the  <em>Uliza!</em> clinicians’ hotline hosted by Safaricom. The <em>Uliza!</em> hotline provides an opportunity for care providers in the periphery to call and receive mentorship from qualified medical doctors in the care of HIV patients. 8) KEMRI has already developed a robotic text messaging software built upon the RapidSMS platform. The software has been extensively tested and refined for the automated delivery of pre-defined text messages at specified times and in any preferred language. The proposed will use a similar platform and benefit from the expertise acquired.</p>\n<p>\n <strong>Organization</strong></p>\n<p>\n The study will have a study coordinator (clinical) and assistant coordinator (nutritionist), monitoring and evaluation specialist and a programmer. There will also be 6 sub-county coordinators in charge of the 6 sub counties in Homabay county. Further the study will employ 21 diploma nurses to do follow up for all pneumonia cases seen in the community</p>\n<p>\n The study will utilise existing community units in Homabay county. The community units must be actively reporting on a monthly basis as per records from the county health management team.</p>\n<p>\n The study will have a hotline number +254734919191 in which every time a community health worker sees a suspected pneumonia case, s/he will send a message which will trigger systems for the case to be verified by a trained nurse</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n<p>\n The trial will be conducted in Kenya which is the host country of the applicant. Both WHO and UNICEF which are the sponsors have country offices in Kenya</p>\n
      • other_details_regulatory_notapproved<p>\n Not applicable</p>\n
      • other_details_regulatory_approved<p>\n -Kenya Medical Research Institute Ethical Research Committee (KEMRI- ERC) 21st May 2013 Homabay County</p>\n<p>\n <br />\n -World Health Organisation Research Ethics Review Committee (WHO ERC) 6th January 2014 Homabay County</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration24 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_areaHomabay County
      • single_site_physical_addressLumumba Health Center, Agoi Street, PO BOX 614-40100 Kisumu-Kenya
      • single_site_contact_personDr. Maricianah Onono
      • single_site_telephone+254 732 390 992
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site888
      • total_participants_worldwideN/A
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentNo
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyChildren under 5years.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameAnne
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB MMed OBGYN MPH PHD
      • investigator1_professional_addressP.O Box 19464- 00202 ,Nairobi
      • investigator1_telephone+254 720 617 503
      • investigator1_emailebukusi@kemri.org
      • organisations_transferred_Yes
      • number_participants888
      • notification<p>\n Dear Reviewers</p>\n<p>\n Rationale for Amoxicillin Dispersible Tablets (DTs) for Pneumonia in children</p>\n<p>\n The overall study is designed to determine whether CHWs can correctly diagnose pneumonia and treat them using Amoxicillin (suspension or dispersible tablets). As investigators we felt that given the evidence already existing for DTs that within the context of this implementation research project, we were best placed to use this amoxicillin DTs as they became available and measure outcomes at day 4 and 6 as per protocol. Currently the trained CHWs are already diagnosing and treating diarrhoea and malaria using Zinc DTs and Coartem DTs. They are also successfully diagnosing and treating pneumonia using Amoxicillin suspension in the community. A total of 192 children have been diagnosed and treated adn treatment confirmed by trained nurses. Given the success in use of DTs and in diagnosing and treating pneumonia, we believe now is the time to introduce the Amoxicllin DTs.</p>\n<p>\n Tablets and capsules can be difficult to swallow, and if perceived as bitter or unpleasant are often refused by childrenespecially when ill (WHO 2008). To overcome these problems, many paediatric medicines are given as liquid suspensions or syrups, with the taste masked by fruity or sweet flavourings. Effective drug administration in children requires formulations which allow for accurate weight or age- based dosing. With syrups and suspensions this is often done as full, half, or quarter spoonfuls, which has been shown to be inaccurate (Grießmann 2007). An alternative is to dispense measured syringes alongside medications. In a position statement on the preferred dosage forms for use in children, the World Health Organization now recommend that where available dispersible tablets should be chosen above suspensions due to advantages in dosing, storage, and transportation (WHO 2009). Dispersible amoxicillin has been identified as a priority medicine for the treatment of pneumonia; formulated as scored tablets of 250mg and 500mg, and packaged in blister packs of 10 (WHO/UNICEF 2010a ). Dispersible amoxicillin offers significant benefits over suspensions in terms of cost, product stability and ease of transport. Further, dispersable tablets have other advantages over the suspension such as 1) Dose accuracy: Dosing of liquids by spoon is unreliable. 2) Storage: Long shelf-life and no need for refridgeration 3) Transport: Less bulky and less susceptible to high temperatures. Paediatric dispersible tablets are already in use in Kenya for malaria, and well tolerated. Additionaly, based on WHO price lists, dispersible tablets could represent a cost saving compared to suspensions. (WHO/UNICEF 2010b).</p>\n<p>\n <strong>References</strong></p>\n<p>\n WHO 2008. The pathway to better medicines for children. 2008. Available at: http://www.who.int/childmedicines/Pathway.pdf</p>\n<p>\n Grießmann K, Breitkreutz J, Schubert-Zsilavecz et al. Dosing accuracy of measuring devices provided with antibiotic  oral suspensions. <em>Paediatric and Perinatal Drug Therapy</em><em>. </em>2007; <strong>8: </strong>61-70.</p>\n<p>\n <em>WHO technical report series; 958</em><em>. </em><em>The selection and use of essential medicines: report of the WHO Expert Committee, March 2009</em>. Geneva, World Health Organization, 2009.</p>\n<p>\n WHO/UNICEF 2010a. Priority essential medicines for child survival. 2010. Available at: http://www.who.int/childmedicines/progress/Unicef_prioriry_meds_child_survival.pdf</p>\n<p>\n WHO/UNICEF 2010b. Sources and prices of selected medicines for children including therapeutic food, dietary vitamin and mineral supplementation. 2010. Second edition. Available at: http://www.who.int/medicines/publications/essentialmedicines/Sources_Prices2010.pdf</p>\n
      • approval_date21-05-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-02-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n  </p>\n<h1>\n Operationalization of integrated community case management in Homabay County, Kenya</h1>\n<h1>\n Executive summary</h1>\n<p>\n In a Kenya Ministry of Health and WHO-supported exercise in 2011, Kenyan experts (academics, clinicians and policy-makers) generated and systematically scored research questions for maternal, newborn and child health interventions to reduce child mortality in Kenya using Child Health and Nutrition Research Initiative methodology. During this exerciseintegrated community case management (iCCM), which included pneumonia home case management was identified as a top priority for research in Kenya. To address this gap, in 2013, the Ministry of Health mandated the Kenya Medical Research Institute (KEMRI) with support from UNICEF and WHO to demonstrate the feasibility and effectiveness of training Community health workers (CHWs) and supplying them with Oral Rehydration Salts (ORS), zinc, rapid diagnostic tests (RDTs) for malaria, artemether-lumefantrin (AL) and amoxicillin to treat diarrhoea, malaria and pneumonia at the community level as envisaged in iCCM. This report describes the implementation strategies, processes and outcomes of an iCCM programme in Homabay County in western Kenya as part of large-scale countywide implementation. In addition, the report examines: i) concordance in identification and classification of lower chest indrawing between CHWs and nurses; ii) acceptability, adherence and clinical outcomes of Amoxicillin dispersible tablets versus oral suspension in treatment of children aged 2-59 months with pneumonia; iii)patient level costs of treating childhood pneumonia at home versus in the health facility; iv) quality of care provided by facility based health care workers vs. community health workers for pneumonia in sick children under 5 years; and v) the association between adherence and multiple drug prescription for pneumonia, malaria and diarrheal in children under five years of age by CHWs</p>\n<p>\n  </p>\n<p>\n <strong>Methods: </strong></p>\n<p>\n This was a prospective observational implementation research project. CHWs in Homabay County, Kenya were trained, equipped and supervised to implement iCCM for sick children aged 2-59 months. Implementation was conducted using a five-pronged approach which involved: i) sensitization of national, county, sub-county, health facility and community teams; ii) training of CHWs, community health extension workers and health care workers; iii) commodity provision and accountability; iv) supervision of CHWs; and v) monitoring and evaluation. Mobile phones were used to ascertain correct management of pneumonia by CHWs, monitoring and evaluation of service level statistics and commodity tracking.</p>\n<p>\n <strong>Key findings:</strong></p>\n<p>\n <strong>Service level statistics: </strong>A total of 2604 CHWs and 200 community health extension workers (CHEWs) from 242 community units received training in iCCM. Between October 2013 and March 2015, 170 079 children were assessed and classified by the CHWs. CHWs treated 11 693 pneumonia, 9869 malaria and 26 713 diarrhoea cases in the community, referred 8906 children to a health facility for immunization, and gave age-appropriate doses of vitamin A supplementation to 137 585 children. </p>\n<p>\n <strong>Concordance in identification and classification of lower chest indrawing pneumonia between CHWs and nurses:</strong>CHWs were able to identify, classify and treat lower chest in-drawing pneumonia in children aged 2-59 months with a five-day course of oral amoxicillin with low treatment failure rates in a real programme setting in Kenya. The concordance for classification of lower chest indrawing between CHWs and nurses was high (88.7% agreement) and the observed treatment failure rate was low (2.1%). The concordance for classification of fast breathing pneumonia between CHWs and nurses was high (97% agreement) with an inter-rater difference of only 2 breaths/count.  CHWs were more likely to misclassify lower chest indrawing in children with co-morbidities such as malaria and diarrhoea, those with moderate malnutrition or those whose caregivers delayed care seeking. This subset of children likely represents sicker children for whom extra care is needed in disease assessment and classification. </p>\n<p>\n <strong>Acceptability, adherence and clinical outcomes of Amoxicillin dispersible tablets:</strong>When compared to Amoxicillin oral suspension, Amoxicillin dispersible tablets had better treatment adherence among the sick children. Amoxicillin dispersible tables were also just as acceptable and as effective as the amoxicillin oral suspension in the treatment of pneumonia in children aged 2-59 months.</p>\n<p>\n <strong>Perceived quality of care provided by facility based health care workers vs. CHWs for pneumonia in sick children under 5 years: </strong>Caregivers rated the quality of CHW provided home-based management for childhood pneumonia to be higher than facility based health workers (FBHW) provided care.  We used the Primary Care Assessment Survey (PCAS), a patient-completed questionnaire that operationalizes formal definitions of primary care. The PCAS measures seven domains of care through 11 summary scales: accessibility (organizational, financial), continuity (longitudinal, visit-based), comprehensiveness (contextual knowledge of patient, preventive counseling), integration, clinical interaction (clinician-patient communication, thoroughness of physical examinations), interpersonal treatment, and trust.</p>\n<p>\n Caregivers rated CHWs higher in regards to ease of access (geographic and financial). This is likely because of both the spatial distribution of CHWs, as they live in the community and therefore are closer to clients, and the fact that CHWs don’t charge user fees for care or medications. CHWs were rated more highly than FBHWs in their ability to communicate with caregivers and instill trust. Patients answered positively when asked about the integrity, friendliness and support in decision-making by CHWs. Even in regards to clinical skills, the area in which FBHWs have a clear advantage, caregivers rated CHWs and FBHWs equally. One explanation could be that CHWs simply spend more time with the patients and are therefore able to perform a more thorough evaluation. In terms of overall satisfaction, CHWs were preferred to FBHWs when examining either a self-reported satisfaction score or a summary score that was calculated as the mean across all PCAS domains indicating acceptability</p>\n<p>\n <strong>Patient level costs of treating childhood pneumonia at home versus in the health facility. </strong>The estimated costs associated with treatment of a pneumonia episode in under-five children can be divided into direct and indirect out-of-pocket expenses incurred by the household for an episode of pneumonia.Direct medical costs are the actual amount paid by the households for consultation, investigations such as radiology, hospital admissions and medicines. Direct non-medical costs are incurred for transportation and meals for caregivers at the health facility. Indirect costs are the opportunity cost of caregiver time and fore gone wages during the time of seeking care for the child.The average total household cost of treatment of pneumonia was KSh. 194.36($2.04) and KSh 2201.64 ($23.18) for the caregivers that sort care from the CHW and health facility respectively. This is an 11-fold difference in cost of treatment. The cost of treatment of pneumonia has significant influence on subsequent health seeking behaviour as caregivers tend to subsequently seek care where it’s deemed cheaper for them. </p>\n<p>\n <strong>Effect of multiple drug prescription for pneumonia, malaria and diarrhoea on adherence in children under five years of age by CHWs: </strong>Among children classified as having pneumonia plus additional diarrhoea and or malaria, the treatment with combinations of anti-malarial, antibiotics and/ORS and zinc sulphate did not lower adherence compared to antibiotic alone. In addition, there was no difference in treatment failure in the two arms. </p>\n<p>\n  </p>\n<p>\n It is anticipated that with the evidence provided by this project, the Kenyan Ministry of health as well as the county health management teams will begin to adopt these practical solutions for iCCM regarding training, supplies and supervision.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>Summary of recommendations:  </strong></p>\n<p>\n This large-scale implementation of iCCM in Homabay demonstrated practical approaches and models of providing services, linking community and health facility commodity management and strengthening the capacity of CHWs to manage common childhood illnesses in a community setting. The project established that when CHWs are trained, supervised and supported, they are able to have adequate knowledge, skills and competency to provide quality services including treatment of sick children. </p>\n<p>\n             The experience of this implementation project has important implications for expansion of iCCM in Kenya. We propose the following recommendations </p>\n<p style=\"margin-left:.25in;\">\n 1.    CHWs in this project demonstrated high competency rates and outranked facility based health care workers in terms of perceived quality of care and overall satisfaction. We therefore recommend that CHWs and iCCM be a key component of increasing access to treatment of childhood illnesses such as diarrhoea malaria and pneumonia to address child survival in Kenya </p>\n<p style=\"margin-left:.25in;\">\n 2.    Mechanisms of performance review and clinical accreditation of skills after basic training are needed in order to produce and maintain competency among CHWs; </p>\n<p style=\"margin-left:.25in;\">\n 3.    Availability of commodities to CHWs coupled with strong health facility-community linkages are crucial to success.</p>\n<p style=\"margin-left:.25in;\">\n 4.    Because CHWs experienced some challenge in classification of sicker children particularly those with moderate malnutrition, training curricula, needs to emphasize prompt identification and referral for all cases of moderate and severe malnutrition. CHWs should be able to identify and refer children with any danger sign and those with malnutrition. Additionally, caregivers need to be educated and motivated to seek appropriate care early</p>\n<p style=\"margin-left:.25in;\">\n 5.    Given the higher adherence rates and equivalence in effectiveness and acceptability, we recommend that Amoxicillin dispersible tablet be preferentially prescribed over the oral suspension for the treatment of pneumonia in children aged 2-59 months.</p>\n<p style=\"margin-left:.25in;\">\n 6.    Given that the household costs of iCCM of pneumonia were eleven times lower than facility based pneumonia treatment, we recommend the scale up of pneumonia treatment with oral amoxicillin at community level. Pneumonia home case management can significantly reduce household cost, improve access and better treatment outcomes to the underprivileged population, preventing many child deaths. It also has potential to decrease economic burden on the families besides decreasing pressure and cost on the already overburdened public health system.</p>\n
      • implication_results(null)
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      • balance_site(null)
      • final_date(null)
      • modified2018-10-15 16:39:47
      • created2014-02-23 05:46:32
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id194
        • application_id278
        • given_nameMaricianah
        • middle_nameAtieno
        • family_nameOnono
        • qualificationMBChB MSC-Clinical Research Global health fellowship
        • professional_addressP.O Box 614 Postal Code 40100, Kisumu-Kenya
        • telephone+254 732 390 992
        • emailmaricianah@yahoo.com
        • created2014-02-23 05:49:04
        • modified2014-02-23 08:35:23
    • SiteDetail(array)
      • 0(array)
        • id240
        • application_id278
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2014-02-23 05:49:04
        • modified2014-02-23 08:35:23
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id152
        • application_id278
        • sponsorUNICEF
        • sponsor_type(null)
        • contact_personDr. Ketema Aschenaki Bizuneh
        • addressUNICEF, Kenya Country Office, P.O. Box 44145-00100,
        • telephone_number254 (20) 762 2209
        • fax_number254 (20) 762 27 46
        • cell_number+254 719 390 115
        • email_addresskbizuneh@unicef.org
        • created2014-02-23 05:49:04
        • modified2014-02-23 08:35:23
      • 1(array)
        • id153
        • application_id278
        • sponsorWorld Health Organization
        • sponsor_type(null)
        • contact_personDr. Shamim Qazi
        • address20 Avenue Appia, Geneva 27, 1211 Switzerland
        • telephone_number(+41-22) 791-2547
        • fax_number(+41-22) 791-4853
        • cell_number(+41-22) 791-2547
        • email_addressqazis@who.int
        • created2014-02-23 06:06:38
        • modified2014-02-23 08:35:23
  • 3(array)
    • Application(array)
      • id705
      • user_id56
      • trial_status_id5
      • abstract_of_study<p>\n Worldwide, the prevalence and incidence of Sexually Transmitted Infections (STIs) is high. In the ongoing Prevention Options for Women Evaluation Research (POWER) cohort study where Pre-Exposer Prophylaxis (PrEP) is being delivered to young women aged 16 to 25 in Kisumu Kenya, we have seen a high incidence of Chlamydia trachomatis and Neisseria gonorrhoeae infections (23% and 11%, respectively) and therefore, strategies to reduce STIs rates in the context of PrEP is a priority. Expedited partner Therapy (EPT) is one of the strategies that has been proved in clinical trials to reduce the recurrence of STIs. EPT is the clinical practice of treating the sex partners of patients diagnosed with a STI (usually Chlamydia trachomatis or Neisseria gonorrhoeae) by providing medications to the patient to take to his/her partner without the health care provider first examining the partner. This study seeks to evaluate the acceptability, feasibility, barriers and unintended consequences of EPT and HIV self-testing (HIVST). We will prospectively observe sexually active young HIV negative women ages 16 to 25 years enrolling in the POWER cohort study in Jaramogi Oginga Odinga Teaching and Referral Hospital’s (JOOTRH) public family planning clinic and Kenya Medical and Education Trust’s (KMET) private family planning clinic, in Kisumu. We will enroll young women whose urine sample test positive for chlamydia and/or gonorrhea at either of the two delivery sites. They will be offered STI treatment and HIV self-test kits for their partner(s) and measure the proportion who agree to take EPT and/or HIV self-test kits to their partner(s) compared to the Standard of Care (SOC). Using quantitative and qualitative methods to evaluate the uptake and acceptability of EPT and partner HIVST, exploring experiences, preferences, barriers and facilitators related to EPT and partner HIV self-testing, and assessing STI reinfection rates in relation to EPT with a view to Inform policy on STI partner treatment and HIV self-testing.</p>\n
      • study_title<p>\n Evaluation of Expedited partner therapy/Partner HIV self-testing for young women enrolled in POWER study and diagnosed with sexually transmitted infections in Kisumu</p>\n
      • laymans_summary<p>\n Determining ways to prevent and treat sexually transmitted infections in young HIV-uninfected women is a priority for HIV prevention. For women using pre-exposure prophylaxis (PrEP), screening and treatment of STIs is recommended. Expedited Partner Therapy and HIVST could provide a useful approach to treat partners of HIV-uninfected women diagnosed with an STI to prevent STI reinfection. In the context of an ongoing PrEP implementation study among young women The POWER study, we propose to evaluate the acceptability, feasibility, barriers and unintended consequences of EPT and HIVST in women who test positive for chlamydia and/or gonorrhea in Jaramogi Oginga Odinga Teaching and Referral Hospital’s family planning clinic and Kisumu Medical and Education Trust’s family planning clinic, in Kisumu with an aim of developing sustainable models for partner treatment by informing policy on STI partner treatment and HIV self-testing.</p>\n
      • short_titleExpedited Partner Therapy and Partner Self-testing
      • protocol_noECCT/18/07/04
      • version_noVersion 1.1
      • date_of_protocol25-05-2018
      • study_drugAZITHROMYCIN 500MG TABLETS AND CEFIXIME TABLETS 400MG
      • disease_conditionChlamydia and Gonorrhea
      • 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_nameAzithromycin/ Cefixime
      • 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_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • 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_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantP.O BOX 614-40100
      • declaration_date123-07-2018
      • declaration_principal_investigatorProf. Elizabeth Bukusi
      • declaration_date223-07-2018
      • placebo_presentNo
      • study_objectives<p>\n Main objective To evaluate the acceptability, feasibility, barriers and unintended consequences of EPT and HIVST.</p>\n<p>\n Specific objectives</p>\n<p>\n 1. We will evaluate uptake and acceptability to expedited partner treatment (EPT) and partner HIV self-testing among HIV-uninfected young women diagnosed with chlamydia or gonorrhea.</p>\n<p>\n 2. To explore experiences, preferences, barriers and facilitators related to expedited partner treatment and partner HIV self-testing.</p>\n<p>\n 3. To assess STI reinfection rates in relation to uptake of expedited partner therapy.</p>\n<p>\n 4. To explore unintended consequences related to expedited partner treatment and partner HIV self-testing.</p>\n
      • principal_inclusion_criteria<p>\n All the women who are enrolled in the POWER Cohort study and test positive for chlamydia and/or gonorrhea at one of the delivery sites in Kisumu and willing to give consent and participate will be eligible.</p>\n<p>\n Participants who accept enrollment into this ancillary study will complete a separate written informed consent that describes quantitative and qualitative procedures. As only selected participants will be approached to participate in the qualitative component of the study, participants will be informed that their consent does not guarantee participation in this component. Participation will be voluntary and not essential to participation in the POWER Cohort study – i.e., women may decline to participate in this ancillary study without it affecting their participation in the POWER Cohort study or their ability to get their partner a referral for STI treatment and HIV testing.</p>\n
      • principal_exclusion_criteria<p>\n Not willing to provide consent</p>\n<p>\n Those who test negative for chlamidia and Gonorrhea</p>\n<p>\n  </p>\n
      • primary_end_points<p>\n 1. Recurrance of  STIs, and HIV, following EPT/Partner HIV self test</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Study staff: 1. Principal investigator: Prof. Elizabeth Ann Bukusi 2. Study coordinator: Dr.Victor Omoll 3. Study Pharmacist: Dr. Arthur Mugendi George 4. Study Pharmaceutical Technologist: Eric Sedah 5. Qualitative personel: 4 6. Dr. Zachary Kwena: Qualitative expert</p>\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 KEMRI SCIENTIFIC AND REVIEW UNIT</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NA</p>\n
      • estimated_duration24 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_areaKisumu
      • single_site_physical_addressP.O Box 614-40100
      • single_site_contact_personProf. Elizabeth Bukusi
      • single_site_telephone0733617503
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site00
      • total_participants_worldwide400
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_nameAnne
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics)
      • investigator1_professional_addressP.O Box 614-40100
      • investigator1_telephone254 733617503/ 720617503
      • investigator1_emailebukusi@kemri.org
      • organisations_transferred_No
      • number_participants400
      • notification
      • approval_date22-09-2018
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-05-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-06-17 11:49:26
      • created2018-07-23 14:17:29
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id445
        • application_id705
        • given_nameProf. Elizabeth Bukusi
        • middle_nameAnne
        • family_nameBukusi
        • qualificationMBChB, M.Med (ObGyn), MPH, PhD, PGD (Research Ethics)
        • professional_addressP.O Box 614-40100
        • telephone254 733617503/ 720617503
        • emailebukusi@kemri.org
        • created2018-07-23 14:35:12
        • modified2020-05-08 08:38:37
    • SiteDetail(array)
      • 0(array)
        • id562
        • application_id705
        • county_id(null)
        • site_name
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        • contact_details
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        • site_capacity(null)
        • misc(null)
        • created2018-07-23 14:35:12
        • modified2020-05-08 08:38:37
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id350
        • application_id705
        • sponsorUnited States Agency for International Development
        • sponsor_typeOthers
        • contact_personJared B
        • addressP.O Box 359470
        • telephone_number206-543-0098
        • fax_number
        • cell_number206-520-381
        • email_addressCWSCOV@UW.edu
        • created2018-07-23 14:35:12
        • modified2020-05-08 08:38:37
  • 4(array)
    • Application(array)
      • id791
      • user_id513
      • trial_status_id5
      • abstract_of_study<p style=\"margin: 0px;\">\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"margin: 0px;\">To further reduce </span></span></span><span style=\"margin: 0px; font-size: 10pt;\"><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">neonatal</span></span><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"> mortality rate in low resource settings (LRS) in Africa, research is needed to develop and optimize innovations in neonatal care, specifically technologies that are low cost, operator-independent, and highly efficient. The purpose of this study is to produce information and data regarding the performance of two existing multiparameter continuous physiological monitoring devices developed by device developers, EarlySense and Sonica. The clinical trial is intended to provide evidence to establish whether these investigational devices can reliably and accurately measure vital signs in neonates (when compared to verified reference devices) and to assess the feasibility, usability </span></span><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">and</span></span><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"> acceptability of these devices for use in neonates in </span></span><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">a LRS</span></span><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"> in Africa. <span style=\"margin: 0px; text-align: left; color: rgb(34, 34, 34); text-transform: none; text-indent: 0px; letter-spacing: normal; font-style: normal; font-variant: normal; font-weight: 400; text-decoration: none; word-spacing: 0px; white-space: normal; orphans: 2; -webkit-text-stroke-width: 0px; background-color: transparent;\">T<span style=\"margin: 0px;\">he investigational devices’ performance will be compared against reference devices, Masimo Rad97^TM and Tempo Bleu Easy thermometer by Spengler, which are </span></span><span style=\"text-align: left; color: rgb(34, 34, 34); text-transform: none; text-indent: 0px; letter-spacing: normal; font-style: normal; font-variant: normal; font-weight: 400; text-decoration: none; word-spacing: 0px; display: inline !important; white-space: normal; orphans: 2; float: none; -webkit-text-stroke-width: 0px; background-color: transparent;\">licensed for use in clinical practice. </span><span style=\"margin: 0px;\">Qualitative data will also be collected through in-depth interview and analyzed to assess feasibility, usability </span></span></span><span style=\"margin: 0px; font-family: "Arial",sans-serif; font-size: 10pt;\"><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">and</span></span></span></span><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"margin: 0px;\"><span style=\"margin: 0px;\"> acceptability of the investigational devices among healthcare providers and hospital administrators, and acceptability among caregivers of enrolled neonates. </span></span>  <span lang=\"EN-GB\" style=\"margin: 0px; font-style: normal;\">The study consists of two phases: 1) a verification and accuracy evaluation phase and 2) a clinical feasibility phase. The i</span>nitial phase will be undertaken at Aga Khan University Hospital's neonatal high dependency unit and the clinical feasibility phase will be conducted at Pumwani Maternity Hospital. Study data will be collected electronically using tablets and/or laptops and transmitted for analysis, including the questionnaires regarding usability, feasibility, and acceptability. Written informed consent will be collected from mothers, fathers, and legal guardians of the newborns. Healthcare providers <span style=\"margin: 0px;\">and hospital administrators involved in the ETNA study will be approached to participate in the qualitative portion of the study. Caregivers with a child enrolled in the study will also be approached to see if they are willing to participate in the qualitative portion of the study</span></span></span><span style=\"margin: 0px; font-family: "Arial",sans-serif; font-size: 10pt;\"><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">. </span></span></span><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Study</span></span><span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"> data will be securely stored to ensure confidentiality.</span></span></p>\n
      • study_title<p>\n EVALUATION OF TECHNOLOGIES FOR NEONATES IN AFRICA</p>\n
      • laymans_summary<p>\n As part of Goal 3's focus on treatment and prevention of acute illness, investments are needed to develop and/or optimize innovations in newborn care. Specifically, we hope to develop newborn care technologies that are low cost, operator-independent, and highly efficient.</p>\n<p>\n An additional evaluation site for promising devices is needed to allow optimization of the devices for use in neonates and in low-resource settings (LRS). This investment, Evaluation of Technologies for Neonates in Africa (ETNA) project, will be to manage the continued development and evaluation at an African site of selected newborn care devices currently in development. The initial candidates will fall within the multiparameter continuous monitoring device category. Of the initial candidates, there are two potential devices that we would like to optimize for newborns in the neonatal intensive care setting and evaluate whether they could be included in the NEST package in a LRS.</p>\n<ul>\n <li>\n <strong>Early Sense contact-free monitoring pad: </strong>EarlySense is an established organization with significant experience in vital signs, contact-free monitoring. The current device from EarlySense is placed under the patient's mattress, using piezoelectric technology to monitor heart rate (HR), respiratory rate (RR), patient motion, and sleep status. This technology is used in combination with artificial intelligence analytics to predict sepsis, respiratory depression, sleep apnea, and arrhythmias, among a few other conditions. The current device is designed to measure children and adults above 10kg. This investment will be a proof-of-concept to establish the applicability of the EarlySense system to this specific population. The scope will include software and algorithm modifications that will allow the EarlySense technology to measure newborns in their cribs.</li>\n <li>\n <strong>Northwestern University advanced neonatal (ANNE) epidermal system sensors</strong>: There are currently two newborn non-invasive adhesive sensors being refined to allow wireless, advanced monitoring for neonatal intensive care. One sensor contains Bluetooth technology with a built-in battery, estimated to cost about $30 USD; whereas the second sensor is battery-free, ultra-thin and is estimated to cost about $3 USD. They both measure electrocardiogram (ECG), oxygen saturation (Sp02), HR, RR, and skin temperature, and monitoring is supported by customized software. A small investment was made to validate these sensors against gold-standard FDA-cleared monitoring devices in healthy newborn subjects in Chicago.</li>\n</ul>\n<p style=\"margin-left:39.0pt;\">\n  </p>\n<p>\n  </p>\n
      • short_titleETNA
      • protocol_noECCT/19/05/02
      • version_no1.0
      • date_of_protocol25-02-2019
      • study_drugNA
      • disease_conditionNA
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameEarlySense Insight System and Sonica\'s Advanced Neonatal Epidermal System
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdorothy.chomba@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_letter1
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data0
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantWilliam M Macharia, Aga Khan University, Nairobi
      • declaration_date130-04-2019
      • declaration_principal_investigatorWilliam M Macharia, Aga Khan University, Nairobi
      • declaration_date230-04-2019
      • placebo_presentNo
      • study_objectives<h3 align=\"left\">\n Primary Objectives</h3>\n<ul>\n <li align=\"left\">\n To assess agreement between repeat observations by the investigational device and the reference device(s) for each relevant measurement parameter of interest based on <em>a priori</em>-determined non-inferiority margins among neonates.</li>\n</ul>\n<ul>\n <li align=\"left\">\n To compare clinical event detection performance between the investigational device and the reference device(s).</li>\n <li align=\"left\">\n To determine whether the investigational device is feasible, usable and acceptable among HCPs, hospital administrators and caregivers of neonates.</li>\n</ul>\n<p align=\"left\">\n Secondary Objectives</p>\n<ul>\n <li align=\"left\">\n To assess diagnostic performance for each relevant measurement parameter of interest based on sensitivity, specificity, positive predictive value, and negative predictive value compared to the reference device(s).</li>\n <li align=\"left\">\n To determine the downtime performance of the investigational device.</li>\n <li align=\"left\">\n To determine the alarm rate (events/hour) and the number of true/false alarms of the investigational device compared to the reference device(s).</li>\n <li align=\"left\">\n To determine the delay time between the investigational device and the reference device(s) in true events.</li>\n <li align=\"left\">\n To determine the number of adverse device effects (ADEs) and serious adverse events (SAEs) resulting in skin damage during use of the investigational device.</li>\n</ul>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n 1. Male or female neonate, corrected age of ≤ 28 days.</div>\n<div>\n 2. Willingness and ability of neonate's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study.</div>\n<div>\n  </div>\n
      • principal_exclusion_criteria<div>\n 1. Receiving mechanical ventilation or continuous positive airway pressure (CPAP).</div>\n<div>\n 2. Skin abnormalities in the nasopharynx and/or oropharynx. </div>\n<div>\n 3. Contraindication to application of skin sensors.</div>\n<div>\n 4. Known arrhythmia.</div>\n<div>\n 5. Presence of a congenital abnormality requiring major surgical intervention.</div>\n<div>\n 6. Any medical or psychosocial condition or circumstance that, in the opinion of the investigators,</div>\n<div>\n would interfere with the conduct of the study or for which study participation might jeopardize the</div>\n<div>\n neonate's health.</div>\n
      • primary_end_points<div>\n 1. Agreement of the relevant measurement parameters of interest between the investigational device and the reference device(s) at each observation.</div>\n<div>\n 2. Agreement of clinical event detection between the investigational device and the reference device(s) at each observation.</div>\n<div>\n 3. Feasibility, usability and acceptability of the investigational device among HCPs and hospital administrators.</div>\n<div>\n 4. Acceptability of the investigational device among caregivers.</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyDevice accuracy evaluation and clinical feasibility
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyDevice accuracy evaluation and clinical feasibility
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n AKU-N neonatal high dependency unit has an 8 bed capacity. The nurse to newborn ratio is 1:3. Staffing includes 2 full-time faculty neonatologists, 3 private neonatologists, 2 full-time pediatric surgeons, a critical care pediatrician, a pediatric pulmonologist, one senior resident and 4 junior residents. Newborns at PMH are managed in shared incubators within the same room as their mothers (144 cots). Staffing includes medical superintendent, a pediatrician and 23 nurses. The nurse to neonate ratio is 1:25 </p>\n
      • other_details_explanation<p>\n We believe continuous physiological monitoring devices would be instrumental in directing care provided to newborns and would be most useful in low-resource settings in sub-Saharan Africa where the need is greatest. We want to conduct this research in the setting in which this technology is intended for use.</p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<p>\n This trial has not be submitted to any other regulatory authorities. Ethics review and approval will also be obtained from the Western Institutional Review Board based in Washington, United States.</p>\n
      • other_details_regulatory_approved<p>\n This trial has not been submitted to any other regulatory authorities.</p>\n
      • other_details_regulatory_rejected<p>\n NA</p>\n
      • other_details_regulatory_halted<p>\n NA</p>\n
      • estimated_duration24 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_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_siteAGA KHAN UNIVERSITY HOSPITAL- 260\nPUMWANI MATERNITY HOSPITAL-240
      • total_participants_worldwide500
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornYes
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyMOTHERS, FATHERS AND LEGAL GUARDIANS WILL PROVIDE CONSENT TO PARTICIPATE AND ENROLL IN THE STUDY ON BEHALF OF THEIR NEWBORN.
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameROSELINE
      • investigator1_middle_nameATIENO
      • investigator1_family_nameOCHIENG
      • investigator1_qualificationMB,CHB, MMED
      • investigator1_professional_addressAGA KHAN UNIVERSITY, P.O BOX. 30270-00100,NAIROBI
      • investigator1_telephone254-722278391
      • investigator1_emailroseline.ochieng@aku.edu
      • organisations_transferred_Yes
      • number_participants500
      • notification
      • approval_date18-06-2019
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-04-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report<p>\n <strong>ENROLLMENT </strong></p>\n<p>\n Evaluation of Technologies for Neonates in Africa (ETNA) study enrollment began at the Aga Khan University Hospital – Nairobi (AKUH) on June 25, 2019.  The study was conducted at two sites, AKUH and Pumwani Maternity Hospital (PMH). Two investigational devices, the EarlySense and the Sibel (previously called Sonica) Advanced Neonatal Epidermal (ANNE), were compared to two reference devices, the Masimo Rad-97 pulse CO-oximeter with capnography and the Spengler Tempo Easy thermometer. Study enrollment was completed on December 15, 2020. A total of 362 neonates were enrolled. 16 neonates had incomplete data sets (12 including the EarlySense and 4 including the Sibel ANNE). There were three study enrollment phases: verification; accuracy; and feasibility.  A qualitative substudy was also conducted at both study sites to evaluate the feasibility, usability, and acceptability of the technologies.</p>\n<p>\n  </p>\n<p>\n The reference device verification phase involved an evaluation of the Masimo Rad-97 and Spengler Tempo Easy reference devices to identify reference device accuracy and set accuracy thresholds for the investigational device evaluations. This was done prior to the accuracy evaluation of the investigational devices and included 35 neonates.</p>\n<p>\n  </p>\n<p>\n The accuracy evaluation phase recruitment began on July 9, 2019 and was completed on September 15, 2020 with a total of 215 neonates. A total of 197 neonates were enrolled using the EarlySense investigational device and 137 neonates were enrolled using the Sibel ANNE investigational device. Both investigational devices were used simultaneously on the same neonates whenever feasible.</p>\n<p>\n  </p>\n<p>\n Recruitment for the clinical feasibility phase began on September 16, 2020 and was completed on December 15, 2020 with a total of 135 neonates enrolled. A total of 120 neonates were enrolled using the EarlySense investigational device and 120 neonates were enrolled using the Sibel ANNE investigational device. Both investigational devices were used simultaneously on the same neonates whenever feasible.</p>\n<p>\n  </p>\n<p>\n <strong>Participant recruitment overview – by phase, device, sex and site</strong></p>\n<p>\n  </p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:529px;\" width=\"529\">\n <tbody>\n <tr>\n <td rowspan=\"2\" style=\"width:129px;height:35px;\">\n <p>\n  </p>\n <p>\n  </p>\n </td>\n <td style=\"width:91px;height:35px;\">\n <p align=\"center\">\n <strong>Participants</strong></p>\n </td>\n <td colspan=\"3\" style=\"width:185px;height:35px;\">\n <p align=\"center\">\n <strong>Sex</strong></p>\n </td>\n <td colspan=\"2\" style=\"width:124px;height:35px;\">\n <p align=\"center\">\n <strong>Site</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:91px;height:21px;\">\n <p align=\"center\">\n <strong>Total</strong></p>\n </td>\n <td style=\"width:60px;height:21px;\">\n <p align=\"center\">\n <strong>Female</strong></p>\n </td>\n <td style=\"width:67px;height:21px;\">\n <p align=\"center\">\n <strong>Male</strong></p>\n </td>\n <td style=\"width:57px;height:21px;\">\n <p align=\"center\">\n <strong>Other</strong></p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p>\n <strong>AKU</strong></p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n <strong>PMH</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:129px;height:21px;\">\n <p>\n <strong>All</strong></p>\n </td>\n <td style=\"width:91px;height:21px;\">\n <p align=\"center\">\n <strong>362</strong></p>\n </td>\n <td style=\"width:60px;height:21px;\">\n <p align=\"center\">\n <strong>186</strong></p>\n </td>\n <td style=\"width:67px;height:21px;\">\n <p align=\"center\">\n <strong>169</strong></p>\n </td>\n <td style=\"width:57px;height:21px;\">\n <p align=\"center\">\n <strong>2</strong></p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n <strong>216</strong></p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n <strong>136</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:129px;height:21px;\">\n <p>\n EarlySense - All</p>\n </td>\n <td style=\"width:91px;height:21px;\">\n <p align=\"center\">\n 322</p>\n </td>\n <td style=\"width:60px;height:21px;\">\n <p align=\"center\">\n 168</p>\n </td>\n <td style=\"width:67px;height:21px;\">\n <p align=\"center\">\n 148</p>\n </td>\n <td style=\"width:57px;height:21px;\">\n <p align=\"center\">\n 2</p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n 197</p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n 120</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:129px;height:21px;\">\n <p>\n Sibel - All</p>\n </td>\n <td style=\"width:91px;height:21px;\">\n <p align=\"center\">\n 261</p>\n </td>\n <td style=\"width:60px;height:21px;\">\n <p align=\"center\">\n 130</p>\n </td>\n <td style=\"width:67px;height:21px;\">\n <p align=\"center\">\n 128</p>\n </td>\n <td style=\"width:57px;height:21px;\">\n <p align=\"center\">\n 2</p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n 137</p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n 120</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:129px;height:21px;\">\n <p>\n <strong>Verification phase</strong></p>\n </td>\n <td style=\"width:91px;height:21px;\">\n <p align=\"center\">\n <strong>35</strong></p>\n </td>\n <td style=\"width:60px;height:21px;\">\n <p align=\"center\">\n <strong>22</strong></p>\n </td>\n <td style=\"width:67px;height:21px;\">\n <p align=\"center\">\n <strong>13</strong></p>\n </td>\n <td style=\"width:57px;height:21px;\">\n <p align=\"center\">\n <strong>0</strong></p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n <strong>35</strong></p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n <strong>0</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:129px;height:21px;\">\n <p>\n <strong>Accuracy phase</strong></p>\n </td>\n <td style=\"width:91px;height:21px;\">\n <p align=\"center\">\n 211</p>\n </td>\n <td style=\"width:60px;height:21px;\">\n <p align=\"center\">\n 109</p>\n </td>\n <td style=\"width:67px;height:21px;\">\n <p align=\"center\">\n 96</p>\n </td>\n <td style=\"width:57px;height:21px;\">\n <p align=\"center\">\n 2</p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n 207</p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n 0</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:129px;height:35px;\">\n <p>\n EarlySense accuracy</p>\n </td>\n <td style=\"width:91px;height:35px;\">\n <p align=\"center\">\n 201</p>\n </td>\n <td style=\"width:60px;height:35px;\">\n <p align=\"center\">\n 105</p>\n </td>\n <td style=\"width:67px;height:35px;\">\n <p align=\"center\">\n 90</p>\n </td>\n <td style=\"width:57px;height:35px;\">\n <p align=\"center\">\n 2</p>\n </td>\n <td style=\"width:61px;height:35px;\">\n <p align=\"center\">\n 197</p>\n </td>\n <td style=\"width:61px;height:35px;\">\n <p align=\"center\">\n 0</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:129px;height:21px;\">\n <p>\n Sibel accuracy</p>\n </td>\n <td style=\"width:91px;height:21px;\">\n <p align=\"center\">\n 136</p>\n </td>\n <td style=\"width:60px;height:21px;\">\n <p align=\"center\">\n 69</p>\n </td>\n <td style=\"width:67px;height:21px;\">\n <p align=\"center\">\n 64</p>\n </td>\n <td style=\"width:57px;height:21px;\">\n <p align=\"center\">\n 2</p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n 135</p>\n </td>\n <td style=\"width:61px;height:21px;\">\n <p align=\"center\">\n 0</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:129px;height:36px;\">\n <p>\n <strong>Feasibility phase - Recruited</strong></p>\n </td>\n <td style=\"width:91px;height:36px;\">\n <p align=\"center\">\n <strong>136</strong></p>\n </td>\n <td style=\"width:60px;height:36px;\">\n <p align=\"center\">\n <strong>69</strong></p>\n </td>\n <td style=\"width:67px;height:36px;\">\n <p align=\"center\">\n <strong>67</strong></p>\n </td>\n <td style=\"width:57px;height:36px;\">\n <p align=\"center\">\n <strong>0</strong></p>\n </td>\n <td style=\"width:61px;height:36px;\">\n <p align=\"center\">\n <strong>0</strong></p>\n </td>\n <td style=\"width:61px;height:36px;\">\n <p align=\"center\">\n <strong>136</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:129px;height:35px;\">\n <p>\n EarlySense feasibility</p>\n </td>\n <td style=\"width:91px;height:35px;\">\n <p align=\"center\">\n 120</p>\n </td>\n <td style=\"width:60px;height:35px;\">\n <p align=\"center\">\n 63</p>\n </td>\n <td style=\"width:67px;height:35px;\">\n <p align=\"center\">\n 58</p>\n </td>\n <td style=\"width:57px;height:35px;\">\n <p align=\"center\">\n 0</p>\n </td>\n <td style=\"width:61px;height:35px;\">\n <p align=\"center\">\n 0</p>\n </td>\n <td style=\"width:61px;height:35px;\">\n <p align=\"center\">\n 120</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:129px;height:35px;\">\n <p>\n Sibel feasibility</p>\n </td>\n <td style=\"width:91px;height:35px;\">\n <p align=\"center\">\n 120</p>\n </td>\n <td style=\"width:60px;height:35px;\">\n <p align=\"center\">\n 59</p>\n </td>\n <td style=\"width:67px;height:35px;\">\n <p align=\"center\">\n 61</p>\n </td>\n <td style=\"width:57px;height:35px;\">\n <p align=\"center\">\n 0</p>\n </td>\n <td style=\"width:61px;height:35px;\">\n <p align=\"center\">\n 0</p>\n </td>\n <td style=\"width:61px;height:35px;\">\n <p align=\"center\">\n 120</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"7\" style=\"width:529px;height:35px;\">\n <p>\n Note: In some instances one and in some instances two investigational devices were used on neonates; thus, there may be a perceived discrepancy in the totals.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n <strong>Qualitative sub-study enrollment</strong></p>\n<p>\n  </p>\n<p>\n Enrollment for the qualitative components were conducted at PMH and AKUH. A total of 54 interviews were conducted. The study began on July 24, 2020 at AKUH and involved in-depth interviews of 10 indirect health care providers, 2 direct health care providers, 5 administrators and 10 caregivers. 12 periods of observation of study nurses conducting study procedures were also done.  The qualitative substudy at AKUHN ended on August 6, 2020. At PMH, the qualitative component began on November 23, 2020 and involved in-depth interviews of 10 indirect health care providers, 2 direct health care providers, 5 administrators and 10 caregivers. 12 periods of observation of study nurses conducting study procedures were done.  Enrollment ended on November 30, 2020.</p>\n<p>\n  </p>\n<p>\n <strong>Assessing diagnostic performance </strong></p>\n<p>\n  </p>\n<p>\n During the verification of the Masimo Rad-97 and Spengler Tempo Easy reference devices, accuracy information gathered from the reference devices was used to set Go/No-Go thresholds for the investigational devices. These Go/No-Go thresholds were used during the accuracy evaluation phase to determine if the investigational devices could move on to the clinical feasibility phase. The study was set up so that each investigational device would have one initial open-label round to gauge and compare initial accuracy, followed by up to 5 closed-label rounds. Each closed-label round had data from 20 unique neonates. Device manufacturers were provided with data for their own devices at the end of each round and were able to modify and/or optimise their algorithms between rounds. Data from new neonates were used for each subsequent round of analysis. Once an investigational device passed the <em>a priori</em>-determined minimum accuracy threshold for each vital sign of interest, the device was allowed to proceed to the clinical feasibility phase.</p>\n<p>\n  </p>\n<p>\n During the accuracy evaluation phase at AKUH, the EarlySense investigational device passed the minimum accuracy threshold on the third closed-label round for both variables of interest (heart rate and respiratory rate) and was approved to move on to the clinical feasibility evaluation phase at PMH.</p>\n<p>\n  </p>\n<p>\n The Sibel ANNE investigational device also passed the minimum accuracy threshold on the third closed-label round for all variables of interest and was approved to move on to the clinical feasibility phase at PMH.</p>\n<p>\n  </p>\n<p>\n <strong>DATA ANALYSIS</strong></p>\n<p>\n Data are presently being analyzed and manuscripts being prepared and submitted. Below are the details of the manuscripts status, </p>\n<ul>\n <li>\n ETNA testing platform commentary- Published: DOI: https://doi.org/10.1016/S2589-7500(21)00025-X</li>\n <li>\n ETNA reference device verification analysis – Submitted to Gates Open Access</li>\n <li>\n ETNA EarlySense accuracy analysis – Submitted </li>\n <li>\n ETNA Sibel accuracy analysis – Manuscript in development </li>\n <li>\n ETNA AKU qualitative analysis – Submitted to JMIR</li>\n <li>\n ETNA PMH qualitative analysis – Manuscript in development </li>\n <li>\n ETNA EarlySense clinical feasibility analysis – Manuscript in development </li>\n <li>\n ETNA Sibel clinical feasibility analysis – Analysis ongoing </li>\n</ul>\n<p>\n ETNA Respiratory rate variability analysis – Manuscript in development</p>\n<p>\n  </p>\n<p>\n <strong>PROTOCOL AMMENDMENTS</strong></p>\n<p>\n August 1, 2019: Ref:2019/REC-01(V3):</p>\n<ul>\n <li>\n Approved addition of the text “we will confirm with you before taking any photographs or videos of your child.”</li>\n</ul>\n<p>\n December 9, 2019: Ref:2019/REC-01(V4):</p>\n<ul>\n <li>\n Approved promotional poster/flyer.</li>\n <li>\n Approved inclusion of statements to capture that recruitment for the study will be publicized at AKU Hospital and PMH using posters/flyers and/or “word of mouth.”</li>\n</ul>\n<p>\n February 19, 2020: Ref:2019/REC-01(V6):</p>\n<ul>\n <li>\n Approved increase in the sample size for accuracy testing of the EarlySense investigational device from 120 to 200 neonates.</li>\n <li>\n Approved recruitment for the accuracy evaluation phase at PMH.</li>\n <li>\n Approved alignment of dates in protocol for consistency.</li>\n</ul>\n<p>\n July 03,2020: Ref:2019/REC-02(V10)</p>\n<ul>\n <li>\n Approved text modification on page 17 and 18 to specify publicizing of the study at Aga Khan and Pumwani Hospitals via posters/flyers and/or "word of mouth" as well as inclusion of the flyer on page 48</li>\n <li>\n Approved protocol update to ensure version date consistency as well as correct table referencing for the schedule of study procedures and evaluations</li>\n <li>\n Approved the update of contact details of the Principal Investigator (Amy Ginsburg)</li>\n <li>\n Approved the exclusion criteria update to capture suspected or confirmed cases of COVID-19.</li>\n</ul>\n<p>\n August 07, 2020: Ref:2019/REC-02(V12)</p>\n<ul>\n <li>\n Approved an increase in sample size to a total of up to 575 neonates</li>\n <li>\n Approved an increase in sample size for up to 240 for the Sibel ANNE device for the accuracy phase</li>\n <li>\n Approved enrollment for a total of 325 neonates for the accuracy phase.</li>\n</ul>\n<p>\n  </p>\n<p>\n <strong>SERIOUS ADVERSE EVENTS AND PROTOCOL DEVIATIONS/VIOLATIONS</strong></p>\n<p>\n At the end of recruitment, as of December 15, 2020, no serious adverse events had been observed. One protocol violation regarding patient confidentiality was discovered on March 9, 2020. This was reported to the AKU IERC on March 17, 2020 and to the Kenya Pharmacy and Poisons Board (PPB) on April 22, 2020. On June 4, 2020, AKU IERC acknowledged and appreciated the efforts and transparency of the team and were assured that the study was being conducted as per the expected rigour and care of the participants.  Delay in submission to the Kenya PPB resulted from the numerous communications with the IERC. PPB took note with a response Ref (Dev/2020/102) on April 23, 2020.  Corrective and preventative measures undertaken to address this protocol violation included:</p>\n<ul>\n <li>\n Device manufacturer permanently deleted all participant data related to the protocol violation.</li>\n <li>\n Staff were retrained on Good Clinical Practice (GCP) and Health Insurance Portability and Accountability Act (HIPAA) policies and procedures and the validity of current GCP training was confirmed.</li>\n <li>\n Strict policies implemented at the site included that visitors will always be accompanied by GCP-trained study staff and no photographs will be taken by visitors.</li>\n</ul>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong>UNFORESEEN CHALLENGES:</strong></p>\n<p>\n The unanticipated development of the worldwide COVID-19 pandemic led to significant project delays. The study was set to begin recruitment at PMH on March 16, 2020; however, due to COVID-19 restrictions at PMH, recruitment began on September 16, 2020.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • implication_results
      • quantity_imported
      • quantity_dispensed
      • quantity_destroyed
      • quantity_exported
      • balance_site
      • final_date0000-00-00
      • modified2021-09-28 16:05:41
      • created2019-04-30 11:28:58
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id493
        • application_id791
        • given_namePROF WILLIAM
        • middle_nameMAINA
        • family_nameMACHARIA
        • qualificationMB,CHB, MMED, MSC
        • professional_addressAGA KHAN UNIVERSITY, P.O BOX. 30270-00100,NAIROBI
        • telephone254-20-3661017
        • emailwilliam.macharia@aku.edu
        • created2019-04-30 11:38:00
        • modified2020-04-24 14:18:30
    • SiteDetail(array)
      • 0(array)
        • id638
        • application_id791
        • county_id47
        • site_nameAGA KHAN UNIVERSITY HOSPITAL
        • physical_addressTHIRD PARKLANDS AVENUE, LIMURU ROAD
        • contact_detailsP.O BOX. 30270-00100,NAIROBI, 254-733627077
        • contact_personPROF WILLIAM MACHARIA
        • site_capacity(null)
        • misc(null)
        • created2019-04-30 11:38:00
        • modified2020-04-24 14:18:30
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id639
        • application_id791
        • county_id47
        • site_namePUMWANI MATERNITY HOSPITAL
        • physical_addressMURATINA STREET
        • contact_detailsPO BOX 42849-00100 NAIROBI CENTRAL, 254-733627077
        • contact_personPROF WILLIAM MACHARIA
        • site_capacity(null)
        • misc(null)
        • created2019-04-30 12:20:42
        • modified2020-04-24 14:18:30
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id385
        • application_id791
        • sponsorSAVE THE CHILDREN
        • sponsor_typeOthers
        • contact_personSWEDBERG ERIC
        • address501 KINGS HIGHWAY EAST, SUITE 400, FAIRFIELD, CONNECTICUT, UNITED STATES 06825
        • telephone_number475 999-3259
        • fax_number
        • cell_number203 434-8604
        • email_addressEswedberg@savechildren.org
        • created2019-04-30 11:38:00
        • modified2020-04-24 14:18:30
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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

Included Files

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