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  • 1Recruiting
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• applications(array)
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    • Application(array)
      • id409
      • user_id73
      • trial_status_id5
      • abstract_of_study<p style=\"text-align: justify;\">\n Our objective is to study effects of a contraceptive vaginal ring (CVR) containing estrogen and progesterone (NuvaRing) on vaginal bacteria, HIV shedding, and local immunity in women. We will build on data that support a favorable effect of CVR on vaginal bacteria. Bacterial vaginosis (BV) is found in <u>></u>50% of women in sub-Saharan Africa. BV significantly increases risk of HIV acquisition in, and HIV transmission to male partners from, HIV-infected women, genital HIV shedding, and viral set point in infected male partners. Pregnancy is also an independent risk for HIV acquisition and transmission. Contraception comprises critical biomedical prevention for women with or at risk for HIV. Systemic depot progesterone—commonly used throughout Africa—may independently increase risk of HIV acquisition and transmission. Hormonal interventions preventing unintended pregnancy and promoting a protective vaginal microenvironment could synergistically reduce HIV risk especially combined with topical antiretrovirals (ARV). We hypothesize NuvaRing use may contribute to reduction in BV, pregnancy prevention, and decreased rates of HIV shedding in HIV-infected women. <u>Sustained vaginal delivery of contraceptive and ARV PrEP as “multicomponent prevention” is a major focus for scientists but effects on the vaginal environment need careful definition before broad implementation</u>.</p>\n<p style=\"text-align: justify;\">\n <strong>Aim 1: Determine effect of CVR on vaginal bacteria, including incident/persistent BV. </strong>Show whether sustained local hormone delivery promotes desirable lactobacilli, and thus reduces risk of BV, in women with and without HIV.</p>\n<p style=\"text-align: justify;\">\n <strong>Aim 2. Define the soluble mucosal host immune response and endocervical immune cell populations with CVR. </strong>Determine if shifts in vaginal bacteria anticipated to occur with CVR will be accompanied by favorable changes in the lower genital tract, including restoration of protective mediators decreased with BV.</p>\n<p style=\"text-align: justify;\">\n <strong>Aim 3. In HIV-infected women, determine effect of CVR on genital HIV shedding. </strong>HIV-infected women not on ART at enrollment will have endocervical swabs collected for HIV RNA quantification.</p>\n<p style=\"text-align: justify;\">\n <strong>Study Site and Population</strong></p>\n<p style=\"text-align: justify;\">\n This study will be conducted at the Thika Partners Study Clinic located in Thika, Kenya. We will enroll approximately 120 women with bacterial vaginosis (BV) based on clinical criteria and a minimum of 75 male sex partners.</p>\n
      • study_title<p align=\"center\">\n <strong>Effects of contraceptive ring on vaginal microbiota, HIV shedding and local immunity</strong></p>\n
      • laymans_summary<p>\n The need for contraceptive options in women at risk for HIV acquisition has taken on urgency with evidence indicating that systemic hormonal contraception (primarily injectable, long-acting progestin) may increase women’s risk of HIV acquisition and transmission to male sex partners.<a href=\"#_ENREF_1\" title=\"Polis, 2013 #1991\">¹</a> Lack of other contraceptive options, especially for women at highest risk of HIV in Sub-Saharan Africa, is a critical barrier to progress towards optimizing women’s reproductive health. While intrauterine devices (IUDs) are an option, implementation of delivery has been slow. The use of a contraceptive vaginal ring (CVR) has been explored and reported on in several Sub-Saharan African countries, and its acceptability in general is excellent.<a href=\"#_ENREF_2\" title=\"van der Straten, 2012 #3050\">²</a> A commonly used CVR in the United States is the NuvaRing. Moreover, the format of drug delivery through the form of a vaginal ring is also being intensely explored with the use of antiretroviral agents (dapivirine, tenofovir) as a means of topical, female-controlled HIV prevention, and formulation work with several antiretroviral drugs for sustained delivery with the NuvaRing format is underway.<a href=\"#_ENREF_3\" title=\"Kiser, 2012 #3052\">³</a> Such “multicomponent prevention” has become a major focus for scientists, advocates, and funders alike.</p>\n<p>\n  </p>\n
      • short_titleNuvaRing Study
      • protocol_noECCT/15/09/01
      • version_no2.4
      • date_of_protocol23-06-2015
      • study_drugNuvaRing (Vaginal contraceptive ring)
      • disease_conditionVaginal Bacteria, HIV & Vaginal local Immunity
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameEstrogen & Progesterone
      • product_type_medical_device_nameContraceptive Vaginal Ring (NuvaRing)
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_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_pi0
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Kenneth Ngure
      • declaration_date102-09-2015
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo
      • declaration_date202-09-2015
      • placebo_presentNo
      • study_objectives<p>\n <strong>Primary Objective:</strong></p>\n<p>\n To assess potential benefits associated with both cyclic (use for 3 weeks, remove for 1 week, as defined in the package insert) and continuous (use for 4 weeks, then replace) CVR use among women (both HIV-negative and HIV-positive) with BV at enrollment (and thus at high risk for BV persistence and recurrence).</p>\n<p>\n <strong>Secondary objectives: </strong></p>\n<ol style=\"list-style-type:lower-roman;\">\n <li>\n To determine the effect of the CVR on clinically defined incidence of BV, the vaginal microbiome and rates of adverse events with CVR use.</li>\n <li>\n To assess the acceptability of the CVR to men who are sex partners of study participants.</li>\n <li>\n To assess acceptability and preference for contraceptive type at study end.</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n <strong>Female Eligibility Criteria:</strong></p>\n<ul>\n <li>\n ≥18-40 year old BV+ by Amsel’s criteria</li>\n <li>\n Not intending or wishing to become pregnant over the course of the study</li>\n <li>\n Capable of providing written informed consent</li>\n</ul>\n<div>\n  </div>\n<p>\n <strong>Male Eligibility Criteria:</strong></p>\n<ul>\n <li>\n Main sex partner of randomized female participant</li>\n <li>\n Capable of providing written informed consent</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n <strong>Female Exclusion Criteria:</strong></p>\n<ul>\n <li>\n Current pregnancy</li>\n <li>\n Desire/intent to become pregnant over the course of the study</li>\n <li>\n Current cigarette smoking if age is older than 35 years</li>\n <li>\n Unable to comprehend consent material because of language barrier or psychological difficulty</li>\n</ul>\n<p>\n <strong>Male Exclusion Criteria:</strong></p>\n<ul>\n <li>\n Unable to comprehend consent material because of language barrier or psychological difficulty</li>\n</ul>\n
      • primary_end_points<p style=\"margin-left:.5in;\">\n Outcome 1:  Quantity of <em>L. crispatus</em> determined by species-specific qPCR assay</p>\n<p style=\"margin-left:.5in;\">\n Outcome 2:  Local immune parameters, including cytokines, innate mediators, and functional antimicrobial activity in cervicovaginal secretions as assessed                        by anti-<em>E. coli</em>, anti-HSV, and anti-HIV activity</p>\n<p style=\"margin-left:.5in;\">\n Outcome 3:  Quantity of genital HIV shedding among HIV-infected participants </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • 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_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Thika partners in Prevention, Site has 32 full time clinical trial staff (including physicians, nurses, counsellors, pharmacists).</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Site Coordinator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Lead Physician for the study: Dr. Elizabeth Irungu  MBChB</p>\n
      • other_details_explanation<p>\n The need for contraceptive options in women at risk for HIV acquisition has taken on urgency with evidence indicating that systemic hormonal contraception (primarily injectable, long-acting progestin) may increase women’s risk of HIV acquisition and transmission to male sex partners.Lack of other contraceptive options, especially for women at highest risk of HIV in Sub-Saharan Africa, is a critical barrier to progress towards optimizing women’s reproductive health. While intrauterine devices (IUDs) are an option, implementation of delivery has been slow. The use of a contraceptive vaginal ring (CVR) has been explored and reported on in several Sub-Saharan African countries, and its acceptability in general is excellent.<span style=\"font-size: 10px;\"> </span>A commonly used CVR in the United States is the NuvaRing. Moreover, the format of drug delivery through the form of a vaginal ring is also being intensely explored with the use of antiretroviral agents (dapivirine, tenofovir) as a means of topical, female-controlled HIV prevention, and formulation work with several antiretroviral drugs for sustained delivery with the NuvaRing format is underway.<span style=\"font-size: 10px;\"> </span>Such “multicomponent prevention” has become a major focus for scientists, advocates, and funders alike.</p>\n
      • other_details_regulatory_notapproved<p>\n University of Washington Institutional Review Board (UW IRB)</p>\n<p>\n Submission will be done before end of September 2015</p>\n
      • other_details_regulatory_approved<p>\n Kenya Medical Research Institute's (KEMRI) Scientific, Ethics and Research Unit (SERU)</p>\n<p>\n                     Approved on 20th July 2015.</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration5 years
      • design_controlled_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_areaThika Partners Study Clinic (Partners in Health Research and Development) affiliated to the University of Washington International Clinical Research Center (ICRC), and KEMRI
      • single_site_physical_addressOAU Road, Near Thika Nursing Home
      • single_site_contact_personDr. Kenneth Ngure
      • single_site_telephone067-2222561
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site195
      • total_participants_worldwide195
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_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_nameJeanne
      • investigator1_middle_name
      • investigator1_family_nameMarrazzo
      • investigator1_qualificationProfessor of Medicine
      • investigator1_professional_addressUniversity of Washington, Seattle
      • investigator1_telephone+1-206-744-3679
      • investigator1_emailjmm2@u.washington.edu
      • organisations_transferred_Yes
      • number_participants120 women with bacterial vaginosis (BV) and a minimum of 75 male sex partners.
      • notification
      • approval_date16-02-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted09-06-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2020-06-15 11:42:25
      • created2015-07-28 16:22:20
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id279
        • application_id409
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MPH
        • professional_addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone0723 914057
        • emailrwamba@csrtkenya.org
        • created2015-08-03 13:46:45
        • modified2020-06-09 00:44:47
    • SiteDetail(array)
      • 0(array)
        • id332
        • application_id409
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-08-03 13:46:45
        • modified2020-06-09 00:44:47
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id217
        • application_id409
        • sponsorUniversity of Washington
        • sponsor_typeOthers
        • contact_personDr. Nelly Rwamba Mugo
        • addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone_number067 22561
        • fax_numbern/a
        • cell_number0723 914057
        • email_addressrwamba@csrtkenya.org
        • created2015-08-03 13:46:45
        • modified2020-06-09 00:44:47
  • 1(array)
    • Application(array)
      • id1173
      • user_id667
      • trial_status_id1
      • abstract_of_study<h1>\n ABSTRACT </h1>\n<p>\n HIV incidence rates remain unacceptably high for adolescent girls and young women (AGYW). Pre-exposure prophylaxis (PrEP) HIV prevention tools are promising with tenofovir (TFV)-based daily oral PrEP and the dapivirine vaginal ring (DPV-VR) recommended by WHO for cisgender women at-risk for HIV. Kenya is a leader for PrEP delivery in Africa and efforts are ongoing to increase PrEP access with AGYW as a priority group. Our team pioneered integrated PrEP delivery in family planning (FP) clinics in Kenya; yet 40% of Kenyan women access contraception without interfacing with facilities, including at retail pharmacies, and would be missed by facility-based PrEP platforms. Retail pharmacies can increase options for reaching at-risk individuals with PrEP and efforts are underway to define pathways for pharmacy-delivered PrEP in Kenya. We adapted our FP clinic-based PrEP model and piloted PrEP delivery facilitated by nurse-navigators for AGYW seeking contraception at pharmacies. AGYW offered daily oral PrEP frequently initiated, planned to continue use, and were willing to pay for PrEP at pharmacies. Pill burden was a common reason for declining oral PrEP and could be addressed by offering DPV-VR. Through close collaboration with the Kenya Ministry of Health both, national- and county-level, we propose a Cluster Random Controlled Trial( cRCT() at 20 pharmacies in Kisumu, Kenya-a region with an HIV prevalence of up to 28% among women -to test the effectiveness of utilizing nurse-navigators at retail pharmacies to enhance AGYW PrEP use. We will expand on our successful pilot to offer both daily oral PrEP and the DPV-VR and prospectively ascertain PrEP outcomes (initiation, persistence, adherence) among AGYW. This effectiveness-implementation hybrid RCT is designed to expedite translation into practice by evaluating clinical effectiveness alongside implementation and cost outcomes. We hypothesize that combining nurse-navigators with pharmacy-based PrEP will provide a cost-effective strategy for delivering novel HIV prevention tools to AGYW in HIV high-burden settings. Aim 1 will determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among AGYW seeking contraception within a pharmacy-based PrEP delivery model through a 2-arm cluster RCT among HIV-negative AGYW at 20 retail pharmacies in Kisumu, Kenya. AGYW seeking contraception will be offered PrEP and self-select daily oral PrEP or the DPV-VR. Primary outcomes will be proportion of AGYW accessing contraception that initiate PrEP, persist with use at 6 months, and adhere (quantified by TFV or DPV hair levels). Secondary outcomes will include PrEP selection (PrEP pills vs. DPV-VR), STI incidence, and adherence cofactors. Aim 2 will identify potential barriers and facilitators to acceptability, feasibility, and sustainability of nurse-navigators and DPV-VR delivery for AGYW accessing PrEP at retail pharmacies through a qualitative evaluation guided by Proctor et al. Aim 3 will estimate the cost-effectiveness of implementing pharmacy-based PrEP delivery with nurse-navigators. This will be the first study aiming to improve PrEP access for AGYW using a pharmacy-based model and will prime pharmacies to deliver novel PrEP agents in the pipeline.</p>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>Enhancing PrEP outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform</strong></p>\n<p>\n  </p>\n
      • laymans_summary<div>\n <p>\n <strong>LAY SUMMARY</strong></p>\n <p>\n Pre- exposure prophylaxis (PrEP) is a HIV prevention method available in both a daily oral form (tenofovir) or a monthly vaginal ring (dapivirine), PrEP works when used as recommended. Increasing locations where PrEP is dispensed may make it easier for adolescent girls and young women (AGYW) to access PrEP. To date, PrEP is available at public health clinics, yet there are major barriers to accessing PrEP at clinics which includes stigma, long waiting times, staffing costs, and healthcare providers’ unfamiliarity with PrEP. In Kenya, people often go to retail pharmacies first access to treatment of urgent and prolonged conditions. AGYW frequently obtain contraception at pharmacies without attending a health facility. Potential PrEP users may prefer pharmacy-delivered PrEP due to convenience and privacy. Additionally, the presence of nurses to provide tailored counselling on PrEP use and related topics in pharmacies can facilitate PrEP use. We will offer PrEP to AGYW  at pharmacies with and without nurses to assess if nurse-navigators effect PrEP use and determine the costs of PrEP delivery in pharmacies.</p>\n</div>\n<p>\n  </p>\n
      • short_titleAGYW Pharmacy PrEP Delivery
      • protocol_noECCT/22/10/01
      • version_no1.0
      • date_of_protocol21-03-2021
      • study_drugDapivirine
      • disease_conditionHuman Immunodeficiency Virus (HIV)
      • 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_nameDapivirine
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameTenofovir Emtricitabine
      • comparator_registeredyes
      • comparator_countriesKenya, Zambia, Botswana, Zimbabwe
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressebukusi@kemri.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_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantGreshon Rota
      • declaration_date104-10-2022
      • declaration_principal_investigatorElizabeth Bukusi
      • declaration_date204-10-2022
      • placebo_presentNo
      • study_objectives<p>\n Our overarching aim is to determine the effectiveness of utilizing nurse navigators at retail pharmacies to enhance the use of pre-exposure prophylaxis (PrEP) use for HIV prevention among adolescent girls and young women. We propose to determine the effect of nurse navigators vs. standard of care (i.e., pharmacy provider-delivered PrEP), in a 2-armed cluster randomized controlled trial (RCT). </p>\n<p>\n  </p>\n<p>\n <u>The primary objectives of this evaluation are to:</u></p>\n<p>\n  </p>\n<ol>\n <li>\n To determine the effect of nurse-navigators on PrEP initiation, persistence, and adherence among HIV-negative AGYW (age 14-24 years) seeking contraception by comparing pharmacy-based PrEP delivery models with and without nurse-navigators at 20 retail pharmacies in Kisumu, Kenya.\n <ol style=\"list-style-type:lower-alpha;\">\n <li>\n <u>Secondary objectives:</u>\n <ol style=\"list-style-type:lower-roman;\">\n <li>\n To compare PrEP selection (pills vs. DPV-VR), STI incidence and adherence cofactors (e.g. depression, relationship climate) by randomization arm.</li>\n <li>\n To describe HIV incidence, quality of care measures and long-acting reversible contraceptive use.</li>\n </ol>\n </li>\n </ol>\n </li>\n <li>\n To evaluate implementation outcomes (acceptability, feasibility, and client satisfaction) of incorporating nurse-navigators and DPV-VR into pharmacy-based PrEP delivery for AGYW by conducting a qualitative evaluation at the individual, provider, and system-level to inform scale up guided by the Proctor model.¹</li>\n <li>\n To estimate the costs and cost-effectiveness of implementing pharmacy-based PrEP delivery with nurse-navigators compared to standard pharmacy-based PrEP by conducting micro-costing and time-and-motion observation to estimate costs.</li>\n</ol>\n<p>\n  </p>\n
      • principal_inclusion_criteria<h3>\n 5.3 Eligibility Criteria </h3>\n<p>\n  </p>\n<ol>\n <li>\n <strong>AGYW (PrEP screening) </strong></li>\n</ol>\n<ol>\n <li>\n <strong><em>Inclusion criteria </em></strong></li>\n</ol>\n<ul>\n <li>\n Female gender </li>\n <li>\n Seeking contraception (emergency contraception, oral contraceptive pills, injectables, implants, and condoms) from the retail pharmacy site </li>\n <li>\n Age between ≥14 and <25 years old </li>\n <li>\n Willingness to receive PrEP screening per national guidelines including HIV testing </li>\n <li>\n Not currently taking PrEP </li>\n <li>\n Able and willing to provide informed consent for participation </li>\n</ul>\n<p style=\"margin-left:36.0pt;\">\n  </p>\n<p>\n  </p>\n<ol>\n <li value=\"2\">\n <strong>AGYW (PrEP offer per NASCOP guidelines) </strong></li>\n</ol>\n<ol>\n <li>\n <strong><em>Inclusion criteria </em></strong></li>\n</ol>\n<ul>\n <li>\n Meets NASCOP PrEP eligibility criteria. PrEP is offered to sexually active HIV-negative individuals who are at significant risk of acquiring HIV infection. Clients must meet ALL of the following criteria before initiating PrEP: </li>\n</ul>\n<ol>\n <li>\n At high risk for acquiring HIV, by meeting ANY of the following indications </li>\n</ol>\n<ul>\n <li>\n Sexual partner is known HIV positive and: not on ART, or on ART < 6 months, or suspected poor adherence to ART, or most recent viral load is detectable </li>\n <li>\n Sexual partner/s are of unknown HIV status and are at high-risk for HIV infection (has multiple sexual partners, has had STIs, engages in transactional sex, injects drugs, from high HIV burden settings) </li>\n <li>\n Engaging in transactional sex </li>\n <li>\n History of recent sexually transmitted infection </li>\n</ul>\n<ul>\n <li>\n Recurrent use of post-exposure prophylaxis </li>\n <li>\n History of sex whilst under the influence of alcohol or drugs  </li>\n <li>\n Inconsistent or no condom use or unable to negotiate condom use during intercourse with persons of unknown HIV status </li>\n <li>\n Injection drug use where needles and syringes are shared </li>\n <li>\n Sero-discordant couples trying to conceive </li>\n</ul>\n<ol>\n <li value=\"2\">\n Additionally, the following criteria must almost be met for PrEP initiation: </li>\n</ol>\n<ul>\n <li>\n Confirmed HIV negative (rapid antibody testing following the HTS algorithm on the day of PrEP initiation is adequate confirmation of HIV-negative status) </li>\n <li>\n Does not have a current or recent (within past one month) illness consistent with acute HIV infection (fever, sore throat, muscle or joint pains, swollen glands, diarrhoea or headache) in combination with a preceding high-risk exposure for HIV </li>\n <li>\n Assessed as ready to adhere to PrEP and willing to attend follow-up evaluations including repeat HIV testing and monitoring for side effects </li>\n <li>\n No contraindication to use of TDF +/- FTC/3TC </li>\n</ul>\n<p>\n  </p>\n<ol>\n <li value=\"3\">\n <strong>AGYW (FGDs) </strong>\n <ol>\n <li>\n <strong><em>Inclusion criteria </em></strong></li>\n </ol>\n </li>\n</ol>\n<ul>\n <li>\n Female gender </li>\n <li>\n Seeking contraception (emergency contraception, oral contraceptive pills, injectables, implants, and condoms) from the retail pharmacy site </li>\n <li>\n Age between ≥14 and <25 years old </li>\n <li>\n Willingness to receive PrEP screening per national guidelines including HIV testing </li>\n <li>\n Not currently taking PrEP </li>\n <li>\n Able and willing to provide informed consent for participation </li>\n <li>\n Randomized to the nurse-navigator arm</li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ol>\n <li>\n <strong>AGYW (PrEP screening) </strong></li>\n <br />\n <li value=\"2\">\n <strong><em>Exclusion criteria</em></strong></li>\n</ol>\n<ul>\n <li>\n Male gender </li>\n <li>\n Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site </li>\n <li>\n Age between <14 or >24 years old  </li>\n <li>\n Not willing to receive PrEP screening per national guidelines or not willing  to receive HIV testing </li>\n <li>\n Currently taking PrEP </li>\n <li>\n Not able or willing to provide informed consent for participation </li>\n</ul>\n<ol>\n <li value=\"2\">\n <strong>AGYW (Focused Group Discussions (FDGs)) </strong></li>\n</ol>\n<ol>\n <li value=\"2\">\n <strong><em>Exclusion criteria</em></strong></li>\n</ol>\n<ul>\n <li>\n Male gender </li>\n <li>\n Not seeking contraception (EC, OCP, injectables, implants, and condoms) from the retail pharmacy site </li>\n <li>\n Age between <14 or >24 years old  </li>\n <li>\n Not willing to receive PrEP screening per national guidelines or not willing  to receive HIV testing </li>\n <li>\n Currently taking PrEP </li>\n <li>\n Not able or willing to provide informed consent for participation </li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n Testing HIV Positive</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImplementation Science
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n <strong><u>FACILITY</u></strong></p>\n<p>\n  </p>\n<ol>\n <li>\n <strong>The main study site is:</strong></li>\n</ol>\n<p>\n KEMRI-RCTP</p>\n<p>\n KEMRI CIS Building</p>\n<p>\n Lumumba Sub-County Hospital</p>\n<p>\n Along Ondiek Highway</p>\n<p>\n P.O Box 614-40100</p>\n<p>\n Kisumu</p>\n<p>\n  </p>\n<p>\n The facility has</p>\n<ol>\n <li>\n Reception and waiting bay</li>\n <li>\n Six Clinic rooms</li>\n <li>\n Pharmacy</li>\n <li>\n Laboratory</li>\n <li>\n Data room</li>\n <li>\n Administration office</li>\n <li>\n Open Office</li>\n <li>\n Washrooms</li>\n</ol>\n<p>\n  </p>\n<p>\n All rooms are equipped with relevant furniture, equipment, and materials to facilitate the activities conducted in the rooms.</p>\n<p>\n  </p>\n<ol>\n <li value=\"2\">\n There will be <strong>20 retail pharmacies</strong> across Kisumu County based on whether they are willing to provide PrEP per national guidelines, have a separate consultation room that can be used for HIV testing and PrEP counseling, and provide the full range of contraceptives to AGYW clients (including EC, OCP, injectables, implants, and condoms). The selection of these pharmacies is currently ongoing.</li>\n</ol>\n<p style=\"margin-left:18.0pt;\">\n  </p>\n<p>\n <strong><u>PERSONNEL </u></strong></p>\n<p>\n  </p>\n<p>\n <strong>Elizabeth Bukusi, MBchB, MMed, PhD, Principal Investigator                                           </strong></p>\n<p>\n Prof. Bukusi leads the KEMRI research site in Kisumu, Kenya. In addition to her appointment at KEMRI, she is jointly appointed as a Research Associate Professor at the University of Washington. She will provide substantial oversight of all activities that take place at the Kisumu site. As the site Principal Investigator (PI) for the KEMRI team leading activities, she will work closely with the coordinating center and provide oversight of implementation of all research components, including study and intervention design, preparation of data collection instruments, intervention implementation, data collection and management, statistical analyses, as well as fiscal and administrative management of the study.</p>\n<p>\n <strong>Josephine Odoyo, Project Director   KRCHN, MPH                                                              </strong></p>\n<p>\n Josephine Odoyo is a trained nurse by profession and has wide experience in HIV research having coordinated earlier clinical trials at the Kisumu site. She has hands on experience in working in the clinic, training of staff and serves as a quality management officer for KEMRI, responsible for research studies implemented in collaboration with KEMRI. Was involved in among others Pharmacy PrEP Pilot study, the site coordination and execution of Partners PrEP study, Partners Demonstration study and the ongoing Partners Scale up Project.  She will be assisting the Principal investigators in the planning and implementation stage of the project and offering regulatory services ensuring quality is maintained throughout the study implementation.</p>\n<p>\n <strong>Dr. Zachary Kwena, MA, PhD, Qualitative Researcher   -Co-investigator                                                            </strong></p>\n<p>\n Dr. Zachary Kwena will take lead in all aspects of qualitative research of the study. He has a wealth of experience in qualitative work having conducted various qualitative studies in KEMRI.</p>\n<p>\n <strong>TBD, Coordinator                                                               </strong></p>\n<p>\n The coordinator will be responsible for the smooth functioning of the research project, coordinating communications with regulatory boards, staff and investigators, assisting investigators with implementation, planning and problem-solving to ensure project goals are met. The coordinator will be in charge of the day to day running of the site on behalf of the site PI and supervision of site personnel, development of standard operating procedures including preparation and study results dissemination to the relevant regulatory review boards.</p>\n<p>\n <strong>TBD, Study Nurses                                                               </strong></p>\n<p>\n The study nurses will be responsible for guiding of the participants in HIV counselling and testing and administering PrEP study drugs as well as collecting any sample that may be required for further analysis in the lab.</p>\n<p>\n <strong>TBD, Research Assistants</strong></p>\n<p>\n The research assistants will be responsible for mobilizing of the study participants for enrolment and making up follow ups as needed. They will also assist in the qualitative aspects of the study.</p>\n<p>\n <strong>TBD, Laboratory Technician                                                           </strong></p>\n<p>\n The Lab Technologist will be responsible for performing all the lab tests required for the participants, maintaining and charting of the temperature logs in the laboratory, preparing samples for archiving and shipment .and ensuring proper storage is done.</p>\n<p>\n <strong>TBD, Data Manager</strong></p>\n<p>\n The data manager will be responsible for overall management of the study data ensuring all the needed data bases are created and reports generated on timely basis as needed for each data base. Ensuring confidentiality of participants data by creating link log between the participants study ID and participants name which will be kept separately under double locked cabinets</p>\n<p>\n <strong>Dr. Greshon Rota, Pharmacist of Records                                                                     </strong></p>\n<p>\n The Pharmacist of records will be involved in all matters pertaining to the Pharmacy and Poisons Board (PPB) in regard to the registration of the protocol and act as a linkage between the Study and PPB.</p>\n<p>\n <strong>TBD, Qualitative Interviewer                                                           </strong></p>\n<p>\n The Qualitative Interviewer will be responsible for conducting the qualitative interviews of the study and transcribing them. This will be done in the fourth year of the study.</p>\n<p>\n <strong>TBD, Driver Nairobi</strong></p>\n<p>\n The driver based in Nairobi will assist with project driving and delivery needs especially since the PI is based in Nairobi. He will be given a 20% FTE. He will also be responsible for vehicle maintenance and keeping track of vehicle work tickets / logs.</p>\n<p>\n <strong>TBD, Administrator                                                                                 </strong></p>\n<p>\n This administrator will be responsible for assisting in overall planning for the project in liaison with the coordinator, PI and the Chief Finance Administrator and assist in budget preparation, maintaining of proper audit trail for study funds and expenditures, generate monthly invoices, and other financial reports as required in the subcontract. He will also be responsible for the handling and accounting for the field advance given to the project.</p>\n<p>\n <strong>TBD, Office Assistant</strong></p>\n<p>\n The office assistant will be responsible for delivering messages for study needs and ensure that there is a clean environment for working. She will liaise with the administrator in sending and receiving parcels and courier services. She will also clean the office area, washrooms, building surrounding and maintenance of study clinic grounds.</p>\n<p>\n <strong>Rachel Mwakisha-PA to the Principal Investigator                                                   </strong></p>\n<p>\n The PA to the principal Investigator ensures that the calendar for Prof. Bukusi is updated and that her appointments are scheduled efficiently and convenient for the operations of the project.</p>\n<p>\n <strong>Grace Waititu, Finance & Admin Manager-Nairobi                                                         </strong></p>\n<p>\n The Finance & Admin Manager is based in Nairobi. She is instrumental in terms of procurement of equipment and fast tracking of project payments to suppliers. She forwards letters to the headquarters and follow up payments on behalf of the Kisumu site. She also facilitates staff contracts, subcontracts and petty cash advances. In collaboration with the Study Coordinator and the PI she will ensure timely sub-contract agreements; budget preparation and monitoring of line items to ensure they conform to budgets.</p>\n<p>\n <strong>Denis Ochola, HRM </strong></p>\n<p>\n The Human Resource Manager is responsible for the recruitment of personnel and all staff related issues such as disciplinary, medical insurance, salaries and remuneration among others. </p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The study is seeking to address persistent drivers of HIV transmission in Africa so as to reduce rate of HIV infection inorder to achieve the UNAIDS “90-90-90” strategy which calls for 90% of HIV-infected individuals to be diagnosed by 2020, 90% of whom will be on anti-retroviral therapy (ART) and 90% of whom will achieve sustained virologic suppression.</span></p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration2 Years
      • 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_comparatorTenofovir/Emtricitabine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI RCTP Lumumba, Kisumu
      • single_site_physical_addressKEMRI-CMR building, P.O Box 614-40100, Agoi street Lumumba Sub-County Hospital, Kisumu
      • single_site_contact_personJosephine Odoyo
      • single_site_telephone+254733276275
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site1900
      • total_participants_worldwide1900
      • 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_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameElizabeth
      • investigator1_middle_name
      • investigator1_family_nameBukusi
      • investigator1_qualificationMBChB,MMed,PHD
      • investigator1_professional_addressKenya Medical Research Institute PO Box 54840,-00200, Nairobi, Kenya
      • investigator1_telephone+254 733617503
      • investigator1_emailebukusi@rctp.or.ke
      • organisations_transferred_Yes
      • number_participants1900
      • notification
      • approval_date23-12-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted04-10-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonAll reviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-01-22 15:54:46
      • created2022-09-09 09:17:55
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id851
        • application_id1173
        • given_nameELIZABETH
        • middle_name
        • family_nameBUKUSI
        • qualificationMBChB,MMed,PHD
        • professional_addressKenya Medical Research Institute PO Box 54840,-00200, Nairobi, Kenya
        • telephone+254 733617503
        • emailebukusi@rctp.or.ke
        • created2022-09-09 11:37:13
        • modified2022-10-04 05:52:23
    • SiteDetail(array)
      • 0(array)
        • id1314
        • application_id1173
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2022-09-09 11:37:13
        • modified2022-10-04 05:52:23
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id605
        • application_id1173
        • sponsorNational Institute of Health
        • sponsor_typeResearch Institution
        • contact_person
        • address9000 Rockville ,PIKE, Bethesda, Maryland 2892
        • telephone_number+1 3014964000
        • fax_number
        • cell_number+1 3014964000
        • email_addressgrantsinfo@nih.gov
        • created2022-09-09 11:37:13
        • modified2022-10-04 05:52:23
  • 2(array)
    • Application(array)
      • id960
      • user_id613
      • trial_status_id1
      • abstract_of_study<p>\n Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) are important health problems worldwide with TB remaining one of the greatest threats to public health and a leading cause of death from an infectious pathogen. It is also known that the HIV epidemic has fueled the resurgence of TB leading to dramatic increase in TB infections in low and middle income countries. The development of appropriate antiretroviral (ARV) and TB drug regimens in pregnant and postpartum women is critical to providing optimal care to women living with human immunodeficiency virus (HIV) and/or TB, and their infants to prevent disease progression There are limited studies looking at pharmacokinetics of ARVs and TB drugs during pregnancy and post-partum.</p>\n<p>\n The study will enroll women who are already on select ARVs and TB medications under study with the aim of obtaining pharmacokinetic(PK) parameters of these medications when used alone or in combination during pregnancy and post-partum in women living with and without HIV by drawing PK samples at various time points. Breastmilk will also be collected from some participants during the postpartum period. The study is comprised of 5 components based on the ARVs or TB medications the participants are receiving. Kericho site will enroll into components 3 and 5. Component 3 are pregnant women living with HIV receiving ARVs and first line TB treatment and their infants while component 5 are postpartum women living with HIV breastfeeding while receiving ARVs and their infants.</p>\n<p>\n Data obtained from this study will establish the effect of pregnancy on drug exposure and also the kinetics of transmission ARVs and TB treatment drugs from mother to infant and thus inform guidelines on appropriate ARVs and TB medications during pregnancy and lactation.</p>\n<p>\n Kericho site will enroll up to 30 mother infant pairs intothe study, 10 mother infant pairs will be enrolled into component 5 while 20 mother infant pairs will be enrolled into component 3. Participants who will be enrolled into component 3 will be enrolled in the second or third trimester and be in the study up to 24 weeks after delivery. Those in component 5 will be enrolled immediately after delivery and followed up for 24 weeks.</p>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs during Pregnancy and Postpartum</strong></p>\n
      • laymans_summary<p>\n <strong>Title</strong>: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs during Pregnancy and Postpartum.</p>\n<p>\n <strong>Lay Title</strong>: Effect of HIV and TB medicines when taken during pregnancy and after delivery.</p>\n<p>\n <strong>What is theproblem/background?</strong></p>\n<p>\n Clinical trials studying the breakdown, absorption and excretion of antiretroviral (ARV) and tuberculosis (TB)medication during pregnancy and/or postpartum, are limited.Obtaining data on how pregnancy affects drug exposure isimportant so that safe and effective doses of ARVs and anti- tuberculin medications for pregnant women can be prescribed.</p>\n<p>\n <strong>What questionsarewetryingtoanswer?</strong></p>\n<p>\n The study seeks to establish the amounts of certain ARVs and TB medications in women taking this medications during pregnancy and postpartum period and also at how much of these medications are transferred from mother to infants during breastfeeding. The aim is to obtain data on how pregnancy affects breakdown and absorption of these medications thus ensure safe and effective use of these medicines during pregnancy and breastfeeding.</p>\n<p>\n <strong>Where is the study taking place,how many people does it involve and how are they selected?</strong></p>\n<p>\n The study will take place in multiple sites, Kericho being one of them. The study will enroll a total of 325 participants across all sites into 5 components. A total of 30 participants (mother-infant pairs) will be enrolled in Kericho, 20 into component 3 and 10 into component 5. The participants will be selected by active identification and referral from surrounding health facilities.</p>\n<p>\n <strong>What does the study involve for those who are in it?</strong></p>\n<p>\n Participants will be enrolled while on selected ARVs and anti-TB medications. They will continue taking these medications while on study. Blood samples will be taken during pregnancy and after they deliver. Blood samples will also be taken from infants of mothers enrolled during pregnancy.</p>\n<p>\n <strong>Whatarethebenefitsandrisks/costsofthestudyforthoseinvolved?</strong></p>\n<p>\n The mothers and infants in the study will benefit from provision of ancillary medical care from entry to completion of the study at no cost to the them. The risks of this study are mainly due to blood collection which may cause pain, bruising, swelling, or fainting. There is a very small chance of infection where the needle is inserted. It may be uncomfortable to express breast milk. Blood collection from infants will be done by heel stick, which may cause some discomfort, bleeding or bruising at the site of the heel stick. There is also risk of breach of confidentiality.</p>\n<p>\n <strong>H</strong><strong>ow will the study benefit society?</strong></p>\n<p>\n Information learned from this study may be of benefit to participants and others in the future.</p>\n<p>\n  </p>\n<p>\n <strong>When does the study start and finish?</strong></p>\n<p>\n The study is expected start in the first quarter of 2021 and take approximately 5 years to end in the year 2026.</p>\n<p>\n  </p>\n<p>\n  </p>\n
      • short_titleP2026
      • protocol_noECCT/21/03/06
      • version_noversion 1.0
      • date_of_protocol22-01-2020
      • study_drugBictegravir (BIC), Doravirine (DOR), Tenofovir Alafenamide (TAF), Cabotegravir (CAB)
      • disease_conditionTB and HIV in pregnancy
      • 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_nameBictegravir (BIC), Doravirine (DOR), Tenofovir Alafenamide (TAF), Cabotegravir (CAB)
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressKericho.DRS@usamru-k.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • 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. Lucy C. Koech ,MBChB.
      • declaration_date102-12-2020
      • declaration_principal_investigatorDr. Lucy C. Koech ,MBChB.
      • declaration_date202-12-2020
      • placebo_presentNo
      • study_objectives<h2>\n Primary Objectives</h2>\n<h2>\n <span style=\"font-size: 12px;\"> 1.   Component 3: Describe the PK parameters during pregnancy and postpartum of selected ARV drugs and first-line TB treatment drugs co-administered to WLHIV.</span></h2>\n<ol>\n <li value=\"2\">\n Component 5: Describe the kinetics of drug transfer of selected ARVs from mother to infant via breast milk.</li>\n</ol>\n<h2>\n <strong>Secondary Objectives</strong></h2>\n<ol>\n <li>\n All Components: Describe maternal and infant safety and clinical outcomes.</li>\n <li>\n Components 1, 3 and 4: Compare drug concentrations in plasma from cord blood with concentrations in maternal plasma at delivery for selected ARV and/or TB treatment drugs.</li>\n <li>\n Components 1, 3 and 4: Describe the neonatal elimination of selected ARV and/or TB treatment drugs acquired across the placenta after maternal dosing during pregnancy.</li>\n <li>\n Components 3 and 4: To describe the kinetics of drug transfer of selected ARVs and/or TB treatment drugs from mother to infant via breast milk.</li>\n</ol>\n<h2>\n <strong>Other Objectives</strong></h2>\n<ol>\n <li>\n Assess plasma protein binding of highly bound ARVs and/or TB treatment drugs during pregnancy and postpartum.</li>\n <li>\n Explore genetic sources for variability in drug exposure in pregnant women, postpartum women, and infants for selected ARV and/or TB treatment drugs.</li>\n</ol>\n<p class=\"MsoListParagraphCxSpLast\" style=\"text-indent:-.25in;mso-list:l1 level1 lfo3\">\n <!--[if !supportLists]--><span new=\"\" style=\"font-size:12.0pt;line-height:107%;font-family:\" times=\"\">4.<span new=\"\" style=\"font-variant-numeric: normal; font-variant-east-asian: normal; font-stretch: normal; font-size: 7pt; line-height: normal; font-family: \" times=\"\">   </span></span>Kericho site will participate in components 3 and 5.</p>\n
      • principal_inclusion_criteria<p>\n <strong>Component 3 Inclusion Criteria</strong></p>\n<ol>\n <li>\n Mother is aged16 years or above and is willing and able to provide written informed consent for her own and her infant’s participation in this study. As per KEMRI IRB SOPs,mature minors aged 16 years and above can consent for themselves and their infants. The legal age for independent consent in Kenya is 18 years.</li>\n <li>\n Prior to study entry, HIV status confirmed as HIV infected. HIV confirmation will be done at the Kericho site Laboratory which operates under good clinical laboratory practice (GCLP).</li>\n <li>\n At study entry, pregnant and in one of the following two enrollment windows, based on best available obstetrical estimate of gestational age:</li>\n</ol>\n<ul>\n <li>\n Second trimester: gestational age of 20 0/7 to 26 6/7 weeks</li>\n <li>\n Third trimester: gestational age of 30 0/7 to 37 6/7 weeks</li>\n</ul>\n<ol>\n <li value=\"4\">\n At study entry, receiving at least two of the following first-line TB treatment drugs under study AND at least one of the following ARV drugs or drug combinations under study, based on maternal report and available medical records:</li>\n</ol>\n<p>\n              First-line TB treatment drugs:</p>\n<ul>\n <li>\n Isoniazid (INH) 4-6 mg/kg (max 300 mg) q.d.</li>\n <li>\n Rifampicin (RIF) 8-12 mg/kg (max 600 mg) q.d</li>\n <li>\n Rifabutin (RFB) 150-300 mg q.d.</li>\n <li>\n Ethambutol (EMB) 15-20 mg/kg q.d.</li>\n <li>\n Pyrazinamide (PZA) 20-30 mg/kg q.d.</li>\n <li>\n Moxifloxacin (MFX) 400 mg or 800mg q.d.</li>\n <li>\n  </li>\n <li>\n ARVs</li>\n <li>\n Arm 3.1 Dolutegravir (DTG) 50 mg b.i.d. when combined with RIF or 50 mg q.d. if RIF is not part of the TB regimen</li>\n <li>\n Arm 3.2 Atazanavir/ritonavir (ATV/r) t of the TB q.d. or Darunavir/ritonavir (DRV/r) t of the TB rb.i.d.</li>\n <li>\n Arm 3.3 Lopinavir/ritonavir (LPV/r) 800/200 mg b.i.d.</li>\n</ul>\n<ol>\n <li>\n At study entry, has been receiving the drug combination under study at the required dose for at least two weeks based on maternal report and available medical records.</li>\n <li>\n At study entry, assessed by study staff as having no identified barriers to completing initial PK sampling within 20 0/7 – 26 6/7 weeks gestation (second trimester) or 30 0/7 to 37 6/7 weeks gestation (third trimester) and within 14 days of enrollment.</li>\n <li>\n At study entry, if receiving a generic ARV or TB formulation of the drug or drug combination under study, approval of the formulation per section 5.1 on page 54 of the Sponsor protocol.</li>\n <li>\n At study entry, planning to continue the current ARV regimen through at least 8 weeks post-delivery, based on maternal report and available medical records.</li>\n</ol>\n<p>\n <strong>Component 5 Inclusion Criteria</strong></p>\n<ol>\n <li>\n .Mother is aged 16 years or above and is willing and able to provide written informed consent for her own and her infant’s participation in this study. As per KEMRI IRB SOPs, mature minors aged 16 years and above can consent for themselves and their infants. The legal age for independent consent in Kenya is 18 years.</li>\n</ol>\n<p>\n  </p>\n<ol>\n <li value=\"2\">\n Prior to study entry, HIV status confirmed as HIV infected</li>\n <li value=\"3\">\n At study entry, within 5-9 days post-delivery (inclusive).</li>\n <li value=\"4\">\n At study entry, breastfeeding mother-infant pair intends to continue exclusive breastfeeding through at least 16 weeks post-delivery.</li>\n <li value=\"5\">\n At study entry, mother is receiving any of the following oral ARV drugs or drug combinations:</li>\n</ol>\n<ul>\n <li>\n <strong>Arm 5.1 </strong>Atazanavir/ritonavir (ATV/r)</li>\n <li>\n <strong>Arm 5.2 </strong>Darunavir/ritonavir (DRV/r)</li>\n <li>\n <strong>Arm 5.3 </strong>Lopinavir/ritonavir (LPV/r)</li>\n</ul>\n<ol>\n <li value=\"6\">\n At study entry, mother has been receiving the drug(s) or drug combination(s) under study at the required dose for at least two weeks, based on maternal report and available medical records.</li>\n <li value=\"7\">\n At study entry, assessed by study staff as having no identified barriers to completing initial PK sampling within the 5-9 days post-delivery PK sampling window.</li>\n <li value=\"8\">\n At study entry, mother is planning to continue the current ARV regimen through at least 16 weeks post-delivery, based on maternal report and available medical records.</li>\n <li value=\"9\">\n At study entry, if receiving a generic ARV formulation of the drug or drug combination under study, approval of the formulation.</li>\n <li value=\"10\">\n At study entry, infant weighs at least 1000 grams, based on available medical records.</li>\n <li>\n At study entry, infant does not have any severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by the site investigator.</li>\n</ol>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n <strong>Component 3 Exclusion criteria</strong></p>\n<ol>\n <li>\n At study entry, mother has received within the past 14 days medicines known to interfere with absorption, metabolism, or clearance of the drug or drug combination under study based on maternal report and available medical records.</li>\n</ol>\n<ol>\n <li value=\"2\">\n At study entry, has a clinical or laboratory finding or condition that, in the opinion of the site investigator, is likely to require a change of the ARV or TB drug under study during the period of study follow-up.</li>\n</ol>\n<p>\n Note: Participants will not be co-enrolled with other studies without approval from the protocol team.</p>\n<p>\n <strong>Exclusion Criteria for Component 5</strong></p>\n<ol>\n <li>\n Mother is currently enrolled in Component 3.</li>\n <li>\n At study entry, the mother or infant has received within the past 14 days medicines known to interfere with absorption, metabolism, or clearance of the drug or drug combination under study based on maternal report and available medical records</li>\n <li>\n At study entry, mother or infant has a clinical or laboratory finding or condition that, in the opinion of the site investigator, is likely to require a change of the drug under study during study follow-up.</li>\n</ol>\n
      • primary_end_points<ol>\n <li>\n Component 3: Describe the PK parameters during pregnancy and postpartum of selected ARV drugs and first-line TB treatment drugs co-administered to WLHIV.</li>\n</ol>\n<p style=\"margin-left:31.5pt;\">\n  </p>\n<ol>\n <li value=\"2\">\n Component 5: Describe the kinetics of drug transfer of selected ARVs from mother to infant via breast milk.</li>\n</ol>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic1
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Kericho CRC has a total of 152 staff with the necessary professional backgrounds and experience to support the clinical trials. The staff consist of 6 doctors (one obstetrician/gynecologist, two infectious disease doctors, one public health physician, a consultant pediatrician, and a medical officer), 15 clinical officers, two pharmacists, one pharmaceutical technologist, 24 nurses, 45 laboratory technologists, 3 IT specialists, 12 data entry staff among others.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The site has five full time doctors that will participate in study implementation and participants’ care, one of whom is a Critical Care Pediatrician (Dr Tsikhutsu), and will be available to oversee newborns who may require care during delivery neonetal period and throughout the study.The study staff (clinicians/nurses) are trained on handling emergencies. Participants will be managed at USAMRD-A/K CRC for outpatient services and when participants require inpatient services, they will be admitted at Unilever Tea Kenya (UTK) Central Hospital which is a private company facility owned by the UTK tea company</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n KEMRI SERU approval dated Nov 05 2020</p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration5 years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKENYA MEDICAL RESEARCH INSTITUTE/WALTER REED PROJECT CLINICAL RESEARCH CENTER
      • single_site_physical_addressOFF HOSPITAL ROAD
      • single_site_contact_personLUCY CHEPKURUI KOECH
      • single_site_telephone+254522036100
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states10
      • number_of_sites
      • multi_country_listBotswana Uganda India\nTanzania Thailand Brazil\nUSA South Africa Malawi\nZimbabwe
      • data_monitoring_committeeYes
      • total_enrolment_per_siteN/A
      • total_participants_worldwide325
      • population_less_than_18_yearsYes
      • population_uteroYes
      • population_preterm_newbornNo
      • population_newbornYes
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenYes
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameWinnie
      • investigator1_middle_nameChelangat
      • investigator1_family_nameKeter
      • investigator1_qualificationDip. Clinical medicine
      • investigator1_professional_addressP.O Box 1357 – 20200,Hospital Road, Kericho, Kenya.
      • investigator1_telephoneTel: +254 052 20 36100 Mobile: +254 717 844997
      • investigator1_emailWinnie.keter@usamru-k.org
      • organisations_transferred_No
      • number_participants60
      • notification
      • approval_date07-08-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted26-03-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application approved by the experts
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2024-06-19 13:40:23
      • created2020-12-02 09:24:12
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id607
        • application_id960
        • given_nameDr. Lucy
        • middle_nameChepkurui
        • family_nameKoech
        • qualificationMBChB
        • professional_addressP.O Box 1357 – 20200,Hospital Road, Kericho, Kenya.
        • telephoneTel: +254 052 20 36100 Mobile: +254 719193275
        • emailLucy.koech@usamru-k.org
        • created2020-12-02 09:28:51
        • modified2021-03-26 10:12:01
    • SiteDetail(array)
      • 0(array)
        • id840
        • application_id960
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-12-02 09:28:51
        • modified2021-03-26 10:12:01
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id470
        • application_id960
        • sponsorNational Institute of Allergy and Infectious Diseases
        • sponsor_typeOthers
        • contact_person
        • address5601 Fishers Lane
        • telephone_number1-240-292-4788
        • fax_number
        • cell_number1-240-292-4788
        • email_addressbetsysmith@niaid.nih.gov
        • created2020-12-02 09:28:51
        • modified2021-03-26 10:12:01
  • 3(array)
    • Application(array)
      • id412
      • user_id73
      • trial_status_id5
      • abstract_of_study<p>\n The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term HIV-1 serodiscordant partnerships, i.e. where one partner is HIV-1 infected and the other uninfected. Heterosexual HIV-1 serodiscordant couples face a difficult dilemma when considering their desire to have children: forego condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and relinquish their childbearing desires. Pregnancy rates among HIV-1 serodiscordant couples are similar to the general population and we have learned from our clinical trial cohorts and qualitative data collection that fertility desires often outweigh HIV-1 risks for these couples and they make conscientious decisions to increase sexual frequency and reduce condom use in order to conceive. Thus, there is a critical need to test the feasibility and acceptance of a “safer conception” intervention for low resource settings, an integrated biomedical and behavioral approach to minimize HIV-1 risk when serodiscordant couples are intending to become pregnant. In the absence of such an intervention, couples will continue to attempt pregnancy, but they will do so with greater HIV-1 transmission risk than necessary.</p>\n<p>\n Based on evidence from rigorous clinical trials demonstrating the strong efficacy of individual interventions  for HIV-1 prevention and formative work with HIV-1 serodiscordant couples and clinicians with expertise in HIV-1 prevention and reproductive health in the Kenyan context, we will pilot a safer conception intervention that focuses on antiretrovirals (as antiretroviral therapy [ART] taken by the HIV-1 infected partner and pre-exposure prophylaxis [PrEP] taken by the HIV-1 uninfected partner) and timed condomless sex.  Additional strategies for couples will include diagnosis and treatment of STIs and male circumcision. The Figure below presents a schematic of the safer conception components that will be incorporated.</p>\n<p>\n mHealth tools, including SMS and tablet applications, are novel and very popular among Kenyans to ease the burden of addressing health problems.  Our safer conception intervention will incorporate mHealth tools to improve couples’ experiences tracking fertility indicators and communicating with providers about their readiness to practice safer conception.  An SMS survey will be used to collect daily information from women about their fertility signs and SMS messages will be used to reinforce HIV-1 prevention, including condom use for couples during periods that do not have a high likelihood of fertility. An in-clinic tablet application will be used to improve clinician-patient counseling and assessments of couple readiness to practice safer conception. To inform future engagement of mHealth tools, will prospectively evaluate clinician and patient experiences using SMS surveys and the tablet application.</p>\n<p>\n This work will take place at the Partners in Health Research and Development site in Thika, Kenya, where the clinical research staff are experts in working with HIV-1 serodiscordant couples since the site inception in 2006.  Couples with immediate fertility intentions and a high likelihood to become pregnant within one year – determined by using a validated, empiric scoring tool that we have developed – will be followed longitudinally, allowing careful tracking of pregnancy and HIV-1 incidence.  This is the exact outcome that HIV-1 prevention programs need to monitor to ensure that we fully understand the preferences and willingness of couples to practice safer conception and the ability of an integrated intervention to reduce HIV-1 transmission risk to the lowest level possible during peri-conception periods.</p>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>Pilot of an mHealth-enhanced, safer conception intervention to reduce HIV-1 risk among Kenyan HIV-1 serodiscordant couples</strong></p>\n<p align=\"center\">\n <strong><em>Safer Conception Intervention for Partners (SCIP)</em></strong></p>\n
      • laymans_summary(null)
      • short_titleSafer Conception Intervention for Partners (SCIP)
      • protocol_noECCT/15/10/03
      • version_no3.0
      • date_of_protocol08-09-2015
      • study_drugEmtricitabine/Tenofovir or Tenofovir Disoproxil Fumarate (SCIP Study)
      • disease_conditionPrEP as a \'\'Safer Conception Tool\'\'
      • 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_nameEmtricitabine/Tenofovir or Tenofovir Disoproxil Fumarate
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressRwamba@csrtkenya.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr. Kenneth Ngure
      • declaration_date122-10-2015
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo
      • declaration_date222-10-2015
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p style=\"margin-left:1.0in;\">\n <u>For couples</u></p>\n<ul>\n <li>\n Immediate fertility intention and a high likelihood of pregnancy</li>\n <li>\n Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months)</li>\n <li>\n Willing to enter the study as a couple and intending to remain as a couple for the next 12 months</li>\n <li>\n Did not participate in the Partners PrEP Study or the Partners Demonstration Project</li>\n</ul>\n<p>\n <u>For HIV-1 infected members of the couple (index participants)</u></p>\n<ul>\n <li>\n Age ≥18</li>\n <li>\n If female, not older than age 49</li>\n <li>\n Able and willing to provide written informed consent</li>\n <li>\n HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm</li>\n <li>\n Not currently pregnant or breastfeeding</li>\n <li>\n No use of injectable contraception for the past 3 months</li>\n <li>\n Not currently enrolled in an HIV-1 treatment study</li>\n <li>\n No clear indication of infertility or subfertility, as determined by medical history</li>\n <li>\n Own a mobile phone for personal use, which operates on a telecom provider supported by the study SMS platform and is distinct from the mobile phone owned by the HIV-1 uninfected partner</li>\n <li>\n Know how to send and receive SMS</li>\n <li>\n Have regular access to electricity or an alternative means for charging a cell phone</li>\n <li>\n Literate in English, Kiswahili or Kikuyu</li>\n</ul>\n<p>\n <u>For HIV-1 uninfected members of the couple (partner participants)</u></p>\n<ul>\n <li>\n Age ≥18</li>\n <li>\n If female, not older than age 49</li>\n <li>\n Able and willing to provide written informed consent</li>\n <li>\n HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrollment visit</li>\n <li>\n Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥60 mL/min</li>\n <li>\n Not infected with hepatitis B virus, as determined by a negative hepatitis B surface antigen test</li>\n <li>\n Not currently pregnant or breastfeeding  </li>\n <li>\n No use of injectable contraception for the past 3 months</li>\n <li>\n Not currently enrolled in an HIV-1 prevention clinical trial</li>\n <li>\n Enrollment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator</li>\n <li>\n No clear indication of infertility or subfertility, as determined by medical history</li>\n <li>\n Own a mobile phone for personal use, which operates on a telecom provider supported by the study SMS platform and is distinct from the mobile phone owned by the HIV-1 infected partner</li>\n <li>\n Know how to send and receive SMS</li>\n <li>\n Have regular access to electricity or an alternative means for charging a cell phone</li>\n <li>\n Literate in English, Kiswahili or Kikuyu</li>\n</ul>\n<p>\n <u>For study clinicians and counselors</u></p>\n<ul>\n <li>\n Active involvement in safer conception counseling for couples and use of the tablet application during counseling sessions</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n Contrary to any of the Inclusion criteria.</p>\n<p>\n Having taken part in Partners PrEP Study or the Partners Demonstration Project.</p>\n
      • primary_end_points<p>\n Pregnancy using the safer conception tools.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • 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 style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Thika partners in Prevention, Site has 32 full time clinical trial staff (including physicians, nurses, counsellors, pharmacists).</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Site Coordinator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; line-height: 20px; font-size: 13px;\">\n Lead Physician for the study: Dr. Njambi Njuguna  MBChB, MSc, MPH</p>\n
      • other_details_explanation<p>\n The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa, where a substantial proportion of infections occur in long-term HIV-1 serodiscordant partnerships, i.e. where one partner is HIV-1 infected and the other uninfected. Heterosexual HIV-1 serodiscordant couples face a difficult dilemma when considering their desire to have children: forego condom use, attempt to conceive and risk HIV-1 transmission or continue condom use and relinquish their childbearing desires. Pregnancy rates among HIV-1 serodiscordant couples are similar to the general population and we have learned from our clinical trial cohorts and qualitative data collection that fertility desires often outweigh HIV-1 risks for these couples and they make conscientious decisions to increase sexual frequency and reduce condom use in order to conceive. Thus, there is a critical need to test the feasibility and acceptance of a “safer conception” intervention for low resource settings, an integrated biomedical and behavioral approach to minimize HIV-1 risk when serodiscordant couples are intending to become pregnant. In the absence of such an intervention, couples will continue to attempt pregnancy, but they will do so with greater HIV-1 transmission risk than necessary.</p>\n
      • other_details_regulatory_notapproved<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n University of Washington Institutional Review Board (UW IRB)</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n Submission will be done before end of October 2015</p>\n
      • other_details_regulatory_approved<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n Kenya Medical Research Institute's (KEMRI) Scientific, Ethics and Research Unit (SERU)</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \'Trebuchet MS\', Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px; line-height: 20px;\">\n                     Approved on 5th October 2015.</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n None</p>\n
      • estimated_duration3 Years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaThika Partners Study Clinic (Partners in Health Research and Development) affiliated to the University of Washington International Clinical Research Center (ICRC), and KEMRI
      • single_site_physical_addressOAU Road, Near Thika Nursing home - Thika section 9
      • single_site_contact_personDr. Kenneth Ngure
      • single_site_telephone067-22561
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site80 couples\nStudy clinicians and counselors delivering the intervention
      • total_participants_worldwide80 couples, Study clinicians and counselors delivering the intervention
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_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_nameRenee
      • investigator1_middle_name
      • investigator1_family_nameHeffron
      • investigator1_qualificationMPH, PhD
      • investigator1_professional_addressUniversity of Washington, Seattle
      • investigator1_telephone+1 2065203817
      • investigator1_emailrheffron@uw.edu
      • organisations_transferred_Yes
      • number_participants80 couples\nStudy clinicians and counselors delivering the intervention
      • notification
      • approval_date11-01-2016
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted22-10-2015
      • 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)
      • modified2018-08-02 11:46:04
      • created2015-08-06 11:19:28
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id280
        • application_id412
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MPH
        • professional_addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone0723 914057
        • emailrwamba@csrtkenya.org
        • created2015-08-06 11:20:52
        • modified2015-10-22 10:45:47
    • SiteDetail(array)
      • 0(array)
        • id333
        • application_id412
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2015-08-06 11:20:52
        • modified2015-10-22 10:45:47
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id218
        • application_id412
        • sponsorUniversity of Washington
        • sponsor_type(null)
        • contact_personDr. Nelly Rwamba Mugo
        • addressUNITID Building, Box 19865-00202, KNH, Nairobi
        • telephone_number067-22561
        • fax_number
        • cell_number0723 914057
        • email_addressrwamba@csrtkenya.org
        • created2015-08-06 11:20:52
        • modified2015-10-22 10:45:47
  • 4(array)
    • Application(array)
      • id1039
      • user_id73
      • trial_status_id6
      • abstract_of_study<p style=\"margin:0in;text-align:justify\">\n <span style=\"font-size:11.0pt;\nfont-family:"Arial",sans-serif;color:#0E101A\">Adolescent girls and young women (AGYW) in Kenya face parallel epidemics for unintended pregnancy and HIV. Existing reproductive health and family planning programs are acceptable and effective entry points to reach AGYW with comprehensive services to prevent these events. AGYW seeking care for an early pregnancy loss- whether from a spontaneous miscarriage or induced abortion- face these epidemics and integrating HIV prevention services, particularly daily oral PrEP, into PAC services is an opportune method to reach them. PrEP is widely available in Kenya for people with substantial risk for HIV. Prior formative work by the protocol investigators found that young women accessing PAC had characteristics (existing STI infection and sexual behavior) that render them susceptible to HIV acquisition. More than half of the women indicated willingness to use PrEP. An additional important finding from the study was that PrEP screening and initiation could be integrated into services provided through the PAC clinic and follow-up for PrEP refills conducted outside of these clinics (e.g. family planning-FP- clinics).<o:p></o:p></span></p>\n<p style=\"text-align:justify\">\n <span style=\"font-size:11.0pt;font-family:"Arial",sans-serif;\ncolor:#0E101A\">Through the proposed work, we plan to pilot PrEP integration into PAC services among 14 health facilities (public and private) providing PAC to AGYW in Thika, Nairobi, Murang’a, Kisumu and their environs. The project will enroll 2000 AGYW accessing PAC services and engage a subset of 400 for research procedures to evaluate: 1) uptake, adherence, and continuation of PrEP and FP 2) linkage and follow-up on PrEP and FP services 3) impact of enhanced adherence support on PrEP continuation and adherence 4) experiences of young women and providers with an integrated PrEP program, and 5) factors associated with adherence to PrEP and FP. Specifically, we hope that the work will result in robust recommendations for how to optimize and advance long-standing delivery of HIV prevention as part of PAC services in Kenya and similar settings.<o:p></o:p></span></p>\n
      • study_title<p align=\"center\">\n <strong>Piloting HIV Pre-exposure Prophylaxis (PrEP) Integration into Services for Early Pregnancy Loss</strong></p>\n
      • laymans_summary<p>\n Adolescent girls and young women (AGYW) receiving care following a pregnancy loss – whether from a spontaneous miscarriage or induced abortion - are extremely vulnerable to ongoing sexual and HIV risk because of infrequent condom use, recent sexual debut, and experiences with psychosocial distress, stigma, and violence that often characterize their recent past. Results from prior formative work showed that AGYW accessing services from PAC clinics were at a high risk for HIV infection and willing to initiate PrEP alongside PAC services but would only access refills from outside of these clinics (e.g. at family planning clinics). Accessing these women through post-abortal care (PAC) clinics provides an entry point to engage women in HIV prevention, specifically oral PrEP, because of the HIV risk they face. Through the proposed study, we will assess the feasibility and impact of using PAC services in both private and public facilities as an entry point to link AGYW to PrEP, as well as integrated PrEP and contraceptive services in Thika, Nairobi, and Kisumu. The project will enroll up to 2000 AGYW 15-30 years on PrEP from whom 400 AGYW will be enrolled for research activities with 6 months follow-up. These include quantitative and qualitative evaluation of PrEP uptake, linkage to follow-on services and adherence through enhanced adherence support and urine testing of PrEP drug levels. We aim to demonstrate new models of integrating de-medicalised HIV and pregnancy prevention services since it is central to our goal of making services as responsive and accessible to women of reproductive age. Further, gain insights on the AGYW behaviour which determines PrEP uptake and adherence.This project will result in recommendations for how to optimize and scale-up the delivery of HIV prevention services including PrEP as part of PAC care in Kenya and similar settings. </p>\n
      • short_titlePrEDIRA - 2
      • protocol_noECCT/21/09/02
      • version_no1.0
      • date_of_protocol11-06-2021
      • study_drugPrEDIRA - 2 ( TDF/FTC & POC Urine Assay kit)
      • disease_conditionHIV Prevention among young seeking post-abortal care
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameTDF/FTC, TDF or TDF/3TC
      • product_type_medical_device_namePoint of Care kit for Urine Monitoring of Adherence
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressregulatory@pipsthika.org
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantPeter Mogere
      • declaration_date113-07-2021
      • declaration_principal_investigatorDr. Nelly Mugo
      • declaration_date213-07-2021
      • placebo_presentNo
      • study_objectives<h2>\n <span style=\"font-size: 12px;\">Building on prior PrEP programs in Kenya focused on AGYW and our work with clinics providing PAC, this project will advance our understanding of how to optimize delivery of PrEP to AGYW through PAC care and long-term family planning and reproductive health care.</span></h2>\n<p>\n <strong>Objectives:</strong></p>\n<ol>\n <li>\n <strong>Among women accessing post-abortal care (PAC) services in Kenya, we will use methods from implementation science to evaluate feasibility of integrating PrEP into PAC services by estimating:</strong></li>\n</ol>\n<p style=\"margin-left:.5in;\">\n <strong>a) uptake of PrEP and FP at the PAC site</strong></p>\n<p style=\"margin-left:.5in;\">\n <strong>b) linkage of women from PAC to follow-on PrEP and FP services</strong></p>\n<p style=\"margin-left:.5in;\">\n <strong>c) retention in PrEP and FP programs</strong></p>\n<p style=\"margin-left:.5in;\">\n <strong>d) continuation of PrEP and FP during a 6 month period</strong></p>\n<p>\n <strong>Approach:</strong> We will support approximately 14 PAC facilities to launch PrEP delivery using standard Kenya MOH approaches and tools. After 12 months of delivery, we will use programmatic data that are abstracted from MOH PrEP client encounter cards and FP client cards to estimate PrEP uptake, linkage, retention, and continuation among approximately 2,000 women in Kisumu, Nairobi, Murang’a, Thika and their environs who are accessing PAC.</p>\n<ol>\n <li value=\"2\">\n <strong>To determine the effect of enhanced adherence activities on PrEP continuation and adherence</strong></li>\n</ol>\n<p>\n Approach: Approximately 3 months after all facilities have launched a foundational PrEP program, we will use a randomization process to assign half of the collaborating PAC facilities to launch enhanced adherence support activities with AGYW accessing PrEP (intervention facilities) and half to maintain the foundational program (control facilities that will not add enhanced adherence support activities). After 9 months of both programs, we will compare PrEP continuation between AGYW accessing PrEP in intervention versus control facilities. In a subset of AGYW engaged for research procedures (N=400), we will objectively measure PrEP adherence and compare adherence between women accessing PrEP through intervention versus control facilities and we will conduct qualitative research to understand key factors influencing PrEP adherence.</p>\n<ol>\n <li value=\"3\">\n <strong>To qualitatively evaluate the feasibility of integrating PrEP into PAC services and experiences of young women and providers with an integrated PrEP program</strong></li>\n</ol>\n<p>\n <strong>Approach: </strong>We will conduct qualitative research with implementing partners, providers, and clients to understand acceptability, satisfaction, facilitators, and barriers to initiating and sustaining PrEP delivery within PAC.</p>\n<ol>\n <li value=\"4\">\n <strong>To determine factors associated with adherence to PrEP and FP</strong></li>\n</ol>\n<p>\n <strong>Approach</strong>: In a subset of AGYW engaged for research procedures (N=400), we will use standardized questionnaires to collect demographic, social, clinical and behavioural information and use these data in statistical models of factors associated with PrEP and FP use/non-use. We will also conduct qualitative research to better understand the reasons that compel young women to continue and discontinue PrEP and family planning.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n <strong>            Inclusion criteria: Program implementation:</strong></p>\n<ul>\n <li>\n Aged 15-30 years</li>\n <li>\n HIV-negative, according to national HIV testing algorithm</li>\n <li>\n Accessing services for early pregnancy loss at one of the participating facilities and other facilities within the program area</li>\n <li>\n Not currently using PrEP</li>\n <li>\n Eligible for PrEP, according to Kenya national guidelines [37]</li>\n</ul>\n<p>\n <strong>            Inclusion criteria: Research procedures with young women:</strong></p>\n<ul>\n <li>\n Aged 15-30 years</li>\n <li>\n Able and willing to provide written informed consent\n <ul>\n <li>\n AGYW ages 15-17 years will provide informed consent as emancipated minors since they have already been pregnant </li>\n </ul>\n </li>\n <li>\n Enrolled in the integrated PrEP program at one of the participating facilities</li>\n</ul>\n<p>\n <strong>Inclusion criteria: Research procedures with healthcare providers, policymakers, and program implementers:</strong></p>\n<ul>\n <li>\n Age ≥18 years</li>\n <li>\n Able and willing to provide informed consent</li>\n <li>\n Providing health care services at one of the facilities, facility partners engaged by the project, engaged in policymaking with Kenya Ministry of Health</li>\n</ul>\n
      • principal_exclusion_criteria<p>\n <strong>Exclusion criteria:- Program</strong></p>\n<ul>\n <li>\n Living with HIV, according to national HIV testing algorithm</li>\n <li>\n Has any condition (social or medical) which in the opinion of the investigator would make program participation unsafe</li>\n</ul>\n<p style=\"margin-left: 0.5in;\">\n <strong>Exclusion criteria: Research component</strong></p>\n<ul>\n <li>\n Not being enrolled in the participating PrEP integration program</li>\n</ul>\n<p style=\"margin-left: 0.5in;\">\n <strong>Exclusion criteria:Healthcare providers</strong></p>\n<ul>\n <li>\n Not working with the facilities implementing the integrated PrEP program</li>\n</ul>\n
      • primary_end_points<p>\n  </p>\n<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Proportion of AGYW who underwent clinical screening and whose HIV test results were negative.</li>\n <li>\n Proportion of individuals who met eligibility criteria for PrEP among AGYW screened</li>\n <li>\n Number of AGYW who were prescribed and dispensed a 1-month supply of PrEP.</li>\n <li>\n Number of AGYW who had returned for a PrEP refill as a proportion of the number of AGYW who initiated PrEP.</li>\n <li>\n Proportion of women engaged with the program at 3- and 6-month after initiating PrEP, regardless of whether their PrEP use is ongoing.</li>\n</ol>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n As part of program procedures, the project will engage a technical advisory team from KEMRI including clinic, counseling, pharmacy, and outreach staff who have extensive experience implementing PrEP programs in public and private facilities. This technical advising team will be responsible for conducting ongoing training on PrEP with staff at each facility. Following the initial training, this team will be responsible for oversight of each program, ensuring sufficient stocks of PrEP commodities, providing continuous on-site technical assistance, and conducting data abstraction from client files. Our team has experience in this role previously through the Partners Scale Up Program where they have been supporting the engagement of >1,000 HIV serodiscordant couples to receive integrated ART and PrEP services at >24 public comprehensive care clinics. The team will visit each facility approximately two times per week to talk with program implementation staff and trouble-shoot issues with program delivery. Part of their role is to facilitate the sharing of experiences across facilities, including challenges and solutions and this will happen during one-on-one conversations with facility teams and during planned workshops. </p>\n
      • other_details_explanation<p>\n <em>High rates of unintended pregnancy and HIV among Kenyan AGYW</em></p>\n<p>\n AGYW in Kenya are facing parallel epidemics of HIV, asymptomatic sexually transmitted infections (STIs), and unintended pregnancy. Young women engaging in condomless sex have high risk for unintended pregnancy and early childbirth, situations that often lead to school dropout and low wage employment – factors that work in tandem to heighten increased risk for HIV acquisition. AGYW experiencing early sexual debut and unintended pregnancy are also more likely to have multiple sexual partners and to have experienced sexual violence.</p>\n<p>\n The HIV prevalence in Kenya is estimated to be 6%, with estimates of 4-7% in key central counties and as high as 26% in western counties. In 2017, the 15-24 year old age group represented 13% of the total population yet contributed 40% of the total incident HIV infections among adults. Furthermore, HIV incidence in this population rose by 17% in 2015, in comparison to declines among adults >25 (by 19%) and children (by 49%). Young women bear the greatest burden of the epidemic in Kenya, with HIV prevalence estimates three times greater for females ages 15-24 than their male age counterparts. The facilities in Thika, Nairobi, and Kisumu, Kenya were selected because they carry some of the greatest proportion of the national burden for teenage pregnancy and HIV prevalence (12.7% and 4.0% in Kiambu, 12.4% and 16.3% for Kisumu, and 13.1% and 6.1% for Nairobi). The burden of HIV among this age group is well recognized by the Kenya Ministry of Health and multiple adolescent policy documents call for the scale up of HIV prevention interventions targeting young women and men.</p>\n<p>\n <em>Reproductive Health and Family Planning as Entry Points for AGYW into health care</em></p>\n<p>\n Young Kenyan women often first encounter the health system through reproductive health clinics, including clinics providing care after an early pregnancy loss, such as Post Abortal Care (PAC) services. Kenya has the highest abortion rate in the East Africa region, estimated at 48/1,000 women. A facility based survey conducted in 2012, estimated 464,000 induced abortions occurred that year for an abortion ratio of 30/100 live births. Spontaneous miscarriage accounted for an additional 53,000 pregnancy losses. Peak age for induced abortion is 20-24 years, where almost 80 abortions occur for every 100 live births, followed by a rate of 40/100 live births among adolescent girls aged 15-19 years. In 2013, the 3^rd most commonly searched topic on Google was “How to abort.” Induced abortion is illegal in Kenya except to protect a woman’s life and health (the 2^nd most restrictive type of law) yet 35% of maternal deaths are attributed to unsafe abortion. Clinics that provide care for women following a pregnancy loss do not initiate abortions but serve women with spontaneous and induced pregnancy losses who need care to be medically stabilized, for complications to be treated, and for counseling. The 2012 survey estimated that 157,000 women access care in Kenyan health facilities for complications related to spontaneous and induced pregnancy loss. Women accessing this care are at high risk for HIV and other sexually transmitted infections because condom use is low and likely to continue despite the recent unintended pregnancy. The strongest predictor of an induced abortion is a prior induced abortion, highlighting the ongoing challenges with sexual and reproductive health facing these women, including unmet need for family planning.</p>\n<p>\n In Kenya, ≥40% of unintended pregnancies end with an early termination or pregnancy loss, some of which need life-saving medical intervention through clinics providing post-abortal care (PAC). AGYW comprise of nearly half of all PAC clients in Kenya. For AGYW receiving PAC, risk for HIV and subsequent pregnancy remain especially high, making these settings ideal for HIV counseling and introducing PrEP. PAC settings represent a set of core interventions for essential reproductive health care, providing women with emergency treatment for incomplete abortions, family planning, and sexual health counseling. Integration of PrEP within PAC settings is a crucial step in successfully strengthening the prevention of both HIV and pregnancy, especially given the vulnerabilities of AGYW.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n University of Washington Institutional Review Board (UW IRB)</p>\n<p>\n Approved on: 12th February 2021</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration2 Years
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites14 Health care facilities offering Post-abortal care services
      • multi_country_list
      • data_monitoring_committeeNo
      • total_enrolment_per_site200
      • 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_elderlyYes
      • gender_female1
      • gender_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersYes
      • subjects_others_specifyAGYW ages 15-17 years will provide informed consent as emancipated minors since they have already been pregnant
      • investigator1_given_nameRenee Heffron
      • investigator1_middle_name
      • investigator1_family_nameHeffron
      • investigator1_qualificationMPH, PhD
      • investigator1_professional_addressUniversity of Washington
      • investigator1_telephone+1 206-520-3800
      • investigator1_emailrheffron@uw.edu
      • organisations_transferred_Yes
      • number_participants400
      • notification
      • approval_date23-01-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-10-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe concerns raised by the reviewers have been conclusively addressed and thus recommended for approval.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-03-02 08:19:40
      • created2021-07-13 12:19:33
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id697
        • application_id1039
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MMeD, MPH
        • professional_addressKEMRI-CCR
        • telephone0733629665
        • emailrwamba@uw.edu
        • created2021-07-13 12:25:26
        • modified2021-10-08 11:05:19
    • SiteDetail(array)
      • 0(array)
        • id1077
        • application_id1039
        • county_id22
        • site_nameKEMRI-CCR PHRD THIKA - Thika, Nairobi, Murang\'a, and their environs
        • physical_addressCounty Hospitals
        • contact_detailsOAU Road, Thika section 9
        • contact_personDr. Nelly Mugo
        • site_capacity(null)
        • misc(null)
        • created2021-07-13 12:25:26
        • modified2021-10-08 11:05:19
        • County(array)
          • id22
          • county_nameKiambu
          • created2012-06-15 10:24:37
          • modified2012-06-15 10:24:37
      • 1(array)
        • id1078
        • application_id1039
        • county_id42
        • site_nameKisumu clinical trial site - Kisumu and its enrvirons
        • physical_addressCounty Hospitals.
        • contact_detailsProf. Elizabeth Bukusi
        • contact_personProf. Elizabeth Bukusi
        • site_capacity(null)
        • misc(null)
        • created2021-07-13 13:46:15
        • modified2021-10-08 11:05:19
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1079
        • application_id1039
        • county_id47
        • site_nameMariestopes - Nairobi
        • physical_addressMariestopes Clinic
        • contact_detailsEric Ayiera
        • contact_personEric Ayiera
        • site_capacity(null)
        • misc(null)
        • created2021-07-13 13:48:53
        • modified2021-10-08 11:05:19
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id524
        • application_id1039
        • sponsorUniversity of Washington
        • sponsor_typeResearch Institution
        • contact_person
        • addressNinth and Jefferson Building 325 Ninth Avenue, Box 359927 Seattle, WA 98104 United States
        • telephone_number+1 206.685.1292
        • fax_number
        • cell_number+1 206.685.1292
        • email_addressrheffron@uw.edu
        • created2021-07-13 12:25:26
        • modified2021-10-08 11:05:19
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • trial_therapeutic_use1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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

Included Files

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