Request History

• Restore to current request
• applications/index/page:74/sort:study_title/direction:desc/approved:1
• applications/index/page:64/sort:protocol_no/direction:desc
• applications/view/146
• applications/index/page:75/sort:protocol_no/direction:asc/approved:1

Session

• Config(array)
  • userAgent9c3d2c89526db53b7b69e8c9faa06145
  • time1746099117
  • countdown10

Request

Cake Params

• plugin(null)
• controllerapplications
• actionindex
• named(array)
  • page79
  • sortstudy_title
  • directiondesc
  • approved2
• pass(empty)
• isAjax(false)
• paging(array)
  • Application(array)
    • page79
    • current5
    • count502
    • prevPage(true)
    • nextPage(true)
    • pageCount101
    • order(array)
      • Application.study_titledesc
    • limit5
    • options(array)
      • page79
      • order(array)
        • Application.study_titledesc
      • sortstudy_title
      • directiondesc
    • paramTypenamed

Post data

• Application(array)
  • approved2

Query string

No querystring data.

Cookie

To view Cookies, add CookieComponent to Controller

Current Route

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

Sql Logs

Logs

View Variables

• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id835
      • user_id73
      • trial_status_id7
      • abstract_of_study<h2>\n Study Summary</h2>\n<p>\n Worldwide expansion of pre-exposure prophylaxis (PrEP) will be critical to ending the HIV epidemic. The original PrEP clinical trials showed us that 1) adherence is critical to effectiveness; 2) daily PrEP adherence was difficult to maintain, especially among women not in serodiscordant relationships; 3) objective adherence measures (e.g. measuring PrEP drug levels) are more reliable than self-reported adherence; and 4) real-time monitoring of PrEP drug levels with feedback to the patient could improve subsequent adherence. Objective measures of PrEP adherence, especially point-of-care measures that enable real-time assessment, intervention and feedback, will be important for both interpreting and optimizing effectiveness during PrEP implementation. Our group has developed a novel point of care urine-based measure of PrEP adherence which has been validated among HIV-uninfected volunteers who were administered TDF/FTC.^1-4The test has now been developed into a lateral flow assay (LFA), allowing real-time monitoring.⁴This test is cheap, easy to perform and can be done at the point-of-care. However, this tool has not yet been tested among participants on PrEP in a trial to see if real-time monitoring of adherence using the urine assay is feasible, acceptable and motivates better adherence in the future.  </p>\n<p>\n  </p>\n<p>\n Pharmacologic measures of adherence to TDF/FTC-based PrEP, where tenofovir (TFV) drug levels are measured in a matrix such as plasma,⁵dried blood spots (DBS),⁶or hair (studied extensively as an adherence metric by our group)^7-47capture drug ingestion and predict outcomes more accurately than self-reported adherence.^{12-14,16,18,19}Pharmacologic adherence monitoring is especially important in PrEP, where a surrogate biomarker of response (e.g. HIV viral loads during HIV treatment) is not available. However, current methods to analyze PrEP drug levels in any matrix, including easily accessible urine,⁴⁸require liquid chromatography-tandem mass spectrometry (LC-MS/MS), which cannot be performed in real-time because expensive equipment and trained laboratory staff are needed. Antibody-based tests allow for point-of-care testing.</p>\n<p>\n  </p>\n<p>\n The UCSF Hair Analytical Laboratory (directed by Dr. Monica Gandhi) has now developed a collaboration with Alere™ (recently bought by Abbott Rapid Diagnostics), a company with vast expertise in point-of-care (POC) diagnostics, to develop one of the first immunoassays that detects TFV in urine. The test is sensitive, specific, precise, and quantitates TFV levels in urine as accurately as LC-MS/MS,^1,2,4allowing for low-cost (<$2.00 per test) POC adherence monitoring. The first iteration of the lateral flow immunoassay (LFA) has been developed⁴and allows for real-time testing, giving the provider qualitative yes/no information on recent adherence to PrEP. This novel POC adherence assay has the potential to address <u>key knowledge gaps</u> in PrEP implementation to both interpret and improve adherence.</p>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>Point-of-care Urine Monitoring of Adherence (PUMA): Testing a Real-Time Urine Assay of Tenofovir in PrEP</strong></p>\n<p align=\"center\" style=\"margin-left:.5in;\">\n <strong><em>Pilot trial to examine the feasibility, acceptability and impact on longer-term adherence of an intervention using a new urine-based tenofovir adherence assay</em></strong></p>\n<p>\n  </p>\n
      • laymans_summary<p>\n Pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) prevents HIV infection if taken every day. However, previous PrEP trials demonstrated that many women in Africa at risk for HIV who are not in couples (with an HIV-positive partner) need help remembering to take the pill every day.  Also, patients on PrEP may not always report their adherence to the pill accurately and “objective” measures of adherence (where PrEP drug levels were measured) are far superior to self-report. We also know that telling a patient his/her PrEP drug levels can be motivating for better adherence in the future. The usual ways to measure PrEP drug levels are very complicated and require expensive equipment and trained laboratory staff. However, our group has now developed a new and innovative way to measure adherence to PrEP using a drug level (specifically tenofovir, TFV) via an antibody-based test (“immunoassay”) in urine that can be performed cheaply at the point-of-care (POC) by any healthcare worker (like a urine pregnancy test). A few drops of the patient’s urine is dropped into the test and tells the provider “yes” or “no” if the patient has been taking PrEP recently. This protocol is for a pilot trial where we randomize women on PrEP (who are not in serodiscordant couples) at Thika Clinic to having information from the urine assay delivered to them (or not delivered to them in the control group) in order to provide feedback on adherence from this test in a supportive, motivating manner and enhance adherence counseling. The pilot trial will assess if the urine tool is acceptable to participants, feasible for the clinic to perform, and if providing feedback on adherence from the urine tool to the participant increases future adherence to PrEP (measured by a longer-term adherence metric with hair levels). Good adherence to PrEP will eventually lead to fewer HIV infections worldwide.</p>\n<p>\n  </p>\n
      • short_titlePoint-of-care Urine Monitoring of Adherence (PUMA)
      • protocol_noECCT/19/11/05
      • version_no3.0
      • date_of_protocol23-09-2019
      • study_drugPUMA Study (POC - TDF/FTC)
      • disease_conditionHIV Prevention
      • 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_nameTenofovir Disoproxil Fumarate/Emtricitabine
      • product_type_medical_device_namePoint of Care Urine Monitoring of Adherence (PUMA)
      • 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_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantPeter Mogere
      • declaration_date119-11-2019
      • declaration_principal_investigatorDr. Nelly Rwamba Mugo
      • declaration_date219-11-2019
      • placebo_presentNo
      • study_objectives<p style=\"margin-left:1.0in;\">\n <strong>Aim #1:           </strong>To perform a pilot randomized controlled trial (RCT) in Kenya to establish the impact of real-time adherence monitoring/feedback via the urine POC TFV immunoassay on increasing PrEP adherence over time (as established by a long-term metric of adherence using hair levels).</p>\n<p style=\"margin-left:1.0in;\">\n <strong>Aim #2:           </strong>To assess acceptability of the urine-based test to participants and feasibility administering the test for research healthcare providers.  Specifically, we seek to understand user and provider experiences, preferences, barriers, and facilitators related to POC urine tenofovir adherence testing among women receiving PrEP and providers after the pilot trial.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<ul>\n <li>\n Female</li>\n <li>\n Adult, age ≥18 years old</li>\n <li>\n HIV-1 uninfected based on a negative HIV-1 rapid test</li>\n <li>\n Not currently enrolled in an HIV-1 prevention clinical trial</li>\n <li>\n Not currently in a serodiscordant relationship</li>\n <li>\n Already taking PrEP and will be enrolled at the 3-month follow-up visit following PrEP initiation</li>\n <li>\n Willing to be randomized to point-of-care tenofovir drug testing</li>\n <li>\n Willing/able to provide informed consent to participate in the study</li>\n <li>\n No contraindication to use of TDF or FTC</li>\n <li>\n Note: Women who are pregnant at screening/enrollment are still eligible</li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n Opposite of inclusion criteria</p>\n
      • primary_end_points<p>\n The primary outcomes for this study will be acceptability of POC urine tenofovir testing among women receiving PrEP in Kenya, feasibility to provide feedback on the POC urine tenofovir assay to participants for healthcare providers, and long-term metrics of adherence as assessed via hair concentrations of TFV and FTC assessed at the 0 (baseline), 3, 6, 9 and 12-months study visits after enrollment.<br />\n  </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_controlledYes
      • site_capacity(null)
      • staff_numbers<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n KEMRI-CCR Partners in Health & Research Development - PHRD (Formerly Partners in Prevention) Thika Project, has 64 full time clinical trial staff (including physicians, nurses, counsellors, pharmacist, pharmaceutical technologists, clinical officers, social scientists, administrative staff etc).</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Principal Investigator: Dr. Nelly R. Mugo  MBChB,MMED,MPH</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Principal Investigator: Dr. Kenneth Ngure  BSc,MPH,MSc,PhD</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n                                         Dr. Elizabeth Irungu MBChB, MPH</p>\n<p font-size:=\"\" line-height:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Site Coordinator: Dr. Catherine Kiptinness, BPharm, MPH</p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">The greatest burden of the HIV-1 epidemic lies in sub-Saharan Africa. </span>Massive advances in HIV biomedical prevention strategies have allowed the end of AIDS to finally come into sight.<span style=\"font-size: 10px;\"> </span>Along with treatment as prevention,<span style=\"font-size: 10px;\"> </span>pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) <span style=\"font-size: 10px;\"> </span>is one of the most effective strategies to prevent HIV acquisition among at-risk individuals. PrEP, now broadly recommended by Kenya's National AIDS & STIs Control Program (NASCOP), Centers for Disease Control and Prevention (CDC)<span style=\"font-size: 10px;\"> </span>and the World Health Organization (WHO),<span style=\"font-size: 10px;\"> </span>is entering an exciting phase of global implementation.</p>\n<p>\n The PrEP trials and demonstration projects to date; however, have highlighted four major lessons that should be addressed in order to increase the effectiveness of this important prevention strategy during implementation . <u>First</u>, there is a profound relationship between adherence and effectiveness.<span style=\"font-size: 10px;\"> </span><u>Second</u>, taking a pill every day for prevention (e.g. maintaining adherence) is difficult, especially among certain key groups such as heterosexual women who are not in a relationship with an HIV-positive man. <u>Third</u>, pharmacologic measures – where drug levels of PrEP drugs are assayed in a biomatrix – predict the efficacy of PrEP more accurately than self-reported adherence.<span style=\"font-size: 10px;\"> </span><u>Fourth</u>, real-time monitoring of PrEP drug levels, as in other disease states,<span style=\"font-size: 10px;\"> </span>may improve subsequent PrEP drug-taking.<span style=\"font-size: 10px;\"> </span>We have now developed one of the first point-of-care tools to assess PrEP adherence objectively<span style=\"font-size: 10px;\"> </span>with the potential to address all four lessons.</p>\n<p>\n  </p>\n
      • other_details_regulatory_notapproved<ol>\n <li>\n University of Washington IRB</li>\n</ol>\n
      • other_details_regulatory_approved<p>\n KEMRI - SERU _ 16 October 2019 - One site approved in Kenya</p>\n<p>\n UCSF IRB - 5 June 2019</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 Years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorNon-intervention arm invo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyIntervention arm will use Point-of-Care Urine Monitoring of Adherence
      • single_site_member_stateYes
      • location_of_areaKEMRI-CCR PHRD (THIKA) PROJECT
      • single_site_physical_addressThika Section 9, OAU Road, Near Thika nursing home
      • single_site_contact_personDr. Kenneth Ngure
      • single_site_telephone+254 722362219
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide100
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_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_nameMonica
      • investigator1_middle_name
      • investigator1_family_nameGandhi
      • investigator1_qualificationMD, MPH
      • investigator1_professional_addressUniversity of California, San Francisco
      • investigator1_telephone+1 415-476-4082
      • investigator1_emailMonica.gandhi@ucsf.edu
      • organisations_transferred_Yes
      • number_participants100
      • notification
      • approval_date15-04-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted09-04-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonStudy has been approved by PPB ECCT
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-05-12 15:52:28
      • created2019-11-18 15:23:55
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id517
        • application_id835
        • given_nameNelly
        • middle_nameRwamba
        • family_nameMugo
        • qualificationMBChB, MMeD, MPH
        • professional_addressKEMRI-CCR
        • telephone+254 722823770
        • emailrwamba@uw.edu
        • created2019-11-18 15:53:40
        • modified2020-04-09 16:29:15
    • SiteDetail(array)
      • 0(array)
        • id679
        • application_id835
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2019-11-18 15:53:40
        • modified2020-04-09 16:29:15
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id405
        • application_id835
        • sponsorUniversity of Washington
        • sponsor_typeOthers
        • contact_personDr. Nelly Rwamba Mugo
        • addressKEMRI-CCR
        • telephone_number+254 722823770
        • fax_numberN/A
        • cell_number+254 722823770
        • email_addressrwamba@uw.edu
        • created2019-11-18 15:53:40
        • modified2020-04-09 16:29:15
      • 1(array)
        • id418
        • application_id835
        • sponsorUniversity of California, San Francisco (UCSF)
        • sponsor_typeOthers
        • contact_personProf. Monica Gandhi
        • address1001 Potrero Ave San Francisco, CA 94110
        • telephone_number+1 415-476-4082
        • fax_number
        • cell_number+1 415-476-4082
        • email_addressMonica.Gandhi@ucsf.edu
        • created2020-03-12 15:59:28
        • modified2020-04-09 16:29:15
  • 1(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
  • 2(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
  • 3(array)
    • Application(array)
      • id697
      • user_id73
      • trial_status_id9
      • abstract_of_study<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:666px;\" width=\"1332\">\n <tbody>\n <tr>\n <td style=\"width:666px;\">\n <p>\n Co-Principal Investigators and Study Centers:</p>\n <p>\n University of Washington, Global Health, International Clinical Research Center (ICRC); <strong>Kenya Medical Research Institute (KEMRI)/Centre for Clinical Research (CCR)</strong></p>\n <p>\n Nelly Mugo, MBChB, MMed, MPH</p>\n <p>\n  </p>\n <p>\n KEMRI/Center for Global Health Research (CGHR) Clinical Research Center, Kisumu (CRC)</p>\n <p>\n Victor Mudhune, B Pharm, MPH</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:666px;\">\n <p>\n Study period (years): Approximately 1 year</p>\n <ul>\n <li>\n Approximately 12-18 months for study approval, training, and implementation; an additional 6-12 months for report preparation and dissemination of findings.</li>\n </ul>\n <ul>\n <li>\n Estimated date first study participant enrolled: Q3 2018</li>\n <li>\n Estimated date last study participant completed: Q2 2019</li>\n </ul>\n <p>\n Rationale for Multipurpose Prevention Technology</p>\n <p>\n The World Health Organization (WHO) estimated that 36.7 million people were living with HIV in 2015. Furthermore, despite the marked expansion of HIV prevention and treatment services over the last 15 years, in 2015, approximately 2.1 million new HIV infections occurred. Africa accounted for approximately two-thirds of the new HIV infections, with the greatest burden borne by women.¹</p>\n <p>\n While gay and bisexual men account for the greatest number of people living with HIV (PLHIV) in the United States (US) and other economically developed settings, an estimated 19% of all new HIV infections in the US occurred among women in 2015, 86% of these attributed to heterosexual sex. Fully 62% of HIV infections among women in the US occurred among African-American women. The statistics emphasize the need for improved HIV prevention for women globally and in the US.</p>\n <p>\n Among the more than 200 million pregnancies worldwide annually, almost half are unintended.² Despite the existence of a variety of effective contraceptives, weak health systems and multiple barriers to utilizing reproductive health services have resulted in an unacceptably high rate of unintended pregnancies. In Kenya, an estimated 43% of the pregnancies are unintended, according to the last national survey in 2012, with about 26% of married women, 30% of women aged 20-29 years and 22% of women aged 30-34 years indicating unmet contraceptive/family planning needs; the unmet need for family planning is highest among adolescents (aged 15-19 years).³ Although contraceptive vaginal rings are not yet available outside of research settings in Kenya, in a recently completed NuvaRing® acceptability and adherence study among women aged 18-34 years in Kisumu, Western Kenya, 91.0% and 9.0%, respectively, of study participants reported that they would recommend or highly recommend the IVR to other women (unpublished data). In the US from 2006-2010, an estimated 37% of pregnancies were determined to be unintended.⁴</p>\n <p>\n Genital herpes is the most common sexually transmitted infection globally, and significantly increases the risk of HIV transmission and acquisition.^5,6 An estimated 417 million people worldwide were living with this chronic infection in 2012.⁵ Sub-Saharan Africa is the most severely affected region of the world with up to 80% of sexually active women infected with herpes simplex virus-2 (HSV-2).^7-10 The longitudinal Mombasa Cohort of high risk Kenyan women analysis showed a population attributable risk of prevalent HSV of around 50% at the time of HIV acquisition.¹¹</p>\n <p>\n A significant number of women in most global regions, particularly resource-constrained settings such as Kenya, could benefit from combined protection against HIV and long-acting, highly effective contraceptive methods to prevent unintended pregnancy, but also concurrent protection against HSV. Market research among women in three sub-Saharan African countries found a preference for multipurpose prevention technology (MPT) that would confer protection against HIV and unintended pregnancies over separate methods for each indication.¹¹</p>\n <p>\n  </p>\n <p>\n CONRAD MPT IVR Platform</p>\n <p>\n Tenofovir (TFV) is a nucleotide reverse transcriptase inhibitor with activity against HIV and other viruses, such as the herpes simplex virus (HSV).^12,13 Data shows that taking daily tenofovir disoproxil fumarate-containing oral pre-exposure prophylaxis (PrEP) [active ingredient TFV] is an effective HIV prevention tool for women; protection rates among discordant couples were 65-75% and among heterosexual men and women 62%.¹² However, uptake and use of oral PrEP, as well as long-term adherence, have been variable, reducing the efficacy and indicating a need for alternative delivery of TFV.^14,15</p>\n <p>\n Vaginal application of TFV gel is associated with cervicovaginal (CV) TFV concentrations that are up to 1000 times as high as those achieved with oral TFV, reaching levels well above the half-maximal effective concentration (EC50) for HSV-2. TFV gel applied before and after vaginal intercourse reduced HSV-2 acquisition by 51% among women in the CAPRISA 004 Study.¹⁶ The HSV-2 incidence rate among women who had been assigned to TFV gel was 10.2 cases per 100 person-years (95% CI, 6.8 to 14.7), as compared with 21.0 cases per 100 person-years (95% CI, 16.0 to 27.2) among women who had been assigned to placebo gel (incidence rate ratio [IRR], 0.49; 95% CI, 0.30 to 0.77; P=0.003).¹⁶ In an as-treated post hoc analysis based on gel use during the trial, TFV gel was associated with a 71% lower risk of HSV-2 acquisition (IRR, 0.29; 95% CI, 0.10 to 0.70) among women who used more than six gel applicators per month, a 52% lower risk (IRR, 0.48; 95% CI, 0.18 to 1.16) among women who used four to six applicators per month, and a 27% lower risk (IRR, 0.73; 95% CI, 0.34 to 1.55) among women who used fewer than four applicators per month.⁵ The efficacy of vaginal TFV 1% gel in preventing HSV-2 acquisition was also evaluated among women in the VOICE Study, a 5-arm, randomized, double-blind, placebo-controlled trial that studied daily use of oral and vaginal TFV for HIV-1 PrEP.¹⁷ Over follow-up of 513 PY, 92 incident HSV-2 cases occurred by enzyme immunoassay (EIA): 77 in women with no plasma TFV detected and 15 in those with plasma TFV (incidence 20.1 (95% CI 15.9-25.2) vs. 11.5 (6.4-18.9), respectively). Plasma TFV detection was associated with reduced risk of HSV-2 seroconversion (unadjusted IRR 0.57 (0.33-0.99; P=0.046); IRR adjusted for country, age, ≥2 sex partners, hormonal contraceptive use (injections and oral pills), anal sex, and HIV status, 0.55 (0.31-0.97; P=0.04).¹⁷</p>\n <p>\n CONRAD has developed an intravaginal ring (IVR) which releases TFV in a controlled and sustained manner for at least 90 days and has completed pre-clinical product development and initiated clinical testing. The CONRAD IVR was designed to be similar in appearance to NuvaRing®. CONRAD 128, a phase I trial to study the safety, PK, PD, and acceptability of the TFV-alone IVR in women has completed (unpublished data). Conclusions include: no safety concerns, PK benchmarks met, TFV effect showing activity against HIV, ring performance within specifications, and high TFV-diphosphate (TFV-DP) levels supporting potential pharmacological forgiveness.¹⁸ Tissue levels of TFV-DP, the active metabolite of TFV, were similar to or exceeded those obtained with the gel after a BAT24 regimen (one dose of gel within 12 hours before sex and a second dose of gel as soon as possible within 12 hours after sex, with no more than two doses in a 24 hour period) identical to that tested in CAPRISA 004 or a daily regimen tested in VOICE. We, therefore, hypothesize that this TFV releasing ring will prevent both HIV and genital acquisition of HSV in women.</p>\n <p>\n A variant of this ring releasing TFV and LNG a hormonal contraceptive, is also under development and was tested clinically in CONRAD 128, meeting both TFV and LNG benchmarks. Levels of TFV-DP remained high in tissues even after ring removal, providing the basis for a pharmacologically forgiving method. Given the continuous release of high amounts of TFV, the potential impact of bacterial vaginosis (BV) on the levels of TFV in CV fluid and tissue is low. The TFV/LNG ring is a stable product with more than 2 years of stability data.</p>\n <p>\n Innovative female-initiated MPTs could both protect against HIV and HSV infections and allow women to better plan and space their children, reducing potentially negative consequences of unintended pregnancy, including maternal and infant mortality and morbidity. Individual interviews conducted with participants from microbicide studies in Malawi and Zimbabwe indicated strong interest in a vaginal HIV prevention product that could also prevent pregnancy.¹⁹ Reasons cited included convenience, reduction of stigma, problems with adverse effects with current contraceptive methods, concerns about long-term effects of contraceptives, and concerns about the health burdens of HIV infection during pregnancy. A quantitative market research survey of 1,722 women aged 15-35 years in high-HIV burden settings in sub-Saharan indicated near universal acceptance of the hypothetical concept of an MPT, which may prevent pregnancy and HIV.¹¹</p>\n <p>\n This will be a first-in-Africa, randomized, placebo-controlled, FDA investigational new drug-enabling (IND) trial on the safety, pharmacokinetics, pharmacodynamics, tolerability, acceptability of, and adherence to a novel 90-day combination intravaginal ring (TFV/LNG) for HIV/HSV prevention and long-acting contraception, and a 90-day HIV/HSV-2 prevention IVR (TFV only) in preparation for the pivotal prevention trial.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>Phase IIa, 90-Day Safety, Adherence, and Acceptability Study of Intravaginal Rings Releasing Tenofovir with and without Levonorgestrel among Women in Western Kenya</strong></p>\n
      • laymans_summary<p>\n <span style=\"color: rgb(0, 0, 0); font-family: "Times New Roman", serif; font-size: 16px; text-align: justify;\">Tenofovir (TFV) is a nucleotide reverse transcriptase inhibitor with activity against HIV and other viruses, such as the herpes simplex virus (HSV).Data shows that taking daily tenofovir disoproxil fumarate-containing oral pre-exposure prophylaxis is an effective HIV prevention tool for women; protection rates among discordant couples were 65-75% and among heterosexual men and women 62%.However, uptake and use of oral PrEP, as well as long-term adherence, have been variable, reducing the efficacy and indicating a need for alternative delivery of TFV. Researchers hope the medication in the rings can prevent HIV infection, pregnancy and herpes virus infections. CONRAD has developed an intravaginal ring (IVR) which releases TFV in a controlled and sustained manner for at least 90 days and has completed pre-clinical product development and initiated clinical testing. The CONRAD IVR was designed to be similar in appearance to NuvaRing®. This research study will examine the safety and acceptability of two types of vaginal rings</span></p>\n
      • short_titleCONRAD RING
      • protocol_noECCT/18/07/02
      • version_no1.0
      • date_of_protocol15-05-2018
      • study_drugTENOFOVIR LEVONORGESTREL
      • disease_conditionHIV
      • product_type_biologicals1
      • product_type_proteins1
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device1
      • product_type_chemical_nameVIREAD
      • product_type_medical_device_nameRing
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addresseayuo@kemricdc.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_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. Victor mudhune
      • declaration_date111-07-2018
      • declaration_principal_investigatorDr. Nelly Mugo
      • declaration_date211-07-2018
      • placebo_presentYes
      • study_objectives<p margin:=\"\" new=\"\" style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <b><i>Primary Objective: Safety</i></b></p>\n<p style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: Calibri, sans-serif; text-align: justify; text-indent: -11.5pt; margin: 0px 0px 0px 34.55pt;\">\n <span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: Symbol, serif, EmojiFont; vertical-align: baseline; color: inherit;\"><span style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">·<span color:=\"\" new=\"\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 7pt; line-height: inherit; font-family: \" times=\"\" vertical-align:=\"\">    </span></span></span><span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">To evaluate genital and systemic safety of the TFV/LNG and TFV IVRs compared to the placebo during and after 90-days of use among women in Western Kenya</span></p>\n<p margin:=\"\" new=\"\" style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: Calibri, sans-serif, serif, EmojiFont; vertical-align: baseline; color: inherit;\"> </span></p>\n<p margin:=\"\" new=\"\" style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <b><i>Secondary Objectives:</i></b></p>\n<p style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: Calibri, sans-serif; text-align: justify; text-indent: -11.5pt; margin: 0px 0px 0px 34.55pt;\">\n <span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: Symbol, serif, EmojiFont; vertical-align: baseline; color: inherit;\"><span style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">·<span color:=\"\" new=\"\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 7pt; line-height: inherit; font-family: \" times=\"\" vertical-align:=\"\">    </span></span></span><span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">Pharmacokinetics (PK) and pharmacodynamics (PD) of the IVR active pharmaceutical agents</span></p>\n<p style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: Calibri, sans-serif; text-align: justify; text-indent: -11.5pt; margin: 0px 0px 0px 46.5pt;\">\n <span color:=\"\" courier=\"\" lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: \" vertical-align:=\"\"><span style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">o<span color:=\"\" new=\"\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 7pt; line-height: inherit; font-family: \" times=\"\" vertical-align:=\"\"> </span></span></span><span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">To evaluate PK of TFV</span></p>\n<p style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: Calibri, sans-serif; text-align: justify; text-indent: -11.5pt; margin: 0px 0px 0px 46.5pt;\">\n <span color:=\"\" courier=\"\" lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: \" vertical-align:=\"\"><span style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">o<span color:=\"\" new=\"\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 7pt; line-height: inherit; font-family: \" times=\"\" vertical-align:=\"\"> </span></span></span><span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">To evaluate PK of LNG</span></p>\n<p style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: Calibri, sans-serif; text-align: justify; text-indent: -11.5pt; margin: 0px 0px 0px 46.5pt;\">\n <span color:=\"\" courier=\"\" lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: \" vertical-align:=\"\"><span style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">o<span color:=\"\" new=\"\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 7pt; line-height: inherit; font-family: \" times=\"\" vertical-align:=\"\"> </span></span></span><span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">To evaluate PD surrogate markers of contraceptive efficacy of LNG</span></p>\n<p style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: Calibri, sans-serif; text-align: justify; text-indent: -11.5pt; margin: 0px 0px 0px 46.5pt;\">\n <span color:=\"\" courier=\"\" lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: \" vertical-align:=\"\"><span style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">o<span color:=\"\" new=\"\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 7pt; line-height: inherit; font-family: \" times=\"\" vertical-align:=\"\"> </span></span></span><span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">To evaluate PD surrogate markers of microbicidal efficacy of TFV</span></p>\n<p style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: Calibri, sans-serif; text-align: justify; text-indent: -11.5pt; margin: 0px 0px 0px 34.55pt;\">\n <span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: Symbol, serif, EmojiFont; vertical-align: baseline; color: inherit;\"><span style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">·<span color:=\"\" new=\"\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 7pt; line-height: inherit; font-family: \" times=\"\" vertical-align:=\"\">    </span></span></span><span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">To assess biological (microbiological/immunological) effects of IVRs on the female genital tract</span></p>\n<p style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: Calibri, sans-serif; text-align: justify; text-indent: -11.5pt; margin: 0px 0px 0px 34.55pt;\">\n <span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: Symbol, serif, EmojiFont; vertical-align: baseline; color: inherit;\"><span style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">·<span color:=\"\" new=\"\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 7pt; line-height: inherit; font-family: \" times=\"\" vertical-align:=\"\">    </span></span></span><span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">To assess subjective and objective measures of tolerability</span></p>\n<p style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: Calibri, sans-serif; text-align: justify; text-indent: -11.5pt; margin: 0px 0px 0px 34.55pt;\">\n <span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: Symbol, serif, EmojiFont; vertical-align: baseline; color: inherit;\"><span style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">·<span color:=\"\" new=\"\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 7pt; line-height: inherit; font-family: \" times=\"\" vertical-align:=\"\">    </span></span></span><span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">To assess subjective and objective measures of adherence</span></p>\n<p style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: Calibri, sans-serif; text-align: justify; text-indent: -11.5pt; margin: 0px 0px 0px 34.55pt;\">\n <span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: Symbol, serif, EmojiFont; vertical-align: baseline; color: inherit;\"><span style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">·<span color:=\"\" new=\"\" style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: 7pt; line-height: inherit; font-family: \" times=\"\" vertical-align:=\"\">    </span></span></span><span lang=\"en-US\" style=\"margin: 0px; padding: 0px; border: 0px; font: inherit; vertical-align: baseline; color: inherit;\">To assess acceptability (through quantitative data collection methods)</span></p>\n<p margin:=\"\" new=\"\" style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <span style=\"margin: 0px; padding: 0px; border: 0px; font-style: inherit; font-variant: inherit; font-weight: inherit; font-stretch: inherit; font-size: inherit; line-height: inherit; font-family: Calibri, sans-serif, serif, EmojiFont; vertical-align: baseline; color: inherit;\"> </span></p>\n<p margin:=\"\" new=\"\" style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n <b><i>Exploratory Objective:</i></b></p>\n<p margin:=\"\" new=\"\" style=\"color: rgb(0, 0, 0); font-size: 12pt; font-family: \" text-align:=\"\" times=\"\">\n To assess IVR acceptability and user experiences (through qualitative in-depth interviews for a subset of study participants)</p>\n
      • principal_inclusion_criteria<ul>\n <li>\n Female, aged 18-34 years, inclusive</li>\n <li>\n General good health (by history and per clinician discretion) without any clinically significant systemic disease (including, but not limited to significant liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease, and diabetes), uterus, and cervix</li>\n <li>\n Not pregnant or planning to become pregnant</li>\n <li>\n Pre-screening (Visit 0) HIV risk score ≤4 (on HIV risk assessment tool developed for women in sub-Saharan Africa (included in Appendix II)</li>\n <li>\n Currently having regular menstrual cycles (approximately 24-35 days) OR with a history of having regular menstrual cycles before contraceptive use, by report, and resumed some menstruation or spotting (with biochemical confirmation of ovulation)</li>\n <li>\n Willing to undergo Visual Inspection with Lugol’s Iodine (VILI) for cervical abnormalities during pelvic exam at Visit 1\n <ul>\n <li>\n Women with an abnormal VILI will be linked directly to cervical cancer screening through Papanicolaou smear testing and will not be eligible for enrollment unless cervical cancer screening is negative</li>\n </ul>\n </li>\n <li>\n Willing to abstain from use of vaginal products other than the study product, including tampons (except for during menses)<a href=\"#_ftn1\" name=\"_ftnref1\" title=\"\">[1]</a>, menstrual cups, vaginally inserted cloths or other materials, spermicides, lubricants, and douches for the whole study</li>\n <li>\n Willing to abstain from any vaginal intercourse starting 48 hours before CM collection, as possible, and 48 hours before Visits 4 and 7</li>\n <li>\n Vaginal and cervical anatomy that, in the opinion of the clinician, lends itself to easy genital tract sample collection and is absent of vesicles and ulcers</li>\n</ul>\n<ul>\n <li>\n No use of hormonal contraceptives within the following periods specified for each type of contraception method:\n <ul>\n <li>\n Oral contraceptives (combined or progestin-only), contraceptive patch or contraceptive vaginal ring at least two (2) months prior to Visit 1</li>\n <li>\n Last DMPA injection received at least four (4) months prior to Visit 1 and <strong><em>has resumed regular menstruation by Visit 2</em></strong></li>\n <li>\n Hormonal IUD/IUS removed at least four (4) months prior to Visit 1 and <strong><em>has resumed regular menstruation by Visit 2</em></strong></li>\n <li>\n Hormonal implant removed at least six (6) months ago prior to Visit 1 and <strong><em>has resumed regular menstruation by Visit 2</em></strong></li>\n </ul>\n </li>\n</ul>\n<ul>\n <li>\n <strong><em>Willing to refrain from using any hormonal contraceptives for the entire study and to use only study-provided non-spermicidal male condoms with or without a study-provided Cu-IUD (if no contraindications to Cu-IUD use, see Appendix V)</em></strong></li>\n <li>\n P4 ≥3.0 ng/ml at Visit 2</li>\n <li>\n Estimated glomerular filtration rate (eGFR) <90ml/min/1.73m² (using the National Institute of Diabetes and Digestive and Kidney Diseases eGFR calculator, <a href=\"https://www.niddk.nih.gov/health-information/health-communication-programs/nkdep/lab-evaluation/gfr-calculators/adults-si-unit-ckd-epi/Pages/default.aspx\">https://www.niddk.nih.gov/health-information/health-communication-programs/nkdep/lab-evaluation/gfr-calculators/adults-si-unit-ckd-epi/Pages/default.aspx</a>)</li>\n <li>\n Willing to give voluntary consent and sign/mark an informed consent form (Appendix 1)</li>\n <li>\n Willing and able to comply with protocol requirements</li>\n</ul>\n<p style=\"margin-left:.75in;\">\n  </p>\n<div>\n <br clear=\"all\" />\n <hr align=\"left\" size=\"1\" width=\"33%\" />\n <div id=\"ftn1\">\n <p>\n <a href=\"#_ftnref1\" name=\"_ftn1\" title=\"\">[1]</a></p>\n </div>\n</div>\n<p>\n  </p>\n
      • principal_exclusion_criteria<ul>\n <li>\n Body mass index (BMI) ≥30 kg/m</li>\n <li>\n History of hysterectomy</li>\n <li>\n Currently pregnant or within less than three (3) calendar months of the last pregnancy outcome. Note: If recently pregnant, must have had at least two spontaneous menses since pregnancy outcome</li>\n <li>\n Currently breastfeeding or having breastfed an infant in the last two (2) months, or planning to breastfeed during the course of the study</li>\n <li>\n <strong><em>Contraindication to any study products—LNG, TFV, or excipient ingredients</em></strong></li>\n <li>\n Contraindication to LNG (detailed in Appendix VI and the standard operating procedures (SOP) manual, which is consistent with WHO guidelines <a href=\"http://apps.who.int/iris/bitstream/10665/181468/1/9789241549158_eng.pdf?ua=1\">http://apps.who.int/iris/bitstream/10665/181468/1/9789241549158_eng.pdf?ua=1</a></li>\n <li>\n In the last three (3) months, diagnosed with or treated for any STI or pelvic inflammatory disease\n <ul>\n <li>\n Note: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six (6) months may be considered for eligibility if pelvic exam shows no vesicles or open lesions.</li>\n </ul>\n </li>\n <li>\n Positive test for HIV-1 (in accordance with national testing algorithm, Appendix IV), syphilis, <em>Trichomonas vaginalis</em> (TV), <em>Neisseria gonorrhea</em> (GC), <em>Chlamydia trachomatis</em> (CT) or HBsAg\n <ul>\n <li>\n NOTE: Women who test positive for HIV-1, syphilis, TV, GC, or CT will be treated for the STI at no cost at the CRC according to the 2015 Kenya National AIDS and STI Control Programme Algorithms for Managing Common STI Syndromes (<a href=\"https://aidsfree.usaid.gov/sites/default/files/hts_policy_kenya_2015.pdf\">https://aidsfree.usaid.gov/sites/default/files/hts_policy_kenya_2015.pdf</a>); they will also receive face-to-face counseling, but will not be eligible to take part in the study.</li>\n </ul>\n </li>\n <li>\n Nugent score greater than or equal to 7 or a symptomatic BV clinical diagnosis as defined by Amsel’s criteria\n <ul>\n <li>\n Must have 3 of the 4 signs for a diagnosis of BV using Amsel’s criteria</li>\n <li>\n Discharge, white & homogeneous</li>\n <li>\n Elevated pH, >4.5</li>\n <li>\n Amine odor present</li>\n <li>\n 20% clue cells present on wet mount</li>\n </ul>\n </li>\n <li>\n Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc.)</li>\n <li>\n Suspected cervical or uterine neoplasia\n <ul>\n <li>\n Includes abnormal VILI</li>\n </ul>\n </li>\n <li>\n Suspected breast cancer or other progestin-sensitive cancer</li>\n <li>\n Suspected hepatic disease, including cirrhosis or viral hepatitis</li>\n <li>\n History of bleeding or coagulation problems</li>\n <li>\n Known current drug or alcohol abuse which could impact study compliance</li>\n <li>\n Grade 2 or higher laboratory abnormality, per the Division of AIDS, National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading the Severity of Adverse Events (Table 6 and <a href=\"http://www.rsc.tech-res.com/docs/default-source/safety/division-of-aids-(daids)-table-for-grading-the-severity-of-adult-and-pediatric-adverse-events-corrected-v-2-1.pdf?sfvrsn=2\">http://www.rsc.tech-res.com/docs/default-source/safety/division-of-aids-(daids)-table-for-grading-the-severity-of-adult-and-pediatric-adverse-events-corrected-v-2-1.pdf?sfvrsn=2</a>), or clinically significant laboratory abnormality as determined by the clinician</li>\n <li>\n Use of any concomitant medications listed in Section 6.4</li>\n <li>\n Participation in any other investigational trial with use of a drug/device within the last 30 days or planned participation in any other investigational trial with use of a drug/device during the study</li>\n <li>\n History of gynecological procedures (including genital piercing) on the external genitalia, vagina, or cervix within the last 14 days of Visit 1</li>\n <li>\n Labial elongation (due to pulling practices and use of botanicals or caustic agents)</li>\n <li>\n Abnormal finding on laboratory or physical examination or a social or medical condition in the volunteer which, in the opinion of the site co-PI(s), would make participation in the study unsafe or would complicate interpretation of data</li>\n <li>\n <strong><em>Currently using, or has used within the preceding one (1) month, emtricitabine/tenofovir disoproxil fumarate (TDF/FTC or Truvada®) or any other tenofovir product, and/or has plans to use a non-study tenofovir product in any form during the study</em></strong></li>\n</ul>\n
      • primary_end_points<p>\n SAFETY, PHARMACOKINETIC AND PHARMOCODYNAMIC</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic1
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPHASE II
      • trial_therapeutic_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n DR. VICTOR MUDHUNE - CO-PI</p>\n<p>\n DR. IDDA KELLY ALUOCH - PHARMACIST OF RECORD</p>\n<p>\n BEATRICE NYAGOL - STUDY COORDINATOR</p>\n<p>\n EUNICE OUMA - STUDY PHYSICIAN</p>\n<p>\n The site has a fully furnished cinic where all clinical trials are done, there is accredited HIV-R laboratory that is ran by all qualified staff.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n IT HAD BEEN DONE IN THE HOST COUNTRY.</p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n KENYA MEDICAL RESEARCH INSTITUTE  - 8TH JUNE 2018</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</p>\n
      • estimated_duration1 YEAR
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorTFV IVR LNG
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKEMRI CRC
      • single_site_physical_addressJOOTRH HOSPITAL GROUNDS
      • single_site_contact_personDR. VICTOR MUDHUNE
      • single_site_telephone+254722687430
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteONLY KENYA - 50 WOMEN
      • total_participants_worldwideKENYA - 50 WOMEN
      • 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_male0
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDR. NELLY
      • investigator1_middle_nameRWAMBA
      • investigator1_family_nameMUGO
      • investigator1_qualificationMD,MPH
      • investigator1_professional_addressKEMRI CRC, BOX 1578, KISUMU 40100
      • investigator1_telephone+254733629665
      • investigator1_emailrwamba@uw.edu
      • organisations_transferred_No
      • number_participants50 WOMEN
      • notification<p>\n CONRAD PROTOCOL WAS BROKEN BECAUSE YOUR LIMIT IS TOO SMALL.</p>\n
      • approval_date22-09-2018
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted08-12-2020
      • 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)
      • modified2021-03-12 09:47:06
      • created2018-06-21 11:46:39
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id440
        • application_id697
        • given_nameDR. NELLY
        • middle_nameRWAMBA
        • family_nameMUGO
        • qualificationMD,MPH
        • professional_addressKEMRI CRC, BOX 1578,KISUMU KENYA
        • telephone+254733629665
        • emailrwamba@uw.edu
        • created2018-06-21 12:05:25
        • modified2020-12-08 14:56:14
    • SiteDetail(array)
      • 0(array)
        • id555
        • application_id697
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2018-06-21 12:05:25
        • modified2020-12-08 14:56:14
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id348
        • application_id697
        • sponsorCONRAD 1911 North Fort Myer Drive Suite 900 Arlington, VA 22209
        • sponsor_typeResearch Institution
        • contact_personAlison Mathews
        • addressCONRAD 1911 North Fort Myer Drive Suite 900 Arlington, VA 22209
        • telephone_number+1 703-524-4474
        • fax_number
        • cell_number+1 703-524-4474
        • email_addressamatthews@conrad.org
        • created2018-06-21 12:05:25
        • modified2020-12-08 14:56:14
  • 4(array)
    • Application(array)
      • id1423
      • user_id81
      • trial_status_id2
      • abstract_of_study<p>\n Rift Valley fever (RVF) is a mosquito-borne viral zoonosis that primarily affects domestic livestock (sheep, goats, cattle) and humans in Africa. RVF was first identified in Kenya in 1930 and is characterized by a wide range of symptoms in humans, ranging from self-limiting febrile illness to life-threatening hemorrhagic manifestations and miscarriage in pregnant women. Overall mortality from RVF is thought to be <1%; however, case fatality rates among patients with hemorrhagic disease can be as high as 50% and debilitating sequelae such as blindness and neurological deficits can occur following ocular and encephalitic forms of the disease. In livestock, RVF causes high rates (>90%) of death in young animals and spontaneous abortion (typically >90%) in those that are pregnant. Licensed vaccines are available for livestock, but no licensed RVF vaccines are available for human use. This, together with the potential for RVF to cause epidemics and a public health emergency, has led the World Health Organization (WHO) and the African Union to include RVF on a shortlist of diseases prioritized for accelerated vaccine research and development. We previously designed and developed a replication-deficient adenovirus vectored RVF vaccine, ChAdOx1 RVF, and assessed its performance in livestock. The vaccine was found to be safe, able to generate a strong durable immune response, and conferred protection against RVF in all major livestock species affected by the disease. In recent human phase 1 trials in adults in the United Kingdom and Uganda, a single dose of ChAdOx1 RVF was shown to be safe and to generate a strong immune response. Further evaluation of ChAdOx1 RVF in larger populations in areas where RVF epidemics occur is required to support subsequent licensure and deployment of the vaccine.</p>\n<p>\n In this randomized controlled double-blinded study, we will evaluate the immunogenicity and safety of ChAdOx1 RVF in adults aged 18-50 years in Kenya in comparison to control rabies vaccine. The study will take place in Kilifi County where RVF outbreaks have previously occurred. We will enroll a total of 240 adults from the general population who will be randomly allocated to one of three groups. Group 1, composed of 120 participants, will receive a single dose of ChAdOx1 RVF vaccine at baseline and a single dose of rabies vaccine 3 months later. Group 2, composed of 60 adults, will receive two doses of ChAdOx1 RVF; the first dose at baseline and the second dose at 3 months later. Group 3, also composed of 60 adults, will receive two doses of rabies vaccine; the first dose at baseline and the second dose at 3 months later. Participants will be followed up for 18 months from the first dose of vaccine. The primary objective of the trial is to assess the rate of seroconversion for RVFV neutralizing antibodies at 28 days post-vaccination with a single dose of ChAdOx1 RVF. The secondary objective of the trial is to describe the kinetics of the immune response generated by ChAdOx1 RVF vaccine when administered as a single dose or as a two-dose regime. The safety objective is to assess the safety, tolerability and reactogenicity of ChAdOx1 RVF in the study population. Results from this trial will support further development of the vaccine for emergency use authorization should an RVF epidemic occur, with a future phase 3 trial supporting vaccine licensure.</p>\n<p>\n  </p>\n
      • study_title<p align=\"center\">\n <strong>Phase 2 trial to assess the immunogenicity and safety of the ChAdOx1 RVF vaccine against Rift Valley fever in adults in Kenya </strong></p>\n<p>\n  </p>\n
      • laymans_summary<p>\n <strong>Lay Title: </strong>A study to assess whether a new vaccine called ChAdOx1 RVF will be safe and work well against Rift Valley Fever in adults in Kenya</p>\n<p>\n  </p>\n<p>\n <strong>What is the problem/background? </strong></p>\n<p>\n Rift Valley fever (RVF) is a mosquito-borne viral illness that was first discovered in Kenya in 1930 and is now present in many parts of thew country including Kilifi and other coastal counties. The disease primarily affects humans and livestock (sheep, goats, cattle) and has spread throughout much of Africa and part of the Middle East. In humans, RVF is characterized by a wide range of symptoms ranging from self-limiting febrile illness to life-threatening bleeding complications and miscarriage in pregnant women. Overall mortality from RVF is thought to be <1%; however, case fatality rates among patients with bleeding complications can be as high as 50% and other serious outcomes of disease such as blindness can occur with some forms of the disease. In livestock, more than 90% of young animals affected by RVF die and spontaneous abortion in almost all pregnant animals on a farm is typical. Vaccines against RVF are available for livestock, but no licensed vaccines are currently available for human use. Owing to the potential for a public health emergency arising from RVF epidemics, both the World Health Organization (WHO) and the African Union have identified the development of a human RVF vaccine as an urgent priority.</p>\n<p>\n  </p>\n<p>\n <strong>What questions are we trying to answer? </strong></p>\n<p>\n We aim to answer the question of whether ChAdOx1 RVF, a candidate vaccine against RVF, provides an adequate immune response and determine its safety among Kenyan adults. The vaccine has been found to be safe, able to generate a strong durable immune response, and to confer protection against RVF in all major livestock species affected by the disease. In human phase 1 trials in adults in the United Kingdom and Uganda, a single dose of ChAdOx1 RVF was also shown to be safe and able to generate a strong immune response. Further evaluation of ChAdOx1 RVF in larger populations in areas where RVF epidemics occur is necessary for subsequent licensure and deployment of the vaccine. In this study, we will evaluate the safety of, and immune response generated by ChAdOx1 RVF vaccine in adults in Kenya. Our main aim is to assess the proportion of individuals mounting an immune response following vaccination with a single dose of ChAdOx1 RVF, and occurrence of any adverse events following vaccination. A secondary aim of the study is to assess whether two doses of ChAdOx1 RVF elicit an immune response that is more durable than that generated by a single dose of ChAdOx1 RVF.</p>\n<p>\n  </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 This phase 2 vaccine trial will be conducted among adults aged 18-50 years resident within the Kilifi Health and Demographic Surveillance System (KHDSS) in Kilifi County, Kenya where RVF outbreaks have previously occurred. We will enroll a total of 240 adults who will be randomly allocated for immunization with ChAdOx1 RVF vaccine (180 adults) or with rabies vaccine as a control (60 adults).</p>\n<p>\n  </p>\n<p>\n <strong>What does the study involve for those who are in it? </strong></p>\n<p>\n Prior to enrolment, study participants will complete screening procedures to ensure they are in good health after they have given written informed consent. Participants will be screened for any significant health problems. This will include sampling of blood and urine for a series of tests to ensure eligibility. Those found eligible to participate will be randomly allocated to one of three study groups and vaccinated with ChAdOx1 RVF or a control Rabies vaccine as follows. Group 1, composed of 120 participants, will receive a single dose of ChAdOx1 RVF vaccine at baseline and a single dose of rabies vaccine 3 months later. Group 2, composed of 60 adults, will receive two doses of ChAdOx1 RVF; the first dose at baseline and the second dose 3 months later. Group 3, composed of 60 adults, will receive two doses of rabies vaccine; the first dose at baseline and the second dose 3 months later. All screening procedures, sampling and vaccination will be done at the study clinic within the KEMRI-Wellcome Trust Research Programme. The choice of Rabies vaccine as a control is due to its good safety profile and the benefit that rabies vaccination offers participants given the risk of rabies in Kenya. After each vaccination, participants will receive daily phone calls for the following six days to gather information on any symptoms they may experience. Participants will be instructed to contact the study team at any time should they experience any clinical symptoms. Blood samples will be collected at baseline (before vaccination) and at scheduled follow-up visits (8 visits over the duration of the study, i.e. days 7, 14, 28, 84, 91, 112, 365 and 540 after the first vaccination) for monitoring of immune responses. Up to 20mls of blood will be collected at each scheduled visit. Participants will be followed-up for 18 months from the first dose of vaccine. Adverse events following vaccination will be monitored throughout the study and reviewed by an independent Data and Safety Monitoring Board (DSMB).</p>\n<p>\n  </p>\n<p>\n <strong>What are the benefits and risks/costs of the study for those involved?  </strong></p>\n<p>\n Participants will benefit by knowledge of their general health status; they will also have close oversight and treatment support from the study team although this will primarily be for risk monitoring. All participants will also be offered the opportunity to receive a complete course of the rabies vaccine at the end of the study. During vaccination and when collecting blood samples, the participants may experience some discomfort, pain and occasionally, bruising at the injection site, which gets better after a short while. With any vaccination there is a risk of rare serious adverse events, such as a severe allergic reaction. In case of this unlikely event, medication for treating allergic reactions is kept in the clinic room and the investigators are appropriately trained in the management of allergic reactions. An extremely rare but serious blood clot condition that can lead to death or serious long-term disability has been observed among individuals vaccinated with a COVID-19 vaccines made using the technology used to make the ChAdOx1 RVF vaccine. A very rare condition that affects the nervous system, called Guillain-Barre Syndrome, has also been observed with COVID-19 vaccines. However, it is not clear whether other vaccines made with the ChAdOx1 technology will carry a similar risk of inducing the clotting condition or the nervous system condition. All participants will be provided with this information via the informed consent form and will be kept updated should further information become available. Participants will be specifically counselled on symptoms that could be warning signs of serious clotting events, and any cases managed as per local Ministry of Health guidelines. Participants will be compensated for study-related out-of-pocket expenses for each clinic study visit at the rate of KES500, reimbursed for transport costs incurred, and pay for their costs of hospitalization in a government facility for any new illness that develop during the study period.</p>\n<p>\n  </p>\n<p>\n <strong>How will the study benefit society?  </strong></p>\n<p>\n The unmet need for a human vaccine against RVF is well recognized among clinicians and public health practitioners in Kenya and other countries in Africa. This has led to the prioritization of RVF for urgent vaccine research by the WHO and the African Union. If found to be safe and good in generating protective immune responses, the ChAdOx1 RVF vaccine will be developed further and licensed for use in controlling RVF in humans.</p>\n<p>\n  </p>\n<p>\n <strong>When does the study start and finish? </strong></p>\n<p>\n The study will start upon receipt of ethical and regulatory approvals. The estimated trial period, starting from when the first participant is screened for eligibility to when the final participant has had their last follow-up visit and the trial database is locked, will be 24 months. We anticipate the total study duration including the time taken to obtain ethics and regulatory approvals, community engagement activities and post-study reporting to take approximately 3 years.</p>\n<p>\n  </p>\n
      • short_titleRVF003 Trial
      • protocol_noECCT/24/07/03
      • version_no2.0
      • date_of_protocol13-04-2024
      • study_drugRift Valley Fever Virus vaccine (RVFV)
      • disease_conditionRift Valley Fever
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameRabies vacine
      • comparator_registeredYes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressCGMRCCSC@kemri-wellcome.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_applicantProf. Philip Bejon
      • declaration_date112-07-2024
      • declaration_principal_investigatorProf. George Warimwe
      • declaration_date211-07-2024
      • placebo_presentNo
      • study_objectives<p>\n <strong>Primary Objective</strong></p>\n<p>\n - To assess the rate of seroconversion for RVFV neutralizing antibodies 28 days post-vaccination with a single dose of ChAdOx1 RVF</p>\n<p>\n <strong>Seconadary Objectives</strong></p>\n<p align=\"left\">\n - To describe the kinetics of the immune response generated by ChAdOx1 RVF vaccine when administered as a single dose or as a two-dose regime</p>\n<p align=\"left\">\n <strong>Safety Objective</strong></p>\n<p align=\"left\">\n - To assess the safety, tolerability and reactogenicity of ChAdOx1 RVF in adults in Kenya</p>\n<p align=\"left\">\n <strong>Exploratory Objectives</strong></p>\n<p align=\"left\">\n - To assess if anti-ChAdOx1 vector immunity influences response to ChAdOx1 RVF vaccination</p>\n<p align=\"left\">\n - To estimate exposure to natural RVFV infection in the trial population</p>\n<p align=\"left\">\n - To assess whether sera from ChAdOx1 RVF vaccinees can passively protect animals from RVFV challenge</p>\n<p align=\"left\">\n  </p>\n<p align=\"left\">\n  </p>\n<p align=\"left\">\n  </p>\n<p align=\"left\">\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n <strong>Inclusion criteria</strong></p>\n<p>\n To be eligible for the study, a participant must satisfy all the following criteria:</p>\n<ul>\n <li>\n Healthy adult aged 18-50 years</li>\n <li>\n For females only, willingness to practice continuous effective contraception up to one month following the second vaccination (i.e. duration of 4 months starting from enrolment) and a negative pregnancy test on the day(s) of screening. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include combined oral contraceptives, injectable progestogen, implants of etenogestrel or levonorgestrel, intrauterine device. Female participants will be asked for written confirmation of any family planning methods used by provision of health records. These records will be reviewed and counselling for adherence done at each study visit as per the protocol schedule of attendances. Participants who do not have adequate methods of contraception will be referred to their local dispensary where this will be dispensed for free or to Kilifi County Hospital (KCH). Costs incurred for obtaining contraception at KCH will be covered by the study.</li>\n <li>\n Agreement to refrain from blood donation during the course of the study</li>\n <li>\n Able and willing to provide written informed consent</li>\n <li>\n Plan to remain resident in the study area for 18 months following vaccination</li>\n</ul>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n <strong>Exclusion criteria</strong></p>\n<p>\n The exclusion criteria relate to conditions/factors that may confound assessment of vaccine immunogenicity or impact participant safety. A participant may not enter the study if any of the following apply:</p>\n<ul>\n <li>\n Prior receipt of any vaccines (licensed or investigational) ≤30 days before enrolment and/or planned receipt of a vaccine ≤30 days after enrolment</li>\n <li>\n Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate</li>\n <li>\n Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)</li>\n <li>\n History of allergic disease or reactions likely to be exacerbated by any component of the vaccine</li>\n <li>\n Any history of hereditary angioedema, acquired angioedema, or idiopathic angioedema.</li>\n <li>\n Any history of anaphylaxis in relation to vaccination</li>\n <li>\n Pregnancy, lactation or willingness/intention to become pregnant during the study</li>\n <li>\n History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)</li>\n <li>\n History of serious psychiatric condition likely to affect participation in the study</li>\n <li>\n Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture</li>\n <li>\n Any other serious chronic illness requiring hospital specialist supervision</li>\n <li>\n Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week (e.g., more than 2 bottles of 500mls Tusker (beer) a day, more than 2 large glasses of 12% wine per day)</li>\n <li>\n Suspected or known injecting drug abuse in the 5 years preceding enrolment</li>\n <li>\n Seropositive for hepatitis B surface antigen (HBsAg)</li>\n <li>\n Seropositive for hepatitis C virus (HCV)</li>\n <li>\n Prior natural exposure to RVFV as determined by seropositivity for RVFV antigens by ELISA</li>\n <li>\n Any clinically significant abnormal finding on screening biochemistry, hematology or coagulation blood tests or urinalysis</li>\n <li>\n Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the participant because of participation in the study, affect the ability of the individual to participate in the study or impair interpretation of the study data</li>\n <li>\n History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism), history of antiphospholipid syndrome, or history of heparin induced thrombocytopenia.</li>\n</ul>\n<p>\n  </p>\n
      • primary_end_points<p>\n The proportion of vaccinees in each study group mounting neutralizing antibodies against live RVFV (i.e., seroconversion, as measured by FRNT₈₀)</p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunogenicity
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other1
      • trial_other_specifyPhase II vaccine trial
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n <strong>Name</strong></p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n <strong>Qualifications</strong></p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n <strong>Study Role</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Prof George Warimwe</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n BVM, PhD</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Principal Investigator</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:44px;\">\n <p>\n John Gitonga</p>\n </td>\n <td style=\"width:145px;height:44px;\">\n <p>\n Dip, BSc</p>\n </td>\n <td style=\"width:223px;height:44px;\">\n <p>\n Lab processes and assessments</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Daisy Mugo</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n BSc, MSc</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Lab processes and assessments</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Mainga Hamaluba</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n MBChB, MSc, PhD</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Clinical Oversight</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Stanley Cheruiyot</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n BSc</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Data Manager</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Benedict Orindi</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n BSc, MSc, PhD</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Trial Statistician</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Noni Mumba</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n BSc, MA</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Head of Community Engagement</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Caroline Ngetsa</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n HND, BSc, MSc.</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Clinical Trial Laboratory manager</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n Caroline Mate</td>\n <td style=\"width:145px;height:29px;\">\n BSc, MSc</td>\n <td style=\"width:223px;height:29px;\">\n Project Management</td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Mwatasa Mwaganyuma</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n BSc, MSc</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Pharmacist of record</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Amek Nyaguara</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n BSc, MSc, PhD</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Head of Surveillance</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Jennifer Kanungi</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n Dip, PG Dip</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Project Coordinator</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Ronald Odongo</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n Dip</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Clinical Officer</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Christopher Oyamo</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n Dip, HND.</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Clinical Officer</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Naomi Baron</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n Dip</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Clinical Officer</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Titus Buluku</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n Dip</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Clinical Officer</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Felix Moki</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n Dip</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Clinical Officer</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Jane Mwendwa</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n Dip, BSc</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Senior Nurse</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:32px;\">\n <p>\n Fred Ogot</p>\n </td>\n <td style=\"width:145px;height:32px;\">\n <p>\n Dip</p>\n </td>\n <td style=\"width:223px;height:32px;\">\n <p>\n Nurse</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Josephine Bendera</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n Certificate</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Senior Fieldworker</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n James Mwavita</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n  O’ level</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Senior Field worker</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Clinton Mwatata</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n  BSc</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Senior Data Clerk</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:174px;height:29px;\">\n <p>\n Rufus Gathitu</p>\n </td>\n <td style=\"width:145px;height:29px;\">\n <p>\n   O’ level</p>\n </td>\n <td style=\"width:223px;height:29px;\">\n <p>\n Senior Data clerk</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_explanation<p>\n Rift Valley fever (RVF) is a mosquito-borne viral illness that was first discovered in Kenya in 1930 and is now present in many parts of the country including Kilifi and other coastal counties. The disease primarily affects humans and livestock (sheep, goats, cattle) and has spread throughout much of Africa and part of the Middle East.</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n Not applicable</p>\n
      • other_details_regulatory_halted<p>\n Not applicable</p>\n
      • estimated_duration3 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorRabies vaccine
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyVaccine
      • single_site_member_stateYes
      • location_of_areaKEMRI-Wellcome Trust Research Programme
      • single_site_physical_addressP.O. Box 230 Kilifi, 80108 Kenya
      • single_site_contact_personProf. George Warimwe
      • single_site_telephone254(0)70983905
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site240
      • total_participants_worldwide240
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_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_nameGeorge
      • investigator1_middle_name
      • investigator1_family_nameWarimwe
      • investigator1_qualificationProfessor of Vaccinology
      • investigator1_professional_addressP.O. Box 230–80108, Kilifi, Kenya
      • investigator1_telephone254(0)70983905
      • investigator1_emailgeorge.warimwe@ndm.ox.ac.uk
      • organisations_transferred_Yes
      • number_participants240
      • notification<p>\n No extra files to upload</p>\n
      • approval_date06-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-07-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted12-07-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonResponse to expert review comments satisfactory. Study approved by PPB ECCT
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-04-11 09:29:02
      • created2024-06-21 12:43:41
      • total_sites(null)
      • ecitizen_invoice362274
    • InvestigatorContact(array)
      • 0(array)
        • id1108
        • application_id1423
        • given_nameGeorge
        • middle_name
        • family_nameWarimwe
        • qualificationProfessor of Vaccinology
        • professional_addressP.O. Box 230–80108, Kilifi, Kenya
        • telephone254(0)70983905
        • emailgeorge.warimwe@ndm.ox.ac.uk
        • created2024-07-08 12:29:27
        • modified2024-12-13 14:52:14
    • SiteDetail(array)
      • 0(array)
        • id1753
        • application_id1423
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2024-07-08 12:29:27
        • modified2024-12-13 14:52:14
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id762
        • application_id1423
        • sponsorUniversity of Oxford
        • sponsor_typeResearch Institution
        • contact_personProf. Philip Bejon
        • addressNuffield Department of Medicine, University of Oxford, Old Road Campus, Oxford, OX3 7BN
        • telephone_number+254709983549
        • fax_number
        • cell_number+254709983549
        • email_addresspbejon@kemri-wellcome.org
        • created2024-07-08 12:29:27
        • modified2024-12-13 14:52:14
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • approved2
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

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

Included Files

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