Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202003743599701 Date of Approval: 24/03/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Partners Scale-Up Project (PSUP)
Official scientific title An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention among Kenyan HIV-1 serodiscordant couples
Brief summary describing the background and objectives of the trial Antiretroviral-based HIV-1 prevention strategies – including antiretroviral treatment (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons to prevent HIV-1 acquisition – are among the most promising new approaches for dramatically decreasing HIV-1 spread worldwide. A priority population for implementation of ART and PrEP for HIV-1 prevention is HIV-1 serodiscordant couples (i.e., one member is HIV-1 infected and the other uninfected). In Kenya, heterosexual HIV-1 serodiscordant couples face high risk of HIV-1 transmission and account for a substantial fraction of new infections. Over the past decade, randomized trials and other clinical investigations have definitively demonstrated that both ART and PrEP have high HIV-1 protection efficacy when used by members of HIV-1 serodiscordant couples. A pragmatic, integrated approach to providing ART and PrEP, with ART promoted for the HIV-1 infected partner in all couples and PrEP offered until six months after ART initiation by the HIV-1 infected partner to permit time to achieve virologic suppression (a strategy called “PrEP as a bridge to ART”), resulted in near-elimination of HIV-1 transmission in a demonstration project among HIV-1 serodiscordant couples. The World Health Organization recommends ART at any CD4 count for persons with HIV-1 infection, particularly those with HIV-1 uninfected partners, and PrEP for persons at high risk of HIV-1 acquisition. The Kenya Ministry of Health has developed an ambitious HIV Prevention Revolution Road Map 2030, including provision of ART regardless of CD4 count and PrEP for HIV-1 serodiscordant couples. In July 2016, the Ministry of Health in Kenya released “Guidelines on use of Antiretroviral Drugs for Treating and Preventing HIV infections in Kenya” which recommend initiation of ART for all HIV infected persons irrespective of CD4 count and oral PrEP for HIV-1 uninfected persons with substantial o
Type of trial CCT
Acronym (If the trial has an acronym then please provide) PSUP
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Prevention
Anticipated trial start date 06/02/2017
Actual trial start date 27/02/2017
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 2400
Actual target sample size (number of participants) 2684
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group This is an implementation study that seeks to scale up delivery of PrEP through public facilities TDF/FTC 1 Tablet once a day During the period of an ongoing risk for HIV Open label 2400
Control Group Open label TDF/FTC During periods of an ongoing risk for HIV This is not a randomized clinical trial 2400 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
For HIV-1 uninfected members of the couple - Age ≥18 - Able and willing to provide consent for follow-up in the cohort - HIV-1 uninfected based on negative HIV-1 tests, per Kenya national guidelines - Not currently using PrEP For HIV-1 infected members of the couple - Age ≥18 - Able and willing to provide consent for follow-up in the cohort - HIV-1 infected based on positive HIV-1 tests, per Kenya national guidelines For both members of the couple - Meet criteria for initiating PrEP as per Kenya national guidelines, including: o HIV-1 infected member not currently using ART, on ART <6 months, or on ART but not virally suppressed based on a viral load test done at the clinic as per Kenya national guidelines or o Trying to conceive For key delivery informants - Able and willing to provide consent Contraindication for TDF/FTC Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/02/2020 PPB ECCT
Ethics Committee Address
Street address City Postal code Country
Lenana Road Nairobi 00100 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/10/2019 KEMRI SERU
Ethics Committee Address
Street address City Postal code Country
Mbagathi way Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Key endpoints will include: a) HIV-1 infected persons whose partner completes HIV-1 testing, b) PrEP initiation and sustained use by HIV-1 uninfected partners through ART initiation and adherence by their infected partner, c) ART initiation and sustained use by HIV- 1 infected persons, d) HIV-1 uninfected partners staying HIV-1 uninfected, and e) couples achieving optimized HIV-1 prevention coverage (defined as PrEP with high adherence, ART with viral suppression, or overlap of the two during the bridge period plus no HIV-1 transmission). We will characterize couples’ risk profiles using our validated risk score [21], which we can use to further predict HIV-1 incidence in the absence of intervention. Finally, in our prior work, retention in prevention services is a strong measure of acceptability and predictor of HIV-1 protection, as loss to follow-up eliminates access to PrEP/ART; we will measure retention in care, as this is also a feasible measure for public health delivery. Finally, our data [44] do not support sexual risk taking in couples but we will analyze for risk compensation and finalize messaging as part of our counseling materials. We will conduct quantitative and qualitative work to assess barriers and facilitators to use of PrEP as a bridge to ART in couples. Adherence to ART and PrEP will be measured through pharmacy refill (i.e., picking up each new supply, which is a feasible measure for an implementation setting), self-report (e.g., frequency, ability, and self-rating, missed doses) [54, 67, 68], and biologic measures (plasma HIV-1 RNA in those on ART and plasma tenofovir in those on PrEP [a random subset plus seroconverters]). Our goal is to understand both execution (i.e., adherence while used) and persistence (i.e., duration of use). We will use multivariable proportional hazards models to assess correlates of time to initiation and generalized estimating equations to assess adherence correlates. HIV Seroconversion, PrEP Refills, Adherence
Secondary Outcome Key endpoints will include: a) HIV-1 infected persons whose partner completes HIV-1 testing, b) PrEP initiation and sustained use by HIV-1 uninfected partners through ART initiation and adherence by their infected partner, c) ART initiation and sustained use by HIV- 1 infected persons, d) HIV-1 uninfected partners staying HIV-1 uninfected, and e) couples achieving optimized HIV-1 prevention coverage (defined as PrEP with high adherence, ART with viral suppression, or overlap of the two during the bridge period plus no HIV-1 transmission). We will characterize couples’ risk profiles using our validated risk score [21], which we can use to further predict HIV-1 incidence in the absence of intervention. Finally, in our prior work, retention in prevention services is a strong measure of acceptability and predictor of HIV-1 protection, as loss to follow-up eliminates access to PrEP/ART; we will measure retention in care, as this is also a feasible measure for public health delivery. Finally, our data [44] do not support sexual risk taking in couples but we will analyze for risk compensation and finalize messaging as part of our counseling materials. We will conduct quantitative and qualitative work to assess barriers and facilitators to use of PrEP as a bridge to ART in couples. Adherence to ART and PrEP will be measured through pharmacy refill (i.e., picking up each new supply, which is a feasible measure for an implementation setting), self-report (e.g., frequency, ability, and self-rating, missed doses) [54, 67, 68], and biologic measures (plasma HIV-1 RNA in those on ART and plasma tenofovir in those on PrEP [a random subset plus seroconverters]). Our goal is to understand both execution (i.e., adherence while used) and persistence (i.e., duration of use). We will use multivariable proportional hazards models to assess correlates of time to initiation and generalized estimating equations to assess adherence correlates. PrEP Refill
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Thika level 5 hospital General Kago road Thika Kenya
St. Marys Hospital Langata Nairobi Kenya
Nyeri PGH Nyeri town Nyeri Kenya
Karatina SubCounty Hospital Karatina Karatina Kenya
Kerugoya County Hospital kerugoya Kerugoya town Kenya
Muranga County Hospital Muranga road Muranga Kenya
Ruiru sub county hospital ruiru Ruiru town Kenya
Kiambu County referral hospital kiambu Kiambu town Kenya
Kikuyu Mission Hospital kikuyu Kikuyu town Kenya
Mbagathi Subcounty hospital Mbagathi way Nairobi Kenya
COPTIC Hospital Ngong road Nairobi Kenya
Pumwani Maternity Hospital estleigh Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
United States National Institutes of Health Bill and Melinda Gates Foundation Bethesda Bethesda United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Washington Kent Seattle United States of America University
COLLABORATORS
Name Street address City Postal code Country
Ministry of Health Facilites as provided in the Recruitment centers. NASCOP Head quarters Nairobi Kenya
Kenya Medical Research Institute Mbagathi way Nairobi Kenya
University of Washington 1410 NE Campus Parkway Seattle United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nelly Mugo rwamba@uw.edu 0723914057 Ngong Road
City Postal code Country Position/Affiliation
Nairobi 00202 Kenya Chief Research Officer Kenya Medical Research Institute
Role Name Email Phone Street address
Public Enquiries Elizabeth Irungu eirungu@pipsthika.org 0721861147 OAU Road
City Postal code Country Position/Affiliation
Thika Kenya Country Director PSUP
Role Name Email Phone Street address
Scientific Enquiries Kenneth Ngure k_ngure@hotmail.com +254722362219 OAU Road
City Postal code Country Position/Affiliation
Nairobi Kenya Senior Lecturer JKUAT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes This study entails scaled delivery of PrEP in public health facilities. All characteristics of participants will be shared once the analysis is complete. Study Protocol This project kicked off in 2017 and is expected to be complete by 2022. We anticipate to share the details once the results are published. Once published, the findings will be available to all that request. We understand some publishers may have controlled access to the published materials.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information