Clinical trial NCT05882916: Reaching the Last 20% (the Pamoja Kwa Afya Study)
Official title: Reaching the Last 20%: a Targeted HIV Self-test Secondary Distribution Intervention to Engage High-risk Men in Kenya
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Keywords: Self-testing
Secondary distribution
Men who purchase sex
Women who sell sex
HIV
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Impact Research & Development Organization
name: University of Pennsylvania
name: University of North Carolina, Chapel Hill
First posted: 2023-05-31
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: randomized stepped wedge trial
Primary purpose: PREVENTION

Brief summary: This cluster randomized controlled trial will test whether the provision of multiple oral fluid-based HIV self-test kits to women who sell sex (WSS) to secondarily distribute to their male partners who purchase sex can promote uptake of HIV service use by male partners. The study will recruit adult women who report exchanging sex for compensation in Kisumu and Siaya counties in Western Kenya. In clusters randomized to the intervention, WSS will be given multiple HIV self-tests and counseled to distribute them to men who purchase sex (MPS). Self-test kits will contain instructions for use and tailored information on clinic location and hours within the cluster, and pilot-tested messaging on the benefits of antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP). In control clusters, standard of care HIV services will continue to be available. To objectively assess impacts of the intervention on post-HIVST linkage outcomes, the investigators will monitor use of HIV services by men at HIV clinics in both study arms on a monthly basis. Our goal will be to determine whether confirmatory testing (primary outcome), case diagnoses, ART initiation, and PrEP initiation by men in intervention clusters are higher than in control clusters. Mixed methods research will be utilized to conduct a process evaluation to assess mechanisms that may have impacted intervention effectiveness, pathways for linkage among MPS, and support for men's linkage to HIV services under a secondary distribution model. Cost-effectiveness analyses will also be undertaken.

Detailed description: Limited use of HIV services by those at highest risk is one of the primary reasons for continued HIV transmission in sub-Saharan Africa. Identifying and engaging these individuals-particularly the 20% of people living with HIV who are unaware of their status-is a major challenge that is not being met by existing service delivery approaches. Men who purchase sex (MPS) are of particularly high priority because they are twice as likely to be HIV-infected as other men and are inherently challenging to identify and reach with HIV services. The proposed project will take place in the region of Kenya with the highest HIV prevalence and seeks to promote engagement in HIV testing, prevention, and care by MPS. Preliminary data demonstrate that "secondary distribution" of HIV self-tests by women who sell sex (WSS) to their sexual partners is acceptable, feasible, and safe and leads to high male partner testing. However, the use of post-self-test services has seldom been promoted or measured in a secondary distribution model. Our interdisciplinary and experienced team of Investigators will address this key gap.

This project will use a stepped wedge trial design to test an innovative, well-targeted HIV self-test secondary distribution intervention to promote uptake of HIV services by MPS. Clusters served by Ministry of Health-supported HIV clinics will be randomized to the start time to receive the secondary distribution intervention. The investigators will recruit WSS from key population clinics and transactional sex "hot spots." WSS will be provided with oral fluid-based HIV self-tests and encouraged to distribute them to their male transactional sex partners. Self-test kits will include salient information for men on clinic location and hours within their cluster, and pilot-tested messaging on the importance of early ART initiation, and the availability and benefits of PrEP. In Aim 1, the investigators will evaluate programmatic data from HIV clinics in study clusters to objectively determine the intervention's impact on uptake of confirmatory testing, HIV case diagnoses, and ART initiation and PrEP initiation by men. In Aim 2, the investigators will conduct a process evaluation to characterize factors influencing intervention effectiveness. The investigators will assess secondary distribution patterns and characterize the MPS population receiving self-tests through quantitative program data and a follow-up questionnaire among enrolled WSS. The investigators will use qualitative data obtained through in-depth interviews with MPS, WSS and clinic staff to explore pathways and contextual factors influencing whether men accessed post-test services. In Aim 3, the investigators will compute the incremental cost-effectiveness of our intervention to inform decisions about broader implementation. This project has the potential to break new ground on ways to engage high-risk and hard-to-reach populations in HIV services. If effective, our approach could be readily adapted to other settings and help advance global goals for HIV elimination.

Eligibility criteria: Inclusion Criteria:

* Female
* Age ≥18 years
* Reports exchanging sex for compensation with ≥2 men in the past month
* Engages in sex for compensation in the intervention cluster catchment area
* Willing to participate in a brief questionnaire 6 weeks after enrollment
* Plan to remain in the area of study recruitment for the next 8 weeks

Exclusion Criteria:

* Unwilling or unable to provide informed consent for participation

Primary outcomes:
measure: HIV testing
timeFrame: 3 months
Secondary outcomes:
measure: HIV case diagnoses
timeFrame: 3 months
measure: ART and PrEP initiation
timeFrame: 3 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Impact Research and Development Organization (IRDO)
Study officials:
affiliation: RTI International
name: Sue Napierala, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thirumurthy H, Masters SH, Mavedzenge SN, Maman S, Omanga E, Agot K. Promoting male partner HIV testing and safer sexual decision making through secondary distribution of self-tests by HIV-negative female sex workers and women receiving antenatal and post-partum care in Kenya: a cohort study. Lancet HIV. 2016 Jun;3(6):e266-74. doi: 10.1016/S2352-3018(16)00041-2. Epub 2016 Apr 8.
citation: Lynch M, Pentecost BL, Littler WA, Stockley RA. The distribution of antibodies to streptokinase. Postgrad Med J. 1996 May;72(847):290-2. doi: 10.1136/pgmj.72.847.290.
citation: Napierala S, Bair EF, Marcus N, Ochwal P, Maman S, Agot K, Thirumurthy H. Male partner testing and sexual behaviour following provision of multiple HIV self-tests to Kenyan women at higher risk of HIV infection in a cluster randomized trial. J Int AIDS Soc. 2020 Jun;23 Suppl 2(Suppl 2):e25515. doi: 10.1002/jia2.25515.
citation: Masters SH, Agot K, Obonyo B, Napierala Mavedzenge S, Maman S, Thirumurthy H. Promoting Partner Testing and Couples Testing through Secondary Distribution of HIV Self-Tests: A Randomized Clinical Trial. PLoS Med. 2016 Nov 8;13(11):e1002166. doi: 10.1371/journal.pmed.1002166. eCollection 2016 Nov.