Reaching the Last 20% (the Pamoja Kwa Afya Study)

Recruiting now · Not applicable

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT05882916

Run by

Sue Napierala

People needed

5000

Starts

2024-03-01

Expected to finish

2026-08-07

Last updated by the study team

2025-03-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Unwilling or unable to provide informed consent for participation

Where it is running

• Impact Research and Development Organization (IRDO) — Kisumu, Kenya (enrolling)

Full record on ClinicalTrials.gov

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