NCT05882916 Reaching the Last 20% (the Pamoja Kwa Afya Study)
| NCT ID | NCT05882916 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sue Napierala |
| Condition | HIV |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-05-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,000 participants in total. It began in 2024-03-01 with a primary completion date of 2026-05-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Sue Napierala, PhD, MPH
PRINCIPAL INVESTIGATOR
RTI International
Frequently Asked Questions
Who can join the NCT05882916 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying HIV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05882916 currently recruiting?
Yes, NCT05882916 is actively recruiting participants. Contact the research team at snapierala@rti.org for enrollment information.
Where is the NCT05882916 trial being conducted?
This trial is being conducted at Kisumu, Kenya.
Who is sponsoring the NCT05882916 clinical trial?
NCT05882916 is sponsored by Sue Napierala. The principal investigator is Sue Napierala, PhD, MPH at RTI International. The trial plans to enroll 5,000 participants.
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