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NCT05882916Not yet recruiting

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

Reaching the Last 20%: a Targeted HIV Self-test Secondary Distribution Intervention to Engage High-risk Men in Kenya
Sue NapieralaClinicalTrials.govdeviceDevice trial
Study focus
Disease/Condition
HIV
Drug/Device/Intervention
HIV self-testing
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Sue Napierala
Funder
RTI International
Location
Kisumu, Kenya
Timeline & enrollment
Phase
N/A
Start date
May 29, 2023
End date
May 30, 2026
Enrollment
5000 participants
Primary outcome

HIV testing

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.

ICD-10 classifications
Human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other conditionsHIV disease resulting in other viral infectionsUnspecified human immunodeficiency virus [HIV] diseaseHuman immunodeficiency virus [HIV] disease resulting in other specified diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05882916
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05882916 through Pure Global AI's free database. This phase not specified trial is sponsored by Sue Napierala and is currently Not yet recruiting. The study focuses on HIV. Target enrollment is 5000 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.