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

NCT05882916 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2025-03-18

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

HIV self-testing

Oral fluid-based HIV self-test kits for secondary distribution

BEHAVIORAL

Behavioral economic 'nudges'

Salient information for men included with the self-test kit 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

Sponsors & Collaborators

  • Impact Research & Development Organization

    collaborator OTHER

  • University of Pennsylvania

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    collaborator OTHER

  • Sue Napierala

    lead OTHER

Principal Investigators

  • Sue Napierala, PhD, MPH · RTI International

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-05-29
Completion
2026-08-07

Countries

  • Kenya

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05882916 on ClinicalTrials.gov