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

NCT05882916 | Recruiting DMC

• 1 other identifier: 0218622
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

Self-testing; Secondary distribution; Men who purchase sex; Women who sell sex; HIV

Outcome Measures

Primary Outcomes (1)

• HIV testing

  The count of adult men from each cluster who completed an HIV test at the clinic within the intervention versus control period.

  3 months

Secondary Outcomes (2)

• HIV case diagnoses

  3 months

• ART and PrEP initiation

  3 months

Study Arms (1)

HIV self-test secondary distribution

EXPERIMENTAL

The investigators will provide women who sell sex enrolled in the study with multiple World Health Organization (WHO) and Kenya-approved oral fluid-based HIV self-test kits. Participants will be counseled to secondarily distribute self-tests to their male transactional sex partners. Self-test kits will contain instructions for use and tailored information on clinic locations and hours within the cluster, the benefits of early ART use, and the availability and benefits of PrEP.

Device: HIV self-testing; Behavioral: Behavioral economic 'nudges'

Interventions

HIV self-testing DEVICE

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

HIV self-test secondary distribution

Behavioral economic 'nudges' BEHAVIORAL

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

HIV self-test secondary distribution

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identifies as female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sue Napierala: lead
• Impact Research & Development Organization: collaborator
• University of Pennsylvania: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Impact Research and Development Organization (IRDO)

Kisumu, Kenya

RECRUITING

Related Publications (4)

• 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.

  PMID: 27240789 BACKGROUND

• 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.

  PMID: 8761502 BACKGROUND

• 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.

  PMID: 32589354 BACKGROUND

• 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.

  PMID: 27824882 BACKGROUND

Study Officials

• Sue Napierala, PhD, MPH

  RTI International

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sue Napierala, PhD, MPH

CONTACT

5104188198; snapierala@rti.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: randomized stepped wedge trial

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 31, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): August 7, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)