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

HIV Clinical Trial

Official title:

Reaching the Last 20%: a Targeted HIV Self-test Secondary Distribution Intervention to Engage High-risk Men in Kenya

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882916
• Other study ID #: 0218622
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: August 7, 2026

Study information

• Verified date: May 2024
• Source: RTI International
• Contact: Sue Napierala, PhD, MPH
• Phone: 5104188198
• Email: snapierala[@]rti.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Limited use of HIV services by those at highest risk is one of the primary reasons for continued HIV transmission in sub-Saharan Africa. Identifying and engaging these individuals-particularly the 20% of people living with HIV who are unaware of their status-is a major challenge that is not being met by existing service delivery approaches. Men who purchase sex (MPS) are of particularly high priority because they are twice as likely to be HIV-infected as other men and are inherently challenging to identify and reach with HIV services. The proposed project will take place in the region of Kenya with the highest HIV prevalence and seeks to promote engagement in HIV testing, prevention, and care by MPS. Preliminary data demonstrate that "secondary distribution" of HIV self-tests by women who sell sex (WSS) to their sexual partners is acceptable, feasible, and safe and leads to high male partner testing. However, the use of post-self-test services has seldom been promoted or measured in a secondary distribution model. Our interdisciplinary and experienced team of Investigators will address this key gap.

This project will use a stepped wedge trial design to test an innovative, well-targeted HIV self-test secondary distribution intervention to promote uptake of HIV services by MPS. Clusters served by Ministry of Health-supported HIV clinics will be randomized to the start time to receive the secondary distribution intervention. The investigators will recruit WSS from key population clinics and transactional sex "hot spots." WSS will be provided with oral fluid-based HIV self-tests and encouraged to distribute them to their male transactional sex partners. Self-test kits will include salient information for men 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. In Aim 1, the investigators will evaluate programmatic data from HIV clinics in study clusters to objectively determine the intervention's impact on uptake of confirmatory testing, HIV case diagnoses, and ART initiation and PrEP initiation by men. In Aim 2, the investigators will conduct a process evaluation to characterize factors influencing intervention effectiveness. The investigators will assess secondary distribution patterns and characterize the MPS population receiving self-tests through quantitative program data and a follow-up questionnaire among enrolled WSS. The investigators will use qualitative data obtained through in-depth interviews with MPS, WSS and clinic staff to explore pathways and contextual factors influencing whether men accessed post-test services. In Aim 3, the investigators will compute the incremental cost-effectiveness of our intervention to inform decisions about broader implementation. This project has the potential to break new ground on ways to engage high-risk and hard-to-reach populations in HIV services. If effective, our approach could be readily adapted to other settings and help advance global goals for HIV elimination.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: August 7, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
Kenya	Impact Research and Development Organization (IRDO)	Kisumu

Sponsors (4)

Lead Sponsor	Collaborator
Sue Napierala	Impact Research & Development Organization, University of North Carolina, Chapel Hill, University of Pennsylvania

Country where clinical trial is conducted

Kenya, 

References & Publications (4)

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. — View Citation

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. — View Citation

Thirumurthy H, Bair EF, Ochwal P, Marcus N, Putt M, Maman S, Napierala S, Agot K. The effect of providing women sustained access to HIV self-tests on male partner testing, couples testing, and HIV incidence in Kenya: a cluster-randomised trial. Lancet HIV. 2021 Dec;8(12):e736-e746. doi: 10.1016/S2352-3018(21)00248-4. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HIV case diagnoses	The test positivity rate at the clinic (proportion of men who obtain an HIV-positive result) within the intervention versus control period.	3 months
Secondary	ART and PrEP initiation	The count of adult men from each cluster who initiated ART or PrEP at the clinic within the intervention versus control period.	3 months