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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV
• Intervention / Treatment: Device: HIV self-testing; Behavioral: Behavioral economic 'nudges'

Detailed 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 cluster-randomized 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 receive the secondary distribution intervention or standard of care. In intervention clusters, 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.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sue Napierala, PhD, MPH; Phone Number: 5104188198; Email: snapierala@rti.org

Study Locations

• Kenya
  • Kisumu, Kenya
    • Impact Research and Development Organization (IRDO)
    • Principal Investigator: Kawango Agot, PhD, MPH
    • Contact: Kawango Agot, PhD, MPH; Phone Number: +254 736 505046; Email: kawango@impact-rdo.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIV self-test secondary distribution; The investigators will provide women who sell sex enrolled in the intervention arm 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; 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
No Intervention: Usual care; No intervention, usual care provided at clinics in control communities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV testing	The count of adult men from intervention versus control clusters who completed an HIV test at the clinic within the 5-month intervention period.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV case diagnoses	The test positivity rate at the clinic (proportion of men who obtain an HIV-positive result) from intervention versus control clusters within the 5-month intervention period.	5 months
ART and PrEP initiation	The count of adult men from intervention versus control clusters who initiated ART or PrEP at the clinic within the 5-month intervention period.	5 months

Collaborators and Investigators

• Sponsor: Sue Napierala
• Collaborators: University of Pennsylvania; University of North Carolina, Chapel Hill; Impact Research & Development Organization
• Investigators: Principal Investigator: Sue Napierala, PhD, MPH, RTI International

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 29, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 26, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: HIV; Self-testing; Secondary distribution; Men who pay for sex; Women who sell sex
• Other Study ID Numbers: 0218622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No