NCT07194902

HIV Self-testing for Partners of HIV-uninfected Postpartum Women

HIV Self-testing for Partners of HIV-uninfected Postpartum Women to Facilitate PrEP and Antiretroviral Therapy Uptake to Promote HIV Treatment and Prevention

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to test the feasibility and acceptability of a combination intervention to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). H4P includes evidence-based cognitive behavioral therapy (CBT) strategies, such as communication skills training, motivational interviewing, and problem-solving. The investigators will conduct a randomized pilot trial of the H4P intervention to evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-step PrEP uptake and HIV self-test kit intervention for postpartum HIV-uninfected women (N = 60 and their male partners) who report a partner of unknown serostatus, and their partners, in the province of KwaZulu-Natal, South Africa.

Conditions

• HIV Self-testing
• Male Partners of HIV-negative Postpartum Women
• PrEP Uptake
• Feasibility
• Acceptability
• HIV Prevention

Interventions

Type	Name	Description
BEHAVIORAL	HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").	For female participants, the intervention includes a 30-45 minute counseling session that will cover (1) SOC PrEP information, (2) communications skills training for HIVST kit distribution, (3) Motivational interviewing strategies (e.g., PrEP/HIVST pros/cons), (4) problem-solving barriers to PrEP uptake or HIVST distribution, (5) linkage enablers (e.g., care sites, transportation, asking questions of providers). For their male partners, an informative video will cover geographically diverse HIV treatment resources, as well as on why linkage to HIV care is needed in the context of the relationship with his female partner and gender norms. The video will also demonstrate a brief motivational exercise whereby men are asked to consider the pros and cons of linking to HIV care versus not (with examples), as well as a step-by-step guide to generate a concrete plan for linkage to care based on "linkage enablers".

Timeline

• Start date: 2026-03-19
• Primary completion: 2026-08-28
• Completion: 2026-08-28
• First posted: 2025-09-26
• Last updated: 2026-03-23

Locations

1 site across 1 country: South Africa