NCT07194902Recruiting
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
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 11 Sept 2025
- Start date
- Mar 2026
- Primary completion date
- Aug 2026
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- HIV
- NCT number
- NCT07194902
What you commit to
- Study type: Interventional
- Planned participants: 120
- From Mar 2026 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Female Inclusion Criteria:
- woman
- Age ≥18
- ≥30 weeks pregnant per medical record due date
- non-reactive third trimester HIV test (verified from their antenatal care chart)
- reporting at least one unknown-serostatus partner
- fluent in English or isiZulu
- willing to give researchers permission to contact them for repeated assessments
- able to provide informed consent
- Male Inclusion Criteria: partners meeting the inclusion criteria as described above, and who complete verification questions to confirm their identity and status as the partners of the enrolled female participants. Additional inclusion criteria for men include:
- man
- Age ≥18
- partner of enrolled women, confirmed via couples verification tool
- fluent in English or isiZulu
- willing to give researchers permission to contact them
- able to provide informed consent.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wits MatCH Research Unit Coordinator of this site? Confirm its status | Durban | South Africa | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.