HIV Self-testing for Partners of HIV-uninfected Postpartum Women (NCT07194902) | Clinical Trial Compass
RecruitingNot Applicable
HIV Self-testing for Partners of HIV-uninfected Postpartum Women
South Africa120 participantsStarted 2026-03-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Exclusion Criteria: Individuals with significant psychiatric illness that could interfere with participation or the ability to provide informed consent will be excluded at the discretion of the study team.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of intervention
Timeframe: Baseline and 3-month follow-up
2
Acceptability
Timeframe: Post-Intervention
3
Safety concerns as a result of HIVST distribution
Timeframe: Baseline and 3-month follow-up
4
Preliminary effectiveness of H4P intervention.
Timeframe: 3-month follow-up
5
Challenges, successes, barriers, facilitators, and preferences for optimizing H4P intervention.