Partner HIV self-testing kits plus PrEP support for HIV-negative new mothers
Official title: HIV Self-testing for Partners of HIV-uninfected Postpartum Women to Facilitate PrEP and Antiretroviral Therapy Uptake to Promote HIV Treatment and Prevention
Run by Massachusetts General Hospital · NCT07194902 · Data updated 2026-11-12
This pilot will try giving partner HIV self-test kits plus counseling to help HIV-negative pregnant or postpartum women and their male partners in KwaZulu-Natal use HIV self-testing and start PrEP when needed.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Durban, KwaZulu-Natal) |
| Status | Recruiting |
| Started | March 19, 2026 |
| Main results expected | August 28, 2026 |
| Study ends | August 28, 2026 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT07194902 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are HIV-negative pregnant or postpartum women aged 18 or older who report at least one partner of unknown HIV status (and their adult male partners), are able to consent, and speak English or isiZulu.
✕Probably not a fit
People unlikely to benefit include those whose partners’ HIV status is already known (especially known positive or already on PrEP), individuals unable to provide informed consent, or those with significant psychiatric illness that prevents participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will run a randomized pilot trial of a combination intervention (called H4P) that packages partner HIV self-test kits with cognitive behavioral strategies such as communication skills training, motivational interviewing, and problem-solving to promote PrEP uptake. The trial will enroll about 60 HIV-uninfected pregnant or postpartum women who report at least one partner of unknown HIV status, plus their male partners, in KwaZulu-Natal, South Africa. The primary aims are to test feasibility and acceptability and to gather preliminary data on whether the approach increases partner testing and PrEP initiation. Participants must be able to consent and speak English or isiZulu, and men are confirmed as partners through a verification tool.
Why it matters
Potential benefit: If successful, the approach could increase partner HIV testing and PrEP uptake among HIV-negative new mothers, reducing the risk of HIV transmission to women and their partners.
How similar studies have gone: Previous research has shown that partner-delivered HIV self-testing and counseling approaches can increase partner testing and uptake of prevention services, though this specific multi-step H4P combination approach is a smaller pilot and less widely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Wits MatCH Research Unit
Durban, KwaZulu-Natal, South Africa Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.