NCT07194902 HIV Self-testing for Partners of HIV-uninfected Postpartum Women
| NCT ID | NCT07194902 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | HIV Self-testing |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2026-08-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-03-19 with a primary completion date of 2026-08-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT07194902 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV Self-testing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07194902 currently recruiting?
Yes, NCT07194902 is actively recruiting participants. Visit ClinicalTrials.gov or contact Massachusetts General Hospital to inquire about joining.
Where is the NCT07194902 trial being conducted?
This trial is being conducted at Durban, South Africa.
Who is sponsoring the NCT07194902 clinical trial?
NCT07194902 is sponsored by Massachusetts General Hospital. The trial plans to enroll 120 participants.
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