HIV Self-testing for Partners of HIV-uninfected Postpartum Women
Recruiting · NCT07194902 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 is running
1 location listed.
- Wits MatCH Research Unit - Durban, KwaZulu-Natal, South Africa