HIV Self-testing for Partners of HIV-uninfected Postpartum Women

Mass General Brigham

Status: Not yet enrolling

Conditions: Acceptability; PrEP Uptake; Feasibility; HIV Prevention; HIV Self-testing; Male Partners of HIV-negative Postpartum Women

Treatments: Behavioral: HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07194902

2025P002271

R34MH132446 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

H4P Intervention Arm

Active Comparator group

Description:

At one of their last scheduled antenatal care visits (i.e., between 30- 40 weeks' gestation), all female participants will be provided with up to three HIVST kits for male partner distribution, and will be provided with information and a demonstration per the standard of care (SOC) for HIVST kit distribution. In addition to what female participants in the control arm engage in, they will engage in 30-45 minutes HIVST and PrEP uptake counseling intervention at the baseline visit. Male partners, in addition to the SOC written information provided to the control arm, will also receive a QR code linked to a brief video created by the study team. The video will communicate, among other things, information on geographically diverse HIV treatment resources, and why linkage to HIV care is needed in the context of the relationship (e.g., increased risk for HIV during the postpartum period, risk of transmission to infant during breastfeeding, his role in protecting the family's health).

Treatment:

Behavioral: HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").

Control Arm

Placebo Comparator group

Description:

At one of their last scheduled antenatal care visits (i.e., between 30- 40 weeks' gestation), all female participants will be provided with up to three HIVST kits for male partner distribution, and will receive 15-20 minutes of counseling. Female participants will receive OraQuick Rapid HIV-1/2 Antibody Tests. OraQuick kits will include step-by-step instructions on use and interpretation of results. All female participants will be provided with information and a demonstration per the standard of care (SOC) for HIVST kit distribution and will engage in a brief exercise that involves evaluating the pros and cons of offering HIVST kits to their partners. All men will be provided with the HIVST kit by their female partners (including directions for use, consistent with SOC), along with a letter describing how to contact the study team.

Treatment:

Behavioral: HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").