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

NCT07194902 | Recruiting DMC

• 2 other identifiers: 2025P002271R34MH132446
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HIV Prevention; PrEP; HIV Self-Testing

Outcome Measures

Primary Outcomes (5)

• Feasibility of intervention

  To evaluate feasibility, the investigators will examine and report on (1) the number of participants (female and male) screened, eligible, and enrolled (whether \> 70% of those screened enroll/agree to participate); (2) the number of female participants who distribute a kit to their male partner; the number of female participants who learn their male partner's status; and the number of male partners who use the kit, complete HIVST verification, use the QR code, and complete confirmatory testing.

  Baseline and 3-month follow-up

• Acceptability

  Acceptability will be evaluated using the Client Satisfaction Questionnaire (CSQ8). The investigators will also record data on reasons for declining enrollment, and will document failure to distribute or use the kit, complete verification, and complete confirmatory testing. All qualitative exit interview data will be explored for categories and themes around intervention acceptability. Qualitative data will be analyzed using content analysis, an iterative, multi-step process as described by Miles and Huberman and Strauss and Corbin.

  Post-Intervention

• Safety concerns as a result of HIVST distribution

  Safety will be evaluated via self-report of any safety concerns anticipated or experienced as a result of HIVST distribution including social, emotional, or physical harms. Female participants will be screened for partner violence (Abuse Assessment Screen) at baseline. If female participants report being a victim of violence, study staff will contact the local site PI/Co-PI (Smit/Mosery) and an appropriate clinical intervention will be delivered. Participants with elevated scores will be provided with a referral for mental health services, using referral systems that are already in place in Dr. Psaros' R01 (R01MH112385) and will be asked to not distribute the kits but stay in the study, as they might benefit from the intervention session. This will also be explored in qualitative interviews (as described above).

  Baseline and 3-month follow-up

• Preliminary effectiveness of H4P intervention.

  Women: Preliminary effectiveness: Proportion of women whose male partners test positive or do not test/share result who initiate and use PrEP at 3 months postpartum, via self-report, and point of care test for tenofovir, via urine dipstick test which reflects use in the past few days. Men: Preliminary effectiveness: Proportion of men with a positive test who link to care, via self-report and paper test result or CD4/viral load result from confirmatory testing, and copy of treatment regimen (or photographs of these documents).

  3-month follow-up

• Challenges, successes, barriers, facilitators, and preferences for optimizing H4P intervention.

  Qualitative exit interviews: Conducted with subsets of women and men assigned to the H4P intervention arm (based on HIV self-test kit distribution, kit use, and linkage) to explore challenges (including gender-based violence), successes, barriers (e.g., motivation to test for HIV during the postpartum period for men), facilitators, preferences around HIV self-test kit distribution (including use of Quick Response codes), HIV self-testing verification, confirmatory testing and verification, and linkage to care (e.g., PrEP or Antiretroviral Therapy, including how women decided to initiate PrEP, and experiences with PrEP linkage and clinic support around PrEP use), and opportunities to optimize the H4P intervention.

  3-month follow-up

Secondary Outcomes (11)

• Estimate PrEP uptake among female participants

  3-month follow-up

• HIV and Pregnancy characteristics

  Baseline and 3-month follow-up

• Physical health

  Baseline and 3-month follow-up

• Depression

  Baseline and 3-month follow-up

• Substance Use

  Baseline and 3-month follow-up

Study Arms (2)

H4P Intervention Arm

ACTIVE COMPARATOR

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).

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

Control Arm

PLACEBO COMPARATOR

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.

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

Interventions

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

For female participants, the intervention includes a 30-45 minute counseling session that will cover (1) SOC PrEP information, (2) communications skills training for HIVST kit distribution, (3) Motivational interviewing strategies (e.g., PrEP/HIVST pros/cons), (4) problem-solving barriers to PrEP uptake or HIVST distribution, (5) linkage enablers (e.g., care sites, transportation, asking questions of providers). For their male partners, an informative video will cover geographically diverse HIV treatment resources, as well as on why linkage to HIV care is needed in the context of the relationship with his female partner and gender norms. The video will also demonstrate a brief motivational exercise whereby men are asked to consider the pros and cons of linking to HIV care versus not (with examples), as well as a step-by-step guide to generate a concrete plan for linkage to care based on "linkage enablers".

Control Arm; H4P Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Wits MatCH Research Unit

Durban, KwaZulu-Natal, South Africa

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Behavioral Medicine Program, Department of Psychiatry

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 26, 2025
• Study Start: March 19, 2026
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): August 28, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

ZA (1)