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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07194902
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Study Start: 2025-12-01
• Primary Completion: 2026-08-28
• Study Completion: 2026-08-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility	Baseline and 3-month follow-up	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.
Acceptability	Post-Intervention	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.
Safety concerns as a result of HIVST distribution	Baseline and 3-month follow-up	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).
Preliminary effectiveness of H4P intervention.	3-month follow-up	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).
Challenges, successes, barriers, facilitators, and preferences for optimizing H4P intervention.	3-month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Structural barriers	Baseline and 3-month follow-up	Modes and costs of transportation to travel to clinic, travel time to clinic visits, and the average amount of time spent at the clinic.
Demographics	Baseline	Age; ethnicity; country of origin; educational level; employment status; occupation; income; religion; housing stability; with whom participant lives.
Substance Use	Baseline and 3-month follow-up	Addiction Severity Index-Lite: Assesses lifetime and recent substance use, including severity. Up to 111 items; previously used in South Africa.
Estimate PrEP uptake among female participants	3-month follow-up	The investigators will estimate PrEP uptake among female participants in a separate logistic regression model, adjusting for covariates carefully given the feasibility/acceptability design and small N.
HIV and Pregnancy characteristics	Baseline and 3-month follow-up	Women: Results of HIV tests (3-month follow-up only); gravity, parity, number of weeks gestation when enrolled in Antenatal Care, ever offered PrEP, ever used PrEP, ever completed couples based counseling and testing. Pregnancy intention: Pregnancy Risk Assessment Monitoring System survey: Up to 4 items assessing attitudes and feelings about the most recent pregnancy.; Men: Date of last HIV test, ever completed couples-based counseling and testing, history of prior positive test (and date), whether currently taking Antiretroviral Therapy, and number of children. Referent pregnancy intention: Pregnancy Risk Assessment Monitoring System survey.
Physical health	Baseline and 3-month follow-up	Multi-Country Study on Women's Health and Violence Core Questionnaire Version 9: 43-item General Health section to measure overall health status and physical symptoms.
Health beliefs	Baseline	Women: Perceived Risk of HIV Infection Scale: 8-item measure of how people perceive their personal risk of HIV. Validated with women in Sub-Saharan Africa. PrEP Optimism: 3 items to assess beliefs about PrEP efficacy in preventing HIV. Items used among HIV-uninfected pregnant women and heterosexual couples in South Africa. Men: Antiretroviral Therapy treatment beliefs: Beliefs about Medicines Questionnaire: Two five-item scales assessing beliefs about the necessity of and concerns about taking prescribed medication. Used in Sub-Saharan Africa.
HIV-related stigma	Baseline and 3-month follow-up	Personal Stigma and Attributed Stigma Scales: parallel 17-item scales to measure personal stigmatizing views about HIV and stigma attributed to others. Both scales validated among HIV-uninfected women in South Africa.; PrEP Use Stigma Scale: 6-item scale measuring internalized stigma related to HIV and PrEP use, adapted for use among young women in Zimbabwe and South Africa (Cronbach's alpha: 0.89).
Depression	Baseline and 3-month follow-up	Women: Edinburgh Postnatal Depression Scale: 10-item scale widely used and validated in South Africa among both pregnant and postpartum women.; Men: Center for Epidemiologic Studies Depression scale: 20-item measure of depressive symptoms. High internal consistency; widely used in South Africa.
Relationship characteristics and communication	Baseline and 3-month follow-up	Partner Communication Scale: 5-item measure of sexual communication between partners around condom use, HIV/STI prevention, pregnancy, and sexual history. Internal consistency has been established. Dyadic Trust Scale: 8- item measures of trust in close relationships. Used and validated in South Africa and other resource-limited settings. Gender-Equitable Men Scale: 24-item measure of attitudes towards gender relations. Used and validated among women in South Africa and other resource-limited settings. Sexual Relationship Power Scale: 23-item measure of decision-making dominance and relationship control. Validated among women in South Africa. Duration of relationship will be assessed.
Partner Violence	Baseline and 3-month follow-up	Women: Abuse Assessment Screen: 5-item measure of presence of violence in the last year. Clinical assessment conducted if answer is "yes" to ≥1 questions. Widely used among those who are pregnant and validated among pregnant women in resource-limited settings

Trial Locations

Locations (1)

Wits MatCH Research Unit; 🇿🇦 Durban, KwaZulu-Natal, South Africa