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

HIV Self-testing for Partners of HIV-uninfected Postpartum Women to Facilitate PrEP and Antiretroviral Therapy Uptake to Promote HIV Treatment and Prevention

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.

Study Overview

• Status: Recruiting
• Conditions: Feasibility; HIV Prevention; PrEP Uptake; Acceptability; HIV Self-testing; Male Partners of HIV-negative Postpartum Women
• Intervention / Treatment: Behavioral: HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa
      • Recruiting
      • Wits MatCH Research Unit
      • Contact: Jenni Smith, PhD; Phone Number: +27 31 001 1915; Email: jsmit@mru.ac.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: H4P Intervention Arm; 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").; 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".
Placebo Comparator: Control Arm; 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").; 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate PrEP uptake among female participants	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.	3-month follow-up
HIV and Pregnancy characteristics	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.	Baseline and 3-month follow-up
Physical health	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.	Baseline and 3-month follow-up
Depression	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.	Baseline and 3-month follow-up
Substance Use	Addiction Severity Index-Lite: Assesses lifetime and recent substance use, including severity. Up to 111 items; previously used in South Africa.	Baseline and 3-month follow-up
Health beliefs	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.	Baseline
Relationship characteristics and communication	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.	Baseline and 3-month follow-up
Partner Violence	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	Baseline and 3-month follow-up
HIV-related stigma	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).	Baseline and 3-month follow-up
Structural barriers	Modes and costs of transportation to travel to clinic, travel time to clinic visits, and the average amount of time spent at the clinic.	Baseline and 3-month follow-up
Demographics	Age; ethnicity; country of origin; educational level; employment status; occupation; income; religion; housing stability; with whom participant lives.	Baseline

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): August 28, 2026

Study Registration Dates

• First Submitted: September 11, 2025
• First Submitted That Met QC Criteria: September 18, 2025
• First Posted (Actual): September 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PrEP; HIV Prevention; HIV Self-Testing
• Other Study ID Numbers: 2025P002271; R34MH132446 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No