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.
woman
Age ≥18
≥30 weeks pregnant per medical record due date
non-reactive third trimester HIV test (verified from their antenatal care chart)
None
Parallel
HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").
BehavioralFor 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".
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.
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.
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).
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).
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.
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.
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.
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.
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Massachusetts General Hospital
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
