HIV self-testing for partners of postpartum women to facilitate HIV pre-exposure prophylaxis and antiretroviral therapy uptake: a protocol to adapt and pilot an intervention via a pilot randomised controlled trial in South Africa

Abstract

Introduction: South African women are vulnerable to HIV acquisition during the postpartum period which can result in perinatal transmission via breastfeeding; many male partners do not know their HIV status. Biomedical approaches to preventing HIV for postpartum women include pre-exposure prophylaxis (PrEP) and antiretroviral treatment for male partners with HIV. Gaps in implementation include low uptake of PrEP among postpartum women and infrequent testing of men who may be motivated to test for HIV to protect the health of their infant.

Methods and analysis: We will conduct a randomised pilot trial in KwaZulu-Natal (KZN) Province, South Africa among postpartum women and their male partners. The study will pilot a combination intervention consisting of cognitive behavioural strategies (including communication skills training, motivational interviewing and problem-solving) to promote H IV self-testing (HIVST) for P artners and P rEP uptake for HIV-uninfected P ost p artum Women, the 'H4P' intervention. The study aims to determine the feasibility, acceptability and preliminary effectiveness of the H4P intervention. We will enrol 60 HIV-uninfected women, aged 18 years and older, in their third trimester of pregnancy and reporting a partner whose HIV-serostatus is unknown. Sixty male partners will also be eligible to enrol. Enrolled women will receive three oral HIVST kits to distribute to their male partners and standard of care information on HIVST and PrEP. Women randomised to the intervention arm will receive additional counselling and reproductive health-centred HIVST information for the male partner, including information about why HIV testing is important during their partners' postpartum period. To evaluate feasibility, we will calculate screening-to-enrolment ratios for women and men, the number of women who distribute HIVST kits to their male partners and the number of men who test. Acceptability will be evaluated using the Client Satisfaction Questionnaire and qualitative interviews. Effectiveness will be assessed at 3 months by measuring the proportion of women initiating PrEP via self-report and urine tenofovir measurements or receipt of injectable PrEP and the proportion of men who test positive who link to HIV care. Qualitative interviews will explore perceptions of the intervention.

Ethics and dissemination: Ethics approval for this study was obtained from the Human Research Ethics Committee at The University of the Witwatersrand, Johannesburg, South Africa (Reference number: 250612) and the Institutional Review Boards at Massachusetts General Brigham (2025P002271, Boston, Massachusetts, USA) and the University of Alabama at Birmingham (300015167, Birmingham, Alabama, USA) in the USA. Site support and approvals were obtained from the health facility and the KwaZulu-Natal Provincial Department of Health. Results will be disseminated through peer-reviewed manuscripts, reports and both local and international presentations.

Trial registration number: NCT07194902.

Keywords: Feasibility Studies; HIV & AIDS; PUBLIC HEALTH; Preventive Health Services; Randomized Controlled Trial.