Supporting Treatment for Anti-Retroviral Therapy (START) together: protocol for a pilot, randomized, couple-based intervention to promote women's ART adherence and men's engagement in HIV care in KwaZulu-Natal, South Africa

Background: South Africa currently has the greatest number of people with HIV globally. The country has not yet met its 95-95-95 goals, with different gaps in the HIV care cascade for women and men. This paper reports on a protocol to pilot test a couple-based intervention designed to improve women's antiretroviral therapy (ART) adherence and men's engagement in care in heterosexual couples living in the Vulindlela area of KwaZulu-Natal, South Africa. Study goals are two-fold: (1) assess the acceptability, feasibility, and fidelity of the experimental intervention, START Together, and (2) collect efficacy data on START Together for women's ART adherence, men's engagement in HIV care, and the couple's relationship functioning. Methods: Women (N = 20) who were not engaged with ART adherence (defined via self-reported ART difficulties, record of missed clinic visits, or viral non-suppression) are the target patients; male partners are not required to know or disclose their HIV status to be part of the study. Couples are randomized 1:1 to the experimental treatment (START Together) or treatment as usual (referrals to the local clinic to support ART adherence or any other HIV-related care). START Together is a 5-session intervention based in cognitive-behavioral couple therapy, which is a skill-based intervention focusing on communication and problem-solving skills, and Life Steps, a problem-solving intervention identifying barriers and solutions to medication adherence. Couples are assessed at baseline, post-treatment (8 weeks post-randomization), and follow-up (12 weeks post-randomization). Conclusion: This study will provide preliminary implementation and efficacy data on whether this novel approach has potential to improve women and men's HIV and healthcare-related needs.