The primary objective of the Men for Health + (from Portuguese Homens Para a Saúde +: HoPS+) project is to develop and assess the impact of a partner-based antiretroviral delivery intervention among HIV+ expectant couples. The first objective is to implement, monitor, and evaluate the effect of couples-based services on HIV-related outcomes for the three members of the mother-male-partner-infant triad from the first antenatal care visit to 18 months postpartum through a clustered randomized controlled trial (CRT). The primary outcome is 12-month retention among female and male partners enrolled in the study with a secondary focus on viral suppression among HIV+ pregnant/lactating women and their HIV+ male partners at 18 months, early acceptance of infant diagnostic services, and vertical transmission among infants at 18 months. The hypothesis is that couples who participate in and receive HIV care services together will have greater retention in HIV treatment and improved viral suppression, with greater uptake of early childhood diagnosis and less mother-to-child transmission at the end of breastfeeding. The second objective is to investigate the intervention's impact on hypotheses-changing mechanisms, including (1) social support from partners; (2) HIV stigma; (3) relationship empathy; (4) knowledge of HIV; (5) patient trust in the provider; and depression, through quantitative surveys of participants at baseline and at 6 months. For the tertiary objective, validated simulation models will be used to assess the cost-effectiveness of the HoPS+ intervention, accounting for clinical and economic outcomes among pregnant and lactating women, their male partners, and their infants.
The study started in October 2017, with recruitment activities and the training of the team. The team comprises 24 health counselors, six study assistants, a study coordinator, and a statistician based in Zambézia province. Twenty-two experienced couples were recruited from 12 intervention study sites, which were responsible for supporting the study couples. 1,080 couples (out of the planned total of 1,080) were enrolled in the study. During 2020, we completed the recruitment of our participants and began conducting qualitative interviews with patients and healthcare professionals to get their opinions on the intervention.
The study design arose from the identification of many serodiscordant couples during recruitment to the HOPS+ study. The main objective of this study is to develop and evaluate the effect of a narrative intervention on the acceptance and adherence of PrEP in pregnant women.
The team completed a qualitative study in the first phase. Twenty HIV-negative people in a serodiscordant relationship and who have ever started PrEP were interviewed. We wanted to know more about their attitudes towards PrEP use, their experience with medication use, their partners' attitudes towards it, and any barriers they faced in adhering to treatment. We used these interviews to create three stories designed to educate, motivate, and provide strategies for future discordant couples starting PrEP/ART to help them adhere to treatment. In a second phase, a randomized controlled trial was designed and approved, to evaluate the effect of the narrative intervention on the acceptance and adherence to PrEP. The training of the study team was done in December 2020. 2021 is the last year of this cohort study.