The primary goal of the Men for Health+ (Homens Para a Saúde+ [HoPS+] in Portuguese) project is to develop and assess the impact of a partner-based antiretroviral delivery intervention among expectant couples living with HIV.
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. The primary outcome is the 12-month retention rate among female and male partners enrolled in the study with a secondary focus on viral suppression at 18 months among pregnant and lactating women living with HIV and their male partners living with HIV, early acceptance of infant diagnostic services, and rates of vertical transmission of HIV 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 infant diagnosis and lower rates of vertical transmission at the end of the breastfeeding period.
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 health care provider; and (6) depression, through quantitative surveys of participants at baseline and at 6 and 18 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 began in October 2017 with training of the team. The team comprises 24 health counselors, six study assistants, a study coordinator, and a data manager based in Zambézia Province.
Twenty-two experienced couples were recruited from 12 intervention study sites and served in a peer support role by providing community-based information sessions and support to the study couples enrolled in the intervention group. Recruitment began in November 2017 and concluded in December 2020, and data collection for all study participants was completed in June 2022. In total, 1,079 couples, i.e., 2,158 participants (out of the planned total of 1,080 couples) were consented and enrolled in the study.
During the study period, 2,685 counseling sessions and 3,761 support sessions were held in the 12 intervention sites. A total of 2,127 (98.5%) first participant surveys (1,070 women, 1057 men), 100 in-depth interviews with health care providers working at study sites, and 64 in-depth interviews with intervention couples were administered. The participants' clinical files were reviewed for manual collection of some variables.
Qualitative data were analyzed in 2021-2022 and preliminary results were presented at the international INTEREST 2023 scientific conference in May 2023. The final results of the impact analysis on clinical service retention and cost-efficiency will be released as soon as they are available.
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 of and adherence to pre-exposure prophylaxis (PrEP) among seronegative 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 and/or antiretroviral treatment (ART) to help them adhere to respective therapies.
In a second phase, a randomized controlled trial was designed and approved in mid-2020 to evaluate the effect of the narrative intervention on the acceptance of and adherence to PrEP among seronegative pregnant and lactating women with male partners living with HIV. The training of the study team took place in December 2020. Recruitment began in January 2021 and concluded in September 2022, and data collection for all study participants was completed in December 2022.
In total, 64 couples, i.e., 128 participants (out of the planned total of 70 couples) were consented and enrolled in the study. During the study period, 81 story narration sessions (82% of planned) were provided to couples enrolled in the intervention group; 144 urine tests to measure tenofovir (PrEP) amounts were completed (47/64 women providing samples in the first month, 39/64 women providing samples in the second month, and 39/64 women providing samples in the third month; a total of 128 (100%) first participant surveys (64 women, 64 men), 92 (72%) second participant surveys (45 women, 47 men) were administered; and 29 in-depth interviews with participants in the intervention group were conducted. The participants' clinical files were reviewed for manual collection of some variables.
Qualitative data were analyzed in 2022 and a manuscript with results was developed and currently pending journal outcome. Findings from the analysis of the impact of the intervention on clinical outcomes, specifically medication adherence and retention in PrEP/ART services, will be released as soon as they are available.