A counseling intervention to address HIV stigma at entry into antenatal care in Tanzania (Maisha): study protocol for a pilot randomized controlled trial.

BACKGROUND: HIV-related stigma significantly impacts HIV care engagement, including in prevention of mother-to-child transmission of HIV (PMTCT) programs. Maisha is a stigma-based counseling intervention delivered during the first antenatal care (ANC) visit, complementing routine HIV counseling and testing. The goal of Maisha is to promote readiness to initiate and sustain treatment among those who are HIV-positive, and to reduce HIV stigmatizing attitudes among those who test negative. METHODS: A pilot randomized control trial will assess the feasibility and acceptability of delivering Maisha in a clinical setting, and the potential efficacy of the intervention on HIV care engagement outcomes (for HIV-positive participants) and HIV stigma constructs (for all participants). A total of 1000 women and approximately 700 male partners will be recruited from two study clinics in the Moshi municipality of Tanzania. Participants will be enrolled at their first ANC visit, prior to HIV testing. It is estimated that 50 women (5%) will be identified as HIV-positive. Following consent and a baseline survey, participants will be randomly assigned to either the control (standard of care) or the Maisha intervention. The Maisha intervention includes a video and counseling session prior to HIV testing, and two additional counseling sessions if the participant tests positive for HIV or has an established HIV diagnosis. A subset of approximately 500 enrolled participants (all HIV-positive participants, and a random selection of HIV-negative participants who have elevated stigma attitude scores) will complete a follow-up assessment at 3 months. Measures will include health outcomes (care engagement, antiretroviral adherence, depression) and HIV stigma outcomes. Quality assurance data will be collected and the feasibility and acceptability of the intervention will be described. Statistical analysis will examine potential differences between conditions in health outcomes and stigma measures, stratified by HIV status. DISCUSSION: ANC provides a unique and important entry point to address HIV stigma. Interventions are needed to improve retention in PMTCT care and to improve community attitudes toward people living with HIV. Results of the Maisha pilot trial will be used to generate parameter estimates and potential ranges of values to estimate power for a full cluster-randomized trial in PMTCT settings, with extended follow-up and enhanced adherence measurement using a biomarker.

HIV Community-Level Stigmatizing Attitudes in Tanzania: Perspectives from Antenatal Care

Introduction: Stigma significantly impacts retention in HIV care and quality of life among people living with HIV. This study explored community-level HIV stigma from the perspective of patients and healthcare workers in antenatal care (ANC) in Moshi, Tanzania.Methods: We conducted in-depth interviews with 32 women (20 living with HIV), key-informant interviews with 7 ANC clinic employees, and two focus group discussions with 13 community health workers.Results: Themes emerged related to drivers and manifestations of stigma, resilience to stigmatizing attitudes, and opportunities to address stigma in ANC. Drivers of stigma included a fear of infection through social contact and associations of HIV with physical weakness (e.g., death, sickness) and immoral behaviour (e.g., sexual promiscuity). Manifestations included gossip, physical and social isolation, and changes in intimate relationships. At the same time, participants identified people who were resilient to stigmatizing attitudes, most notably individuals who worked in healthcare, family members with relevant life experiences, and some supportive male partners.Conclusion/Recommendations: Supportive family members, partners, and healthcare workers can serve as role models for stigma-resilient behaviour through communication platforms and peer programs in ANC. Manifestations of HIV stigma show clear links to constructs of sexuality, gender, and masculinity, which may be particularly impactful during pregnancy care. The persistence of stigma emphasizes the need for innovation in addressing stigmatizing attitudes in the community. Campaigns and policies should go beyond dispelling myths about HIV transmission and immorality to innovate peer-led and couples-based stigma reduction programming in the ANC spac

MASI, a Smartphone App to Improve Treatment Adherence Among South African Adolescents and Young Adults With HIV: Protocol for a Pilot Randomized Controlled Trial

BackgroundAdolescents and young adults with HIV repeatedly demonstrate low rates of antiretroviral therapy (ART) adherence as well as low rates of viral suppression. Digital health interventions are a promising way to engage adolescents and young adults with HIV to support ART adherence. However, few digital health interventions have been developed and tested with adolescents and young adults in countries like South Africa, where the HIV burden among adolescents and young adults is greatest. Masakhane Siphucule Impilo Yethu (MASI; Xhosa for “Let's empower each other and improve our health”) is a comprehensive ART adherence-supporting app for South African adolescents and young adults with HIV. It was culturally adapted using the HealthMpowerment platform. ObjectiveThe aim of this paper is to describe the protocol for a pilot randomized controlled trial examining the feasibility, acceptability, and preliminary efficacy of MASI on self-reported ART adherence and social support. MethodsWe will enroll 50 adolescents and young adults with HIV ages 15-21 years. Participants will be recruited from public ART clinics linked to a large government-funded teaching hospital in Cape Town, South Africa. Participants will be randomized 1:1 into either the intervention arm receiving a full version of MASI or the control arm receiving an information-only version of the app (n=25 per arm). Participants will be asked to engage with MASI daily for 6 months. All participants will complete baseline and follow-up assessments at 3 and 6 months. ResultsStudy screening began in May 2022 and the first participant was enrolled on June 21, 2022. As of June 12, 2023, 81 participants have completed screeners, and 36 eligible participants have been enrolled in the pilot randomized controlled trial. Recruitment is anticipated to last through August 31, 2023, with study activities anticipated through February 29, 2024. ConclusionsThere is an urgent need for innovative interventions to improve ART adherence among adolescents and young adults in settings like South Africa. If found to be feasible and acceptable, MASI could be implemented with adolescents and young adults with HIV in other parts of the country. Trial RegistrationClinicalTrials.gov NCT04661878; https://clinicaltrials.gov/ct2/show/study/NCT04661878 International Registered Report Identifier (IRRID)DERR1-10.2196/4713