A stigma reduction intervention at time of entry into antenatal care to improve PMTCT services in Tanzania

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PROJECT SUMMARY Antenatal care (ANC) provides a unique and important entry point to address HIV stigma. Stigma-based counseling during the first ANC visit can promote readiness to initiate and sustain treatment among those who are HIV infected, and can address stigmatizing attitudes and behaviors among those who are HIV uninfected. With this application, we are proposing to develop and pilot test a brief, scalable intervention called Maisha (Swahili for life), to address HIV stigma for women presenting to ANC in Tanzania. The intervention will include: 1) a video and brief counseling that addresses HIV stigma at the start of the ANC visit (prior to HIV testing), and 2) two stigma-based counseling sessions for women who are HIV infected, building on the video content to provide emotional support, promote acceptance, address stigma, and reinforce care engagement. The primary intervention outcome is early engagement in PMTCT care among women who are HIV infected. We will also examine HIV stigma outcomes (enacted, anticipated, internalized) among all groups of women, including women who are already established on ART and women who are HIV uninfected. The intervention content is based on principles of cognitive-behavioral therapy (addressing automatic negative thoughts about the self, future and the world) to address and mitigate multiple forms of HIV stigma (internalized, anticipated and enacted). The study has three aims: 1) to develop Maisha to address stigma during ANC, 2) to establish the methodological protocol for the evaluation of Maisha in a clinical setting, and 3) to pilot test Maisha to determine feasibility and acceptability in a PMTCT care setting and explore potential for impact on early PMTCT care engagement, HIV disclosure, and stigma. For Aims 1 & 2, we will use multiple qualitative methods with a variety of stakeholders and clinical observations, as well as cognitive interviews to refine our stigma measures. For Aim 3, we will conduct a pilot RCT of the intervention, enrolling all women who attend a first ANC appointment at two clinics in the Moshi district. Maisha will be compared to the standard of HIV counseling without the focus on stigma. In addition to a baseline assessment, all women who are identified as HIV-infected (n=25 intervention, 25 control) and a subset of women who are identified as HIV-uninfected (n=50 intervention, 50 control) will get a 3-month assessment. Measures will include health outcomes (care engagement, adherence, depression) and stigma outcomes including HIV disclosure. Quality assurance data will be collected and the feasibility and acceptability of the intervention and RCT will be described. Statistical analysis will examine differences between conditions in health outcomes and stigma measures, stratified by HIV status. Results will be used to generate parameter estimates and potential ranges of values to estimate power for a future R01 proposal, which will be a full cluster-randomized trial in PMTCT settings, with extended follow-up and enhanced adherence measurement using a biomarker.