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Background  Black and Latina transgender women (TW) experience a disparate burden of HIV and related comorbidities, including poor mental health and cardiovascular disease (CVD) risks. Pervasive multilevel stigma and discrimination operate as psychosocial stressors for TW living with HIV and shape health disparities for this population. Gender-affirming hormone therapy (GAHT) is commonly used by TW to facilitate alignment of the body with gender identity; in the context of stigma, GAHT may both improve mental health and increase CVD risks.    Objective  This study aims to quantify the longitudinal relationship between stigma and chronic stress among black and Latina TW living with HIV. Secondary objectives include identifying pathways linking chronic stress to HIV comorbidities and exploring chronic stress as a mediator in the pathway linking stigma and GAHT to CVD comorbidities.    Methods  This US-based mixed methods longitudinal study will enroll a prospective cohort of 200 black and Latina TW living with HIV, collecting quantitative survey data, qualitative interviews, and biomarkers of chronic stress. Interviewer-administered surveys will include validated psychosocial measures of self-reported stigma and discrimination, perceived stress, CVD risk factors, mental health, access to gender-affirming care, coping, and social support. Medical record abstraction will collect data on GAHT use, CD4 count, HIV viral load, antiretroviral therapy, treatment, and comorbid conditions. Clinical measures will include physiological biomarkers as well as salivary and blood-based biomarkers of chronic stress. Survey data will be collected every 6 months (baseline, and 6, 12, 18, and 24 months), and biospecimens will be collected at baseline and at 12 and 24 months. A purposive subsample (stratified by use of GAHT and presence of depressive symptoms) of 20 to 30 TW living with HIV will be invited to participate in in-depth interviews at 6 and 18 months to explore experiences of intersectional stigma, chronic stress, and the role of GAHT in their lives.    Results  This study was funded by the National Institute on Minority Health and Health Disparities in December 2018. The study community advisory board and scientific advisors provided critical input on study design. Recruitment began in October 2019 (n=29 participants as of submission) and data collection will continue through 2022, with publication of baseline results anticipated summer 2021.    Conclusions  This study will focus on black and Latina TW living with HIV, an understudied health disparities population, advance both stigma and intersectionality research, and move chronic stress physiology research toward a more nuanced understanding of sex and gender. The comprehensive methodology will support the exploration of the role of exogenous estrogen in the pathways between stress and HIV comorbidities, elucidating the role of GAHT in the stress-health relationship. Finally, this study will provide longitudinal evidence of the impact of stigma-related chronic stress on the lives of black and Latina TW living with HIV integrating qualitative and quantitative data with psychosocial, clinical, and biological measures.    International Registered Report Identifier (IRRID)  DERR1-10.2196/17076

jmir research protocols

Biopsychosocial Mechanisms Linking Gender Minority Stress to HIV Comorbidities Among Black and Latina Transgender Women (LITE Plus): Protocol for a Mixed Methods Longitudinal Study