Abstract
Introduction: Transgender women (assigned “male” at birth but who do not identify as male) are disproportionately impacted by HIV and experience unique barriers and facilitators to HIV care engagement. In formative work, we identified culturally specific and modifiable barriers to HIV treatment engagement among transgender women living with HIV (TWH), including prioritizing transition-related healthcare over HIV treatment, avoiding HIV care settings due to gender-related and HIV stigma, concerns about potential drug interactions with hormones, and inadequate social support. Grounded in the investigators' Models of Gender Affirmation and Health Care Empowerment, we developed the Healthy Divas intervention to optimize engagement in HIV care among TWH at risk for treatment failure and consequential morbidity, mortality, and onward transmission of HIV.Methods and Analysis: We conducted a 2-arm randomized controlled trial (RCT) of the intervention's efficacy in Los Angeles and San Francisco to improve engagement in care among TWH (N = 278). The primary outcome was virologic control indicated by undetectable HIV-1 level (undetectability = < 20 copies/mL), at baseline and follow-up assessment for 12 months at 3-month intervals.Ethics and Dissemination: This study was approved by University of California, San Francisco Institutional Review Board (15-17910) and Western Institutional Review Board (20181370). Participants provided informed consent before enrolment in the study. We are committed to collaboration with National Institutes of Health officials, other researchers, and health and social services communities for rapid dissemination of data and sharing of materials. The results will be published in peer-reviewed academic journals and scientific presentations. We will make our results available to researchers interested in transgender health to avoid unintentional duplication of research, as well as to others in health and social services communities, including HIV clinics, LGBT community-based organizations, and AIDS service organizations.Clinical Trial Registration: Clinicaltrials.gov, identifier NCT03081559.
Highlights
Transgender women are disproportionately impacted by HIV and experience unique barriers and facilitators to HIV care engagement
The Healthy Divas intervention and corresponding randomized controlled trial (RCT) protocols were developed with extensive formative work, including input from transgender women living with HIV (TWH), providers, and other community stakeholders
The forthcoming results will represent a critical step in the development of an intervention that addresses the unique and wide-ranging challenges experienced by TWH, a group whose disproportionate rates of HIV infection and poor outcomes warrant focused efforts
Summary
Transgender women (assigned “male” at birth but who do not identify as male) are disproportionately impacted by HIV and experience unique barriers and facilitators to HIV care engagement. In formative work, we identified culturally specific and modifiable barriers to HIV treatment engagement among transgender women living with HIV (TWH), including prioritizing transition-related healthcare over HIV treatment, avoiding HIV care settings due to gender-related and HIV stigma, concerns about potential drug interactions with hormones, and inadequate social support. Disparate prevalence of HIV is pronounced for African American transgender women [2]. In San Francisco, high HIV incidence and prevalence persist among African American transgender women, at 1.4 per 100 personyears and more than 30%, respectively [3]. Compared to other populations in the city, viral suppression is lowest among transgender women living with HIV (TWH) (68%) [4]. Among African American people living with HIV in Los Angeles, 26.5% are transgender [7] and among street- and venue-recruited transgender women, overall HIV prevalence ranges from 21.9– 26.1% [8, 9]. Adherence self-efficacy Treatment readiness Social support Coping Patient communication Shared decision making
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