The purpose of this study is to assess the feasibility and acceptability of Sheroes, a theory-driven, culturally grounded intervention to reduce sexual risk behavior among male-to-female transgender women (transwomen) at risk for HIV acquisition or transmission. HIV prevalence estimates among this population are markedly higher than estimates for other at-risk groups, and transwomen also experience severe stigma, discrimination, alienation, poverty, and victimization. Despite elevated risk for HIV, the rates of HIV testing among transwomen are much lower than other at-risk groups, and our team's research with transwomen living with HIV indicates unique barriers to treatment uptake and antiretroviral medication adherence, which puts them at elevated risk of poor HIV-related clinical outcomes, including morbidity, mortality, and transmission of HIV to uninfected partners. There is a dire need for rigorously-evaluated interventions designed specifically to meet the unique needs of transwomen. To address this need, we developed 'Sheroes,'a group-based intervention that addresses the unifying lived experiences of HIV-positive, HIV-negative, and unknown status high-risk transwomen. Sheroes was designed in close collaboration with the transgender community and is grounded in our team's innovative Model of Gender Affirmation. While a number of investigators have observed an intense need for (and often lack of access to) gender affirmation among transgender individuals, its relationship to high-risk behavior has rarely been directly investigated. This study is a pilot randomized controlled trial (RCT) comparing the Sheroes intervention to a time- and attention-matched film-based control condition. From a projected 223 to be screened, 60 self-identified transwomen who are at least 18 years of age, of any HIV status, and reporting unprotected receptive and/or insertive anal intercourse (UAI) in the past 3 months will be stratified by HIV status and randomized to receive the 5-session Sheroes intervention or a time- and attention- matched control group. Follow-up assessments will be conducted at 3 and 6 months post-randomization. While this pilot study is not powered for a formal test of outcomes or effect size estimation, we will collect data on our primary and secondary outcomes of interest to determine feasibility and acceptability of data collection and to explore our hypotheses via preliminary analyses. We hypothesize that following intervention exposure relative to control group, Sheroes participants will report a lower mean number of unprotected sexual partners. Moreover, we will test the secondary/exploratory hypotheses that Sheroes participants will report a) higher HIV testing rates (for HIV-negative transwomen at baseline);b) higher STI testing rates (for all serostatus transwomen), and c) higher HIV medical appointment attendance and ART readiness or ART use and adherence (for HIV-positive transwomen). An additional secondary/exploratory aim is to examine mediators/mechanisms of change based on the Model of Gender Affirmation (e.g., need for gender affirmation, self-objectification) and moderators of the intervention (e.g., HIV status, dru use).
Transgender women are an understudied and highly vulnerable group at high risk for HIV acquisition and transmission with unique intervention needs. The purpose of this study is to assess the feasibility and acceptability of Sheroes, a theory-driven, culturally grounded intervention to reduce sexual risk behavior among transgender women at risk for HIV acquisition or transmission. Such interventions are urgently needed as they have the potential to curb new HIV infections from both sources and targets of HIV.
|Grant, Robert M; Sevelius, Jae M; Guanira, Juan V et al. (2016) Transgender Women in Clinical Trials of Pre-Exposure Prophylaxis. J Acquir Immune Defic Syndr 72 Suppl 3:S226-9|