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Background: HIV prevalence is high among transgender women. A global meta-analysis of HIV burden among transgender women found a 19% HIV prevalence and 49-fold increased odds of HIV infection compared with all adults of reproductive age. A U.S.-based meta-analysis found an overall 28% laboratory-confirmed HIV prevalence. No evidence-based HIV prevention interventions (EBIs) for transgender women exist in the Centers for Disease Control and Prevention (CDC) compendium of EBIs. We addressed this gap by testing a culturally-specific, behavioral intervention for HIV prevention (“LifeSkills”) among young transgender women (YTW) in a randomized controlled efficacy trial. LifeSkills is theoretically-driven and grounded in the social realities of YTW, with content developed using a community-based participatory approach with guidance from a multidisciplinary research team.
Methods: We recruited 300 YTW, ages 16-29, in two US cities (Boston and Chicago), who were randomly assigned 2:2:1 in a 3-arm (LifeSkills, standard-of-care, and time-matched attention control) trial examining the efficacy of a multi-session, group-based intervention for HIV prevention. Participants were followed for one year, with visits at 4, 8 and 12-months post-randomization. Enrollment was completed between 2012-2015, with follow-up visits through September 2016. Generalized linear models (GLM) examined differences in condomless sex (CS) acts between intervention and control arms.
Results: Participants were racially/ethnically diverse; 49% Black, 12% Latina, 25% White, and 14% other. At enrollment, 22% of participants were HIV-infected (3% previously undiagnosed). Interim analysis with >90% of visits completed indicates feasibility and efficacy of the intervention to reduce CS acts compared to the standard-of-care control arm. We found a >20% difference in reduction in CS acts (vaginal and anal) from baseline with a significant 12-month arm x time interaction (F(3,447) = 12.29, p<0.0001). Intervention participants reported high satisfaction with the curriculum: 98% indicated they would refer a friend and 99% said the intervention met their expectations.
Conclusions: Using the CDC “Guide to the Continuum of Evidence for Efficacy” as a framework, LifeSkills may be the first well-supported, evidence-based behavioral intervention (EBI) for HIV prevention among YTW. Additional research is needed to demonstrate independent replication of findings and guide implementation and dissemination of LifeSkills in other U.S communities and regions of the world.