Efficacy of an Empowerment-Based, Group-Delivered HIV Prevention Intervention for Young Transgender Women

Abstract

IMPORTANCEThe incidence of HIV infection among transgender women in the United States is extremely high, with young transgender women (YTW) at highest risk; condomless sex is the primary risk behavior for transmission. However, there are no published randomized clinical trials to date examining interventions to reduce sexual risk for HIV acquisition and transmission within this group.OBJECTIVE To determine the efficacy of a culturally specific, empowerment-based, and group-delivered behavioral prevention intervention to reduce sexual risk for HIV acquisition and transmission in sexually active YTW aged 16 to 29 years. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical efficacy trial of Project LifeSkills, a group-delivered, behavioral HIV prevention intervention, vs standard of care conducted among 190 sexually active YTW between March 26, 2012, and August 15, 2016, at community-based locations in Boston, Massachusetts, and Chicago, Illinois, to reduce sexual risk for HIV acquisition or transmission. Data analysis was by a modified intention-to-treat approach. INTERVENTIONS Participants were randomized (approximately 2:2:1) to the LifeSkills intervention (n = 116), standard of care only (n = 74), or a diet and nutrition time-and attention-matched control (attention control) arm (n = 43). The attention control arm was dropped during active enrollment per the Data Safety and Monitoring Board's recommendation. The LifeSkills intervention was delivered in six 2-hour sessions spanning a 3-week period.MAIN OUTCOMES AND MEASURES Primary outcome was change in the number of self-reported condomless anal or vaginal sex acts in the 4 months before the baseline assessment and that reported at the 4-, 8-, and 12-month visits. RESULTSOf the 190 study participants, the mean (SD) age was 23.4 (3.4) years (range, 16-29 years); 47 (24.7%) were white, 83 (43.7%) were black or African American, 25 (13.2%) were Hispanic or Latina, and 35 (18.4%) were another race/ethnicity. From baseline to 4 months, the LifeSkills group had a 30.8% greater mean (SE) reduction in condomless sex acts (2.26 [0.40] at baseline vs 1.22 [0.22] at 4 months) compared with the standard of care group (2.69 [0.59] at baseline vs 2.10 [0.47] at 4 months) (risk ratio [RR], 0.69; 95% CI, 0.60-0.80; P < .001). Similarly, the LifeSkills group had a 39.8% greater mean (SE) reduction in condomless sex acts at the 12-month follow-up visit compared with the standard of care group (0.71 [0.13] vs 1.40 [0.32]; RR, 0.60; 95% CI, 0.50-0.72; P < .001).CONCLUSIONS AND RELEVANCE Among YTW at sexual risk of HIV acquisition or transmission, the LifeSkills intervention resulted in a 39.8% greater mean reduction in condomless sex acts during the 12-month follow-up in comparison to the standard of care group. This trial is the first to date to demonstrate evidence of efficacy for a behavioral intervention to reduce sexual risk in YTW.

HIV Prevention Interventions for Adolescents

“…Promising new behavioral interventions continue to be developed and tested among youth at greatest risk for HIV infection. Garofalo and colleagues [55] recently published data from a randomized controlled trial of a group delivered HIV prevention intervention for transgender young women. The intervention, LifeSkills, demonstrated a 40% larger reduction in condomless sex acts compared to an attention matched control group at the 12 month follow-up point.…”

Urgent Need for Research to Achieve Health Equity for Sexual and Gender Minority Youth

“…9 Yet only 1 evidence-based intervention for HIV prevention exists for this group, and no interventions exist to specifically address daily threats of violence and victimization. 10 We agree that more research to inform interventions at organizational, community, and policy levels is needed. This is amplified by policy interventions showing that legalizing same-sex marriage reduced suicide attempts, and antibullying legislation reduced victimization among sexual-minority youth.…”

“You talk about problems until you feel free”: South African adolescent and young women’s narratives on the value of HIV prevention peer support clubs

“…Similar transformative effects have been noted in other settings where peer-led, curriculum-based sessions using an empowerment approach have been tested. One example is Project LifeSkills for young transgender women in the US, which was found to be highly effective in changing HIV risk behaviours, largely because its structured sessions were "grounded in participant social realities, focused on empowerment and practical needs, and delivered by peers" [45].…”