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Original Investigation
October 2018

Efficacy of an Empowerment-Based, Group-Delivered HIV Prevention Intervention for Young Transgender Women: The Project LifeSkills Randomized Clinical Trial

Author Affiliations
  • 1Division of Adolescent Medicine, Ann & Robert H. Lurie Children’s Hospital, Chicago, Illinois
  • 2Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
  • 3Division of General Pediatrics, Boston Children’s Hospital/Harvard Medical School, Boston, Massachusetts
  • 4Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts
  • 5The Fenway Institute, Fenway Health, Boston, Massachusetts
  • 6Department of Behavioral and Social Health Sciences, Brown University School of Public Health, Providence, Rhode Island
  • 7Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island
  • 8Center for Health Equity Research, Brown University, Providence, Rhode Island
  • 9Department of Psychiatry and Human Behavior, Alpert Medical School, Brown University, Providence, Rhode Island
JAMA Pediatr. 2018;172(10):916-923. doi:10.1001/jamapediatrics.2018.1799
Key Points

Question  Does the Project LifeSkills intervention reduce condomless vaginal or anal sex acts among young transgender women?

Findings  In this randomized clinical efficacy trial of 190 young transgender women, individuals who received the LifeSkills intervention had a significantly greater reduction in condomless vaginal and anal sex compared with those who received standard preventive care during the 12-month follow-up period.

Meaning  The Project LifeSkills intervention reduced sexual risk for HIV infection and transmission in young transgender women, a population with extremely high rates of HIV infection.


Importance  The 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.

Results  Of 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.

Trial Registration  ClinicalTrials.gov Identifier: NCT01575938