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Efficacy of an empowerment-based, group-delivered HIV prevention intervention for young transgender women: The Project LifeSkills randomized clinical trial

JAMA Pediatrics Aug 20, 2018

Garofalo R, et al. - In sexually active young transgender women (YTW) aged 16 to 29 years, researchers tested the effectiveness of a culturally specific, empowerment-based, and group-delivered behavioral intervention to decrease sexual risk for acquiring and transmitting HIV. Researchers, for the first time, showed the effectiveness of a behavioral intervention to decrease sexual risk in YTW. The LifeSkills intervention resulted in a 39.8% greater mean reduction in condomless sex acts during the 12-month follow-up vs the standard of care group among YTW at sexual risk of acquiring and transmitting HIV.

Methods

  • Researchers performed a 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, MA, and Chicago, Il, to decrease sexual risk for HIV acquisition or transmission.
  • By a modified intention-to-treat approach, data analysis was conducted.
  • Participants in the study 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).
  • During active enrollment per the Data Safety and Monitoring Board’s recommendation, the attention control arm was dropped.
  • The LifeSkills intervention was delivered in six 2-hour sessions spanning a 3-week period.
  • Change in the number of self-reported condomless anal or vaginal sex acts in the 4 months before the baseline assessment and reported at the 4-, 8-, and 12-month visits was the primary outcome.

Results

  • According to the findings, out of the 190 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.
  • It was observed that 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) vs 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).
  • It was noted that the LifeSkills group had a 39.8% greater mean (SE) reduction in condomless sex acts at the 12-month follow-up visit vs 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).
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