HIV Prevention Intervention for Young Transgender Women
Condition: Sexual Transmission of Infection
MeSH terms: Infections
Study type: Interventional

Summary: 
      The purpose of this study is to test the efficacy of a uniquely targeted HIV risk reduction
      intervention for young transgender women (YTW), ages 16 to 29, at risk for HIV acquisition or
      transmission.
    

Detailed description: 
      The purpose of this study is to test the efficacy of a uniquely targeted HIV risk reduction
      intervention for young transgender women (YTW), ages 16 to 29, at risk for HIV acquisition or
      transmission. The study will test this intervention in a three-arm randomized controlled
      trial in two major U.S. cities with excellent access to and research experience with the
      population (Chicago, Boston). We will enroll at risk YTW, ages 16-29; two-fifths of the
      sample randomized to the intervention will participate in the 6-session group-based and
      manualized Life Skills intervention; two-fifths will be randomized to the standard-of-care
      (SOC) control condition; and one-fifth will be randomized to the time-matched attention
      control condition and receive standard health promotion information in a group-based
      multi-session format. All three arms will receive HIV and sexually transmitted infection
      (STI) (Chlamydia and gonorrhea) testing and pre-posttest risk reduction counseling (i.e.,
      SOC). Sexual risk will be assessed at baseline, 4, 8 and 12 months post-randomization. Our
      specific aims are: 1) to determine the efficacy of the Life Skills intervention in comparison
      to a SOC arm and a time-matched attention control on the primary outcome: number of
      unprotected anal and vaginal sex acts in the previous 4 months among YTW, ages 16-29; and 2)
      to examine the degree to which improvements in sexual risk taking are mediated by the
      conceptual mediators of the intervention: transgender adaptation and integration, collective
      self-esteem/empowerment, information (HIV knowledge), motivation (attitudes, norms, and
      intentions for safer sex), and behavioral skills (discussing sex and condom use with sexual
      partners, acquiring and using condoms); and to explore whether reductions in sexual risk are
      associated with epidemiologically-linked moderators of sexual risk behavior: age,
      race/ethnicity, and psychosocial factors. An additional exploratory aim is to describe the
      prevalence of HIV and STIs in the community recruited sample; in the SOC arm, we will assess
      the natural trajectory of sexual risk behavior and the acquisition of HIV and STIs (incidence
      rate) in YTW over a 12-month follow-up period.
    

Intervention name(s): HIV prevention intervention; Diet and Nutrition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The 6-session HIV prevention intervention curriculum, "LifeSkills," incorporates interactive activities, in-depth discussions, videos, games, and role-plays to help young transgender women develop, practice, and integrate new skills into "real-life" situations. Activities address each aspect our theoretical framework (information, motivation, behavior), including experiences that may pre-dispose young transgender women to HIV/STI risk. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.; The comparison condition is a 6-session group-based and manualized health promotion intervention. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV infection