HIV Prevention Intervention for Young Transgender Women

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.

Inclusion Criteria:

- age 16-29

- self-identified as transgender, transsexual, and/or female with a male biological or
birth sex

- self-reported history of unprotected anal or vaginal intercourse, anal or vaginal sex
with more than one sexual partner, anal or vaginal sex in exchange for money, food,
shelter, or diagnosis with HIV or another STI in the previous 4 months

- able to speak and understand English

- willing and able to provide informed consent/assent

- intention to reside in the local area throughout the 12 month follow-up period

Exclusion Criteria:

- unable to provide informed consent due to severe mental or physical illness, or
substance intoxication at the time of interview

- active suicidal ideation at the time of baseline interview