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 24, at risk for HIV acquisition or transmission. Evidence indicates that transgender women have HIV prevalence rates as high as or higher than other high risk groups (i.e., >25%), compounded by a startling rate of unrecognized infection (i.e., >10%), with the largest percentage among YTW (ages 29 and younger). High rates of risky sexual behavior and HIV infection among this population of young women indicate a need for comprehensive HIV prevention programs targeted to their unique circumstances. A prior CDC-funded pilot study conducted by the study team suggests that intervening among this group is feasible, acceptable, and efficacious. In 2008-2009, members of the target population (i.e., YTW), with guidance from a multidisciplinary research team, led the development of a holistic, theoretically-driven intervention curriculum (i.e., """"""""Life Skills"""""""") grounded in the social realities of YTW. We found that enrollment and retention of the study population was feasible (i.e., 51 participants enrolled in 6 months) and both retention and session attendance were high (84% retained over the course of the study). We propose to 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. We will enroll 375 at risk YTW, ages 16-24;two-fifths of the sample (N=150) randomized to the intervention will participate in the 6-session group-based and manualized Life Skills intervention;two-fifths (N=150) will be randomized to the standard-of-care (SOC) control condition;and one- fifth will be randomized to the time-matched attention control condition (N=75) and receive standard health promotion information in a group-based multi-session format. All three arms will receive HIV and 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-intervention 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 sex acts (UAS) (in the previous four months) among YTW, ages 16-24;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.

Public Health Relevance

High rates of risky sexual behavior and HIV infection among young transgender women indicate a need for comprehensive HIV prevention programs targeted to their unique circumstances. 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 24, at risk for HIV acquisition or transmission. Effective interventions to prevent HIV infection in YTW may decrease the population burden of disease.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH094323-04
Application #
8644925
Study Section
Behavioral and Social Science Approaches to Preventing HIV/AIDS Study Section (BSPH)
Program Officer
Kamath, Susannah M Allison
Project Start
2011-06-13
Project End
2016-03-31
Budget Start
2014-04-01
Budget End
2015-03-31
Support Year
4
Fiscal Year
2014
Total Cost
$713,801
Indirect Cost
$26,126
Name
Children's Memorial Hospital (Chicago)
Department
Type
DUNS #
074438755
City
Chicago
State
IL
Country
United States
Zip Code
60611
Katz-Wise, Sabra L; Reisner, Sari L; White Hughto, Jaclyn M et al. (2016) Self-Reported Changes in Attractions and Social Determinants of Mental Health in Transgender Adults. Arch Sex Behav :
Reisner, Sari L; White Hughto, Jaclyn M; Gamarel, Kristi E et al. (2016) Discriminatory experiences associated with posttraumatic stress disorder symptoms among transgender adults. J Couns Psychol 63:509-519
Reisner, Sari L; White Hughto, Jaclyn M; Pardee, Dana et al. (2016) Syndemics and gender affirmation: HIV sexual risk in female-to-male trans masculine adults reporting sexual contact with cisgender males. Int J STD AIDS 27:955-66
Reisner, Sari L; Biello, Katie B; White Hughto, Jaclyn M et al. (2016) Psychiatric Diagnoses and Comorbidities in a Diverse, Multicity Cohort of Young Transgender Women: Baseline Findings From Project LifeSkills. JAMA Pediatr 170:481-6
White Hughto, Jaclyn M; Hidalgo, Anna P; Bazzi, Angela R et al. (2016) Indicators of HIV-risk resilience among men who have sex with men: a content analysis of online profiles. Sex Health :
Reisner, Sari L; Hughto, Jaclyn M White; Pardee, Dana J et al. (2016) LifeSkills for Men (LS4M): Pilot Evaluation of a Gender-Affirmative HIV and STI Prevention Intervention for Young Adult Transgender Men Who Have Sex with Men. J Urban Health 93:189-205
Katz-Wise, Sabra L; Reisner, Sari L; Hughto, Jaclyn White et al. (2016) Differences in Sexual Orientation Diversity and Sexual Fluidity in Attractions Among Gender Minority Adults in Massachusetts. J Sex Res 53:74-84
Garofalo, Robert; Kuhns, Lisa M; Reisner, Sari L et al. (2016) Behavioral Interventions to Prevent HIV Transmission and Acquisition for Transgender Women: A Critical Review. J Acquir Immune Defic Syndr 72 Suppl 3:S220-5
Kuhns, Lisa M; Reisner, Sari L; Mimiaga, Matthew J et al. (2016) Correlates of PrEP Indication in a Multi-Site Cohort of Young HIV-Uninfected Transgender Women. AIDS Behav 20:1470-7
Reisner, Sari L; Vetters, Ralph; White, Jaclyn M et al. (2015) Laboratory-confirmed HIV and sexually transmitted infection seropositivity and risk behavior among sexually active transgender patients at an adolescent and young adult urban community health center. AIDS Care 27:1031-6

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