HIV Prevention Intervention for Young Transgender Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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HIV Prevention Intervention for Young Transgender Women

Conditions
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Sexual Transmission of Infection

Intervention / Treatment
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* Behavioral: HIV prevention intervention
* Behavioral: Diet and Nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIV group-based prevention intervention<br>The HIV prevention intervention is a 6-session group-based and manualized intervention. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention. | Behavioral: HIV prevention intervention<br>* 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.<br>|
| Active Comparator: Diet and nutrition<br>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. | Behavioral: Diet and Nutrition<br>* 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.<br>|
| No Intervention: Standard-of-care<br>This arm will receive HIV and STI testing and counseling only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in number of unprotected anal and vaginal sex acts in the previous 4 months | Self-reported unprotected anal and vaginal sex acts in the previous 4 months assessed via computer-assisted self-interviewing. | Baseline, 4-months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV infection