HIV Prevention Intervention for Young Transgender Women

Sexual Transmission of Infection Clinical Trial

— LifeSkills  

Official title:

HIV Prevention Intervention for Young Transgender Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575938
• Other study ID #: R01MH094323
• Secondary ID: R01MH094323
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: October 2016

Study information

• Verified date: January 2021
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Sexual Transmission of Infection

Intervention

Behavioral:
• HIV prevention intervention
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.
• Diet and Nutrition
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.

Locations

Country	Name	City	State
United States	The Fenway Institute	Boston	Massachusetts
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Garofalo R, Johnson AK, Kuhns LM, Cotten C, Joseph H, Margolis A. Life skills: evaluation of a theory-driven behavioral HIV prevention intervention for young transgender women. J Urban Health. 2012 Jun;89(3):419-31. doi: 10.1007/s11524-011-9638-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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