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HIV Prevention Intervention for Young Transgender Women (LifeSkills)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01575938
First received: March 29, 2012
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Sexual Transmission of Infection
Behavioral: HIV prevention intervention
Behavioral: Diet and Nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV Prevention Intervention for Young Transgender Women

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • Change from baseline in number of unprotected anal sex acts in the previous 4 months [ Time Frame: Baseline, 4-months post-intervention ] [ Designated as safety issue: No ]
    Self-reported unprotected anal sex acts in the previous 4 months assessed via computer-assisted self-interviewing.


Estimated Enrollment: 375
Study Start Date: March 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HIV group-based prevention intervention
The 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
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.
Active Comparator: 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.
Behavioral: 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.
No Intervention: Standard-of-care
This arm will receive HIV and STI testing and counseling only.

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 375 at risk YTW, ages 16-29; 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 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-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 16-29; 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.

  Eligibility

Ages Eligible for Study:   16 Years to 29 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575938

Contacts
Contact: Robert Garofalo, MD 773-303-6058 rgarofalo@luriechildrens.org
Contact: Abigail Muldoon, BS 773-649-1916 amuldoon@luriechildrens.org

Locations
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Robert Garofalo, MD, MPH         
Principal Investigator: Robert Garofalo, MD         
United States, Massachusetts
The Fenway Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Matthew Mimiaga, Sc.D.         
Principal Investigator: Matthew Mimiaga, ScD, MPH         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Robert Garofalo, MD Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator: Matthew Mimiaga, ScD, MPH Massachusetts General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01575938     History of Changes
Other Study ID Numbers: R01MH094323, R01MH094323
Study First Received: March 29, 2012
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
HIV infection

Additional relevant MeSH terms:
Infection

ClinicalTrials.gov processed this record on October 19, 2014