HIV Prevention Intervention for Young Transgender Women (LifeSkills)
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ClinicalTrials.gov Identifier: NCT01575938 |
Recruitment Status
:
Completed
First Posted
: April 12, 2012
Last Update Posted
: December 5, 2017
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Condition or disease | Intervention/treatment | Phase |
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Sexual Transmission of Infection | Behavioral: HIV prevention intervention Behavioral: Diet and Nutrition | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | HIV Prevention Intervention for Young Transgender Women |
Actual Study Start Date : | March 2012 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | October 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: HIV group-based prevention intervention
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.
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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.
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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.
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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.
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No Intervention: Standard-of-care
This arm will receive HIV and STI testing and counseling only.
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- Change from baseline in number of unprotected anal and vaginal sex acts in the previous 4 months [ Time Frame: Baseline, 4-months post-intervention ]Self-reported unprotected anal and vaginal sex acts in the previous 4 months assessed via computer-assisted self-interviewing.

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Ages Eligible for Study: | 16 Years to 29 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575938
United States, Illinois | |
Ann & Robert H. Lurie Children's Hospital of Chicago | |
Chicago, Illinois, United States, 60611 | |
United States, Massachusetts | |
The Fenway Institute | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Robert Garofalo, MD | Ann & Robert H Lurie Children's Hospital of Chicago | |
Principal Investigator: | Matthew Mimiaga, ScD, MPH | Massachusetts General Hospital |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Ann & Robert H Lurie Children's Hospital of Chicago |
ClinicalTrials.gov Identifier: | NCT01575938 History of Changes |
Other Study ID Numbers: |
R01MH094323 ( U.S. NIH Grant/Contract ) |
First Posted: | April 12, 2012 Key Record Dates |
Last Update Posted: | December 5, 2017 |
Last Verified: | December 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
HIV infection |