Digital Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in YTW (NCT05018611) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Digital Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in YTW
United States5,100 participantsStarted 2022-01-22
Plain-language summary
The LifeSkills Mobile app will be evaluated in a randomized controlled trial (RCT) among 5,000 young transgender women (YTW), ages 16-29 in the United States (U.S.). Study findings will demonstrate if the intervention will reduce HIV incidence.
Who can participate
Age range16 Years – 29 Years
SexMALE
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Inclusion Criteria:
* Self-identified as transgender, woman, and/or along the feminine spectrum with a male assigned sex at birth
* Ages 16-29
* HIV uninfected at enrollment visit, verified via HIV home test kit
* Self-reported lifetime history of condomless sex or recent history of sex (anal or vaginal in the past 12 months)
* Able to speak/understand English
* Owns a smartphone or home computer or willing to use one in the study
* Willing and able to provide informed consent/assent
Exclusion Criteria:
* Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at time of enrollment
* Discovery of active suicidal ideation or major mental illness (e.g. untreated psychosis or mania) at the time of the interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
* A positive Home HIV test kit result at baseline; these individuals will be immediately linked to HIV clinical care in their local areas.
What they're measuring
1
HIV incidence
Timeframe: 12-48 months post-baseline (depending on when participants enroll in the study)