Digital Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in YTW (LifeSkills)

  • End date
    Feb 28, 2026
  • participants needed
  • sponsor
    University of California, Los Angeles
Updated on 4 October 2022
Accepts healthy volunteers


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.


LifeSkills Mobile is an mHealth intervention to promote biobehavioral HIV prevention strategies based on empowerment theory and was developed using a community-based participatory research approach. An RCT assesses the efficacy of the LifeSkills Mobile intervention in comparison to a standard of care (SOC) condition among 5,000 YTW recruited online. At baseline and every 6 months through 12-48 months (depending on when the participant enrolled), enrolled participants will complete an online survey sent via a link to their mobile phone and will be mailed an OraQuick In-Home HIV Test kit. We will also estimate the total and incremental costs of the LifeSkills Mobile intervention relative to SOC, from healthcare sector and societal perspectives.

Condition HIV Prevention
Treatment LifeSkills Mobile
Clinical Study IdentifierNCT05018611
SponsorUniversity of California, Los Angeles
Last Modified on4 October 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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