Using a mobile app to reduce HIV incidence in young transgender women
Digital, Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in Young Transgender Women
This study is testing if a mobile app can help young transgender women reduce their risk of HIV compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5100 (estimated) |
| Ages | 16 Years to 29 Years |
| Sex | Male |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los angeles, California) |
| Trial ID | NCT05018611 on ClinicalTrials.gov |
What this trial studies
The LifeSkills Mobile app will be tested in a randomized controlled trial involving 5,000 young transgender women aged 16-29 in the U.S. This mHealth intervention aims to promote biobehavioral HIV prevention strategies based on empowerment theory and was developed through community-based participatory research. Participants will complete online surveys and receive OraQuick In-Home HIV Test kits at baseline and every six months for up to 48 months. The study will compare the efficacy of the LifeSkills Mobile intervention against standard care and assess the associated costs from healthcare and societal perspectives.
Who should consider this trial
Good fit: Ideal candidates are young transgender women aged 16-29 who are HIV uninfected and have a history of condomless sex.
Not a fit: Patients with active suicidal ideation, major mental illness, or those who test positive for HIV at baseline may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce HIV incidence among young transgender women.
How similar studies have performed: Other studies have shown promise in using mobile health interventions for HIV prevention, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los angeles, California
- UCLA — Los angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Marvin Belzer, MD — Children's Hospital Los Angeles
- Study coordinator: Matthew J Mimiaga, ScD, MPH
- Email: mmimiaga@ph.ucla.edu
- Phone: 617-901-9276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.