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

NCT05018611 | Active Not Recruiting

• 1 other identifier: 1 U01 A1156875
• Study Type: interventional
• Target: 5,100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Prevention

Keywords

Transgender women (TGW); PrEP; mHealth; HIV Prevention; Sexual Behavior

Outcome Measures

Primary Outcomes (1)

• HIV incidence

  Participants will be mailed and take an OraQuick In-Home HIV Test. Reactive HIV screening tests will be confirmed via dried blood spot (DBS; detectable antibodies). The main analysis will assess whether there are differences in survival (or cumulative incidence of HIV) among those randomized to LifeSkills Mobile versus those randomized to SOC.

  12-48 months post-baseline (depending on when participants enroll in the study)

Secondary Outcomes (10)

• Changes in sexual risk behavior at 6 months based on self-report

  6 months post-baseline

• Changes in sexual risk behavior at 12 months based on self-report

  12 months post-baseline

• Changes in sexual risk behavior at 18 months based on self-report

  18 months post-baseline

• Changes in sexual risk behavior at 24 months based on self-report

  24 months post-baseline

• Changes in sexual risk behavior at 30 months based on self-report

  30 months post-baseline

Study Arms (2)

LifeSkills Mobile

EXPERIMENTAL

Access to LifeSkills Mobile app. Participants will complete 4 modules with 20 activities across 6 months. Participants can log in at their convenience but will not be able to access the next module until the previous module is completed.

Behavioral: LifeSkills Mobile

Standard of Care

NO INTERVENTION

HIV home testing every 6 months, information regarding sexual and other behaviors that potentiate one's risk for HIV infection, receipt of a fact sheet about PrEP and PEP and referrals to the local PrEP clinics, and sexually transmitted infection testing via an on-line location findings app.

Interventions

LifeSkills Mobile BEHAVIORAL

A mobile app designed to facilitate the broad reach and impact of the LifeSkills intervention to reduce sexual risk behavior which drives HIV infection. The LifeSkills intervention addresses the specific structural, developmental, and interpersonal challenges to HIV prevention among YTW ages 16-29, with prior evidence of the efficacy to reduce sexual risk.

LifeSkills Mobile

Eligibility Criteria

• Age: 16 Years - 29 Years
• Gender Eligibility Details: Self-identified as transgender, woman, and/or along the feminine spectrum
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Children's Hospital Los Angeles: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Kuhns LM, Garofalo R, Belzer M, McAvoy-Banerjea J, Holzman J, Kwak E, Johnson AK, Biello K, Schnall R, Hidalgo MA, Reisner SL, Mimiaga MJ. Digital limited interaction efficacy trial of LifeSkills Mobile to reduce HIV incidence in young transgender women: study protocol. Trials. 2025 Dec 17;27(1):62. doi: 10.1186/s13063-025-09353-0.

  PMID: 41402905 DERIVED

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Marvin Belzer, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

• Matthew J Mimiaga, ScD, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Lisa Kuhns, PhD, MPH

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology, UCLA Fielding School of Public Health, and Psychiatry & Biobehavioral Sciences, UCLA David Geffen School of Medicine

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: January 22, 2022
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)