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

University of California, Los Angeles (UCLA)

Status: Enrolling

Conditions: HIV Prevention

Treatments: Behavioral: LifeSkills Mobile

Study type: Interventional

Funder types: Other

Identifiers

NCT05018611

1 U01 A1156875

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5,100 estimated patients

Sex: Male

Ages: 16 to 29 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,100 participants in 2 patient groups

LifeSkills Mobile

Experimental group

Description:

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.

Treatment:

Behavioral: LifeSkills Mobile

Standard of Care

No Intervention group

Description:

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.