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

University of California, Los Angeles5,100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

5,100

Conditions

HIV Prevention

Interventions

LifeSkills MobileBEHAVIORAL

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.

Eligibility

Sex: MALEMin age: 16 YearsMax age: 29 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

UCLA

Los Angeles, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

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