Clinical trial NCT05018611: Digital Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in YTW
Official title: Digital, Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in Young Transgender Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention
Keywords: Transgender women (TGW)
PrEP
mHealth
HIV Prevention
Sexual Behavior
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2021-08-24
Enrollment: 5100
Sex: MALE
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: HIV incidence
timeFrame: 12-48 months post-baseline (depending on when participants enroll in the study)
Secondary outcomes:
measure: Changes in sexual risk behavior at 6 months based on self-report
timeFrame: 6 months post-baseline
measure: Changes in sexual risk behavior at 12 months based on self-report
timeFrame: 12 months post-baseline
measure: Changes in sexual risk behavior at 18 months based on self-report
timeFrame: 18 months post-baseline
measure: Changes in sexual risk behavior at 24 months based on self-report
timeFrame: 24 months post-baseline
measure: Changes in sexual risk behavior at 30 months based on self-report
timeFrame: 30 months post-baseline
measure: Changes in sexual risk behavior at 36 months based on self-report
timeFrame: 36 months post-baseline
measure: Changes in sexual risk behavior at 42 months based on self-report
timeFrame: 42 months post-baseline
measure: Changes in sexual risk behavior at 48 months based on self-report
timeFrame: 48 months post-baseline
measure: Comparison of costs between LifeSkills Mobile intervention vs SOC
timeFrame: End of study
measure: PrEP outcomes (linkage, initiation, retention)
timeFrame: 12-48 months post-baseline (depending on when participants enroll in the study)
Other outcomes:
Locations:
city: Los angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Marvin Belzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Matthew J Mimiaga, ScD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Lisa Kuhns, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: