Digital Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in YTW
- Conditions
- HIV Prevention
- Interventions
- Behavioral: LifeSkills Mobile
- Registration Number
- NCT05018611
- Lead Sponsor
- University of California, Los Angeles
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 5100
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LifeSkills Mobile LifeSkills Mobile 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.
- Primary Outcome Measures
Name Time Method HIV incidence 12-48 months post-baseline (depending on when participants enroll in the study) 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.
- Secondary Outcome Measures
Name Time Method Changes in sexual risk behavior at 24 months based on self-report 24 months post-baseline Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP
Changes in sexual risk behavior at 30 months based on self-report 30 months post-baseline Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP
PrEP outcomes (linkage, initiation, retention) 12-48 months post-baseline (depending on when participants enroll in the study) PrEP care linkage defined as attending at least one PrEP-related care visit to assess medical eligibility for PrEP initiation in the prior 6 months, per self-report PrEP initiation defined as starting PrEP medication in the prior 6-month period by self-report PrEP retention defined as: at least one PrEP care visit in a 6-month period PrEP visit constancy defined as at least one visit every six months over a 12-month period per self-report
Changes in sexual risk behavior at 18 months based on self-report 18 months post-baseline Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP
Changes in sexual risk behavior at 12 months based on self-report 12 months post-baseline Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP
Changes in sexual risk behavior at 36 months based on self-report 36 months post-baseline Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP
Comparison of costs between LifeSkills Mobile intervention vs SOC End of study Total and incremental costs of the LifeSkills Mobile intervention relative to SOC, from healthcare sector and societal perspectives
Changes in sexual risk behavior at 6 months based on self-report 6 months post-baseline Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP
Changes in sexual risk behavior at 42 months based on self-report 42 months post-baseline Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP
Changes in sexual risk behavior at 48 months based on self-report 48 months post-baseline Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP
Trial Locations
- Locations (1)
UCLA
🇺🇸Los angeles, California, United States