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

HIV Prevention Clinical Trial

— LifeSkills  

Official title:

Digital, Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in Young Transgender Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05018611
• Other study ID #: 1 U01 A1156875
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2021
• Est. completion date: February 28, 2026

Study information

• Verified date: September 2023
• Source: University of California, Los Angeles
• Contact: Matthew J Mimiaga, ScD, MPH
• Phone: 617-901-9276
• Email: mmimiaga[@]ph.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 5100
• Est. completion date: February 28, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Prevention

Intervention

Behavioral:
• LifeSkills Mobile
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.

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Ann & Robert H Lurie Children's Hospital of Chicago, Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in sexual risk behavior at 6 months based on self-report	Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP	6 months post-baseline
Secondary	Changes in sexual risk behavior at 12 months based on self-report	Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP	12 months post-baseline
Secondary	Changes in sexual risk behavior at 18 months based on self-report	Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP	18 months post-baseline
Secondary	Changes in sexual risk behavior at 24 months based on self-report	Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP	24 months post-baseline
Secondary	Changes in sexual risk behavior at 30 months based on self-report	Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP	30 months post-baseline
Secondary	Changes in sexual risk behavior at 36 months based on self-report	Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP	36 months post-baseline
Secondary	Changes in sexual risk behavior at 42 months based on self-report	Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP	42 months post-baseline
Secondary	Changes in sexual risk behavior at 48 months based on self-report	Self-reported total condomless anal or vaginal sex acts in the prior 30 days without protection via PrEP	48 months post-baseline
Secondary	Comparison of costs between LifeSkills Mobile intervention vs SOC	Total and incremental costs of the LifeSkills Mobile intervention relative to SOC, from healthcare sector and societal perspectives	End of study
Secondary	PrEP outcomes (linkage, initiation, retention)	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	12-48 months post-baseline (depending on when participants enroll in the study)