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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HIV Prevention
• Intervention / Treatment: Behavioral: LifeSkills Mobile

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.

• Study Type: Interventional
• Enrollment (Estimated): 5100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Kuhns, PhD, MPH; Phone Number: 312-227-6119; Email: LKuhns@luriechildrens.org
• Study Contact Backup: Name: Matthew J Mimiaga, ScD, MPH; Phone Number: 617-901-9276; Email: mmimiaga@ph.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • UCLA
      • Contact: Matthew J Mimiaga, ScD, MPH, MA; Email: mmimiaga@ph.ucla.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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)

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago; Children's Hospital Los Angeles
• Investigators: Principal Investigator: Marvin Belzer, MD, Children's Hospital Los Angeles; Principal Investigator: Matthew J Mimiaga, ScD, MD, University of California, Los Angeles; Principal Investigator: Lisa Kuhns, PhD, MPH, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: August 17, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: PrEP; mHealth; Sexual Behavior; HIV Prevention; Transgender women (TGW)
• Other Study ID Numbers: 1 U01 A1156875

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No