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

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ClinicalTrials.gov Identifier: NCT05018611
Recruitment Status : Recruiting
First Posted : August 24, 2021
Last Update Posted : July 26, 2022
Sponsor:
Collaborators:
Children's Hospital Los Angeles
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Matthew Mimiaga, ScD, MPH, MA, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE August 17, 2021
First Posted Date  ICMJE August 24, 2021
Last Update Posted Date July 26, 2022
Actual Study Start Date  ICMJE December 6, 2021
Estimated Primary Completion Date February 28, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2021)		 HIV incidence [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2022)
  • Changes in sexual risk behavior at 6 months based on self-report [ Time Frame: 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 12 months based on self-report [ Time Frame: 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 18 months based on self-report [ Time Frame: 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 24 months based on self-report [ Time Frame: 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 [ Time Frame: 30 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 [ Time Frame: 36 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 [ Time Frame: 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 [ Time Frame: 48 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 [ Time Frame: End of study ]
    Total and incremental costs of the LifeSkills Mobile intervention relative to SOC, from healthcare sector and societal perspectives
  • PrEP outcomes (linkage, initiation, retention) [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2021)
  • Changes in sexual risk behavior at 6 months based on self-report [ Time Frame: 6 months post-baseline ]
    Self-reported total condomless anal or vaginal sex acts in the prior 6 months (since baseline) without protection via PrEP during the study period
  • Changes in sexual risk behavior at 12 months based on self-report [ Time Frame: 12 months post-baseline ]
    Self-reported total condomless anal or vaginal sex acts in the 6 months since the prior visit (12 months since the baseline visit) without protection via PrEP during the study period
  • Changes in sexual risk behavior at 18 months based on self-report [ Time Frame: 18 months post-baseline ]
    Self-reported total condomless anal or vaginal sex acts in the 6 months since the prior visit (18 months since the baseline visit) without protection via PrEP during the study period
  • Changes in sexual risk behavior at 24 months based on self-report [ Time Frame: 24 months post-baseline ]
    Self-reported total condomless anal or vaginal sex acts in the 6 months since the prior visit (24 months since the baseline visit) without protection via PrEP during the study period
  • Changes in sexual risk behavior at 30 months based on self-report [ Time Frame: 30 months post-baseline ]
    Self-reported total condomless anal or vaginal sex acts in the 6 months since the prior visit (30 months since the baseline visit) without protection via PrEP during the study period
  • Changes in sexual risk behavior at 36 months based on self-report [ Time Frame: 36 months post-baseline ]
    Self-reported total condomless anal or vaginal sex acts in the 6 months since the prior visit (36 months since the baseline visit) without protection via PrEP during the study period
  • Changes in sexual risk behavior at 42 months based on self-report [ Time Frame: 42 months post-baseline ]
    Self-reported total condomless anal or vaginal sex acts in the 6 months since the prior visit (42 months since the baseline visit) without protection via PrEP during the study period
  • Changes in sexual risk behavior at 48 months based on self-report [ Time Frame: 48 months post-baseline ]
    Self-reported total condomless anal or vaginal sex acts in the 6 months since the prior visit (48 months since the baseline visit) without protection via PrEP during the study period
  • Comparison of costs between LifeSkills Mobile intervention vs SOC [ Time Frame: End of study ]
    Total and incremental costs of the LifeSkills Mobile intervention relative to SOC, from healthcare sector and societal perspectives
  • PrEP outcomes (linkage, initiation, retention) [ Time Frame: 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Digital Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in YTW
Official Title  ICMJE Digital, Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in Young Transgender Women
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE HIV Prevention
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: LifeSkills Mobile
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 15, 2022)		 5100
Original Estimated Enrollment  ICMJE
 (submitted: August 17, 2021)		 5000
Estimated Study Completion Date  ICMJE February 28, 2026
Estimated Primary Completion Date February 28, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Self-identified as transgender, woman, and/or along the feminine spectrum
Ages  ICMJE 16 Years to 29 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Matthew J Mimiaga, ScD, MPH 617-901-9276 mmimiaga@ph.ucla.edu
Contact: Lisa Kuhns, PhD, MPH 312-227-6119 LKuhns@luriechildrens.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05018611
Other Study ID Numbers  ICMJE 1 U01 A1156875
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Matthew Mimiaga, ScD, MPH, MA, University of California, Los Angeles
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, Los Angeles
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Children's Hospital Los Angeles
  • Ann & Robert H Lurie Children's Hospital of Chicago
Investigators  ICMJE
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
PRS Account University of California, Los Angeles
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP