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NCT Number: NCT05018611

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

HIV Prevention Behavior Sexual Behavior

Age range

16 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCLA

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LifeSkills Mobile

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Children's Hospital Los Angeles

Registry information

Official study title

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

Acronym: LifeSkills

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2021
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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