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

March 25, 2026 updated by: Matthew Mimiaga, ScD, MPH, MA, University of California, Los Angeles

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12-48 months post-baseline (depending on when participants enroll in the study)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 months post-baseline
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
12 months post-baseline
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
18 months post-baseline
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
24 months post-baseline
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
30 months post-baseline
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
36 months post-baseline
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
42 months post-baseline
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
48 months post-baseline
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
End of study
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
12-48 months post-baseline (depending on when participants enroll in the study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Los Angeles

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ann & Robert H Lurie Children's Hospital of Chicago
Children's Hospital Los Angeles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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