HIV PreventionLifeSkillsNCT05018611

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

A study testing LifeSkills Mobile in people with HIV Prevention, run by University of California, Los Angeles at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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. Read more about this study

Who is it for?: Ages 16 to 29 years, men onlyHealthy volunteers can take part
Conditions the study is for: HIV Prevention
What is being tested?: LifeSkills Mobile
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5,100 participants
Where: 1 siteUnited States
Study dates: 22 Jan 2022to 28 Feb 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 29 years
Men only
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA
Los Angeles, California, 90095

Other trials in United States

About this study

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

Read the 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.

Conditions: HIV Prevention
Being tested: LifeSkills Mobile
Keywords: Transgender women (TGW), PrEP, mHealth, HIV Prevention, Sexual Behavior
Medical subject headings: Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LifeSkills MobileBehavioural
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 groups in NCT05018611
Study group	Role	What they receive
LifeSkills Mobile	Experimental	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. Receives: Behavioral: LifeSkills Mobile
Standard of Care	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12-48 months post-baseline (depending on when participants enroll in the study)

Secondary outcomes (10)

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12-48 months post-baseline (depending on when participants enroll in the study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 202228 Feb 2027

First posted24 Aug 2021
Study start22 Jan 2022
Primary completion28 Feb 2027 (estimated)
Study completion28 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV PreventionStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 5,100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05018611
Sponsor's protocol ID: 1 U01 A1156875
Acronym: LifeSkills
Status last verified: Mar 2026
First submitted: 17 Aug 2021
Last updated: 31 Mar 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Kuhns LM, Garofalo R, Belzer M, McAvoy-Banerjea J, Holzman J, Kwak E, Johnson AK, Biello K, Schnall R, Hidalgo MA, Reisner SL, Mimiaga MJ. Digital limited interaction efficacy trial of LifeSkills Mobile to reduce HIV incidence in young transgender women: study protocol. Trials. 2025 Dec 17;27(1):62. doi: 10.1186/s13063-025-09353-0.
PubMed 41402905

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Digital, Limited Interaction Efficacy Trial of LifeSkills Mobile to Reduce HIV Incidence in Young Transgender Women
ClinicalTrials.gov ID: NCT05018611
Acronym / sponsor ID: LifeSkills / 1 U01 A1156875
Conditions: HIV Prevention
Keywords: Transgender women (TGW), PrEP, mHealth, HIV Prevention, Sexual Behavior
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 5,100 participants (estimated)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Collaborators: Children's Hospital Los Angeles, Ann & Robert H Lurie Children's Hospital of Chicago
Study start: 22 Jan 2022 (actual)
Primary completion: 28 Feb 2027 (estimated)
Study completion: 28 Feb 2027 (estimated)
First posted: 24 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LifeSkills Mobile	Experimental	Behavioral: LifeSkills MobileAccess 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.
Standard of Care	No intervention	–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.

Who may qualify

Ages: 16 to 29 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LifeSkills MobileA 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.	Behavioural	LifeSkills Mobile

Primary outcome

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.

10 secondary outcomes

Changes in sexual risk behavior at 6 months based on self-report
Time frame: 6 months post-baseline
Changes in sexual risk behavior at 12 months based on self-report
Time frame: 12 months post-baseline
Changes in sexual risk behavior at 18 months based on self-report
Time frame: 18 months post-baseline
Changes in sexual risk behavior at 24 months based on self-report
Time frame: 24 months post-baseline
Changes in sexual risk behavior at 30 months based on self-report
Time frame: 30 months post-baseline
Changes in sexual risk behavior at 36 months based on self-report
Time frame: 36 months post-baseline
Changes in sexual risk behavior at 42 months based on self-report
Time frame: 42 months post-baseline
Changes in sexual risk behavior at 48 months based on self-report
Time frame: 48 months post-baseline
Comparison of costs between LifeSkills Mobile intervention vs SOC
Time frame: End of study
PrEP outcomes (linkage, initiation, retention)
Time frame: 12-48 months post-baseline (depending on when participants enroll in the study)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
Derived from this study: PubMed 41402905Kuhns LM, Garofalo R, Belzer M, McAvoy-Banerjea J, Holzman J, Kwak E, Johnson AK, Biello K, Schnall R, Hidalgo MA, Reisner SL, Mimiaga MJ. Digital limited interaction efficacy trial of LifeSkills Mobile to reduce HIV incidence in young transgender women: study protocol. Trials. 2025 Dec 17;27(1):62. doi: 10.1186/s13063-025-09353-0.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marvin Belzer, MD principal investigator

Children's Hospital Los Angeles

Matthew J Mimiaga, ScD, MD principal investigator

University of California, Los Angeles

Lisa Kuhns, PhD, MPH principal investigator

Ann & Robert H Lurie Children's Hospital of Chicago

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LifeSkills Mobile in people with HIV Prevention, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HIV incidence (time frame: 12-48 months post-baseline (depending on when participants enroll in the study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05018611, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.