An interventional study of LifeSkills Mobile in HIV Prevention, sponsored by University of California, Los Angeles. Active, not recruiting at 1 site in United States. Open to male participants aged 16 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Prevention
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.
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.
224 studies on the registry are indexed under Sexual Behavior; 30 are open to participants now.
This study's planned enrollment of 5,100 is above the median of 264 across 179 interventional studies indexed under Sexual Behavior.
Browse Sexual Behavior studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
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.
Time frame: 12-48 months post-baseline (depending on when participants enroll in the study)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12-48 months post-baseline (depending on when participants enroll in the study)
Started Jan 2022 (actual). Primary completion is estimated for Feb 2027, 61 months after the start.
Of 106 non-industry interventional studies with no phase under Sexual Behavior, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 61 months is above that.
Counting every sponsor, half of 107 studies reached it within 23 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Los Angeles →