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| Name | Class |
|---|---|
| Children's Hospital Los Angeles | OTHER |
| Ann & Robert H Lurie Children's Hospital of Chicago | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-48 months post-baseline (depending on when participants enroll in the study) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months post-baseline |
| Changes in sexual risk behavior at 12 months based on self-report |
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Inclusion Criteria:
Exclusion Criteria:
Self-identified as transgender, woman, and/or along the feminine spectrum
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41402905 | Derived | 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. |
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| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) |