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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV Prevention

Intervention / Treatment
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* Behavioral: LifeSkills Mobile


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LifeSkills Mobile<br>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<br>* 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.<br>|
| No Intervention: Standard of Care<br>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?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transgender women (TGW), PrEP, mHealth, HIV Prevention, Sexual Behavior