HIV Clinical Trial
Official title:
Engaging Seronegative Youth to Optimize HIV Prevention Continuum
Verified date | December 2022 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The focus of this study (Engaging Seronegative Youth to Optimize HIV Prevention Continuum) - will be to stop HIV-related risk acts and to encourage youth at high risk for HIV to adopt antiretroviral medications as treatment and prevention (either pre exposure prophylaxis (PrEP) or post exposure prophylaxis) among gay, bisexual and transgender and/or homeless youth with contact with the criminal justice system in the HIV epicenters of Los Angeles and New Orleans. A cohort of 1500 youth at the highest risk of seroconverting over 24 months will be identified. The goal will be to optimize the HIV Prevention Continuum over 24 months. The proposed randomized controlled trial (RCT) aims to compare youth outcomes when randomized to one of four automated and person-mediated social media delivered intervention conditions: 1) Automated Messaging and Monitoring Intervention (AMMI) only (n=900) consisting of daily motivational, instructional, and referral text-messaging (SMS), and brief, weekly SMS monitoring surveys of outcomes; 2) Peer Support through social media plus AMMI (n=200) via private online discussion boards; 3) Coaching plus AMMI (n=200) to provide service linkages, eligibility support, appointment coordination and follow-up, communication with healthcare providers, and brief motivational and strengths-based counseling for linkage and retention to prevention, mental health, and substance abuse services; and, 4) Coaching plus Peer Support and AMMI (n=200).
Status | Completed |
Enrollment | 1478 |
Est. completion date | November 30, 2022 |
Est. primary completion date | October 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 24 Years |
Eligibility | Inclusion Criteria: - Youth aged 12-24 - HIV-negative status - Able to provide informed consent - At high-risk* of HIV - Youth will be considered at high-risk of HIV based on their responses to a screening questionnaire, which assesses - HIV status; PrEP / PEP use; gender; race/ethnicity; sexual orientation; homelessness; history of probation/incarceration; history of hospitalization for mental health issues; history of substance abuse use and treatment; and, history of STI. Exclusion Criteria: - Youth under 12 years of age or above 24 years of age - HIV-positive (if you become HIV-positive, they will be invited to participate in another, related ATN study) - Unable to understand the study procedures due to intoxication or cognitive difficulties (any youth who appear to be under the influence of alcohol or drugs will be unable to enroll in the study but invited to return at a later date) - Unable to provide voluntary written informed consent - Do not meet aforementioned criteria for being at high-risk of HIV |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Friends Research Institute, Inc., Tulane University Health Sciences Center, University of California, San Francisco |
United States,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HIV Testing | Self-reported # of times - lifetime, past 4 months (reported at four-month assessment points) | 24 months | |
Primary | STI Testing | Self-reported # of times - lifetime, past 4 months (reported at four-month assessment points) | 24 months | |
Primary | Condom Use Frequency | Self-reported condomless sex - lifetime, past four months - using Likert-type scale (reported on weekly surveys, at four-month assessment points) | 24 months | |
Primary | PEP Use / Adherence | Self-reported current use, lifetime use, adherence, willingness to use - using Likert-type scale (all reported at four-month assessment points, adherence also reported on weekly surveys) | 24 months | |
Primary | PrEP Use / Adherence | Self-reported current use, lifetime use, adherence; using Likert-type scale (all reported at four-month assessment points, adherence also reported on weekly surveys) | 24 months | |
Primary | Sexual Partners | Self-reported # of sexual partners, # of female/male/transgender sexual partners - lifetime, past 4 months (reported at four-month assessment points) | 24 months | |
Secondary | Mental Health Symptoms | Self-reported symptoms of anxiety and depression (reported on weekly surveys, at four-month assessment points) | 24 months | |
Secondary | Substance Use | Rapid Diagnostic Tests (RDTs) for alcohol, marijuana, methamphetamines, opiates, cocaine (at four-month assessment points); self-reported AUDIT-C measure (at four-month assessment points); self-reported excessive substance use (reported on weekly surveys) | 24 months | |
Secondary | Housing Insecurity | Self-reported housing insecurity (reported on weekly surveys, at four-month assessment points) | 24 months |
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