Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)

Study Overview
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Brief Summary
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This research study proposes to embed HIV testing outreach workers from a young adult focused medical and HIV treatment program into an alternative sentencing program to deliver a new service delivery model (Link2CARE) that integrates evidence-based protocols for justice-involved young adults to: a) promote HIV and STI testing, and HIV and SU risk screening, b) provide onsite intervention, and c) cross-system linkage to HIV, STI, and SU care. Phase 1 has already been completed. In phase 1, the intervention components were adapted for use among justice involved young adults and the resulting protocols were piloted with justice involved young adults, finalizing the resulting 4-session Link2CARE intervention. In phase 2, we will test Link2CARE among N=450 justice-involved young adults enrolled at the alternative sentencing program and conduct process evaluations with N=15 alternative sentencing program staff.

Official Title
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Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)

Conditions
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HIV/AIDS, HIV Infections, Substance Use, Substance Abuse, Substance Use Disorders, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: Link2CARE


Participation Criteria
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Eligibility Criteria
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Young Adults Inclusion Criteria: Between 18-24 years of age Currently enrolled at the alternative to sentencing program Conversant in English Engaged in any unprotected or vaginal sexual activity (in the past 12 months) Exclusion Criteria: Cognitively unable to complete the interview HIV positive Alternative to Sentencing Staff Inclusion Criteria: Currently employed at the alternative to sentencing program Between ages of 18-80 Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

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: Link2CARE<br>This arm is comprised of participants randomized to the 4-session Link2CARE intervention. | Behavioral: Link2CARE<br>* The Link2CARE intervention consists of 4 sessions. Session 1 consists of a one-on-one meeting with a Health Coach, during which participants will be offered an oral rapid HIV test and STI test. Sessions 2, 3, and 4 are group-based. During these sessions, participants will engage in discussions and activities regarding sexual and substance use risk behaviors.<br>|
| No Intervention: Standard of Care<br>This arm is comprised of participants who will not receive the 4-session Link2CARE intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months | measured by participant report in the Sexual Risk section of the questionnaires | at 12-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Young Adults Substance Use in Past 30 Days | measured by participant report in the Substance Use section of the questionnaires | at 3-, 6-, and 12-month follow-ups | 
| Number of Young Adults Referred to Substance Use Treatment | measured by Health Coach report in the Health Coach logs and participant report in the Substance Use Referral section of the questionnaires | at 3-, 6-, and 12-month follow-ups | 
| Number of Young Adults Attending Intake Plus One Treatment Session | measured by Health Coach report in the Health Coach logs and participant report in the Substance Use Treatment section of the questionnaires | at 3-, 6-, and 12-month follow-ups | 
| Acceptance of STI Testing (Yes/no) | measured by Health Coach report in the Session 1 Sexual Risk questionnaire | at day 1 of enrollment | 
| Any STI Testing | measured by participant report in the STI Testing section of the questionnaires | between 6- and 12-month follow-ups | 
| Number of STI+ Young Adults Referred to STI Treatment | measured by the Health Coach report in the Health Coach Logs and participant report in the STI Referral section of the questionnaires | at 3-, 6-, and 12-month follow-ups | 
| Number of STI+ Young Adults Attending 1 or More Treatment Appointments | measured by Health Coach report in the Health Coach logs and participant report in the STI Treatment section of the questionnaires | at 3-, 6-, and 12-month follow-ups | 
| Acceptance of HIV Testing (Yes/no) | measured by Health Coach report in the Session 1 Sexual Risk questionnaire | at day 1 of enrollment | 
| Any HIV Testing | measured by participant report in the HIV Testing section of the questionnaires | between 6-month and 12-month follow-ups |