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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369249
• Other study ID #: 7574
• Secondary ID: R01DA043122
• Status: Completed
• Phase: N/A
• Start date: December 9, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2022
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: December 1, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• HIV/AIDS
• Sexually Transmitted Diseases
• Substance Abuse
• Substance Use
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Link2CARE
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.

Locations

Country	Name	City	State
United States	Kings County Criminal Court	Brooklyn	New York

Sponsors (5)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Center for Court Innovation, Columbia University, National Institute on Drug Abuse (NIDA), The National Center on Addiction and Substance Abuse at Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of HIV+ Young Adults Referred to HIV Treatment	measured by Health Coach report in the Health Coach logs and participant report in the "HIV Referral" section of the questionnaires	at 3-, 6-, and 12-month follow-ups
Other	Number of HIV+ Young Adults Attending at Least One Treatment Appointment	measured by Health Coach report in the Health Coach logs and participant report in the "HIV Treatment" section of the questionnaires	at 3-, 6-, and 12-month follow-ups
Other	Number of Young Adults Behaviorally PrEP Eligible Referred to PrEP/Medical Care	measured by Health Coach report in the Health Coach logs and participant report in the "PrEP Referral" section of the questionnaires	at 3-, 6-, and 12-month follow-ups
Other	Number of Young Adults Behaviorally PrEP Eligible Attending at Least One HIV Care Appointment	measured by Health Coach report in the Health Coach logs and participant report in the "PrEP Uptake" section of the questionnaires	at 3-, 6-, and 12-month follow-ups
Primary	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	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
Secondary	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
Secondary	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
Secondary	Acceptance of STI Testing (Yes/no)	measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire	at day 1 of enrollment
Secondary	Any STI Testing	measured by participant report in the "STI Testing" section of the questionnaires	between 6- and 12-month follow-ups
Secondary	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
Secondary	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
Secondary	Acceptance of HIV Testing (Yes/no)	measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire	at day 1 of enrollment
Secondary	Any HIV Testing	measured by participant report in the "HIV Testing" section of the questionnaires	between 6-month and 12-month follow-ups