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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Sexually Transmitted Diseases; HIV/AIDS; Substance Use; Substance Use Disorders; Substance Abuse
• Intervention / Treatment: Behavioral: Link2CARE

• Study Type: Interventional
• Enrollment (Actual): 307
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11201
      • Kings County Criminal Court

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Link2CARE; This arm is comprised of participants randomized to the 4-session Link2CARE 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.
No Intervention: Standard of Care; This arm is comprised of participants who will not receive the 4-session Link2CARE intervention.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute on Drug Abuse (NIDA); Columbia University; Center for Court Innovation; The National Center on Addiction and Substance Abuse at Columbia University
• Investigators: Principal Investigator: Katherine Elkington, PhD, New York State Psychiatric Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2017
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Substance-Related Disorders; Sexually Transmitted Diseases
• Other Study ID Numbers: 7574; R01DA043122 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No