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

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03369249
Collaborator
Center for Court Innovation (Other), The National Center on Addiction and Substance Abuse at Columbia University (Other), National Institute on Drug Abuse (NIDA) (NIH), Columbia University (Other)
465
1
2
59.7
7.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Link2CARE
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
465 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)
Actual Study Start Date :
Dec 9, 2017
Actual Primary Completion Date :
Sep 30, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. total number of unprotected anal and vaginal sex occasions in past 3 months [at 12-month follow-up]

    measured by participant report in the "Sexual Risk" section of the questionnaires

  2. acceptance of HIV testing (yes/no) [at day 1 of enrollment]

    measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire

  3. any HIV testing [between 6-month and 12-month follow-ups]

    measured by participant report in the "HIV Testing" section of the questionnaires

Secondary Outcome Measures

  1. frequency of young adults substance use in past 30 days [at 3-, 6-, and 12-month follow-ups]

    measured by participant report in the "Substance Use" section of the questionnaires

  2. number of young adults referred to substance use treatment [at 3-, 6-, and 12-month follow-ups]

    measured by Health Coach report in the Health Coach logs and participant report in the "Substance Use Referral" section of the questionnaires

  3. number of young adults attending intake plus one treatment session [at 3-, 6-, and 12-month follow-ups]

    measured by Health Coach report in the Health Coach logs and participant report in the "Substance Use Treatment" section of the questionnaires

  4. acceptance of STI testing (yes/no) [at day 1 of enrollment]

    measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire

  5. any STI testing [between 6- and 12-month follow-ups]

    measured by participant report in the "STI Testing" section of the questionnaires

  6. number of STI+ young adults referred to STI treatment [at 3-, 6-, and 12-month follow-ups]

    measured by the Health Coach report in the Health Coach Logs and participant report in the "STI Referral" section of the questionnaires

  7. number of STI+ young adults attending 1 or more treatment appointments [at 3-, 6-, and 12-month follow-ups]

    measured by Health Coach report in the Health Coach logs and participant report in the "STI Treatment" section of the questionnaires

Other Outcome Measures

  1. number of HIV+ young adults referred to HIV treatment [at 3-, 6-, and 12-month follow-ups]

    measured by Health Coach report in the Health Coach logs and participant report in the "HIV Referral" section of the questionnaires

  2. number of HIV+ young adults attending at least one treatment appointment [at 3-, 6-, and 12-month follow-ups]

    measured by Health Coach report in the Health Coach logs and participant report in the "HIV Treatment" section of the questionnaires

  3. number of young adults behaviorally PrEP eligible referred to PrEP/medical care [at 3-, 6-, and 12-month follow-ups]

    measured by Health Coach report in the Health Coach logs and participant report in the "PrEP Referral" section of the questionnaires

  4. number of young adults behaviorally PrEP eligible attending at least one HIV care appointment [at 3-, 6-, and 12-month follow-ups]

    measured by Health Coach report in the Health Coach logs and participant report in the "PrEP Uptake" section of the questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kings County Criminal Court Brooklyn New York United States 11201

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Katherine Elkington, PhD, New York State Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katherine Elkington, Research Scientist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT03369249
Other Study ID Numbers:
  • 7574
  • R01DA043122
First Posted:
Dec 11, 2017
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2022