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

Primary Purpose

HIV/AIDS, HIV Infections, Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Link2CARE
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kings County Criminal Court

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Link2CARE

Standard of Care

Arm Description

This arm is comprised of participants randomized to the 4-session Link2CARE intervention.

This arm is comprised of participants who will not receive the 4-session Link2CARE intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Frequency of Young Adults Substance Use in Past 30 Days
measured by participant report in the "Substance Use" section of the questionnaires
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
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
Acceptance of STI Testing (Yes/no)
measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire
Any STI Testing
measured by participant report in the "STI Testing" section of the questionnaires
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
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
Acceptance of HIV Testing (Yes/no)
measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire
Any HIV Testing
measured by participant report in the "HIV Testing" section of the questionnaires

Full Information

First Posted
November 30, 2017
Last Updated
December 21, 2022
Sponsor
New York State Psychiatric Institute
Collaborators
Center for Court Innovation, The National Center on Addiction and Substance Abuse at Columbia University, National Institute on Drug Abuse (NIDA), Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03369249
Brief Title
Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)
Official Title
Health and Justice: A Continuum of Care for HIV and SU for Justice-Involved Young Adults (PHASE 2)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2017 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Center for Court Innovation, The National Center on Addiction and Substance Abuse at Columbia University, National Institute on Drug Abuse (NIDA), Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, HIV Infections, Substance Use, Substance Abuse, Substance Use Disorders, Sexually Transmitted Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Link2CARE
Arm Type
Experimental
Arm Description
This arm is comprised of participants randomized to the 4-session Link2CARE intervention.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
This arm is comprised of participants who will not receive the 4-session Link2CARE intervention.
Intervention Type
Behavioral
Intervention Name(s)
Link2CARE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months
Description
measured by participant report in the "Sexual Risk" section of the questionnaires
Time Frame
at 12-month follow-up
Secondary Outcome Measure Information:
Title
Frequency of Young Adults Substance Use in Past 30 Days
Description
measured by participant report in the "Substance Use" section of the questionnaires
Time Frame
at 3-, 6-, and 12-month follow-ups
Title
Number of Young Adults Referred to Substance Use Treatment
Description
measured by Health Coach report in the Health Coach logs and participant report in the "Substance Use Referral" section of the questionnaires
Time Frame
at 3-, 6-, and 12-month follow-ups
Title
Number of Young Adults Attending Intake Plus One Treatment Session
Description
measured by Health Coach report in the Health Coach logs and participant report in the "Substance Use Treatment" section of the questionnaires
Time Frame
at 3-, 6-, and 12-month follow-ups
Title
Acceptance of STI Testing (Yes/no)
Description
measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire
Time Frame
at day 1 of enrollment
Title
Any STI Testing
Description
measured by participant report in the "STI Testing" section of the questionnaires
Time Frame
between 6- and 12-month follow-ups
Title
Number of STI+ Young Adults Referred to STI Treatment
Description
measured by the Health Coach report in the Health Coach Logs and participant report in the "STI Referral" section of the questionnaires
Time Frame
at 3-, 6-, and 12-month follow-ups
Title
Number of STI+ Young Adults Attending 1 or More Treatment Appointments
Description
measured by Health Coach report in the Health Coach logs and participant report in the "STI Treatment" section of the questionnaires
Time Frame
at 3-, 6-, and 12-month follow-ups
Title
Acceptance of HIV Testing (Yes/no)
Description
measured by Health Coach report in the "Session 1 Sexual Risk" questionnaire
Time Frame
at day 1 of enrollment
Title
Any HIV Testing
Description
measured by participant report in the "HIV Testing" section of the questionnaires
Time Frame
between 6-month and 12-month follow-ups
Other Pre-specified Outcome Measures:
Title
Number of HIV+ Young Adults Referred to HIV Treatment
Description
measured by Health Coach report in the Health Coach logs and participant report in the "HIV Referral" section of the questionnaires
Time Frame
at 3-, 6-, and 12-month follow-ups
Title
Number of HIV+ Young Adults Attending at Least One Treatment Appointment
Description
measured by Health Coach report in the Health Coach logs and participant report in the "HIV Treatment" section of the questionnaires
Time Frame
at 3-, 6-, and 12-month follow-ups
Title
Number of Young Adults Behaviorally PrEP Eligible Referred to PrEP/Medical Care
Description
measured by Health Coach report in the Health Coach logs and participant report in the "PrEP Referral" section of the questionnaires
Time Frame
at 3-, 6-, and 12-month follow-ups
Title
Number of Young Adults Behaviorally PrEP Eligible Attending at Least One HIV Care Appointment
Description
measured by Health Coach report in the Health Coach logs and participant report in the "PrEP Uptake" section of the questionnaires
Time Frame
at 3-, 6-, and 12-month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine Elkington, PhD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kings County Criminal Court
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States

12. IPD Sharing Statement

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

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