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Completed

NCT Number: NCT03369249

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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Disease Attributes Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance Abuse Substance Use Substance Use Disorders Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kings County Criminal Court

Brooklyn, New York, 11201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Link2CARE

Behavioral

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 outcomes

  1. Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months

    Time frame: at 12-month follow-up

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

Secondary outcomes

  1. Frequency of Young Adults Substance Use in Past 30 Days

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: at day 1 of enrollment

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

  5. Any STI Testing

    Time frame: 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

    Time frame: 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

    Time frame: 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

  8. Acceptance of HIV Testing (Yes/no)

    Time frame: at day 1 of enrollment

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

  9. Any HIV Testing

    Time frame: between 6-month and 12-month follow-ups

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

Other outcomes

  1. Number of HIV+ Young Adults Referred to HIV Treatment

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Dec 11, 2017
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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