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Clinical Trials/NCT03369249
NCT03369249CompletedNot Applicable

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

New York State Psychiatric Institute1 site in 1 country307 target enrollmentStarted: December 9, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
307
Locations
1
Primary Endpoint
Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion 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:

Arms & Interventions

Link2CARE

Experimental

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

Intervention: Link2CARE (Behavioral)

Standard of Care

No Intervention

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

Outcomes

Primary Outcomes

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

  • Frequency of Young Adults Substance Use in Past 30 Days(at 3-, 6-, and 12-month follow-ups)
  • Any STI Testing(between 6- and 12-month follow-ups)
  • Any HIV Testing(between 6-month and 12-month follow-ups)
  • Acceptance of STI Testing (Yes/no)(at day 1 of enrollment)
  • Number of Young Adults Attending Intake Plus One Treatment Session(at 3-, 6-, and 12-month follow-ups)
  • Number of Young Adults Referred to Substance Use Treatment(at 3-, 6-, and 12-month follow-ups)
  • Number of STI+ Young Adults Referred to STI Treatment(at 3-, 6-, and 12-month follow-ups)
  • Number of STI+ Young Adults Attending 1 or More Treatment Appointments(at 3-, 6-, and 12-month follow-ups)
  • Acceptance of HIV Testing (Yes/no)(at day 1 of enrollment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Katherine Elkington

Research Scientist

New York State Psychiatric Institute

Study Sites (1)

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