Clinical trial NCT03369249: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
HIV Infections
Substance Use
Substance Abuse
Substance Use Disorders
Sexually Transmitted Diseases
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Center for Court Innovation
name: The National Center on Addiction and Substance Abuse at Columbia University
name: National Institute on Drug Abuse (NIDA)
name: Columbia University
First posted: 2017-12-11
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Total Number of Unprotected Anal and Vaginal Sex Occasions in Past 3 Months
timeFrame: at 12-month follow-up
Secondary outcomes:
measure: Frequency of Young Adults Substance Use in Past 30 Days
timeFrame: at 3-, 6-, and 12-month follow-ups
measure: Number of Young Adults Referred to Substance Use Treatment
timeFrame: at 3-, 6-, and 12-month follow-ups
measure: Number of Young Adults Attending Intake Plus One Treatment Session
timeFrame: at 3-, 6-, and 12-month follow-ups
measure: Acceptance of STI Testing (Yes/no)
timeFrame: at day 1 of enrollment
measure: Any STI Testing
timeFrame: between 6- and 12-month follow-ups
measure: Number of STI+ Young Adults Referred to STI Treatment
timeFrame: at 3-, 6-, and 12-month follow-ups
measure: Number of STI+ Young Adults Attending 1 or More Treatment Appointments
timeFrame: at 3-, 6-, and 12-month follow-ups
measure: Acceptance of HIV Testing (Yes/no)
timeFrame: at day 1 of enrollment
measure: Any HIV Testing
timeFrame: between 6-month and 12-month follow-ups
Other outcomes:
measure: Number of HIV+ Young Adults Referred to HIV Treatment
timeFrame: at 3-, 6-, and 12-month follow-ups
measure: Number of HIV+ Young Adults Attending at Least One Treatment Appointment
timeFrame: at 3-, 6-, and 12-month follow-ups
measure: Number of Young Adults Behaviorally PrEP Eligible Referred to PrEP/Medical Care
timeFrame: at 3-, 6-, and 12-month follow-ups
measure: Number of Young Adults Behaviorally PrEP Eligible Attending at Least One HIV Care Appointment
timeFrame: at 3-, 6-, and 12-month follow-ups
Locations:
city: Brooklyn
country: United States
facility: Kings County Criminal Court
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Katherine Elkington, PhD
role: PRINCIPAL_INVESTIGATOR
References: