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

December 21, 2022 updated by: Katherine Elkington, New York State Psychiatric Institute
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
307

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11201
        • Kings County Criminal Court

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
at 12-month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
at 3-, 6-, and 12-month follow-ups
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
at 3-, 6-, and 12-month follow-ups
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
at 3-, 6-, and 12-month follow-ups
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
at day 1 of enrollment
Any STI Testing
Time Frame: between 6- and 12-month follow-ups
measured by participant report in the "STI Testing" section of the questionnaires
between 6- and 12-month follow-ups
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
at 3-, 6-, and 12-month follow-ups
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
at 3-, 6-, and 12-month follow-ups
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
at day 1 of enrollment
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
between 6-month and 12-month follow-ups

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
at 3-, 6-, and 12-month follow-ups
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
at 3-, 6-, and 12-month follow-ups
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
at 3-, 6-, and 12-month follow-ups
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
at 3-, 6-, and 12-month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York State Psychiatric Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Columbia University
Center for Court Innovation
The National Center on Addiction and Substance Abuse at Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine Elkington, PhD, New York State Psychiatric Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7574
  • R01DA043122 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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