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

NCT ID: NCT03369249

Last Updated: 2023-01-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-09

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV/AIDS HIV Infections Substance Use Substance Abuse Substance Use Disorders Sexually Transmitted Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Link2CARE

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

Group Type EXPERIMENTAL

Link2CARE

Intervention Type 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.

Standard of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)


* Currently employed at the alternative to sentencing program
* Between ages of 18-80

Exclusion Criteria

* Cognitively unable to complete the interview
* HIV positive

Alternative to Sentencing Staff


* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Center for Court Innovation

OTHER

Sponsor Role collaborator

The National Center on Addiction and Substance Abuse at Columbia University

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Katherine Elkington

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Katherine Elkington, PhD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kings County Criminal Court

Brooklyn, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Ertl MM, Jones A, Hickson R, Achebe I, Gyamfi Ertl SL, Sichel CE, Campos S, O'Grady MA, Tross S, Wilson P, Cohall RM, Cohall AT, Elkington KS. Technology Access and Perceptions of Telehealth Services Among Young Adults Involved in the Court System. J Adolesc Health. 2024 Mar;74(3):582-590. doi: 10.1016/j.jadohealth.2023.09.019. Epub 2023 Dec 8.

Reference Type DERIVED
PMID: 38069927 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Cover Sheet

View Document

Document Type: Informed Consent Form: Authorization for the Release of Information

View Document

Document Type: Informed Consent Form: YA IC for Participation in a Study BJI

View Document

Document Type: Informed Consent Form: YA IC for Participation in a Study CASES

View Document

Document Type: Informed Consent Form: HIPAA

View Document

Document Type: Informed Consent Form: YA IC for HIV and/or STI Testing

View Document

Document Type: Informed Consent Form: YA IC for HIV and/or STI Testing at 6 and12 Mo

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DA043122

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7574

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Linkage to Care - Part II
NCT00891644 COMPLETED
Linkage to Care - Part I
NCT00703040 COMPLETED