NCT03369249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

December 9, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 22, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 18, 2023

Status Verified

December 1, 2022

Enrollment Period

3.8 years

First QC Date

November 30, 2017

Results QC Date

September 27, 2022

Last Update Submit

December 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

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

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

    at 12-month follow-up

Secondary Outcomes (9)

  • Frequency of Young Adults Substance Use in Past 30 Days

    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 Young Adults Attending Intake Plus One Treatment Session

    at 3-, 6-, and 12-month follow-ups

  • Acceptance of STI Testing (Yes/no)

    at day 1 of enrollment

  • Any STI Testing

    between 6- and 12-month follow-ups

  • +4 more secondary outcomes

Other Outcomes (4)

  • Number of HIV+ Young Adults Referred to HIV Treatment

    at 3-, 6-, and 12-month follow-ups

  • Number of HIV+ Young Adults Attending at Least One Treatment Appointment

    at 3-, 6-, and 12-month follow-ups

  • Number of Young Adults Behaviorally PrEP Eligible Referred to PrEP/Medical Care

    at 3-, 6-, and 12-month follow-ups

  • +1 more other outcomes

Study Arms (2)

Link2CARE

EXPERIMENTAL

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

Behavioral: Link2CARE

Standard of Care

NO INTERVENTION

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

Interventions

Link2CAREBEHAVIORAL

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.

Link2CARE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Cognitively unable to complete the interview
  • HIV positive
  • Alternative to Sentencing Staff
  • Currently employed at the alternative to sentencing program
  • Between ages of 18-80
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kings County Criminal Court

Brooklyn, New York, 11201, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV InfectionsSubstance-Related DisordersSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Katherine Elkington
Organization
New York State Psychiatric Institute

Study Officials

  • Katherine Elkington, PhD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

November 30, 2017

First Posted

December 11, 2017

Study Start

December 9, 2017

Primary Completion

September 30, 2021

Study Completion

December 1, 2022

Last Updated

January 18, 2023

Results First Posted

November 22, 2022

Record last verified: 2022-12

Locations