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Youth Services Navigation Intervention for HIV+ Youth Being Released From or At-risk for Incarceration (LINK2)

Primary Purpose

HIV/AIDS

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LINK2 Youth Services Navigation Intervention
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS focused on measuring Youth,, Criminal justice, Sexual/gender minorities, Navigation

Eligibility Criteria

16 Years - 25 Years (Child, Adult)MaleDoes not accept healthy volunteers

If recruited in jail:

  1. Diagnosed HIV+;
  2. at least 18 but younger than 26 (25 and 364 days);
  3. non-cis women;
  4. Fluent in speaking English;
  5. Have an anticipated sentence of no more than 12 months;
  6. Going to live in the State of Illinois, LA County, Kern County, San Diego County, Riverside County, Ventura, County or San Bernardino County

If recruited outside of jail:

  1. Diagnosed HIV+;
  2. at least 16 but younger than 26 (25 and 364 days);
  3. non-cis women;
  4. Fluent in speaking English;
  5. Incarceration or arrest history within the last 12 months of enrollment; or
  6. At risk for incarceration defined as having one or more of the following risk factors: mental illness, substance use disorder, current financial hardship, homelessness, unstable housing in the prior 6 months, foster care or parental incarceration;
  7. Living in the State of Illinois, LA County, Kern County, San Diego County, Riverside County, Ventura County or San Bernardino County

Exclusion Criteria:

1. Inability to give informed consent; 2. Parole hold or transfer to prison

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention arm

Control arm

Arm Description

Subjects participate in a youth service navigation intervention and are eligible to receive contingency management incentives.

Standard of care as set forth by the national HIV care guidelines.

Outcomes

Primary Outcome Measures

Linkage to HIV care, retention in HIV, adherence to anti-retroviral therapy (ART), and viral suppression
Linkage to care HIV care is measured as HIV primary care provider visits; time to 1st post-release HIV care visit. Measures will involve survey and electronic record sources; self-reported measures derived from Outreach Initiative and HCSUS instrument. Retention in HIV care is measured as number of visits and missed visits to HIV primary care providers. Measurement tools include surveys and electronic record sources; self-reported measures derived from the Outreach Initiative and the HCSUS instrument. ART adherence is measured using a visual analogue scale of % (0-100) in surveys. Additional tools include electronic record sources; self-reported measures derived from Outreach Initiative; HCSUS instrument. Viral suppression is deemed undetectable at < 50 copies/ml as defined by the Los Angeles County Department of Public Health. Tools will include survey and electronic record sources and items from the HCSUS instrument and Outreach Initiative.

Secondary Outcome Measures

Effects on recidivism, costs and potential cost-offset/effectiveness
Cost offsets/effectiveness will be measured as number of outpatient HIV/general primary and specialty care; number of mental health and substance abuse treatment visits and stays. Measures will involve electronic data sets for outpatient HIV primary and specialty care; and data sets for mental health and substance abuse treatment visits/stays.

Full Information

First Posted
June 18, 2018
Last Updated
November 18, 2022
Sponsor
University of California, Los Angeles
Collaborators
Children's Hospital Los Angeles, University of Chicago, Cook County Health & Hospitals System
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1. Study Identification

Unique Protocol Identification Number
NCT03584932
Brief Title
Youth Services Navigation Intervention for HIV+ Youth Being Released From or At-risk for Incarceration
Acronym
LINK2
Official Title
Youth Services Navigation Intervention for HIV+ Adolescents and Young Adults Being Released From or at Risk for Incarceration: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Children's Hospital Los Angeles, University of Chicago, Cook County Health & Hospitals System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
HIV prevalence among incarcerated youth living with HIV (YWH) is three times that of the general population and one in seven of all persons with HIV experience incarceration each year. Furthermore, less than half of all youth in the United States with HIV achieve HIV viral load suppression, due to poor retention and adherence to anti-retroviral therapy (ART). Existing linkage and retention services are insufficient to meet the acute needs of youth with HIV who are at risk for incarceration, recently experienced incarceration or arrest, or those nearing reentry from a correctional facility. This holds particularly true in the high-need period following release from incarceration. The LINK2 study will develop and implement a youth service navigation (YSN) intervention to improve linkage and retention among YWH at risk for incarceration and with current incarceration and arrest histories and analyze results to address existing gaps in the literature. The investigators will enroll 142 YWH, aged 16-25 (+364 days), incarcerated in Los Angeles and Chicago jails and through community providers serving those at risk for incarceration and YWH with recent incarceration and arrest histories. The investigators will randomize participants to the YSN intervention (n=71) vs. a usual-care control group (n=71). The youth services navigators (YSNs) will assist with addressing immediate unmet needs such as housing, transportation, and food prior to clinical care and ongoing; will guide intervention participants to a range of community services to support progress along the continuum of HIV care; and will provide direct ART adherence support. The proposed study has two Primary Specific Aims: Adapt an existing peer navigation intervention for adults to create a Youth Service Navigation (YSN) intervention sensitive to sexual and gender minority (SGM) culture that guides youth to needed services along the continuum of HIV care. This intervention combines medical, substance use and mental health care with comprehensive reentry support for YWH, aged 16-25 (+364 days) upon release from large county jails and juvenile detention systems or with arrests in the prior 12 months and those at risk for incarceration based on various social determinants. Using a two-group RCT design, the investigators will test the effectiveness of the new YSN, youth SGM-sensitive intervention among YLWH aged 16-25 (+364 days), compared to controls offered standard of care. The investigators will evaluate the YSN Intervention's effect on post-incarceration linkage, retention, adherence, and viral suppression, as well as on substance use disorders, mental health, services utilization, and met needs. Secondary Aims: The investigators will assess YSN's effects on recidivism, costs and potential cost-offset/effectiveness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Youth,, Criminal justice, Sexual/gender minorities, Navigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Subjects participate in a youth service navigation intervention and are eligible to receive contingency management incentives.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Standard of care as set forth by the national HIV care guidelines.
Intervention Type
Behavioral
Intervention Name(s)
LINK2 Youth Services Navigation Intervention
Intervention Description
There will be 6 in-person sessions delivered by a youth services navigator, plus weekly check-in calls after session 2 for a total of six months. As part of the learning sessions, the participant will learn important information about HIV and how to get the most out of his/her HIV care.
Primary Outcome Measure Information:
Title
Linkage to HIV care, retention in HIV, adherence to anti-retroviral therapy (ART), and viral suppression
Description
Linkage to care HIV care is measured as HIV primary care provider visits; time to 1st post-release HIV care visit. Measures will involve survey and electronic record sources; self-reported measures derived from Outreach Initiative and HCSUS instrument. Retention in HIV care is measured as number of visits and missed visits to HIV primary care providers. Measurement tools include surveys and electronic record sources; self-reported measures derived from the Outreach Initiative and the HCSUS instrument. ART adherence is measured using a visual analogue scale of % (0-100) in surveys. Additional tools include electronic record sources; self-reported measures derived from Outreach Initiative; HCSUS instrument. Viral suppression is deemed undetectable at < 50 copies/ml as defined by the Los Angeles County Department of Public Health. Tools will include survey and electronic record sources and items from the HCSUS instrument and Outreach Initiative.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Effects on recidivism, costs and potential cost-offset/effectiveness
Description
Cost offsets/effectiveness will be measured as number of outpatient HIV/general primary and specialty care; number of mental health and substance abuse treatment visits and stays. Measures will involve electronic data sets for outpatient HIV primary and specialty care; and data sets for mental health and substance abuse treatment visits/stays.
Time Frame
5 years

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Non-cis woman
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
If recruited in jail: Diagnosed HIV+; at least 18 but younger than 26 (25 and 364 days); non-cis women; Fluent in speaking English; Have an anticipated sentence of no more than 12 months; Going to live in the State of Illinois, LA County, Kern County, San Diego County, Riverside County, Ventura County or San Bernardino County If recruited outside of jail: 1) Diagnosed HIV+; 2) At least 16 but younger than 26 (25 and 364 days); 3) Non-cis women; 4) Fluent in speaking English; 5) Incarceration or arrest history within the last 12 months of enrollment; or 6) At risk for incarceration defined as having one or more of the following risk factors: mental illness, substance use disorder, current financial hardship, homelessness, unstable housing in the prior 6 months, foster care or parental incarceration; 7) Living in the State of Illinois, LA County, Kern County, San Diego County, Riverside County, Ventura County or San Bernardino County Exclusion Criteria: 1. Inability to give informed consent; 2. Parole hold or transfer to prison
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Youth Services Navigation Intervention for HIV+ Youth Being Released From or At-risk for Incarceration

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