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Youth Services Navigation Intervention for HIV+ Adolescents and Young Adults Being Released From Incarceration (LINK2)

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ClinicalTrials.gov Identifier: NCT03584932
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
Children's Hospital Los Angeles
University of Chicago
Cook County Health & Hospitals System
Information provided by (Responsible Party):
Nina T. Harawa, MPH, PhD, University of California, Los Angeles

Brief Summary:

HIV prevalence among incarcerated youth living with HIV (YLWH) is three times that of the general population and one in seven of all HIV+ persons experience incarceration each year. Furthermore, only an estimated 6% of HIV+ youth 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 criminal justice-involved (CJI) HIV+ youth, particularly 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 CJI YLWH and analyze results to address existing gaps in the literature.

The investigators will enroll 240 CJI YLWH, aged 16-29 (+364 days), incarcerated in Los Angeles and Chicago jails and through community clinics serving recently released CJI YLWH. Participants will be randomized to the YSN intervention (n=120) vs. a usual-care control group (n=120). 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: 1. 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 CJI YLWH, aged 16-29 (+364 days) upon release from large county jails and juvenile detention systems; 2. Using a two-group RCT design, the study will test the effectiveness of the new YSN, youth SGM-sensitive intervention among CJI YLWH aged 16-29 (+364 days), compared to controls offered standard of care. The study team 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 are to assess the intervention's effects on recidivism, costs and potential cost-offset/effectiveness.


Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: LINK2 Youth Services Navigation Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Youth Services Navigation Intervention for HIV+ Adolescents and Young Adults Being Released From Incarceration: A Randomized Control Trial
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention arm
Subjects participate in a youth service navigation intervention and are eligible to receive contingency management incentives.
Behavioral: LINK2 Youth Services Navigation Intervention
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.

No Intervention: Control arm
Standard of care as set forth by the national HIV care guidelines.



Primary Outcome Measures :
  1. Linkage to HIV care, retention in HIV, adherence to anti-retroviral therapy (ART), and viral suppression [ Time Frame: 12 months ]
    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 :
  1. Effects on recidivism, costs and potential cost-offset/effectiveness [ Time Frame: 5 years ]
    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.



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Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Non-cis woman
Accepts Healthy Volunteers:   No
Criteria

RECRUITED IN JAIL

  1. Diagnosed HIV+;
  2. ages 18-29 and 364 days;
  3. non-cis woman;
  4. English language fluency;
  5. anticipated sentence of no more than 12 months;
  6. Residing in LA County or Cook County upon release

RECRUITED OUTSIDE OF JAIL

  1. Diagnosed HIV+;
  2. ages 16-29 and 364 days;
  3. non-cis woman;
  4. English language fluency;
  5. Incarceration history within the last 90 days of enrollment;
  6. Residing in LA County or Cook County

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584932


Contacts
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Contact: Danielle Seiden, MPP 3107943556 dseiden@mednet.ucla.edu
Contact: Julie McAvoy-Banerjea, MPH 323-361-5023 jmcavoy@chla.usc.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Russell Brewer, Dr.Ph    608-618-6968      
Sponsors and Collaborators
University of California, Los Angeles
Children's Hospital Los Angeles
University of Chicago
Cook County Health & Hospitals System

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Responsible Party: Nina T. Harawa, MPH, PhD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03584932     History of Changes
Other Study ID Numbers: R01MD011773-02 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nina T. Harawa, MPH, PhD, University of California, Los Angeles:
Youth,
Criminal justice
Sexual/gender minorities
Navigation