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Completed

NCT Number: NCT03584932

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

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:

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 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. 2. 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.

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Coitus Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexual Behavior Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

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

Treatment and study plan

LINK2 Youth Services Navigation Intervention

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Children's Hospital Los Angeles
  • Cook County Health & Hospitals System
  • University of Chicago

Registry information

Official study title

Youth Services Navigation Intervention for HIV+ Adolescents and Young Adults Being Released From or at Risk for Incarceration: A Randomized Control Trial

Acronym: LINK2

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2018
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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