Clinical trial NCT03584932: Youth Services Navigation Intervention for HIV+ Youth Being Released From or At-risk for Incarceration
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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: Youth,
Criminal justice
Sexual/gender minorities
Navigation
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: University of Chicago
name: Cook County Health & Hospitals System
First posted: 2018-07-12
Enrollment: 106
Sex: MALE
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.


Eligibility criteria: 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

Primary outcomes:
measure: Linkage to HIV care, retention in HIV, adherence to anti-retroviral therapy (ART), and viral suppression
timeFrame: 12 months
Secondary outcomes:
measure: Effects on recidivism, costs and potential cost-offset/effectiveness
timeFrame: 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References: