Clinical trial NCT05605054: UCSD RELINK: Connecting Adults To Supportive Services
Official title: An RCT Testing a Health Literacy Intervention to Reduce Disparities in Access to Care Among Minority Justice-Involved Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Care Utilization
Keywords: Justice Involved Adults
Re-entry Population
Health Coaching
Service Navigation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-11-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this randomized intervention study is to learn about effective health literacy teaching methods in Justice Involved Adults (JIA).

Researchers will compare coach-guided health literacy or self-study design to see if there is a difference in the access and use of healthcare in this population.

The main questions it aims to answer are:

* Will this improve access and use of heath services?
* Will this improve health insurance coverage and long term use of health services?

Participants will:

* Meet with a health coach and service navigator during 12 sessions or meet with service navigator and complete online training over 12 weeks.
* Complete surveys at different time (6months, 1 year)

Detailed description: Health literacy refers to the skills needed to effectively access, understand, and use health resources. Inadequate health literacy annually costs the U.S. $100-$200 billion and is observed among justice involved adults (JIA)-a group of \~20 million U.S. persons who are disproportionately non-elderly and African American, Black, and Hispanic due to systemic racism and over-policing. JIA face numerous barriers in accessing healthcare which contributes to a high, lifelong burden of chronic and infectious disease. Healthcare access is defined as 1) having health insurance coverage, 2) having a regular source of care and 3) obtaining healthcare in a timely manner. Health literacy interventions for JIA are critically needed but are unavailable and NIH-funded research that is inclusive of JIA is sorely lacking. This timely study addresses these gaps. This study will implement a longitudinal mixed-methods randomized clinical trial (RCT) to assess the impact of the UCSD RELINK coach-guided health literacy intervention vs. a self-study control group on JIA's healthcare access. To achieve this aim, 300 JIA ages 18+ will be recruited in San Diego, CA and randomized 1:1 to the Treatment Group (i.e., coach-guided health literacy intervention) or the Control Group (i.e., self-study of the intervention). This study is timely and may inform health literacy interventions for JIA, policies to build health literacy among JIA in institutional and community settings, and the service delivery models for JIA. The proposed intervention has great potential for increasing health literacy among JIA and thus improving the well-being of this sizeable and underserved community. Findings from this study may also have relevance for interventions seeking to build the health literacy of other low-income communities.

Eligibility criteria: Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Persons, aged 18 and over
4. Resident of San Diego County
5. Not incarcerated at time of enrollment
6. Justice involved in the past 3 years (on parole, probation, court diverted)
7. Understands English
8. Access to a cell phone

Exclusion Criteria:

1. Under the age of 18 years old
2. Not a resident of San Diego County
3. Incarcerated at enrollment
4. Not justice-involved within the last 3 years (i.e., not on probation or parole or was court-diverted in the past 3 years)
5. No access to a cell phone
6. Cannot provide informed consent
7. Does not understand English
8. Previously enrolled in the pilot UCSD RELINK program
9. Adults who have current or prior convictions related to sexual violence/abuse (Penal Code \[PC\] 290), lewd acts with a child (PC 288), child abduction (PC 280), or arson (PC 451)

Primary outcomes:
measure: Recent Use of Health Services
timeFrame: 6 months
Secondary outcomes:
measure: Health Insurance Coverage
timeFrame: 6 months
measure: Regular Source of Care
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Center for employment opportunities
state: California
city: San Diego
country: United States
facility: San Diego Probation Department
state: California
Study officials:
affiliation: University of California, San Diego
name: Victoria Ojeda, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ojeda VD, Berliant E, Parker T, Lyles M, Edwards TM, Jimenez C, Linke S, Hiller-Venegas S, Lister Z. Overview of a Pilot Health-focused Reentry Program for Racial/Ethnic Minority Probationers ages 18 to 26 in Southern California. Int J Offender Ther Comp Criminol. 2022 Sep;66(12):1303-1326. doi: 10.1177/0306624X211013739. Epub 2021 May 12.