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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05605054
Other study ID # 161903
Secondary ID R01MD016959
Status Recruiting
Phase N/A
First received
Last updated
Start date March 17, 2023
Est. completion date April 2027

Study information

Verified date February 2024
Source University of California, San Diego
Contact Victoria Ojeda, PhD, MPH
Phone (858) 822-6165
Email vojeda@health.ucsd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date April 2027
Est. primary completion date July 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
UCSD RELINK
UCSD RELINK coach-guided health literacy intervention and in-person service navigation assistance
Self-study
Self-studying of programmatic information and list of service referrals

Locations

Country Name City State
United States Center for employment opportunities San Diego California
United States San Diego Probation Department San Diego California

Sponsors (2)

Lead Sponsor Collaborator
Victoria D. Ojeda National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Recent Use of Health Services Any healthcare use in the past 6 months (vs. never received services or received services more than 6 months ago) 6 months
Secondary Health Insurance Coverage Defined as uninsured versus any insurance 6 months
Secondary Regular Source of Care Presence of one (or multiple) source(s) of care identified by participants 6 months
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