UCSD RELINK: Connecting Adults To Supportive Services

July 14, 2026 updated by: Victoria D. Ojeda

An RCT Testing a Health Literacy Intervention to Reduce Disparities in Access to Care Among Minority Justice-Involved Adults

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92101
        • Center for employment opportunities
      • San Diego, California, United States, 92104
        • San Diego Probation Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Coach-guided
In person or phone call with an assigned Health Coach for about 1 hour per week for 12 weeks to complete the Health Literacy course, and with an assigned Service Navigator for 30 minutes per week for 12 weeks to address health and social service needs.
Behavioral: UCSD RELINK
UCSD RELINK coach-guided health literacy intervention and in-person service navigation assistance
Active Comparator: Self study
Self-guided printed or online version of the Health Literacy course (approximately 1 hour per week for 12 weeks) and comprehensive Service Navigation report with recommended referrals to services, providers, and contact information for service providers so that the participant can access these resources independently (i.e., without Navigator assistance).
Behavioral: Self-study
Self-studying of programmatic information and list of service referrals

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recent Use of Health Services
Time Frame: 6 months
Any healthcare use in the past 6 months (vs. never received services or received services more than 6 months ago)
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health Insurance Coverage
Time Frame: 6 months
Defined as uninsured versus any insurance
6 months
Regular Source of Care
Time Frame: 6 months
Presence of one (or multiple) source(s) of care identified by participants
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Victoria D. Ojeda

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Victoria Ojeda, PhD, MPH, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 161903
  • R01MD016959 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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