Health Care UtilizationNCT05605054
UCSD RELINK: Connecting Adults To Supportive Services
A study testing UCSD RELINK and Self-study in people with Health Care Utilization, run by Victoria D. Ojeda at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization
- What is being tested?
- UCSD RELINK and Self-study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Mar 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons, aged 18 and over
- Resident of San Diego County
- Not incarcerated at time of enrollment
- Justice involved in the past 3 years (on parole, probation, court diverted)
- Understands English
- Access to a cell phone
Who cannot join
- Under the age of 18 years old
- Not a resident of San Diego County
- Incarcerated at enrollment
- Not justice-involved within the last 3 years (i.e., not on probation or parole or was court-diverted in the past 3 years)
- No access to a cell phone
- Cannot provide informed consent
Show all 9Show fewer
- Does not understand English
- Previously enrolled in the pilot UCSD RELINK program
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for employment opportunities
San Diego, California, 92101
San Diego Probation Department
San Diego, California, 92104
About this study
Official title: 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)
Read the 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.
- Conditions
- Health Care Utilization
- Being tested
- UCSD RELINK, Self-study
- Keywords
- Justice Involved Adults, Re-entry Population, Health Coaching, Service Navigation
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCSD RELINKBehavioural
UCSD RELINK coach-guided health literacy intervention and in-person service navigation assistance
Self-studyBehavioural
Self-studying of programmatic information and list of service referrals
| Study group | Role | What they receive |
|---|---|---|
| Coach-guided | Experimental | 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. Receives: Behavioral: UCSD RELINK |
| Self study | Active comparator | 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). Receives: Behavioral: Self-study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (2)
Health Insurance Coverage
Defined as uninsured versus any insurance
Measured: 6 months
Regular Source of Care
Presence of one (or multiple) source(s) of care identified by participants
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start17 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Victoria D. Ojeda
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor-investigator, Victoria D. Ojeda, University of California, San Diego
- Investigators
- Victoria Ojeda, PhD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605054
- Sponsor's protocol ID
- 161903
- Other IDs
- R01MD016959
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33980068
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT Testing a Health Literacy Intervention to Reduce Disparities in Access to Care Among Minority Justice-Involved Adults
- ClinicalTrials.gov ID
- NCT05605054
- Acronym / sponsor ID
- 161903
- Conditions
- Health Care Utilization
- Keywords
- Justice Involved Adults, Re-entry Population, Health Coaching, Service Navigation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Victoria D. OjedaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coach-guided | Experimental | Behavioral: UCSD RELINKIn 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. |
| Self study | Active comparator | Behavioral: Self-studySelf-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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Persons, aged 18 and over
- Resident of San Diego County
- Not incarcerated at time of enrollment
Key exclusion criteria (9 listed)
- Under the age of 18 years old
- Not a resident of San Diego County
- Incarcerated at enrollment
- Not justice-involved within the last 3 years (i.e., not on probation or parole or was court-diverted in the past 3 years)
- No access to a cell phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCSD RELINKUCSD RELINK coach-guided health literacy intervention and in-person service navigation assistance | Behavioural | Coach-guided |
| Self-studySelf-studying of programmatic information and list of service referrals | Behavioural | Self study |
Primary outcome
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)
2 secondary outcomes
Health Insurance Coverage
Time frame: 6 months
Regular Source of Care
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Results publication: PubMed 33980068Ojeda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Ojeda, PhD, MPH principal investigator
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UCSD RELINK and Self-study in people with Health Care Utilization, run by Victoria D. Ojeda at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recent Use of Health Services (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05605054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.