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Not yet recruitingNCT06530953Updated Jul 31, 2024

Comparing Two Linkage-to-Care Models for Latinx Immigrant Patients : A Pilot Comparative Clinical Effectiveness Trial

An interventional study of Patient Navigator Model in Chronic Disease, sponsored by University of California, Riverside. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by University of California, Riverside · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this randomized clinical comparative effectiveness trail is to compare the effects of patient navigator models on follow-up care in Latinx and Indigenous Mexican immigrant patient populations. The main question[s] it aims to answer [is/are]:

  • Participants randomized to PN-CHW compared to the PN-CS model will be more likely to follow through with follow-up care referrals
  • Trust will be a driving factor as to why PN-CHW will be a more effective intervention for the patient population.

Researchers will compare patients in a patient navigator community health worker (PN-CHW) intervention to those in a patient navigator clinical staff (PN-CS) intervention to see which model of linkage to care is more effective for follow-up care in the patient population.

Participants will be asked to:

  • Complete a baseline survey about healthcare access
  • Receive calls and text messages from either a CHW or clinical staff
  • Complete a follow up survey
Read the detailed description

The research project will be conducted at a free clinic that serves a primarily Spanish-speaking Latinx patient population in the Inland Southern California region. Patients in this study will be randomized to one of two intervention arms: Arm 1: PN model delivered by CHWs/promotoras and Arm 2: PN model delivered by clinic staff. CHWs who live in the region and work at the free clinic will deliver the PN model for Arm 1 participants. CHWs have a detailed knowledge of local health resources, as well as lived experience of the barriers patients in their community face when accessing healthcare services. Medical students who are volunteer clinic staff will deliver the PN model for Arm 2 participants. Medical students are the doctors in training who provide primary care services to patients at the CVFC under the supervision of well-established physicians. Baseline data and follow-up data at 12 weeks will be collected along with qualitative interviews with patients in both arms of the study.

02

Conditions studied

  • Chronic Disease

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03

In context

Chronic Disease

781 studies on the registry are indexed under Chronic Disease; 144 are open to participants now.

This study's planned enrollment of 50 is below the median of 140 across 582 interventional studies indexed under Chronic Disease.

Browse Chronic Disease studies →

Lead sponsor

University of California, Riverside is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. live in the Coachella Valley, 2) 18 or older, 3) household income less than or equal to or below 200% of federal poverty guidelines, 4) do not currently have health insurance, and 5) have access to a telephone.

Exclusion criteria

Exclusion Criteria:

  • Do not speak English, Spanish or Purépecha (an indigenous dialect spoken among the Purépecha of Mexico).
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Patient Navigator/ Community Health Worker

    The community health worker will contact the participant two days after their initial clinic visit. They will call the participant to offer support and counseling on accessing their follow-up visits with local healthcare system. Additionally, the PN will call 1 day prior to the scheduled appointment to offer support and information to the patient followed by a reminder text the morning of the appointment.

    Behavioral: Patient Navigator Model

  • Active comparator
    Patient Navigator/Clinic Staff

    Clinic staff will contact the participant two days after their initial clinic visit. They will call the participant to offer support and counseling on accessing their follow-up visits with local healthcare system. Additionally, the clinic staff will call 1 day prior to the scheduled appointment to offer support and information to the patient followed by a reminder text the morning of the appointment.

    Behavioral: Patient Navigator Model

Interventions

  • BehavioralPatient Navigator Model

    The patient navigator model is an evidence-based intervention to improve access to healthcare services.

06

What researchers measure

Primary outcomes

  1. Follow up care

    Follow up care for referred healthcare need

    Time frame: 12 weeks post randomization

Secondary outcomes

  1. Trust in physicians

    Trust in physicians measured by 10-item physician trust Scale

    Time frame: 12 weeks post randomization

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — De-identified data will be shared upon request to the study principal investigator.

Supporting information: Clinical study report

Time frame: De-identified data will be available after the completion of main analysis and scientific dissemination.

Access criteria: Interested parties should contact the principal investigator at ann.cheney@medsch.ucr.edu

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2024; primary completion for Jun 2025, 9 months later.

Of 318 non-industry interventional studies with no phase under Chronic Disease, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 33. This study's planned 9 months is below that.

Counting every sponsor, half of 328 studies reached it within 21 months; a quarter within 11 and three quarters within 33.

Chronic Disease covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 28, 2024
First posted
Jul 31, 2024
StartEst.
Sep 1, 2024
Primary completionEst.
Jun 30, 2025
CompletionEst.
Dec 31, 2025
Last update
Jul 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06530953
Lead sponsor
University of California, Riverside
Responsible party
Ann Cheney (Associate Professor, University of California, Riverside) — Principal investigator
First posted
Jul 31, 2024
Start date
Sep 1, 2024 (estimated)
Primary completion
Jun 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jul 31, 2024

Study contacts

Ann M Cheney, PhD
Contact
ann.cheney@medsch.ucr.edu
951-827-2917
Monica Wicker
Contact
IRB@ucr.edu
Ann M Cheney, PhD
principal investigator · Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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