Actively Recruiting

Phase Not Applicable
Age: 13Years +
All Genders
Healthy Volunteers
ID06829485

Florida Community-Engaged Research Alliance (FL-CEAL) Study Evaluating Community Health Workers Versus Educational Materials For Supporting People with Non-Medical Health Challenges

Led by University of Miami · Updated on 2025-09-11

900

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Miami

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to learn more about ways to support people facing non-medical challenges that affect their health. It focuses on whether Community Health Workers, who are local members providing basic health and medical assistance, can be more helpful than simply giving people educational materials to manage these issues on their own. Participants will be randomly assigned to one of two groups. One group will be connected with a Community Health Worker for up to six months, meeting at least three times either in person or virtually to receive personalized help with health challenges like food insecurity and accessing care. The other group will receive educational materials about health resources to review at their own pace. During the study, researchers will measure changes in participants' general well-being using the Personal Wellbeing Index at the start and after six months. They will also track changes in health insurance status, access to usual care, delays in medical care, and food insecurity. Participants' progress will be monitored over the six-month period to understand the impact of the support provided.

CONDITIONS

Brief Title

Florida Community-Engaged Research Alliance (FL-CEAL)

Who Can Participate

Age: 13Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals living in the target community who do not plan to move out within the next six months
  • Have at least two unmet social or health-related needs
  • Age 18 or over for most sites except:
  • Female minors aged 11-14 years at Florida A&M University/Mother Care Network
  • Black/African American or Hispanic ethnicity at Florida A&M University/Mother Care Network
  • Women aged 18 and over at University of Florida including pregnant and recently postpartum minority women
  • Able to consent to participate
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide consent
  • Plans to move out of the community during the next six months
  • Enrolled in a research study addressing social determinants of health in the last three years
  • Prisoners

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - Up to 6 months

Participants receive support through either community health workers or educational materials to help address non-medical health challenges.

At least 3 meetings with a community health worker or one-time receipt of educational materials

Trial Site Locations

Total: 7 locations

1

University of Florida

Gainesville, Florida, United States, 32611

Actively Recruiting

2

Mayo Clinic Florida Comprehensive Cancer Center

Jacksonville, Florida, United States, 32224

Actively Recruiting

3

Healthy Little Havana

Miami, Florida, United States, 33130

Actively Recruiting

4

Florida International University

Miami, Florida, United States, 33136

Not Yet Recruiting

5

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

6

Health Choice Network

Miami, Florida, United States, 33137

Actively Recruiting

7

Florida A&M University

Tallahassee, Florida, United States, 32307

Not Yet Recruiting

Loading map...

Research Team

O

Olveen Carrasquillo, MD

V

Victor Cueto, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Similar Trials

A Phase I, Randomized, Double-Blind, Placebo-Controlled Stud...

Health, Subjective

Actively Recruiting

1 location

Coping After Breast Cancer - CABC - Stressmestring Etter Bry...

Breast Cancer Patients

Actively Recruiting

1 location

Validity and Reliability of a Smartphone Application for Gai...

Health, Subjective

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here