Florida Community-Engaged Research Alliance (FL-CEAL)

NCT ID: NCT06829485

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2028-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is learn more about ways to help people with non-medical issues that can affect participant health. The study team will examine if Community Health Workers, members of a community who provide basic health and medical care within communities, are more helpful to people with non-medical issues than simple reading materials on how participants can do it themselves.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Health, Subjective

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Community Health worker Group

Participants in this group will be linked to a community health worker for up to 6 months and also be offered the opportunity to participate in group level activities

Group Type EXPERIMENTAL

Community health workers (CHW)

Intervention Type BEHAVIORAL

Participants will meet with a Community Health Worker (CHW) who will help facilitate and provide personalized navigation to existing resources for addressing health challenges such as food insecurity and access to care. CHW will meet with participants in person or virtually at least three times for approximately 15-60 minutes for over the six month period

Educational material group

Participants in this group will be provided with educational material on health resources for up to 6 months

Group Type ACTIVE_COMPARATOR

Educational Materials

Intervention Type BEHAVIORAL

Participants will receive one time educational materials including information of existing health resources. Participants will be able to review materials at participant discretion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Community health workers (CHW)

Participants will meet with a Community Health Worker (CHW) who will help facilitate and provide personalized navigation to existing resources for addressing health challenges such as food insecurity and access to care. CHW will meet with participants in person or virtually at least three times for approximately 15-60 minutes for over the six month period

Intervention Type BEHAVIORAL

Educational Materials

Participants will receive one time educational materials including information of existing health resources. Participants will be able to review materials at participant discretion.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Individuals living within the target community who do not plan to move out of the community within the next six months
* Having two un-met SDOH needs



* Age 18 and over


* Age 18 and over



-Age 21 and over


* Female minors between the ages 11-14 years
* Black/African American; Hispanic or Non-Hispanic ethnicity


* Women aged 18 and over
* Pregnant and recently post-partum minority women

Exclusion Criteria

* Are unable or unwilling to consent
* Plans to move out of the community during the next six months
* Enrollment in a research study addressing Social Determinants Determinants Of Health (SDOH) in the last three years.
* Prisoners
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Westat

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Olveen Carrasquillo

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Olveen Carrasquillo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Mayo Clinic Florida Comprehensive Cancer Center

Jacksonville, Florida, United States

Site Status RECRUITING

Healthy Little Havana

Miami, Florida, United States

Site Status RECRUITING

Florida International University

Miami, Florida, United States

Site Status NOT_YET_RECRUITING

University of Miami

Miami, Florida, United States

Site Status RECRUITING

Health Choice Network

Miami, Florida, United States

Site Status RECRUITING

Florida A&M University

Tallahassee, Florida, United States

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Olveen Carrasquillo, MD

Role: CONTACT

3052439765

Victor Cueto, MD

Role: CONTACT

3052439765

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Elizabeth Shenkman, PhD

Role: primary

352-265-7220

Carrasquillo, MD

Role: backup

(305) 243-5096

Odedina Folakemi, PhD

Role: primary

904-953-0853

Olveen Carrasquillo, MD

Role: backup

3052435096

Islara X Souto

Role: primary

786-391-4061

Olveen Carrasquillo, MD MPH

Role: backup

3052439765

Patria Rojas, PhD

Role: primary

305-348-7352

Olveen Carrasquillo, MD

Role: backup

(305) 243-5096

Ana Riccio

Role: primary

305-243-4480

Katherine Chung-Bridges, MD, MPH

Role: primary

305-392-8065

Olveen Carrasquillo, MD

Role: backup

(305) 243-5096

Cynthia Harris, PhD

Role: primary

850-599-3301

Olveen Carrasquillo, MD

Role: backup

(305) 243-5096

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

OT2HL158287

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6922-03-COVID-S005

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20240463

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Community Garden Health Block
NCT06455215 RECRUITING NA
CommunityRx-Cardiovascular Disease
NCT06264726 ACTIVE_NOT_RECRUITING NA