Florida Community-Engaged Research Alliance (FL-CEAL)

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.

Study Overview

• Status: Recruiting
• Conditions: Health, Subjective
• Intervention / Treatment: Behavioral: Community health workers (CHW); Behavioral: Educational Materials

• Study Type: Interventional
• Enrollment (Estimated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olveen Carrasquillo, MD; Phone Number: 3052439765; Email: ocarrasquillo@miami.edu
• Study Contact Backup: Name: Victor Cueto, MD; Phone Number: 3052439765; Email: vcueto@miami.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • University of Florida
      • Contact: Carrasquillo, MD; Phone Number: (305) 243-5096; Email: ocarrasquillo@miami.edu
      • Sub-Investigator: Elizabeth Shenkman, PhD
      • Contact: Elizabeth Shenkman, PhD; Phone Number: 352-265-7220; Email: eshenkman@ufl.edu
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Florida Comprehensive Cancer Center
      • Contact: Odedina Folakemi, PhD; Phone Number: 904-953-0853; Email: Odedina.Folakemi@mayo.edu
      • Contact: Olveen Carrasquillo, MD; Phone Number: 3052435096; Email: ocarrasquillo@miami.edu
      • Sub-Investigator: Odedina Folakemi, PhD
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Olveen Carrasquillo
      • Contact: Ana Riccio; Phone Number: 305-243-4480; Email: akr63@miami.edu
      • Sub-Investigator: Victor Cueto
    • Miami, Florida, United States, 33130
      • Recruiting
      • Healthy Little Havana
      • Contact: Olveen Carrasquillo, MD MPH; Phone Number: 3052439765
      • Sub-Investigator: Islara X Souto
      • Contact: Islara X Souto; Phone Number: 786-391-4061; Email: islaraxs@healthylittlehavana.org
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • Florida International University
      • Contact: Olveen Carrasquillo, MD; Phone Number: (305) 243-5096; Email: ocarrasquillo@miami.edu
      • Sub-Investigator: Patria Rojas, PhD
      • Contact: Patria Rojas, PhD; Phone Number: 305-348-7352; Email: proja003@fiu.edu
    • Miami, Florida, United States, 33137
      • Recruiting
      • Health Choice Network
      • Contact: Olveen Carrasquillo, MD; Phone Number: (305) 243-5096; Email: ocarrasquillo@miami.edu
      • Sub-Investigator: Katherine Chung-Bridges, MD, MPH
      • Contact: Katherine Chung-Bridges, MD, MPH; Phone Number: 305-392-8065; Email: KChung@hcnetwork.org
    • Tallahassee, Florida, United States, 32307
      • Not yet recruiting
      • Florida A&M University
      • Contact: Olveen Carrasquillo, MD; Phone Number: (305) 243-5096; Email: ocarrasquillo@miami.edu
      • Contact: Cynthia Harris, PhD; Phone Number: 850-599-3301; Email: cynthia.harris2@famu.edu
      • Sub-Investigator: Cynthia Harris, PhD
      • Sub-Investigator: Sandra Suther, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Site Specific Inclusion Criteria:

University of Miami/ Healthy Little Havana Inclusion Criteria

• Age 18 and over

Health Choice Network/ Broward Community Health Center/ Genesis Community Health Center Inclusion Criteria

• Age 18 and over

Florida International University Inclusion Criteria -Latina Women Age 18 and over

Mayo Clinic Florida Inclusion Criteria

-Age 21 and over

Florida A&M University/ Mother Care Network Inclusion Criteria

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

University of Florida Inclusion Criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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
Active Comparator: Educational material group; Participants in this group will be provided with educational material on health resources for up to 6 months	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI)	In the PWI, each item is rated on a 0-to-10 scale (0 = No satisfaction at all; 10 = Very satisfied).	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of participants health insurance status as measured by CEAL Common Survey 4 (CS4)	Health insurance status will measured by the number of participants who answered yes to the health insurance status	Baseline, 6 months
Change in number of participants having a usual source of care as measured by CEAL Common Survey 4 (CS4)	Having a usual source of care will measured by the number of participants who answered yes to having usual source of care	Baseline, 6 months
Change in number of participants delayed medical care as measured by CEAL Common Survey 4 (CS4)	Delayed medical care will measured by the number of participants who answered yes to having delayed medical care due the cost.	Baseline, 6 months
Food Insecurity as measured by U.S. Department of Agriculture Economic Research Service Questionnaire	Food security status is assigned as follows: Raw score 0-1-High or marginal food security (raw score 1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score zero on the six-item scale) Raw score 2-4-Low food security Raw score 5-6-Very low food security	Baseline, 6 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Westat
• Investigators: Principal Investigator: Olveen Carrasquillo, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Health Determinants
• Additional Relevant MeSH Terms: Health Care Facilities Workforce and Services; Health Personnel; Allied Health Personnel; Community Health Workers
• Other Study ID Numbers: 20240463; OT2HL158287 (U.S. NIH Grant/Contract); 6922-03-COVID-S005 (Other Grant/Funding Number: Westat)

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