Florida Community-Engaged Research Alliance (FL-CEAL) in Communities Disproportionately Affected by Health Inequities

Not Applicable

Not yet recruiting

• Conditions: Health, Subjective

• Registration Number: NCT06829485
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-11
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-17
• Last Update Posted: 2025-02-17
• Study Start: 2025-05-01
• Primary Completion: 2028-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 900

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

• Age 50 and over
• Individuals who identify as Lesbian, Gay, Bisexual, Transsexual (LGBT)

Mayo Clinic Florida Inclusion Criteria

• Age 21 and over
• Black/African American; Hispanic or Non-Hispanic ethnicity

Florida A&M University/ Mother Care Network Inclusion Criteria

• Women between the ages 13-19 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
• Black/African American or Caucasian race; Hispanic or Non-Hispanic ethnicity
• Are uninsured or underinsured

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in number of participants health insurance status as measured by CEAL Common Survey 4 (CS4)	Baseline, 6 months	Health insurance status will measured by the number of participants who answered yes to the health insurance status
Change in number of participants having a usual source of care as measured by CEAL Common Survey 4 (CS4)	Baseline, 6 months	Having a usual source of care will measured by the number of participants who answered yes to having usual source of care
Change in number of participants delayed medical care as measured by CEAL Common Survey 4 (CS4)	Baseline, 6 months	Delayed medical care will measured by the number of participants who answered yes to having delayed medical care due the cost.
Food Insecurity as measured by U.S. Department of Agriculture Economic Research Service Questionnaire	Baseline, 6 months	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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States