Clinical trial NCT06829485: Florida Community-Engaged Research Alliance (FL-CEAL) in Communities Disproportionately Affected by Health Inequities
Official title: Florida Community-Engaged Research Alliance (FL-CEAL) in Communities Disproportionately Affected by Health Inequities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health, Subjective
Keywords: Social Determinants of Health
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Westat
First posted: 2025-02-17
Enrollment: 900
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI)
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in number of participants health insurance status as measured by CEAL Common Survey 4 (CS4)
timeFrame: Baseline, 6 months
measure: Change in number of participants having a usual source of care as measured by CEAL Common Survey 4 (CS4)
timeFrame: Baseline, 6 months
measure: Change in number of participants delayed medical care as measured by CEAL Common Survey 4 (CS4)
timeFrame: Baseline, 6 months
measure: Food Insecurity as measured by U.S. Department of Agriculture Economic Research Service Questionnaire
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: Healthy Little Havana
state: Florida
city: Miami
country: United States
facility: Florida International University
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Miami
country: United States
facility: Health Choice Network
state: Florida
city: Tallahassee
country: United States
facility: Florida A&M University
state: Florida
Study officials:
affiliation: University of Miami
name: Olveen Carrasquillo, MD
role: PRINCIPAL_INVESTIGATOR
References: