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Florida Community-Engaged Research Alliance (FL-CEAL)

Florida Community-Engaged Research Alliance (FL-CEAL)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06829485
Enrollment
900
Registered
2025-02-17
Start date
2025-03-31
Completion date
2028-12-01
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health, Subjective

Keywords

Health Determinants

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 themselves.

Interventions

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

BEHAVIORALEducational Materials

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Westat
CollaboratorOTHER
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in number of participants health insurance status as measured by CEAL Common Survey 4 (CS4)Baseline, 6 monthsHealth 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 monthsHaving 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 monthsDelayed 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 QuestionnaireBaseline, 6 monthsFood 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

Countries

United States

Contacts

Primary ContactOlveen Carrasquillo, MD
ocarrasquillo@miami.edu3052439765
Backup ContactVictor Cueto, MD
vcueto@miami.edu3052439765

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026