Community health worker support versus self-help materials for people with social needs in Florida communities
Official title: Florida Community-Engaged Research Alliance (FL-CEAL)
Run by University of Miami · NCT06829485 · Data updated 2026-11-12
This project will test whether community health workers help people with unmet social needs more than giving them reading materials, for residents of selected Florida communities.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 13 Years and up |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | University of Miami Academic / other |
| Locations | 7 sites (Gainesville, Florida and 6 other locations) |
| Status | Recruiting |
| Started | March 31, 2025 |
| Main results expected | December 1, 2028 |
| Study ends | December 1, 2028 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT06829485 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are residents of the participating Florida communities who meet the site age criteria and report at least two unmet social determinants of health.
✕Probably not a fit
People without unmet social needs, those planning to move away within six months, or those unable or unwilling to consent are unlikely to receive benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The trial enrolls community members who report at least two unmet social determinants of health (SDOH) needs and who plan to remain in their community for at least six months. Participants receive either one-on-one support from Community Health Workers (CHWs) who connect them to local resources or self-directed educational materials explaining how to address non-medical needs. Study teams at multiple Florida sites collect measures of resource use, unresolved needs, and health-related outcomes over follow-up to compare the two approaches. The initiative includes diverse settings such as Miami, Jacksonville, and Gainesville to reach varied populations.
Why it matters
Potential benefit: If successful, CHW support could reduce unmet social needs and improve access to services that support better health outcomes.
How similar studies have gone: Community health worker programs have shown benefits in other settings for linking people to services and improving some outcomes, but direct comparisons with self-help materials in these specific Florida communities are limited.
Who can join: the full rules
Show full inclusion / exclusion 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 -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 Of Health (SDOH) in the last three years. * Prisoners
Where it's running
-
University of Florida
Gainesville, Florida, United States Recruiting -
Mayo Clinic Florida Comprehensive Cancer Center
Jacksonville, Florida, United States Recruiting -
Healthy Little Havana
Miami, Florida, United States Recruiting -
University of Miami
Miami, Florida, United States Recruiting -
Health Choice Network
Miami, Florida, United States Recruiting -
Florida International University
Miami, Florida, United States Not yet recruiting
Show 1 more location
-
Florida A&M University
Tallahassee, Florida, United States Not yet recruiting
Study contacts
- Principal investigator: Olveen Carrasquillo, MD — University of Miami
- Study coordinator: Olveen Carrasquillo, MD
- Email: ocarrasquillo@miami.edu
- Phone: 3052439765
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Pro-resolving lipid mediators in postmenopausal women with and without breast cancer
This project will test whether levels of certain inflammation-resolving fats made from dietary fatty acids differ between postmenopausal women with or without breast cancer and with or without overweight.
-
Assessing gait using a smartphone application
This study is testing a smartphone app for measuring walking patterns to see if it works as well as traditional methods for healthy young adults.
-
Digital interventions for stress management in breast cancer patients
This study is testing two online programs to help breast cancer patients manage stress and see if they can improve their quality of life compared to a control group.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.