Community health worker support versus self-help materials for people with social needs in Florida communities

Florida Community-Engaged Research Alliance (FL-CEAL)

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 900 (estimated)
• Ages: 13 Years and up
• Sex: All
• Sponsor: University of Miami (Academic / other)
• Locations: 7 sites (Gainesville, Florida and 6 other locations)
• Trial ID: NCT06829485 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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 -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

Where this trial is running

Gainesville, Florida and 6 other locations

• 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)
• Florida International University — Miami, Florida, United States (Not_yet_recruiting)
• University of Miami — Miami, Florida, United States (Recruiting)
• Health Choice Network — Miami, Florida, United States (Recruiting)
• 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

Conditions Health, Subjective; Health Determinants