Florida Community-Engaged Research Alliance (FL-CEAL)
Part of paid clinical trials in Gainesville, Florida.
- Sponsor
- University of Miami
- Study ID
- NCT06829485
- Status
- Recruiting
Conditions
- Health, Subjective
Eligibility Criteria
- Sex
- ALL
- Age
- 13 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Community health workers (CHW) — BEHAVIORALParticipants 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
- Educational Materials — BEHAVIORALParticipants will receive one time educational materials including information of existing health resources. Participants will be able to review materials at participant discretion.
Study Details
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.
Key Dates
- Start date
- Mar 31, 2025
- Status verified
- Sep 2025
- Primary completion
- Dec 1, 2028
- Completion
- Dec 1, 2028
Study Design
- Enrollment
- 900 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Community Health worker GroupParticipants in this group will be linked to a community health worker for up to 6 months and also be offered the opportunity to participate in group level activities
- Active Comparator: Educational material groupParticipants in this group will be provided with educational material on health resources for up to 6 months
Primary Outcome Measure
Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI) [ Time Frame: Baseline, 6 months ]
Central Contacts
- Olveen Carrasquillo, MD3052439765
- Victor Cueto, MD3052439765
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | Elizabeth Shenkman, PhD (SUB_INVESTIGATOR) |
| Mayo Clinic Florida Comprehensive Cancer Center | Jacksonville | Florida | 32224 | Odedina Folakemi, PhD (SUB_INVESTIGATOR) |
| Florida International University | Miami | Florida | 33136 | Patria Rojas, PhD (SUB_INVESTIGATOR) |
| Health Choice Network | Miami | Florida | 33137 | Katherine Chung-Bridges, MD, MPH (SUB_INVESTIGATOR) |
| Healthy Little Havana | Miami | Florida | 33130 | Olveen Carrasquillo, MD MPH 3052439765 Islara X Souto (SUB_INVESTIGATOR) |
| University of Miami | Miami | Florida | 33136 | Victor Cueto (SUB_INVESTIGATOR) Olveen Carrasquillo (PRINCIPAL_INVESTIGATOR) |
| Florida A&M University | Tallahassee | Florida | 32307 | Cynthia Harris, PhD (SUB_INVESTIGATOR) Sandra Suther, PhD (SUB_INVESTIGATOR) |