| Registry | NCT06829485 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 900 (Estimated) |
| Sponsor | University of Miami (Other); collaborators: National Heart, Lung, and Blood Institute (NHLBI), Westat |
| Conditions | Health, Subjective |
| Interventions | Community health workers (CHW), Educational Materials (Behavioral) |
| Dates | start 2025-03-31, primary completion 2028-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2025-02-17, last updated 2026-10-01 |
| Locations | 7 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Health, Subjective All trials of Community health workers (CHW) All trials of Educational Materials
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Community Health worker Group | Experimental | Behavioral: Community health workers (CHW) | Participants 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 |
| Educational material group | Active comparator | Behavioral: Educational Materials | Participants in this group will be provided with educational material on health resources for up to 6 months |
Sex: All, ages: 13 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |
NIH grants: OT2HL158287