Florida Community-Engaged Research Alliance (FL-CEAL) in Communities Disproportionately Affected by Health Inequities

University of Miami

Status: Not yet enrolling

Conditions: Health, Subjective

Treatments: Behavioral: Educational Materials; Behavioral: Community health workers (CHW)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06829485

OT2HL158287 (U.S. NIH Grant/Contract)

20240463

6922-03-COVID-S005 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: 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

• Age 50 and over
• Individuals who identify as Lesbian, Gay, Bisexual, Transsexual (LGBT)

Mayo Clinic Florida Inclusion Criteria

• Age 21 and over
• Black/African American; Hispanic or Non-Hispanic ethnicity

Florida A&M University/ Mother Care Network Inclusion Criteria

• Women between the ages 13-19 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
• Black/African American or Caucasian race; Hispanic or Non-Hispanic ethnicity
• Are uninsured or underinsured

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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900 participants in 2 patient groups

Community Health worker Group

Experimental group

Description:

Participants in this group will be linked to a community health worker for up to 6 months

Treatment:

Behavioral: Community health workers (CHW)

Educational material group

Active Comparator group

Description:

Participants in this group will be provided with educational material on Social Determinants of health resources for up to 6 months

Treatment:

Behavioral: Educational Materials