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Recruiting

NCT Number: NCT06829485

Florida Community-Engaged Research Alliance (FL-CEAL)

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.

Recruiting

Interested in participating?

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Key information

Conditions

Health, Subjective

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community Health Workers (CHW)

Behavioral

Participants 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

Behavioral

Participants will receive one time educational materials including information of existing health resources. Participants will be able to review materials at participant discretion.

Primary outcomes

  1. Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI)

    Time frame: Baseline, 6 months

    In the PWI, each item is rated on a 0-to-10 scale (0 = No satisfaction at all; 10 = Very satisfied).

Secondary outcomes

  1. Change in number of participants health insurance status as measured by CEAL Common Survey 4 (CS4)

    Time frame: Baseline, 6 months

    Health insurance status will measured by the number of participants who answered yes to the health insurance status

  2. Change in number of participants having a usual source of care as measured by CEAL Common Survey 4 (CS4)

    Time frame: Baseline, 6 months

    Having a usual source of care will measured by the number of participants who answered yes to having usual source of care

  3. Change in number of participants delayed medical care as measured by CEAL Common Survey 4 (CS4)

    Time frame: Baseline, 6 months

    Delayed medical care will measured by the number of participants who answered yes to having delayed medical care due the cost.

  4. Food Insecurity as measured by U.S. Department of Agriculture Economic Research Service Questionnaire

    Time frame: Baseline, 6 months

    Food security status is assigned as follows:

    Raw score 0-1-High or marginal food security (raw score 1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score zero on the six-item scale) Raw score 2-4-Low food security Raw score 5-6-Very low food security

Study contacts

Contact information is provided by the study sponsor or research team.

Olveen Carrasquillo, MD

CONTACT

[email protected]

3052439765

Victor Cueto, MD

CONTACT

[email protected]

3052439765

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Westat

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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