Recruiting

Community Health Workers

Sponsor:

University of Miami

Code:

NCT06829485

Conditions

Health, Subjective

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

Interventions

Community health workers (CHW)

Educational Materials

Study Details

Brief summary:

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.

Conditions

Health, Subjective

Study ID

NCT06829485

Start date

Mar 31, 2025

Status verified date

Sep, 2025

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Community Health worker Group

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

active comparator: Educational material group

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

Interventions

Community health workers (CHW)

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

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

Primary outcome measure

  • Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI) [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Olveen Carrasquillo, MD

3052439765ocarrasquillo@miami.edu

Victor Cueto, MD

3052439765vcueto@miami.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Elizabeth Shenkman, PhD

352-265-7220eshenkman@ufl.edu

Carrasquillo, MD

(305) 243-5096ocarrasquillo@miami.edu

Mayo Clinic Florida Comprehensive Cancer Center

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Odedina Folakemi, PhD

904-953-0853Odedina.Folakemi@mayo.edu

Olveen Carrasquillo, MD

3052435096ocarrasquillo@miami.edu

Healthy Little Havana

Recruiting

Miami, Florida, United States, 33130

Contacts

Islara X Souto

786-391-4061islaraxs@healthylittlehavana.org

Olveen Carrasquillo, MD MPH

3052439765

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Ana Riccio

305-243-4480akr63@miami.edu

Principal Investigator:

Olveen Carrasquillo

Health Choice Network

Recruiting

Miami, Florida, United States, 33137

Contacts

Katherine Chung-Bridges, MD, MPH

305-392-8065KChung@hcnetwork.org

Olveen Carrasquillo, MD

(305) 243-5096ocarrasquillo@miami.edu

More Information

Sponsor

University of Miami

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

  • Health Determinants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-09-11.