Health, SubjectiveNCT06829485
Florida Community-Engaged Research Alliance (FL-CEAL)
A study testing Community health workers (CHW) and Educational Materials in people with Health, Subjective, run by University of Miami at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health, Subjective
- What is being tested?
- Community health workers (CHW) and Educational Materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 7 sitesUnited States
- Study dates
- 31 Mar 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32611
Elizabeth Shenkman, PhD, (352) 265-7220, eshenkman@ufl.edu
Carrasquillo, MD, (305) 243-5096, ocarrasquillo@miami.edu
- Recruiting
Mayo Clinic Florida Comprehensive Cancer Center
Jacksonville, Florida, 32224
Odedina Folakemi, PhD, 904-953-0853, Odedina.Folakemi@mayo.edu
Olveen Carrasquillo, MD, 3052435096, ocarrasquillo@miami.edu
- Recruiting
Healthy Little Havana
Miami, Florida, 33130
Islara X Souto, (786) 391-4061, islaraxs@healthylittlehavana.org
Olveen Carrasquillo, MD MPH, 3052439765
- Not yet recruiting
Florida International University
Miami, Florida, 33136
Patria Rojas, PhD, 3053487352, proja003@fiu.edu
Olveen Carrasquillo, MD, (305) 243-5096, ocarrasquillo@miami.edu
- Recruiting
University of Miami
Miami, Florida, 33136
Ana Riccio, 3052434480, akr63@miami.edu
Victor Cueto
- Recruiting
Health Choice Network
Miami, Florida, 33137
Katherine Chung-Bridges, MD, MPH, (305)392-8065, KChung@hcnetwork.org
Olveen Carrasquillo, MD, (305) 243-5096, ocarrasquillo@miami.edu
- Not yet recruiting
Florida A&M University
Tallahassee, Florida, 32307
Cynthia Harris, PhD, 850-599-3301, cynthia.harris2@famu.edu
Olveen Carrasquillo, MD, (305) 243-5096, ocarrasquillo@miami.edu
About this study
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
- Being tested
- Community health workers (CHW), Educational Materials
- Keywords
- Health Determinants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community health workers (CHW)Behavioural
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 MaterialsBehavioural
Participants will receive one time educational materials including information of existing health resources. Participants will be able to review materials at participant discretion.
| Study group | Role | What they receive |
|---|---|---|
| Community Health worker Group | Experimental | 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 Receives: Behavioral: Community health workers (CHW) |
| Educational material group | Active comparator | Participants in this group will be provided with educational material on health resources for up to 6 months Receives: Behavioral: Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI)
In the PWI, each item is rated on a 0-to-10 scale (0 = No satisfaction at all; 10 = Very satisfied).
Measured: Baseline, 6 months
Secondary outcomes (4)
Change in number of participants health insurance status as measured by CEAL Common Survey 4 (CS4)
Health insurance status will measured by the number of participants who answered yes to the health insurance status
Measured: Baseline, 6 months
Change in number of participants having a usual source of care as measured by CEAL Common Survey 4 (CS4)
Having a usual source of care will measured by the number of participants who answered yes to having usual source of care
Measured: Baseline, 6 months
Change in number of participants delayed medical care as measured by CEAL Common Survey 4 (CS4)
Delayed medical care will measured by the number of participants who answered yes to having delayed medical care due the cost.
Measured: Baseline, 6 months
Food Insecurity as measured by U.S. Department of Agriculture Economic Research Service Questionnaire
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
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start31 Mar 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health, SubjectiveStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Westat
- Responsible party
- Principal investigator, Olveen Carrasquillo, University of Miami
- Investigators
- Olveen Carrasquillo, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829485
- Sponsor's protocol ID
- 20240463
- Other IDs
- OT2HL158287, 6922-03-COVID-S005
- Status last verified
- Sep 2026
- First submitted
- 11 Feb 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Florida Community-Engaged Research Alliance (FL-CEAL)
- ClinicalTrials.gov ID
- NCT06829485
- Acronym / sponsor ID
- 20240463
- Conditions
- Health, Subjective
- Keywords
- Health Determinants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Westat
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 MaterialsParticipants in this group will be provided with educational material on health resources for up to 6 months |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Community Health worker Group |
| Educational MaterialsParticipants will receive one time educational materials including information of existing health resources. Participants will be able to review materials at participant discretion. | Behavioural | Educational material group |
Primary outcome
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).
4 secondary outcomes
Change in number of participants health insurance status as measured by CEAL Common Survey 4 (CS4)
Time frame: Baseline, 6 months
Change in number of participants having a usual source of care as measured by CEAL Common Survey 4 (CS4)
Time frame: Baseline, 6 months
Change in number of participants delayed medical care as measured by CEAL Common Survey 4 (CS4)
Time frame: Baseline, 6 months
Food Insecurity as measured by U.S. Department of Agriculture Economic Research Service Questionnaire
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olveen Carrasquillo, MD principal investigator
University of Miami
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community health workers (CHW) and Educational Materials in people with Health, Subjective, run by University of Miami at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olveen Carrasquillo, MD (3052439765, ocarrasquillo@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in General well-being (GWB), measured by the Personal Wellbeing Index (PWI) (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.