NCT04124224

Brief Summary

For 19 years, the Centers for Disease Control and Prevention-funded Arizona Prevention Research Center (AzPRC) has been engaged in academic community collaborative research to reduce chronic disease health disparities among the Latino border communities in Arizona. Our research project, Unidos: Linking Individuals' to Social Determinant and Community Health Services, will result in a model Community-Clinical Linkage intervention to reduce chronic disease risk among Latinos in Arizona. Further, the investigators expect this intervention model to be applicable in other regions and populations. To execute this research, the AzPRC will implement the intervention in partnership with county health departments and Federally Qualified Health Centers. In Unidos the county/community-based CHWs will: 1) support and connect participants to health promotion resources; 2) provide individual and group-based support guided by a novel framework for understanding Latino's health advantages, the sociocultural resiliency model; and, 3) leverage community resources to help individuals address SDH-related needs.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

September 16, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

3.3 years

First QC Date

October 3, 2019

Last Update Submit

November 3, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Chronic Disease Risk

    Number of Participants with Chronic Disease Risk as Assessed by the American Heart Association Simple 7 (smoking, nutrition, physical activity, weight, blood pressure, cholesterol, and blood sugar) Change from Baseline in Simple 7 score at 3, 6, and 9 months.

    9 months

  • Social Networks

    Number of Participants with Improved Social Networks as Assessed by the Berkman-Syme Network Index, Change from Baseline to 6 month follow-up.

    6 months

  • Unidos Implementation within Local Health Departments

    Organizational readiness as assessed through qualitative data collection including focus groups and interviews.

    2 months

  • Social Determinant of Health Factors

    Number of participants with improved Social Determinant of Health Factors as assessed by the Protocol for Responding to and Assessing Patients' Assets, Risks, and Experiences (PRAPARE), change from baseline to 6 month follow-up.

    6 months

Study Arms (2)

Unidos Participants

In the Unidos intervention the county/community-based CHWs will: 1) support and connect participants to health promotion resources; 2) provide individual and group-based support guided by a novel framework for understanding Latino's health advantages, the sociocultural resiliency model; and, 3) leverage community resources to help individuals address SDH-related needs.

Other: Unidos

Non-Unidos Participants: Comparison Group

Using propensity score matching, the investigators will use the medical records of Unidos participants and the electronic health record comparison group to compare health outcomes.

Interventions

UnidosOTHER

The investigators will collaborate with our community partners to implement and evaluate a Community-Clinical Linkage (CCL) model in which Community Health Workers (CHWs) connect individuals to social determinant and community health services and build sociocultural resilience through CHW-facilitated individual and group support. As a public health practice-based study that incorporates evidence-based strategies, the investigators seek to establish Unidos effectiveness in Arizona counties with the highest percentage of Latinos of Mexican origin (Yuma, Pima, Santa Cruz, and Maricopa). Unidos CHWs, based in local health departments, will use evidence-based strategies to address three elements that are important in addressing chronic disease risk: 1) health promotion resources and programs; 2) individual and group-based social support; and 3) leveraging community resources to address social determinants of health.

Unidos Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Arizona counties with significant Latino populations experience underlying social and economic disparities that place them at risk for chronic disease and negative health outcomes. The participating Maricopa, Pima, Yuma, and Santa Cruz counties are where a significant number of the Latino population for the state reside. Compared to the US population, communities in Arizona with a higher percentages of Latinos are more likely to face poverty, be uninsured, and have chronic disease risks.

You may qualify if:

  • Adult participants 18 years or older;
  • Adults of Latino origin;
  • Participants who speak either English or Spanish; and
  • Participants who consent to participate in the study.

You may not qualify if:

  • Excluded will be participants who do not consent to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mariposa Community Health Center

Nogales, Arizona, 85621, United States

NOT YET RECRUITING

Maricopa County Health Department

Phoenix, Arizona, 85012, United States

NOT YET RECRUITING

Valle del Sol Community Health

Phoenix, Arizona, 85014, United States

NOT YET RECRUITING

El Rio Community Health Center

Tucson, Arizona, 85714, United States

RECRUITING

Pima County Health Department

Tucson, Arizona, 85714, United States

RECRUITING

Sunset Community Health Center

Yuma, Arizona, 85364, United States

RECRUITING

Yuma County Health District

Yuma, Arizona, 85364, United States

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 11, 2019

Study Start

September 16, 2020

Primary Completion

December 31, 2023

Study Completion

September 30, 2024

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

As this is a community-based participatory research study, the investigators will work with our Community Action Board to determine what data will be shared.

Locations