RADx-UP- Impact of Community Health Worker Deployment

RADx-UP- Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake

The proposed project will implement and evaluate a brief Community Health Worker (CHW) intervention through the Albany Area Primary Health Care, a rural Federally Qualified Health Center (FQHC). The primary goal of this study is to maximize effective outreach, education, and communication through CHWs in order to facilitate improved COVID-19 vaccine confidence and uptake in underserved and vulnerable communities. CHWs will be deployed to the homes of adults with increased risk of morbidity and mortality (i.e., African Americans or Latinos with uncontrolled diabetes or prediabetes, age <50 years, and non-COVID-19 vaccinated) in order to educate them about diabetes, COVID-19 and related vaccines. Health assessments, including blood glucose measurement, will be conducted on the indexed patient and offered to all other adult family members in the household (i.e., "bubble"). Adults with Type 2 diabetes likely live in households with other adults who have or are at increased risk for diabetes (i.e., prediabetes and obesity).1 It is expected that they will also share similar COVID-19 exposure risk. The specific aims are to: 1) Evaluate a community-driven education program to increase and enhance COVID-19 vaccine confidence and uptake in individuals with uncontrolled diabetes and their families (i.e., their "bubble") and 2) Evaluate a community-driven education program to improve diabetes self-management behaviors and related outcomes (e.g., blood glucose) in individuals with uncontrolled diabetes in rural, Southwest Georgia.

Study Overview

• Status: Completed
• Conditions: COVID-19; Diabetes; Health Behavior; Health Knowledge, Attitudes, Practice; Community Health Workers
• Intervention / Treatment: Behavioral: Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Albany, Georgia, United States, 31707
      • Albany Area Primary Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must be between18 and 50 years
• Self-identify as African American/Black or Latino
• English speaking
• Have received care for uncontrolled diabetes (HbA1c > 9%) or prediabetes diagnosis within one of the AAPHC 27 community sites
• Unvaccinated for Phase 1 (vaccinated for Phase 2)

Exclusion Criteria:

• Not meeting the Inclusion Criteria
• Enrolled in the parent RADx-UP Project PEACH study
• Unable or unwilling to provide informed consent to participate in the study (ie: incarcerated individuals and children)
• Individuals with a terminal cancer diagnosis, have chronic kidney disease (stage 4-5), pregnant women, and people with severe psychological disorders (i.e., dementia,suicide ideation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: CHW Intervention; A six week CHW home-visit behavioral intervention examining changes in diabetes outcomes.

Behavioral: Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake; CHWs will conduct home visits to provide diabetes and COVID-19 health education based on the participant's needs, interests, and clinical health assessment results. All adults in the household will be invited to participate in the health education discussions. At each visit, the CHW will use diabetes management and COVID-19 educational materials to facilitate and inform discussions. CHWs will also make available at-home COVID-19 testing kits with instructions for the patient and their household family members. The discussion of COVID-19 beliefs, perceptions, and related behaviors will be raised during a later visit, i.e., after rapport and trust has been established and if it has not been raised by the participants during the earlier visits. In addition, CHWs will help schedule vaccination and healthcare appointments upon participant's interest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Glucose Level	Change in HbA1c level from using clinical assessment parameters from week 1 to week 6.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Self-Management Score	Change in overall diabetes self-management score using diabetes self-management questionnaire from week 1 to week 6.	6 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 Vaccination Confidence and Uptake	Change in COVID-19 vaccination status and confidence using diabetes self-management questionnaire from week 1 to week 6.	6 weeks

Collaborators and Investigators

• Sponsor: Morehouse School of Medicine
• Investigators: Principal Investigator: Rakale C Quarells, PhD, Morehouse School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2022
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: diabetes; COVID-19; community health workers; rural population; rural communities; rural health center
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: 1854646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No