RADx-UP- Impact of Community Health Worker Deployment

NCT05863884 | Completed DMC

• 1 other identifier: 1854646
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Knowledge, Attitudes, Practice; Diabetes; COVID-19; Community Health Workers; Health Behavior

Keywords

diabetes; COVID-19; rural communities; rural health center; rural population; community health workers

Outcome Measures

Primary Outcomes (1)

• Blood Glucose Level

  Change in HbA1c level from using clinical assessment parameters from week 1 to week 6.

  6 weeks

Secondary Outcomes (1)

• Diabetes Self-Management Score

  6 weeks

Other Outcomes (1)

• COVID-19 Vaccination Confidence and Uptake

  6 weeks

Study Arms (1)

CHW Intervention

OTHER

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

Interventions

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

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.

CHW Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Morehouse School of Medicine: lead

Study Sites (1)

Albany Area Primary Health Care

Albany, Georgia, 31707, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; COVID-19; Health Behavior; Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rakale C Quarells, PhD

  Morehouse School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: May 18, 2023
• Study Start: February 11, 2022
• Primary Completion: November 30, 2024
• Study Completion: April 30, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)