RADx-UP- Impact of Community Health Worker Deployment

NCT ID: NCT05863884

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-11
• Study Completion Date: 2025-04-30

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CHW Intervention

A six week CHW home-visit behavioral intervention examining changes in diabetes outcomes.

Group Type: OTHER

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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Morehouse School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rakale C Quarells, PhD

Role: PRINCIPAL_INVESTIGATOR

Morehouse School of Medicine

Locations

Albany Area Primary Health Care

Albany, Georgia, United States

Countries

United States

Other Identifiers

1854646

Identifier Type: -

Identifier Source: org_study_id