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OpenTrials
Completed

NCT Number: NCT05863884

RADx-UP- Impact of Community Health Worker Deployment

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Blood Glucose Level

    Time frame: 6 weeks

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

Secondary outcomes

  1. Diabetes Self-Management Score

    Time frame: 6 weeks

    Change in overall diabetes self-management score using diabetes self-management questionnaire from week 1 to week 6.

Other outcomes

  1. COVID-19 Vaccination Confidence and Uptake

    Time frame: 6 weeks

    Change in COVID-19 vaccination status and confidence using diabetes self-management questionnaire from week 1 to week 6.

Sponsors and collaborators

Lead sponsor

Morehouse School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
May 18, 2023
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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