Clinical trial NCT05863884: RADx-UP- Impact of Community Health Worker Deployment
Official title: RADx-UP- Impact of Community Health Worker Home Deployment on COVID-19 Vaccine Confidence and Uptake
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes
COVID-19
Community Health Workers
Health Behavior
Health Knowledge, Attitudes, Practice
Keywords: diabetes
COVID-19
rural communities
rural health center
rural population
community health workers
Lead sponsor: Morehouse School of Medicine
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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)

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)

Primary outcomes:
measure: Blood Glucose Level
timeFrame: 6 weeks
Secondary outcomes:
measure: Diabetes Self-Management Score
timeFrame: 6 weeks
Other outcomes:
measure: COVID-19 Vaccination Confidence and Uptake
timeFrame: 6 weeks
Locations:
city: Albany
country: United States
facility: Albany Area Primary Health Care
state: Georgia
Study officials:
affiliation: Morehouse School of Medicine
name: Rakale C Quarells, PhD
role: PRINCIPAL_INVESTIGATOR
References: