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COVID-2019 Testing and Vaccination Among African American and Latinx Public Housing Residents

Primary Purpose

Coronavirus

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Increasing Willingness and Uptake of COVID-19 Testing and Vaccination

About this trial

This is an interventional supportive care trial for Coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Identify as Latino/Hispanic or African American/Black
Reside in one of the six collaborating public housing
18 years old and older
Speak either English or Spanish

Exclusion Criteria:

Does not self-identify as African American and/or Black
Under the age of 18
Unable to speak English or Spanish
Does not Reside in one of the six collaborating public housing

Sites / Locations

Housing Authority of Clty of Los Angeles

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Increasing Uptake of COVID-19 Testing and Vaccination

Arm Description

This is a pre-experimental "one group pretest-posttest" design to improve COVID-19 associated health outcomes and willingness and uptake toward testing and vaccination among 310 Hispanic and African American public housing residents in South Los Angeles. The proposed intervention will employ (1) culturally sensitive, (2) theoretically based intervention that will be jointly delivered by our COVID-19 health ambassadors and our researchers. We will use the Information, Motivation, and Behavioral Skills (IMB) model and the Transtheoretical Model to implement the intervention.

Outcomes

Primary Outcome Measures

Prevalence of COVID-19 testing, pneumococcal and influenza vaccinations Using Test History Self-Report

By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 30% change in willingness and uptake for testing and vaccination.

Percentage of Participants Achieving Decreased Levels of COVID-19 Risk Using the NIH Toolbox Surveys on COVID-19

By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 30% change in perceived COVID-19 risk.

Percentage of Participants Achieving Decreased Levels of COVID-19 Mistrust and Barriers Using the NIH Toolbox Surveys on COVID-19

By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 40% change in mistrust and perceived barriers toward COVID-19 testing and vaccination,

Secondary Outcome Measures

Full Information

NCT ID

NCT04542395

First Posted

September 3, 2020

Last Updated

August 17, 2022

Sponsor

Charles Drew University of Medicine and Science

1. Study Identification

Unique Protocol Identification Number

NCT04542395

Brief Title

COVID-2019 Testing and Vaccination Among African American and Latinx Public Housing Residents

Official Title

Multilevel Participatory Intervention to Reduce Barriers and Promote Social and Behavioral Facilitators of COVID-19 Testing Among African Americans and Latinx Public Housing Residents

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Study not funded

Study Start Date

June 1, 2023 (Anticipated)

Primary Completion Date

November 30, 2025 (Anticipated)

Study Completion Date

November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Charles Drew University of Medicine and Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This proposal seeks to enhance acceptability and uptake of COVID-19 testing and vaccination to engage African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to reduce barriers and implement innovate strategies to engage this population in the uptake of COVID-19 testing and vaccination.

Detailed Description

Through the engagement and empowerment of 15 trained COVID-19 health ambassadors, the investigators will jointly implement and evaluate a theoretically based and culturally-sensitive socio-behavioral intervention that will: a) reduce mistrust, fatalistic beliefs, and related psychosocial barriers that hinder COVID-19 testing and vaccination; b) increase receptivity and willingness for uptake of COVID-19 testing and vaccination; and c) assess perceived impact of psychosocial and health outcomes related to COVID-19 testing and vaccination for 310 African American and Latinx public housing residents.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronavirus

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Increasing Uptake of COVID-19 Testing and Vaccination

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Increasing Willingness and Uptake of COVID-19 Testing and Vaccination

Intervention Description

Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 related risk and challenges and increase willingness and uptake in COVID-19 testing and vaccination.

Primary Outcome Measure Information:

Title

Prevalence of COVID-19 testing, pneumococcal and influenza vaccinations Using Test History Self-Report

Description

By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 30% change in willingness and uptake for testing and vaccination.

Time Frame

Intervention: 3 months; Follow-up Point: 6 months post-intervention

Title

Percentage of Participants Achieving Decreased Levels of COVID-19 Risk Using the NIH Toolbox Surveys on COVID-19

Description

By comparison of pre-, post- intervention, and six-months follow-up data, we anticipate the following compared to baseline: a 30% change in perceived COVID-19 risk.

Time Frame

Intervention: 3 months; Follow-up Point: 6 months post-intervention

Title

Percentage of Participants Achieving Decreased Levels of COVID-19 Mistrust and Barriers Using the NIH Toolbox Surveys on COVID-19

Description

Time Frame

Intervention: 3 months; Follow-up Point: 6 months post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Identify as Latino/Hispanic or African American/Black Reside in one of the six collaborating public housing 18 years old and older Speak either English or Spanish Exclusion Criteria: Does not self-identify as African American and/or Black Under the age of 18 Unable to speak English or Spanish Does not Reside in one of the six collaborating public housing

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohsen Bazargan, PhD

Organizational Affiliation

Charles R. Drew University of Medicine & Science

Official's Role

Principal Investigator

Facility Information:

Facility Name

Housing Authority of Clty of Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90059

Country

United States

12. IPD Sharing Statement

Learn more about this trial

COVID-2019 Testing and Vaccination Among African American and Latinx Public Housing Residents

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