- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04542395
COVID-2019 Testing and Vaccination Among African American and Latinx Public Housing Residents
August 17, 2022 updated by: Charles Drew University of Medicine and Science
Multilevel Participatory Intervention to Reduce Barriers and Promote Social and Behavioral Facilitators of COVID-19 Testing Among African Americans and Latinx Public Housing Residents
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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Los Angeles, California, United States, 90059
- Housing Authority of Clty of Los Angeles
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Increasing Uptake of COVID-19 Testing and Vaccination
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of COVID-19 testing, pneumococcal and influenza vaccinations Using Test History Self-Report
Time Frame: Intervention: 3 months; Follow-up Point: 6 months post-intervention
|
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.
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Intervention: 3 months; Follow-up Point: 6 months post-intervention
|
Percentage of Participants Achieving Decreased Levels of COVID-19 Risk Using the NIH Toolbox Surveys on COVID-19
Time Frame: Intervention: 3 months; Follow-up Point: 6 months post-intervention
|
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.
|
Intervention: 3 months; Follow-up Point: 6 months post-intervention
|
Percentage of Participants Achieving Decreased Levels of COVID-19 Mistrust and Barriers Using the NIH Toolbox Surveys on COVID-19
Time Frame: Intervention: 3 months; Follow-up Point: 6 months post-intervention
|
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,
|
Intervention: 3 months; Follow-up Point: 6 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
June 1, 2023
Primary Completion (ANTICIPATED)
November 30, 2025
Study Completion (ANTICIPATED)
November 30, 2025
Study Registration Dates
First Submitted
September 3, 2020
First Submitted That Met QC Criteria
September 4, 2020
First Posted (ACTUAL)
September 9, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 19, 2022
Last Update Submitted That Met QC Criteria
August 17, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVID19testingvacc
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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