- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04779138
Increasing Vaccine Uptake in Underresourced Public Housing Areas
April 23, 2024 updated by: Charles Drew University of Medicine and Science
Community Partnered Intervention to Increase COVID-19 Vaccine Uptake in Low Income Underresourced African Americans and Latinx Public Housing Residents
This proposal seeks to enhance uptake and completion of COVID-19 vaccination among 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 provide education at multiple levels and implement innovate strategies to engage this population in the uptake of COVID-19 vaccination.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
One particular group, African American and Latinx public housing residents, are facing adverse effects related to worsening social determinants and health disparities.
Utilizing a community-driven approach, the overall objective of this proposed study is to increase COVID-19 vaccine uptake and completion the impact of COVID-19 among African American and Latinx public housing residents.
Guided by the Community Based Participatory Model, the Information, Motivation, and Behavioral Skills (IMB) and the Transtheoretical Model will be utilized to carry out this intervention.
Through this innovative program, we will establish Academic-Community Team for Improving Vaccine Acceptability and Targeted Engagement (ACTIVATE) program, which will develop leadership triads of public housing resident leaders, nurse practitioner students, and public health students to carry out this multilevel intervention.
Study Type
Interventional
Enrollment (Actual)
462
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
-
Los Angeles, California, United States, 90059
- Charles R. Drew University of Medicine & Science
-
-
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
Description
Aim 2:
Inclusion Criteria:
- identify as Latinx or African American
- age 18 or older
- reside in one of the six collaborating public housing area
- Speak either English or Spanish
Exclusion Criteria:
- Not a resident at one of the collaborating public housing areas
- Does not self-identify as African American or Latinx
- Age 17 and younger
- Unable to speak either English or Spanish
Aim 3:
Inclusion Criteria:
- identify as Latinx or African American
- age 18 or older
- reside in one of the six collaborating public housing area
- Speak either English or Spanish
- Report vaccine hesitancy
Exclusion Criteria:
- Not a resident at one of the collaborating public housing areas
- Does not self-identify as African American or Latinx
- Age 17 and younger
- Unable to speak either English or Spanish
- Received all recommended vaccines for COVID-19
- No reporting of vaccine hesitancy
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Increasing Uptake of COVID-19 Vaccination
This is a pre-experimental "one group pretest-posttest" design to increase COVID-19 vaccine uptake and completion among African American and Latinx 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 ACTIVATE triad leaders 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 vaccine hesitancy and increase willingness and uptake in COVID-19 vaccination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report
Time Frame: Intervention: 4 months; Follow-up Point: 3 months post-intervention
|
1.
By comparison of pre-, post- intervention, and 9- and 18-months follow-up data, we anticipate the following compared to baseline: a 40% change in completion of COVID-19 vaccination series
|
Intervention: 4 months; Follow-up Point: 3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of COVID-19 vaccine Using the NIH Toolbox Surveys on COVID-19
Time Frame: Intervention: 4 months; Follow-up Point: 3 months post-intervention
|
1.
By comparison of pre-, post- intervention, and 3-months follow-up data, we anticipate the following compared to baseline: a 40% change in hesitancy toward COVID-19 vaccination.
|
Intervention: 4 months; Follow-up Point: 3 months post-intervention
|
|
Percentage of Participants Achieving Increased Level of Behavior Change toward COVID-19 Vaccination Using the NIH Toolbox Surveys on COVID-19
Time Frame: Intervention: 4 months; Follow-up Point: 3 months post-intervention
|
2. By comparison of pre-, post- intervention, and 3-months follow-up data, we anticipate the following compared to baseline: a 40% change in their behavior stage of change toward COVID-19 vaccination
|
Intervention: 4 months; Follow-up Point: 3 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sharon Cobb, Charles R. Drew University of Medicine & Science
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 (Actual)
September 11, 2021
Primary Completion (Actual)
November 30, 2023
Study Completion (Actual)
April 1, 2024
Study Registration Dates
First Submitted
February 27, 2021
First Submitted That Met QC Criteria
February 27, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Actual)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- vaccinehousing
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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