Increasing Vaccine Uptake in Underresourced Public Housing Areas
Primary Purpose
Coronavirus, Vaccine Refusal
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Increasing Willingness and Uptake of COVID-19 Vaccination
Sponsored by
About this trial
This is an interventional supportive care trial for Coronavirus
Eligibility Criteria
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
Sites / Locations
- Charles R. Drew University of Medicine & ScienceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Increasing Uptake of COVID-19 Vaccination
Arm Description
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.
Outcomes
Primary Outcome Measures
Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report
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
Secondary Outcome Measures
Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of COVID-19 vaccine Using the NIH Toolbox Surveys on COVID-19
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.
Percentage of Participants Achieving Increased Level of Behavior Change toward COVID-19 Vaccination Using the NIH Toolbox Surveys on COVID-19
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
Full Information
NCT ID
NCT04779138
First Posted
February 27, 2021
Last Updated
February 28, 2023
Sponsor
Charles Drew University of Medicine and Science
1. Study Identification
Unique Protocol Identification Number
NCT04779138
Brief Title
Increasing Vaccine Uptake in Underresourced Public Housing Areas
Official Title
Community Partnered Intervention to Increase COVID-19 Vaccine Uptake in Low Income Underresourced African Americans and Latinx Public Housing Residents
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, Vaccine Refusal
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
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Increasing Uptake of COVID-19 Vaccination
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Increasing Willingness and Uptake of COVID-19 Vaccination
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of vaccination uptake for COVID-19, influenza, and pneumonia using Vaccination History Self Report
Description
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
Time Frame
Intervention: 4 months; Follow-up Point: 3 months post-intervention
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of COVID-19 vaccine Using the NIH Toolbox Surveys on COVID-19
Description
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.
Time Frame
Intervention: 4 months; Follow-up Point: 3 months post-intervention
Title
Percentage of Participants Achieving Increased Level of Behavior Change toward COVID-19 Vaccination Using the NIH Toolbox Surveys on COVID-19
Description
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
Time Frame
Intervention: 4 months; Follow-up Point: 3 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Cobb
Phone
3235683329
Email
sharoncobb1@cdrewu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Cobb
Organizational Affiliation
Charles R. Drew University of Medicine & Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charles R. Drew University of Medicine & Science
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon COBB, PHD
Phone
323-568-3329
Email
sharoncobb1@cdrewu.edu
12. IPD Sharing Statement
Learn more about this trial
Increasing Vaccine Uptake in Underresourced Public Housing Areas
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