search
Back to results

ACTIVATE in Public Housing

Primary Purpose

Pneumonia, Influenza, Varicella Zoster

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 Vaccination
Sponsored by
Charles Drew University of Medicine and Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pneumonia

Eligibility Criteria

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

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 Influenza, Pneumonia, Meningitis, VZV, and COVID-19 No reporting of vaccine hesitancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ACTIVATE Leaders

    Arm Description

    This is a 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 ACTIVATE triad leaders and researchers. The investigators will use the Information, Motivation, and Behavioral Skills (IMB) model and the Transtheoretical Model to implement the intervention. PRISM, a Dissemination and implementation (D&I) D&I-based model can guide the implementation of the ACTIVATE program for successfully expansion and maintenance in community settings, especially for under-resourced populations.

    Outcomes

    Primary Outcome Measures

    Prevalence of vaccination uptake for Influenza, Pneumonia, Meningitis, VZV, and COVID-19 using Vaccination History Self Report
    By comparison of pre-, post- intervention, and 9- and 18-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in completion of Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination series

    Secondary Outcome Measures

    Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccine Using the NIH Toolbox Surveys on COVID-19
    By comparison of pre-, post- intervention, and 3- and 9-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in hesitancy toward Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination
    Percentage of Participants Achieving Increased Level of Behavior Change toward COVID-19 Vaccination Using the NIH Toolbox Surveys on Influenza, Pneumonia, Meningitis, VZV, and COVID-19
    By comparison of pre-, post- intervention, and 3- and 9-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in their behavior stage of change toward Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination

    Full Information

    First Posted
    October 4, 2023
    Last Updated
    October 16, 2023
    Sponsor
    Charles Drew University of Medicine and Science
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06075732
    Brief Title
    ACTIVATE in Public Housing
    Official Title
    Academic-Community Team for Improving Vaccine Acceptability and Targeted Engagement: Public Housing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2024 (Anticipated)
    Primary Completion Date
    June 30, 2029 (Anticipated)
    Study Completion Date
    December 31, 2029 (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 multilevel, multidisciplinary, theoretically based, culturally sensitive, community-engaged intervention sets out to mitigate uptake barriers and non-adherence to vaccination schedules as recommended by the CDC and increase influenza, meningitis, pneumonia, VZV, and COVID-19 vaccine rates among under-resourced African American and Latino public housing residents in South Los Angeles.
    Detailed Description
    Vaccinations are critical for preventing infectious diseases such as influenza, meningitis, pneumonia, varicella zoster virus (VZV), and COVID-19. Despite increasing national distribution and promotion of routine recommendations for adult vaccination, coverage remains low, with historically lower uptake among racial and ethnic minorities. This is compounded by higher levels of vaccine hesitancy, which may be attributed to a myriad of issues, including worsening social determinants, medical mistrust, and lack of access to health services. Specifically, African American and Latino public housing residents may benefit from public health campaigns and vaccination initiatives to support high vaccine uptake and confidence. This R01 proposal seeks to expand on a proven, multilevel, multidisciplinary, theoretically based, culturally sensitive, community-engaged intervention by expanding the Academic-Community Team for Improving Vaccine Acceptability and Targeted Engagement (ACTIVATE) program. Guided by a fusion of the Social-Ecological framework (SEM) and the Practical, Robust Implementation and Sustainability Model (PRISM), the ACTIVATE program is inclusive of health factors on the individual, interpersonal, community, and societal level and elements for successful implementation. Led by leadership triads of public housing resident leaders, nurse practitioner students, and public health students, the ACTIVATE program centers on mitigating uptake barriers and non-adherence to vaccination schedules as recommended by the CDC and to increase influenza, meningitis, pneumonia, VZV, and COVID-19 vaccine rates among under-resourced AA and Latino adults in South LA.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumonia, Influenza, Varicella Zoster, Meningitis, COVID-19, Vaccine Hesitancy

    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
    ACTIVATE Leaders
    Arm Type
    Experimental
    Arm Description
    This is a 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 ACTIVATE triad leaders and researchers. The investigators will use the Information, Motivation, and Behavioral Skills (IMB) model and the Transtheoretical Model to implement the intervention. PRISM, a Dissemination and implementation (D&I) D&I-based model can guide the implementation of the ACTIVATE program for successfully expansion and maintenance in community settings, especially for under-resourced populations.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 Vaccination
    Intervention Description
    Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce Influenza, Pneumonia, Meningitis, HZV, and COVID-19 vaccine hesitancy and increase willingness and uptake in Influenza, Pneumonia, Meningitis, HZV, and COVID-19 vaccination.
    Primary Outcome Measure Information:
    Title
    Prevalence of vaccination uptake for Influenza, Pneumonia, Meningitis, VZV, and COVID-19 using Vaccination History Self Report
    Description
    By comparison of pre-, post- intervention, and 9- and 18-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in completion of Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination series
    Time Frame
    Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants Achieving Decreased Vaccine Hesitancy Levels of Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccine Using the NIH Toolbox Surveys on COVID-19
    Description
    By comparison of pre-, post- intervention, and 3- and 9-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in hesitancy toward Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination
    Time Frame
    Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention
    Title
    Percentage of Participants Achieving Increased Level of Behavior Change toward COVID-19 Vaccination Using the NIH Toolbox Surveys on Influenza, Pneumonia, Meningitis, VZV, and COVID-19
    Description
    By comparison of pre-, post- intervention, and 3- and 9-months follow-up data, the investigators anticipate the following compared to baseline: a 40% change in their behavior stage of change toward Influenza, Pneumonia, Meningitis, VZV, and COVID-19 vaccination
    Time Frame
    Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 Influenza, Pneumonia, Meningitis, VZV, and COVID-19 No reporting of vaccine hesitancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sharon Cobb, PhD
    Phone
    3235634800
    Email
    sharoncobb1@cdrewu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    ACTIVATE in Public Housing

    We'll reach out to this number within 24 hrs