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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06075732
Other study ID # vaccpublichousing
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date December 31, 2029

Study information

Verified date October 2023
Source Charles Drew University of Medicine and Science
Contact Sharon Cobb, PhD
Phone 3235634800
Email sharoncobb1@cdrewu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 600
Est. completion date December 31, 2029
Est. primary completion date June 30, 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Increasing Willingness and Uptake of Influenza, Pneumonia, Meningitis, HZV, and COVID-19 Vaccination
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Charles Drew University of Medicine and Science

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention
Secondary 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 Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention
Secondary 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 Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention
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