NCT06075732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2024

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

5 months

First QC Date

October 4, 2023

Last Update Submit

February 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

    Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention

  • 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

    Intervention: 8 months; Follow-up Point: 3- and 9-months post-intervention

Study Arms (1)

ACTIVATE Leaders

EXPERIMENTAL

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.

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

Interventions

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.

ACTIVATE Leaders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles R. Drew University of Medicine & Science

Los Angeles, California, 90059, United States

Location

MeSH Terms

Conditions

PneumoniaInfluenza, HumanMeningitisCOVID-19Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesNeuroinflammatory DiseasesNervous System DiseasesPneumonia, ViralCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsVaccination RefusalTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 10, 2023

Study Start

July 1, 2024

Primary Completion

November 30, 2024

Study Completion

December 2, 2024

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations