Viewing Study NCT00155974



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Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00155974
Status: UNKNOWN
Last Update Posted: 2006-09-22
First Post: 2005-09-08

Brief Title: Rapid Vaccination of Hard-To-Reach Populations
Sponsor: The New York Academy of Medicine
Organization: The New York Academy of Medicine

Study Overview

Official Title: Rapid Vaccination of Hard-to-Reach Populations
Status: UNKNOWN
Status Verified Date: 2005-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to develop and determine the effectiveness of a multi-level community participatory intervention designed to rapidly immunize hard-to-reach populations including substance users within disadvantaged minority communities

Specific Aims of the project are as follows

1 To identify the relative contributions of personal factors and structural barriers to immunization status in hard-to-reach populations
2 To estimate the size of the hard-to-reach population in specified disadvantaged urban communities using venue-based sampling probability-based sampling capture-recapture methods and modified Delphi techniques
3 To compare vaccination rates in hard-to-reach populations between neighborhoods that receive a community-based vaccine outreach intervention versus neighborhoods where vaccines are offered through standard public health programs using an incremental crossover multilevel community intervention design
Detailed Description: This study follows a quasi-experimental design involving a multilevel community participatory intervention that is designed to rapidly immunize hard-to-reach HTR populations in disadvantaged minority communities Low vaccination coverage among minorities and persons living in and near poverty is a persistent problem that is particularly acute among HTR populations eg injection drug users elderly shut-ins Immunization rates are affected by multiple factors including demographics attitudes about vaccination health norms barriers to access and immunization delivery methods Efforts to successfully vaccinate HTR populations must address these factors A community-based program with rapid vaccination can serve as an initial model for emergency preparedness vaccination plans and for future efforts to widely introduce HIV vaccination in disadvantaged urban communities This project will be conducted by a community-public health partnership in eight disadvantaged neighborhoods within Harlem and the South Bronx in three phases In Phase 1 we will implement a brief survey assessment of residents in designated neighborhoods to identify current key barriers to immunization faced by the target HTR populations in these neighborhoods Also using several estimation methods we will determine the size of the target populations in the study neighborhoods to establish vaccine needed and to estimate denominators for vaccination rates In Phase 2 we will implement two waves of a multilevel community intervention trial developed with input from the survey and community partners In the first wave four randomly selected neighborhoods will receive the intervention ie community education community-organization engagement and door-to-door influenza vaccination program for eligible groups etc In the four control communities target populations will be invited to come for vaccination at specified locations as part of usual public health efforts In the second vaccination wave using a crossover design after updating and revising the approach based on experience from Wave 1 we will implement the intervention in the four control communities this vaccination wave will be conducted over one week to test the feasibility of rapid vaccination of these populations Phase 3 of this project will identify the promising elements of the program and develop materials to allow generalizability to other urban areas and to other vaccines eg HIV HBV etc

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
DA017004 None None None