Rapid Vaccination of Hard-To-Reach Populations
Recruitment status was Recruiting
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:
- To identify the relative contributions of personal factors and structural barriers to immunization status in hard-to-reach populations.
- 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.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Rapid Vaccination of Hard-to-Reach Populations|
- Compare vaccination rates in selected neighborhoods before and after a multilevel community-based participatory intervention trial.
- Determine and identify the relative contributions of personal factors and structural barriers to immunization status in hard-to-reach populations.
- Estimate the size of the hard-to-reach populations.
|Study Start Date:||February 2004|
|Estimated Study Completion Date:||October 2005|
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 (e.g. 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 (i.e., 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 (e.g., HIV, HBV, etc).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00155974
|Contact: Sandro Galea, MD, DrPHfirstname.lastname@example.org|
|Contact: Micaela H Coady, MSemail@example.com|
|United States, New York|
|Center for Urban Epidemiologic Studies, The New York Academy of Medicine||Recruiting|
|New York, New York, United States, 10029|
|Contact: Micaela H Coady, MS 212-822-7277 firstname.lastname@example.org|
|Contact: Danielle Ompad, PhD 212-419-3589 email@example.com|
|Principal Investigator: David Vlahov, PhD|
|Principal Investigator: Sandro Galea, MD, DrPH|
|Principal Investigator:||David Vlahov, PhD||Center for Urban Epidemiologic Studies, The New York Academy of Medicine|
|Principal Investigator:||Sandro Galea, MD, DrPH||Center for Urban Epidemiologic Studies, The New York Academy of Medicine|