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Rapid Vaccination of Hard-To-Reach Populations

Primary Purpose

Influenza

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community-based vaccine outreach intervention
Sponsored by
The New York Academy of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccination, Hard-to-Reach Populations, Urban, Disadvantaged

Eligibility Criteria

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

Inclusion Criteria: The possible participant pool for this project is the adult population (over the age of 18) of 8 circumscribed neighborhoods in East Harlem and South Bronx in NYC. These neighborhoods have a total population of approximately 24,000 people (based on the 2000 US Census) and we anticipate that up to 4,000 may be among the eligible hard-to-reach populations that are the target of this proposal. We will identify eligible populations through a brief survey instrument. During the intervention phase of this study, persons who are eligible to receive influenza vaccination will be offered influenza vaccination. Eligibility criteria for influenza vaccination are the eligibility criteria established by the Advisory Committee on Immunization Practices guidelines. These will be determined as part of the standard data collection instrument. Eligible persons include persons over the age of 65 and persons concurrent comorbidity including immunosuppression (HIV or active injection drug use), chronic pulmonary or cardiovascular disorder (including asthma), or chronic metabolic diseases (including diabetes mellitus, renal or hepatic dysfunction). Exclusion Criteria: Exclusion criteria include an allergy to vaccines, an allergy to eggs, inability to provide consent, currently under care of a physician and a plan to receive influenza vaccine in the near-future, or having already received the influenza vaccine during this year (CDC 1999).

Sites / Locations

  • Center for Urban Epidemiologic Studies, The New York Academy of MedicineRecruiting

Outcomes

Primary Outcome Measures

Compare vaccination rates in selected neighborhoods before and after a multilevel community-based participatory intervention trial.

Secondary Outcome Measures

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.

Full Information

First Posted
September 8, 2005
Last Updated
September 21, 2006
Sponsor
The New York Academy of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00155974
Brief Title
Rapid Vaccination of Hard-To-Reach Populations
Official Title
Rapid Vaccination of Hard-to-Reach Populations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The New York Academy of Medicine

4. Oversight

5. Study Description

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: 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.
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 (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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Vaccination, Hard-to-Reach Populations, Urban, Disadvantaged

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Community-based vaccine outreach intervention
Primary Outcome Measure Information:
Title
Compare vaccination rates in selected neighborhoods before and after a multilevel community-based participatory intervention trial.
Secondary Outcome Measure Information:
Title
Determine and identify the relative contributions of personal factors and structural barriers to immunization status in hard-to-reach populations.
Title
Estimate the size of the hard-to-reach populations.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The possible participant pool for this project is the adult population (over the age of 18) of 8 circumscribed neighborhoods in East Harlem and South Bronx in NYC. These neighborhoods have a total population of approximately 24,000 people (based on the 2000 US Census) and we anticipate that up to 4,000 may be among the eligible hard-to-reach populations that are the target of this proposal. We will identify eligible populations through a brief survey instrument. During the intervention phase of this study, persons who are eligible to receive influenza vaccination will be offered influenza vaccination. Eligibility criteria for influenza vaccination are the eligibility criteria established by the Advisory Committee on Immunization Practices guidelines. These will be determined as part of the standard data collection instrument. Eligible persons include persons over the age of 65 and persons concurrent comorbidity including immunosuppression (HIV or active injection drug use), chronic pulmonary or cardiovascular disorder (including asthma), or chronic metabolic diseases (including diabetes mellitus, renal or hepatic dysfunction). Exclusion Criteria: Exclusion criteria include an allergy to vaccines, an allergy to eggs, inability to provide consent, currently under care of a physician and a plan to receive influenza vaccine in the near-future, or having already received the influenza vaccine during this year (CDC 1999).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandro Galea, MD, DrPH
Phone
734-647-9741
Email
sgalea@nyam.org
First Name & Middle Initial & Last Name or Official Title & Degree
Micaela H Coady, MS
Phone
212-822-7277
Email
mcoady@nyam.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Vlahov, PhD
Organizational Affiliation
Center for Urban Epidemiologic Studies, The New York Academy of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandro Galea, MD, DrPH
Organizational Affiliation
Center for Urban Epidemiologic Studies, The New York Academy of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Urban Epidemiologic Studies, The New York Academy of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Micaela H Coady, MS
Phone
212-822-7277
Email
mcoady@nyam.org
First Name & Middle Initial & Last Name & Degree
Danielle Ompad, PhD
Phone
212-419-3589
Email
dompad@nyam.org
First Name & Middle Initial & Last Name & Degree
David Vlahov, PhD
First Name & Middle Initial & Last Name & Degree
Sandro Galea, MD, DrPH

12. IPD Sharing Statement

Citations:
PubMed Identifier
15682961
Citation
Galea S, Sisco S, Vlahov D. Reducing disparities in vaccination rates between different racial/ethnic and socioeconomic groups: the potential of community-based multilevel interventions. J Ambul Care Manage. 2005 Jan-Mar;28(1):49-59. doi: 10.1097/00004479-200501000-00007.
Results Reference
background

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Rapid Vaccination of Hard-To-Reach Populations

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