Rapid Vaccination of Hard-To-Reach Populations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by The New York Academy of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The New York Academy of Medicine
ClinicalTrials.gov Identifier:
NCT00155974
First received: September 8, 2005
Last updated: September 21, 2006
Last verified: September 2005
  Purpose

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.

Condition Intervention
Influenza
Biological: Community-based vaccine outreach intervention

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by The New York Academy of Medicine:

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.

Estimated Enrollment: 4000
Study Start Date: February 2004
Estimated Study Completion Date: October 2005
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00155974

Contacts
Contact: Sandro Galea, MD, DrPH 734-647-9741 sgalea@nyam.org
Contact: Micaela H Coady, MS 212-822-7277 mcoady@nyam.org

Locations
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    mcoady@nyam.org   
Contact: Danielle Ompad, PhD    212-419-3589    dompad@nyam.org   
Principal Investigator: David Vlahov, PhD         
Principal Investigator: Sandro Galea, MD, DrPH         
Sponsors and Collaborators
The New York Academy of Medicine
Investigators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00155974     History of Changes
Other Study ID Numbers: 091603, DA017004
Study First Received: September 8, 2005
Last Updated: September 21, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by The New York Academy of Medicine:
Influenza
Vaccination
Hard-to-Reach Populations
Urban
Disadvantaged

ClinicalTrials.gov processed this record on October 23, 2014