Rapid Vaccination of Hard-To-Reach Populations

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ClinicalTrials.gov Identifier: NCT00155974

Recruitment Status : Unknown

Verified September 2005 by The New York Academy of Medicine.
Recruitment status was: Recruiting

First Posted : September 12, 2005

Last Update Posted : September 22, 2006

Sponsor:

Information provided by:

The New York Academy of Medicine

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.

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: Community-based vaccine outreach intervention	Not Applicable

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).

Study Design


Study Type :	Interventional (Clinical Trial)
Enrollment :	4000 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Rapid Vaccination of Hard-to-Reach Populations
Study Start Date :	February 2004
Study Completion Date :	October 2005

Arms and Interventions

Outcome Measures

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

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.


ClinicalTrials.gov Identifier:	NCT00155974 History of Changes
Other Study ID Numbers:	091603 DA017004
First Posted:	September 12, 2005 Key Record Dates
Last Update Posted:	September 22, 2006
Last Verified:	September 2005

Keywords provided by The New York Academy of Medicine:


Influenza Vaccination Hard-to-Reach Populations Urban Disadvantaged

Additional relevant MeSH terms:


Vaccines Immunologic Factors Physiological Effects of Drugs

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