Influenza Clinical Trial
Official title:
Rapid Vaccination of Hard-to-Reach Populations
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.
Status | Recruiting |
Enrollment | 4000 |
Est. completion date | October 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Center for Urban Epidemiologic Studies, The New York Academy of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
The New York Academy of Medicine |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare vaccination rates in selected neighborhoods before and after a multilevel community-based participatory intervention trial. | |||
Secondary | Determine and identify the relative contributions of personal factors and structural barriers to immunization status in hard-to-reach populations. | |||
Secondary | Estimate the size of the hard-to-reach populations. |
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