NCT00155974

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:

  1. 1.To identify the relative contributions of personal factors and structural barriers to immunization status in hard-to-reach populations.
  2. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

September 22, 2006

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

September 21, 2006

Conditions

Influenza

Keywords

InfluenzaVaccinationHard-to-Reach PopulationsUrbanDisadvantaged

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

  • 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.

Interventions

Community-based vaccine outreach interventionBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Urban Epidemiologic Studies, The New York Academy of Medicine

New York, New York, 10029, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 15682961BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandro Galea, MD, DrPH

CONTACT

734-647-9741sgalea@nyam.org

Micaela H Coady, MS

CONTACT

212-822-7277mcoady@nyam.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

February 1, 2004

Study Completion

October 1, 2005

Last Updated

September 22, 2006

Record last verified: 2005-09

Locations

US(1)