Recruiting

Observational Study

Sponsor:

The New York Academy of Medicine

Code:

NCT00155974

Conditions

Influenza

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Community-based vaccine outreach intervention

Study Details

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. 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.

Conditions

Influenza

Study ID

NCT00155974

Start date

Feb, 2004

Status verified date

Sep, 2005

Completion date

Oct, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

4000 participants

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Interventions

Community-based vaccine outreach intervention

Primary outcome measure

  • Compare vaccination rates in selected neighborhoods before and after a multilevel community-based participatory intervention trial. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Sandro Galea, MD, DrPH

734-647-9741sgalea@nyam.org

Micaela H Coady, MS

212-822-7277mcoady@nyam.org

Locations

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

Recruiting

New York, New York, United States, 10029

Contacts

Micaela H Coady, MS

212-822-7277mcoady@nyam.org

Danielle Ompad, PhD

212-419-3589dompad@nyam.org

Principal Investigator:

David Vlahov, PhD

More Information

Sponsor

The New York Academy of Medicine

Last update posted

Sep 22, 2006

Last verified

Sep, 2005

Keywords

  • Influenza
  • Vaccination
  • Hard-to-Reach Populations
  • Urban
  • Disadvantaged

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The New York Academy of Medicine on 2006-09-22.