Rapid Vaccination of Hard-To-Reach Populations
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
- Compare vaccination rates in selected neighborhoods before and after a multilevel community-based participatory intervention trial.
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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).

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