InfluenzaNCT00155974
Rapid Vaccination of Hard-To-Reach Populations
A study testing Community-based vaccine outreach intervention in people with Influenza, run by The New York Academy of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Community-based vaccine outreach intervention
- Type of treatment
- Vaccines
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Oct 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Center for Urban Epidemiologic Studies, The New York Academy of Medicine
New York, New York, 10029
Micaela H Coady, MS, 212-822-7277, mcoady@nyam.org
Danielle Ompad, PhD, 212-419-3589, dompad@nyam.org
About this study
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:
- 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.
Read the 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).
- Conditions
- Influenza
- Being tested
- Community-based vaccine outreach intervention
- Keywords
- Influenza, Vaccination, Hard-to-Reach Populations, Urban, Disadvantaged
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based vaccine outreach interventionBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4,000 participants
Sponsor and investigators
- Lead sponsor
- The New York Academy of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- David Vlahov, PhD, Principal investigator, Center for Urban Epidemiologic Studies, The New York Academy of MedicineSandro Galea, MD, DrPH, Principal investigator, Center for Urban Epidemiologic Studies, The New York Academy of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155974
- Sponsor's protocol ID
- 091603
- Other IDs
- DA017004
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 22 Sep 2006
- Results posted
- No
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. doi: 10.1097/00004479-200501000-00007.
PubMed 15682961
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Vaccination of Hard-to-Reach Populations
- ClinicalTrials.gov ID
- NCT00155974
- Acronym / sponsor ID
- 091603
- Conditions
- Influenza
- Keywords
- Influenza, Vaccination, Hard-to-Reach Populations, Urban, Disadvantaged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants
- Lead sponsor
- The New York Academy of MedicineUniversity, hospital or other
- Study start
- Feb 2004
- Study completion
- Oct 2005
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community-based vaccine outreach intervention | Biological | – |
Primary outcome
Compare vaccination rates in selected neighborhoods before and after a multilevel community-based participatory intervention trial.
2 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2006.
- Background: PubMed 15682961Galea 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Vlahov, PhD principal investigator
Center for Urban Epidemiologic Studies, The New York Academy of Medicine
Sandro Galea, MD, DrPH principal investigator
Center for Urban Epidemiologic Studies, The New York Academy of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based vaccine outreach intervention in people with Influenza, run by The New York Academy of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandro Galea, MD, DrPH (734-647-9741, sgalea@nyam.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare vaccination rates in selected neighborhoods before and after a multilevel community-based participatory intervention trial.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00155974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2006.