Influenza VaccineNCT00828555
Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting
An observational study of Influenza Vaccine and Papillomavirus Infection, run by Duke University at 4 sites in United States.
Trial summary
PURPOSE To develop, implement, and evaluate the effectiveness of a program designed to assist community Ob/Gyns in vaccinating adolescent and adult women against vaccine-preventable diseases. SPECIFIC AIMS 1. Read more about this study
- Who is it for?
- Ages 12 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccine, Papillomavirus Infection, Pertussis
- What is being tested?
- Vaccination Program
- Type of treatment
- Vaccines
- How many people
- 3,988 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2008to Feb 2012
- Phase
- Observational
- 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 12 to 26 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Population Groups: Adults Minors Patients Pregnant Women Fetuses
Who may be able to join
- 4-5 community Ob/Gyn practices
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Westside OBGYN
Burlington, North Carolina
DWHA
Durham, North Carolina, 27707
Atrium OBGYN
Raleigh, North Carolina
Blue Ridge OBGYN
Raleigh, North Carolina
About this study
PURPOSE To develop, implement, and evaluate the effectiveness of a program designed to assist community Ob/Gyns in vaccinating adolescent and adult women against vaccine-preventable diseases.
SPECIFIC AIMS
Read more
- Determine the feasibility of implementing a successful vaccination program for adolescent and adult women in Ob/Gyn offices by direct assessment of medical personnel \& office staff on their:
- Attitudes towards vaccination of women against preventable diseases
- Perceived barriers to implementing a program to vaccinate women in their offices
- Ideas on how to overcome barriers to successful program implementation
- Current vaccination practices and office-specific administrative processes
- Design \& implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, \& pertussis
- Determine the effectiveness of the vaccination program based on
- Pre- and post-program vaccination rates
- Program satisfaction amongst Ob/Gyn providers and office staff
- Willingness to continue and possibly extend the program to additional vaccines
- Quantify the level of support and resources needed to develop and implement the vaccination program
- Conditions
- Influenza Vaccine, Papillomavirus Infection, Pertussis
- Being tested
- Vaccination Program
- Keywords
- HPV vaccine, Tdap vaccine
- Medical subject headings
- Influenza, Human, Papillomavirus Infections, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination ProgramOther
Design \& implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, \& pertussis
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation and measurement of a health services intervention in community or private Ob/Gyn practices to improve the delivery of standard clinical care to vaccinate women against human papillomavirus, influenza, & pertussis.
Measured: Full-scale program implementation will cover a 12 month period, tentatively planned to begin in April 2009.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionApr 2009
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VaccineStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 3,988 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Geeta Swamy, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00828555
- Sponsor's protocol ID
- Pro00011038
- Status last verified
- Sep 2012
- First submitted
- 22 Jan 2009
- Last updated
- 16 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting
- ClinicalTrials.gov ID
- NCT00828555
- Acronym / sponsor ID
- Pro00011038
- Conditions
- Influenza Vaccine, Papillomavirus Infection, Pertussis
- Keywords
- HPV vaccine, Tdap vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,988 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Nov 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 26 Jan 2009 (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.
PURPOSE To develop, implement, and evaluate the effectiveness of a program designed to assist community Ob/Gyns in vaccinating adolescent and adult women against vaccine-preventable diseases.
SPECIFIC AIMS
- Determine the feasibility of implementing a successful vaccination program for adolescent and adult women in Ob/Gyn offices by direct assessment of medical personnel \& office staff on their:
- Attitudes towards vaccination of women against preventable diseases
- Perceived barriers to implementing a program to vaccinate women in their offices
- Ideas on how to overcome barriers to successful program implementation
- Current vaccination practices and office-specific administrative processes
- Design \& implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, \& pertussis
- Determine the effectiveness of the vaccination program based on
- Pre- and post-program vaccination rates
- Program satisfaction amongst Ob/Gyn providers and office staff
- Willingness to continue and possibly extend the program to additional vaccines
- Quantify the level of support and resources needed to develop and implement the vaccination program
Study design
Who may qualify
- Ages
- 12 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Population Groups: Adults Minors Patients Pregnant Women Fetuses
Key inclusion criteria (1 listed)
- 4-5 community Ob/Gyn practices
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Vaccination ProgramDesign \& implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, \& pertussis | Other | – |
Primary outcome
Implementation and measurement of a health services intervention in community or private Ob/Gyn practices to improve the delivery of standard clinical care to vaccinate women against human papillomavirus, influenza, & pertussis.
Time frame: Full-scale program implementation will cover a 12 month period, tentatively planned to begin in April 2009.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
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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.
Geeta Swamy, MD principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Vaccine and Papillomavirus Infection, run by Duke University at 4 sites 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 0 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: finished, as of the sponsor's last update on 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation and measurement of a health services intervention in community or private Ob/Gyn practices to improve the delivery of standard clinical care to vaccinate women against human papillomavirus, influenza, & pertussis. (time frame: Full-scale program implementation will cover a 12 month period, tentatively planned to begin in April 2009.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2012.