Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting - Full Text View

Sponsors and Collaborators:	Duke University Centers for Disease Control and Prevention
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00828555

Purpose

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

Condition	Intervention
Influenza Vaccine Papillomavirus Infection Pertussis	Other: Vaccination Program

Study Type:	Observational
Official Title:	Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting

Resource links provided by NLM:

MedlinePlus related topics: Flu Whooping Cough

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1540
Study Start Date:	November 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Design & implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, & pertussis

Eligibility

Ages Eligible for Study:	12 Years to 26 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Population Groups:

Adults

Minors

Patients

Pregnant Women

Fetuses

Criteria

Inclusion Criteria:

4-5 community Ob/Gyn practices

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828555

Contacts

Contact: Bonnie Thiele, BSN

thiel006@mc.duke.edu

Locations

United States, North Carolina
DWHA	Recruiting
Durham, North Carolina, United States

Sponsors and Collaborators

Duke University

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Geeta Swamy, MD

Duke University

More Information

No publications provided

Responsible Party:	Duke University Medical Center ( Dr. Geeta Swamy )
Study ID Numbers:	Pro00011038
Study First Received:	January 22, 2009
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00828555 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

HPV vaccine
Tdap vaccine

Study placed in the following topic categories:

Virus Diseases
Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Cough

Whooping Cough
DNA Virus Infections
Papillomavirus Infections
Orthomyxoviridae Infections
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Bacterial Infections
RNA Virus Infections
Tumor Virus Infections
Whooping Cough
Orthomyxoviridae Infections
Infection
Gram-Negative Bacterial Infections

Bordetella Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Influenza, Human
Papillomavirus Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 10, 2009