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Effectiveness of a Vaccination Program in the Community Ob/Gyn Setting

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00828555
First received: January 22, 2009
Last updated: October 15, 2012
Last verified: September 2012
History of Changes
  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

  1. 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
  2. Design & implement a program for Ob/Gyns to vaccinate women against human papillomavirus, influenza, & pertussis

  3. 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
  4. 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:

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 ]
Enrollment: 3988
Study Start Date: November 2008
Study Completion Date: February 2012
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Vaccination Program
    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   (Child, Adult)
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
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, see Learn About Clinical Studies.

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

Locations
United States, North Carolina
Westside OBGYN
Burlington, North Carolina, United States
DWHA
Durham, North Carolina, United States, 27707
Atrium OBGYN
Raleigh, North Carolina, United States
Blue Ridge OBGYN
Raleigh, 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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00828555     History of Changes
Other Study ID Numbers: Pro00011038 
Study First Received: January 22, 2009
Last Updated: October 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
HPV vaccine
Tdap vaccine

Additional relevant MeSH terms:
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
 Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016