NCT00828555

Brief 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

  • 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,988

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

October 16, 2012

Status Verified

September 1, 2012

Enrollment Period

5 months

First QC Date

January 22, 2009

Last Update Submit

October 15, 2012

Conditions

Keywords

HPV vaccineTdap vaccine

Outcome Measures

Primary Outcomes (1)

  • 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.

    Full-scale program implementation will cover a 12 month period, tentatively planned to begin in April 2009.

Interventions

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

Eligibility Criteria

Age12 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Population Groups: Adults Minors Patients Pregnant Women Fetuses

You may qualify if:

  • community Ob/Gyn practices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Westside OBGYN

Burlington, North Carolina, United States

Location

DWHA

Durham, North Carolina, 27707, United States

Location

Atrium OBGYN

Raleigh, North Carolina, United States

Location

Blue Ridge OBGYN

Raleigh, North Carolina, United States

Location

MeSH Terms

Conditions

Influenza, HumanPapillomavirus InfectionsWhooping Cough

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesDNA Virus InfectionsTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBordetella InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Geeta Swamy, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 26, 2009

Study Start

November 1, 2008

Primary Completion

April 1, 2009

Study Completion

February 1, 2012

Last Updated

October 16, 2012

Record last verified: 2012-09

Locations