CClinicalTrials.gg
CompletedNCT00828555Updated Oct 16, 2012

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

An observational study in Influenza Vaccine, Papillomavirus Infection and Pertussis, sponsored by Duke University. Completed at 4 sites in United States. Open to female participants aged 12 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-16.

Sponsored by Duke University · Observational

Study type
Observational
Enrollment
3,988
Ages
12 Years to 26 Years
Sex
Female
01

Study 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. 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
02

Conditions studied

  • Influenza Vaccine
  • Papillomavirus Infection
  • Pertussis

Keywords

  • HPV vaccine
  • Tdap vaccine
03

In context

Papillomavirus Infections

495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.

This study's enrollment of 3,988 is above the median of 400 across 147 observational studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 26 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Population Groups:

Adults

Minors

Patients

Pregnant Women

Fetuses

Eligibility criteria

Inclusion Criteria:

  • 4-5 community Ob/Gyn practices
05

Study design

Enrollment
3,988 participants (actual)

Interventions

  • OtherVaccination Program

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

06

What researchers measure

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.

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

07

Study locations

4 sites
  • Westside OBGYN
    Burlington, North Carolina, United States
  • DWHA
    Durham, North Carolina 27707, United States
  • Atrium OBGYN
    Raleigh, North Carolina, United States
  • Blue Ridge OBGYN
    Raleigh, North Carolina, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00828555
Lead sponsor
Duke University
Collaborators
Centers for Disease Control and Prevention
Responsible party
Sponsor
First posted
Jan 26, 2009
Start date
Nov 2008
Primary completion
Apr 2009
Completion
Feb 2012
Last update
Oct 16, 2012

Study contacts

Geeta Swamy, MD
principal investigator · Duke University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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