The Acceptability of the HPV Vaccine Postpartum

The Acceptability of the HPV Vaccine Postpartum

This study is to get women who are not yet 26 but are pregnant to accept the Gardasil vaccination during postpartum. To have the pediatrician recommend the vaccine for the mother during the young child’s well visits.

Wonder if they will also inform that the package for Gardasil states that it is not suggested for breastfeeding mothers?

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Trial record 9 of 266 for:    HPV children

The Acceptability of the HPV Vaccine Postpartum and With Pediatric Well-child Visits: A Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Kimberly Kilfoyle, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02602626
First received: November 5, 2015
Last updated: June 7, 2016
Last verified: November 2015
  Purpose

The purpose of this study is to determine if women would find it acceptable to receive the HPV vaccine postpartum at the pediatrician’s office at the time of their child’s two-month well- child visit when offered during the third trimester of pregnancy.
Condition
Vaccination
Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The Acceptability of the HPV Vaccine Postpartum and With Pediatric Well-child Visits: A Pilot Study
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:

  • Acceptability of HPV vaccination [ Time Frame: At time of enrollment ] [ Designated as safety issue: No ]
    Estimation of the proportion of women indicating that they would be willing to receive the HPV vaccine postpartum at pediatric well-child visits if offered in the third trimester of pregnancy


Secondary Outcome Measures:

  • Proportion of women attending postpartum visits [ Time Frame: At time of follow-up which will occur 8 weeks after delivery. This could occur up to 5 months after enrollment. ] [ Designated as safety issue: No ]
    Estimation of the proportion of women who attend postpartum visits with their obstetric care providers


  • Estimate of baseline prevalence of prior HPV vaccination in study population [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    Participants eligible for participation based on maternal age and gestational age will be screened for prior doses of HPV vaccine by self-report. Number of participants with self-report of prior HPV vaccination will be recorded and baseline prevalence from our population will be determined.


Other Outcome Measures:

  • Attitudes and beliefs regarding HPV immunization [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    This will be assessed using the Carolina HPV Immunization Attitudes and Belief Scale


  • Health Literacy [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    Health literacy will be screened using the “Newest Vital Sign” Measure


  • HPV and HPV vaccine Knowledge [ Time Frame: at time of enrollment ] [ Designated as safety issue: No ]
    A series of questions will be used to determine baseline knowledge of HPV and HPV vaccination


Enrollment: 600
Study Start Date: November 2015
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)

Detailed Description:

There are a large number of young adult women who have not received any doses of HPV vaccine or are incompletely vaccinated. Recommendation for HPV vaccine could occur during pregnancy with the administration of the vaccine postpartum. Finding a way to make it easy for women to present for vaccination is imperative as this is currently a 3-vaccine series. The investigators are interested in understanding if women would find it acceptable if the investigators discussed and encouraged the vaccine while pregnant with receipt of the vaccine through their child’s pediatrician at well-child visits in the postpartum period. The investigators will survey women in the third trimester of pregnancy to determine if they would find this acceptable and follow-up with them after their child’s two month pediatric visit to reevaluate their opinion. No doses of the vaccine will be given.

The investigators are also interested in understanding other factors that could affect whether or not women would be interested in receiving the HPV vaccine postpartum. This includes rates of attendance at postpartum visits as well as behavioral, knowledge and demographic characteristics that may be associated with acceptability of receiving the vaccine.

  Eligibility

Ages Eligible for Study: 18 Years to 26 Years   (Adult)
Genders Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Sampling Method: Non-Probability Sample
Study Population
Women will be recruited from the hospital based UNC Obstetric and Gynecology (UOG) Clinic including the resident clinic, faculty clinics and maternal fetal medicine clinics. The UOG Clinic cares for a diverse population of women from the immediate geographical area as well as referrals from 14 surrounding funded health centers.
Criteria

Inclusion Criteria:

  • Pregnant women at 28 weeks of gestational age or greater

Exclusion Criteria:

  • Primary language other than English or Spanish
  • Receipt of any prior doses of HPV vaccine.

  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: NCT02602626

Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Kimberly Kilfoyle, MD University of North Carolina, Chapel Hill
Study Chair: Lisa Rahandale, MD University of North Carolina, Chapel Hill
  More Information

Responsible Party: Kimberly Kilfoyle, MD, Clinical Instructor and Teaching Fellow, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02602626     History of Changes
Other Study ID Numbers: 14-2178  5T32HD040672-15
Study First Received: November 5, 2015
Last Updated: June 7, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:

Human Papillomavirus
HPV
Postpartum

ClinicalTrials.gov processed this record on June 30, 2016

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