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?
Follow our blog for more info too
The Acceptability of the HPV Vaccine Postpartum and With Pediatric Well-child Visits: A Pilot Study
|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|
- 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
- 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.
- 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
|Study Start Date:||November 2015|
|Study Completion Date:||April 2016|
|Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
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.
|Ages Eligible for Study:||18 Years to 26 Years (Adult)|
|Genders Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- Pregnant women at 28 weeks of gestational age or greater
- Primary language other than English or Spanish
- Receipt of any prior doses of HPV vaccine.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02602626
|Principal Investigator:||Kimberly Kilfoyle, MD||University of North Carolina, Chapel Hill|
|Study Chair:||Lisa Rahandale, MD||University of North Carolina, Chapel Hill|
|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:
ClinicalTrials.gov processed this record on June 30, 2016