The Acceptability of the HPV Vaccine Postpartum and With Pediatric Well-child Visits: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT02602626|
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : April 25, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||600 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||The Acceptability of the HPV Vaccine Postpartum and With Pediatric Well-child Visits: A Pilot Study|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
- Acceptability of HPV vaccination [ Time Frame: At time of enrollment ]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. ]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 ]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 ]This will be assessed using the Carolina HPV Immunization Attitudes and Belief Scale
- Health Literacy [ Time Frame: at time of enrollment ]Health literacy will be screened using the "Newest Vital Sign" Measure
- HPV and HPV vaccine Knowledge [ Time Frame: at time of enrollment ]A series of questions will be used to determine baseline knowledge of HPV and HPV vaccination
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602626
|Principal Investigator:||Kimberly Kilfoyle, MD||University of North Carolina, Chapel Hill|
|Study Chair:||Lisa Rahandale, MD||University of North Carolina, Chapel Hill|