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

Completed

• Conditions: Vaccination

• Registration Number: NCT02602626
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

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.

Study Timeline

• Status Verified: 2015-11
• Study Start: 2015-11
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-09
• Study First Posted: 2015-11-11
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2017-04-21
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptability of HPV vaccination	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

Secondary Outcome Measures

Name	Time	Method
Proportion of women attending postpartum visits	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	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.