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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02602626
Enrollment
600
Registered
2015-11-11
Start date
2015-11-30
Completion date
2016-04-30
Last updated
2017-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaccination

Keywords

Human Papillomavirus, HPV, Postpartum

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.

Interventions

None listed

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 26 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of HPV vaccinationAt time of enrollmentEstimation 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

MeasureTime frameDescription
Proportion of women attending postpartum visitsAt 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 populationat time of enrollmentParticipants 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

MeasureTime frameDescription
Attitudes and beliefs regarding HPV immunizationat time of enrollmentThis will be assessed using the Carolina HPV Immunization Attitudes and Belief Scale
Health Literacyat time of enrollmentHealth literacy will be screened using the Newest Vital Sign Measure
HPV and HPV vaccine Knowledgeat time of enrollmentA series of questions will be used to determine baseline knowledge of HPV and HPV vaccination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026