CClinicalTrials.gg
CompletedNCT02602626Updated Apr 25, 2017

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

An observational study in Vaccination, sponsored by University of North Carolina, Chapel Hill. Completed. Open to female participants aged 18 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-25.

Sponsored by University of North Carolina, Chapel Hill · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
600
Ages
18 Years to 26 Years
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Vaccination

Keywords

  • Human Papillomavirus
  • HPV
  • Postpartum
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In context

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 26 Years
Sexes eligible
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.

Inclusion criteria

  • Pregnant women at 28 weeks of gestational age or greater

Exclusion criteria

Exclusion Criteria:

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

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
600 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Acceptability of HPV vaccination

    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

    Time frame: At time of enrollment

Secondary outcomes

  1. Proportion of women attending postpartum visits

    Estimation of the proportion of women who attend postpartum visits with their obstetric care providers

    Time frame: At time of follow-up which will occur 8 weeks after delivery. This could occur up to 5 months after enrollment.

  2. Estimate of baseline prevalence of prior HPV vaccination in study population

    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.

    Time frame: at time of enrollment

Other outcomes

  1. Attitudes and beliefs regarding HPV immunization

    This will be assessed using the Carolina HPV Immunization Attitudes and Belief Scale

    Time frame: at time of enrollment

  2. Health Literacy

    Health literacy will be screened using the "Newest Vital Sign" Measure

    Time frame: at time of enrollment

  3. HPV and HPV vaccine Knowledge

    A series of questions will be used to determine baseline knowledge of HPV and HPV vaccination

    Time frame: at time of enrollment

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02602626
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Nov 11, 2015
Start date
Nov 2015
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Apr 25, 2017

Study contacts

Kimberly Kilfoyle, MD
principal investigator · University of North Carolina, Chapel Hill
Lisa Rahandale, MD
study chair · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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