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OpenTrials
Completed

NCT Number: NCT02602626

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

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.

Completed

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Key information

Conditions

Age range

18 year–26 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

Other outcomes

  1. 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

  2. Health Literacy

    Time frame: at time of enrollment

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

  3. 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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2015
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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