Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602626
Recruitment Status : Completed
First Posted : November 11, 2015
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
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.

Condition or disease
Vaccination

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Kimberly Kilfoyle, MD University of North Carolina, Chapel Hill
Study Chair: Lisa Rahandale, MD University of North Carolina, Chapel Hill

Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02602626     History of Changes
Other Study ID Numbers: 14-2178
5T32HD040672-15 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: November 2015
Keywords provided by University of North Carolina, Chapel Hill:
Human Papillomavirus
HPV
Postpartum
Additional relevant MeSH terms:
Layout table for MeSH terms
Vaccines
Immunologic Factors
Physiological Effects of Drugs