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

• ClinicalTrials.gov Identifier: NCT02602626
• Recruitment Status: Completed
• First Posted: November 11, 2015
• Last Update Posted: April 25, 2017
• Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): University of North Carolina, Chapel Hill

Study Description

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Sponsors and Collaborators

University of North Carolina, Chapel Hill

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

Investigators

• Principal Investigator: Kimberly Kilfoyle, MD; University of North Carolina, Chapel Hill
• Study Chair: Lisa Rahandale, MD; University of North Carolina, Chapel Hill

More 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
• 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:

Vaccines; Immunologic Factors; Physiological Effects of Drugs