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

Vaccination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02602626
• Other study ID #: 14-2178
• Secondary ID: 5T32HD040672-15
• Status: Completed
• Phase: N/A
• First received: November 5, 2015
• Last updated: April 21, 2017
• Start date: November 2015
• Est. completion date: April 2016

Study information

• Verified date: November 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 26 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaccination

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attitudes and beliefs regarding HPV immunization	This will be assessed using the Carolina HPV Immunization Attitudes and Belief Scale	at time of enrollment
Other	Health Literacy	Health literacy will be screened using the "Newest Vital Sign" Measure	at time of enrollment
Other	HPV and HPV vaccine Knowledge	A series of questions will be used to determine baseline knowledge of HPV and HPV vaccination	at time of enrollment
Primary	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	At time of enrollment
Secondary	Proportion of women attending postpartum visits	Estimation of the proportion of women who attend postpartum visits with their obstetric care providers	At time of follow-up which will occur 8 weeks after delivery. This could occur up to 5 months after enrollment.
Secondary	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.	at time of enrollment