Clinical trial NCT02602626: The Acceptability of the HPV Vaccine Postpartum and With Pediatric Well-child Visits: A Pilot Study
Official title: The Acceptability of the HPV Vaccine Postpartum and With Pediatric Well-child Visits: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccination
Keywords: Human Papillomavirus
HPV
Postpartum
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-11-11
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Acceptability of HPV vaccination
timeFrame: At time of enrollment
Secondary outcomes:
measure: Proportion of women attending postpartum visits
timeFrame: At time of follow-up which will occur 8 weeks after delivery. This could occur up to 5 months after enrollment.
measure: Estimate of baseline prevalence of prior HPV vaccination in study population
timeFrame: at time of enrollment
Other outcomes:
measure: Attitudes and beliefs regarding HPV immunization
timeFrame: at time of enrollment
measure: Health Literacy
timeFrame: at time of enrollment
measure: HPV and HPV vaccine Knowledge
timeFrame: at time of enrollment
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kimberly Kilfoyle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Lisa Rahandale, MD
role: STUDY_CHAIR
References: