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

NCT02602626 | Completed

• 2 other identifiers: 14-21785T32HD040672-15
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vaccination

Keywords

Human Papillomavirus; HPV; Postpartum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of women attending postpartum visits

  At time of follow-up which will occur 8 weeks after delivery. This could occur up to 5 months after enrollment.

• Estimate of baseline prevalence of prior HPV vaccination in study population

  at time of enrollment

Other Outcomes (3)

• Attitudes and beliefs regarding HPV immunization

  at time of enrollment

• Health Literacy

  at time of enrollment

• HPV and HPV vaccine Knowledge

  at time of enrollment

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Pregnant women at 28 weeks of gestational age or greater

You may not qualify if:

• Primary language other than English or Spanish
• Receipt of any prior doses of HPV vaccine.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Officials

• Kimberly Kilfoyle, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Lisa Rahandale, MD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 11, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 25, 2017

Record last verified: 2015-11