Clinical trial NCT04430907: HPV Vaccine in Postpartum Women
Official title: Increasing Human Papillomavirus Vaccination in Postpartum Women at Penn State Hershey Medical Center
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HPV Infection
Keywords: HPV vaccination
cervical cancer
postpartum
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women postpartum with a live birth at Penn State Hershey Medical Center (PSHMC), either vaginal or cesarean delivery between the ages of 18-26 (inclusive).

Brief summary: The purpose of this study is to determine the acceptability of HPV vaccination in postpartum women in Central Pennsylvania. Participants will be recruited while inpatient in the postpartum unit. Participants will complete a survey asking about knowledge, attitudes, and beliefs around vaccination, including HPV vaccination, as well as breastfeeding intentions. After survey completion, the participant will have the option to receive the HPV vaccine, Gardasil 9, prior to discharge from the hospital. All participants will then be contacted 1- week later for the follow-up survey.

Detailed description: The purpose of this pilot study is to determine if postpartum women serve as a potential population to target in order to increase human papillomavirus (HPV) vaccination in Central Pennsylvania.

Despite being available for almost a decade, uptake of the HPV vaccine in the US remains below other countries, including England, Scotland, and Australia. In fact, in 2017, only 67% of US girls aged 13-17 had obtained even one dose of the HPV vaccine series. Due to low rates of HPV vaccination in the United States and Central Pennsylvania, effective interventions are needed to help increase these rates.

While vaccination is recommended at a younger age, it is effective among women 18-25 years old. Based on clinical trial data, giving the vaccine to this age group has resulted in reduced abnormal Pap test findings, referral for colposcopy, and treatment related to abnormal cervical cytology. However, the HPV vaccine is not usually discussed during prenatal care or routinely administered during pregnancy. Previous studies have shown that offering other vaccines postpartum (e.g. tetanus or pertussis) has been successful.

By offering the vaccine to this demographic group, the investigators could potentially discover an untapped target population to help increase rates of HPV vaccination.

Eligibility criteria: Inclusion Criteria:

1. Women postpartum with a live birth at Penn State Hershey Medical Center (PSHMC), either vaginal or cesarean delivery.
2. Women aged 18-26 (inclusive) years
3. Women who are on a Floor Status level of care.
4. Women who have completed 0 or 1 doses of the HPV vaccine STUDY00013831 Approval: 5/8/2020 Page 6 of 24 (V.01/21/2019)
5. Fluent in written and spoken English and other languages in which the Human Subjects Protection Office (HSPO) Consent Short From is available (French, Italian, Russian, Spanish, Vietnamese, Hindi, Chinese and Nepali)

Exclusion Criteria:

1. Women who have completed 2 or 3 doses of the HPV vaccine
2. Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL 9 or GARDASIL®.
3. Allergic reaction to amorphous aluminum hydroxyphosphate sulfate or polysorbate 80
4. Women being actively treated for cancer.
5. Have a fever over 100.4 degrees Fahrenheit (38.0 degrees Celsius)
6. Women who are at an ICU level of Care
7. Women who are on a Labor and Delivery Level of Care
8. Women receiving continuous IV magnesium.

Primary outcomes:
measure: Prevalence of postpartum women who agree to HPV vaccination
timeFrame: Day 1
measure: Perception of HPV vaccination
timeFrame: Day 8
measure: Satisfaction to receive the HPV vaccine
timeFrame: Day 8
Secondary outcomes:
measure: Perception of vaccines in general
timeFrame: Day 1
measure: Breastfeeding intentions and practices
timeFrame: Days 1 and 8
Other outcomes:
Locations:
Study officials:
affiliation: Penn State College of Medicine
name: Stacey L Milunic, MD
role: PRINCIPAL_INVESTIGATOR
References: