HPV Vaccine in Postpartum Women

Increasing Human Papillomavirus Vaccination in Postpartum Women at Penn State Hershey Medical Center

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.

Study Overview

• Status: Withdrawn
• Conditions: HPV Infection
• Intervention / Treatment: Biological: HPV 9-valent Vaccine, Recombinant

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vaccine Accepting; This group will receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital.	Biological: HPV 9-valent Vaccine, Recombinant; After consent, participants will complete an intake survey confirming eligibility. Participants will also 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 be asked if they would like to be administered the HPV vaccine, Gardasil 9. If participants do not agree, they will be contacted 1-week later for the follow-up survey. If participants do agree, the project coordinator will notify the study physician, who will place an order for the vaccine. The vaccine will be administered to the patient prior to discharge from the hospital. Participants will be contacted 1-week later for the follow-up survey.; Other Names: Gardasil-9
Vaccine Rejecting; This group will not receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of postpartum women who agree to HPV vaccination	Percentage of women who accept HPV vaccination when offered in the inpatient postpartum setting	Day 1
Perception of HPV vaccination	Perception of HPV vaccination as measured via Likert scale questions in pre- and post survey. The investigators use a 5-point Likert scale, where '1' means 'strongly disagree', '2' means somewhat disagree, '3' means neither agree or disagree, '4' means somewhat agree, and '5' means 'strongly agree'. The higher the score, the more favorable the outcome.	Day 8
Satisfaction to receive the HPV vaccine	Patient satisfaction with her decision to receive (or not receive) the HPV vaccine as measured via Likert scale questions in pre and post survey. The investigators use a 5-point Likert scale, where '1' means 'strongly disagree', '2' means somewhat disagree, '3' means neither agree or disagree, '4' means somewhat agree, and '5' means 'strongly agree'. The higher the score, the more favorable the outcome.	Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of vaccines in general	Perception of vaccines overall (not specific to HPV) as measured via Likert scale questions in pre-survey. The investigators use a 5-point Likert scale, where '1' means 'strongly disagree', '2' means somewhat disagree, '3' means neither agree or disagree, '4' means somewhat agree, and '5' means 'strongly agree'. The higher the score, the more favorable the outcome.	Day 1
Breastfeeding intentions and practices	Differences in breastfeeding intentions/practices for women who get HPV vaccine in the postpartum setting versus women who refuse HPV vaccine in the postpartum setting as measured by pre- and post-surveys.	Days 1 and 8

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Stacey L Milunic, MD, Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: postpartum; cervical cancer; HPV vaccination
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Tumor Virus Infections; Papillomavirus Infections
• Other Study ID Numbers: 13831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes