HPV Vaccine in Postpartum Women

NCT ID: NCT04430907

Last Updated: 2021-07-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2023-09-30

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.

Conditions

HPV Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Vaccine Accepting

This group will receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital.

HPV 9-valent Vaccine, Recombinant

Intervention Type: BIOLOGICAL

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.

Vaccine Rejecting

This group will not receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital.

No interventions assigned to this group

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Gardasil-9

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Stacey Milunic

Associate Professor, Family and Community Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stacey L Milunic, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Other Identifiers

13831

Identifier Type: -

Identifier Source: org_study_id