HPV Vaccine in Postpartum Women

NCT04430907 | Withdrawn FDA Drug

• 1 other identifier: 13831
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HPV Infection

Keywords

HPV vaccination; cervical cancer; postpartum

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Perception of vaccines in general

  Day 1

• Breastfeeding intentions and practices

  Days 1 and 8

Study Arms (2)

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

Vaccine Rejecting

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

Interventions

HPV 9-valent Vaccine, Recombinant 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.

Also known as: Gardasil-9

Vaccine Accepting

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 postpartum with a live birth at Penn State Hershey Medical Center (PSHMC), either vaginal or cesarean delivery between the ages of 18-26 (inclusive).

You may qualify if:

• Women postpartum with a live birth at Penn State Hershey Medical Center (PSHMC), either vaginal or cesarean delivery.
• Women aged 18-26 (inclusive) years
• Women who are on a Floor Status level of care.
• 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)
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Stacey L Milunic, MD

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Family and Community Medicine

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: July 2, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share