HPV InfectionNCT04430907
HPV Vaccine in Postpartum Women
An observational study of HPV Infection, run by Milton S. Hershey Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV Infection
- What is being tested?
- HPV 9-valent Vaccine, Recombinant
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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
- Being tested
- HPV 9-valent Vaccine, Recombinant
- Keywords
- HPV vaccination, cervical cancer, postpartum
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV 9-valent Vaccine, RecombinantBiological
Also called Gardasil-9
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.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Accepting | This group will receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of postpartum women who agree to HPV vaccination
Percentage of women who accept HPV vaccination when offered in the inpatient postpartum setting
Measured: 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.
Measured: 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.
Measured: Day 8
Secondary outcomes (2)
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.
Measured: 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.
Measured: Days 1 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Revising protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacey Milunic, Milton S. Hershey Medical Center
- Investigators
- Stacey L Milunic, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430907
- Sponsor's protocol ID
- 13831
- Status last verified
- Jun 2021
- First submitted
- 11 Jun 2020
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Human Papillomavirus Vaccination in Postpartum Women at Penn State Hershey Medical Center
- ClinicalTrials.gov ID
- NCT04430907
- Acronym / sponsor ID
- 13831
- Conditions
- HPV Infection
- Keywords
- HPV vaccination, cervical cancer, postpartum
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Revising protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine Accepting | – | Biological: HPV 9-valent Vaccine, RecombinantThis group will receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital. |
| Vaccine Rejecting | – | –This group will not receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV 9-valent Vaccine, RecombinantAlso: Gardasil-9After 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. | Biological | Vaccine Accepting |
Primary outcome
Prevalence of postpartum women who agree to HPV vaccination
Time frame: Day 1
Percentage of women who accept HPV vaccination when offered in the inpatient postpartum setting
Perception of HPV vaccination
Time frame: Day 8
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.
Satisfaction to receive the HPV vaccine
Time frame: Day 8
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.
2 secondary outcomes
Perception of vaccines in general
Time frame: Day 1
Breastfeeding intentions and practices
Time frame: Days 1 and 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey L Milunic, MD principal investigator
Penn State College of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Infection, run by Milton S. Hershey Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of postpartum women who agree to HPV vaccination (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.