HPV Vaccine in Postpartum Women
Increasing Human Papillomavirus Vaccination in Postpartum Women at Penn State Hershey Medical Center
研究概览
地位
地位
干预/治疗
干预/治疗
详细说明
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.
研究类型
研究类型
参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
团体/队列数
队列和干预
团体/队列团体/队列 |
干预/治疗干预/治疗 |
|---|---|
|
Vaccine Accepting
This group will receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital.
|
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.
其他名称：
|
|
Vaccine Rejecting
This group will not receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital.
|
研究衡量的是什么？
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Prevalence of postpartum women who agree to HPV vaccination
大体时间：Day 1
|
Percentage of women who accept HPV vaccination when offered in the inpatient postpartum setting
|
Day 1
|
|
Perception of HPV vaccination
大体时间：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.
|
Day 8
|
|
Satisfaction to receive the HPV vaccine
大体时间：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.
|
Day 8
|
次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Perception of vaccines in general
大体时间：Day 1
|
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
大体时间：Days 1 and 8
|
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
|
合作者和调查者
调查人员
调查人员
- 首席研究员：Stacey L Milunic, MD、Penn State College of Medicine
研究记录日期
研究主要日期
学习开始 (预期的)
学习开始
初级完成 (预期的)
初级完成
研究完成 (预期的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (实际的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
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