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HPV Vaccine in Postpartum Women

2021年6月30日 更新者：Stacey Milunic、Milton S. Hershey Medical Center

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.

調査の概要

状態

引きこもった

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～26年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

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).

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Vaccine Accepting
This group will receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital.
生物学的：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.

他の名前：
  • ガーダシル-9
Vaccine Rejecting
This group will not receive the HPV vaccine in the inpatient postpartum period prior to discharge from the hospital.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Prevalence of postpartum women who agree to HPV vaccination
時間枠：Day 1
Percentage of women who accept HPV vaccination when offered in the inpatient postpartum setting
Day 1
Perception of HPV vaccination
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Perception of vaccines in general
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Milton S. Hershey Medical Center

捜査官

  • 主任研究者：Stacey L Milunic, MD、Penn State College of Medicine

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2021年9月1日

一次修了 (予想される)

2022年9月1日

研究の完了 (予想される)

2023年9月1日

試験登録日

最初に提出

2020年6月11日

QC基準を満たした最初の提出物

2020年6月11日

最初の投稿 (実際)

2020年6月16日

学習記録の更新

投稿された最後の更新 (実際)

2021年7月2日

QC基準を満たした最後の更新が送信されました

2021年6月30日

最終確認日

2021年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 13831

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

HPV感染の臨床試験

HPV 9-valent Vaccine, Recombinantの臨床試験

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