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Educational Intervention to Minimize Disparities in Humanpapillomavirus Vaccination (HPV)

2017年5月30日 更新者:University of Colorado, Denver

Educational Intervention to Minimize Disparities in HPV Vaccination

The purpose of this study is to evaluate an innovative approach to improving HPV vaccination among the Hispanic population. The clinical objectives/aims of this HPV educational intervention project are to determine:

  1. The number of young adults and adolescents in each arm who received any dose of the HPV vaccine during the study period,
  2. The number of young adults and adolescents in each arm who initiated the HPV vaccine series during the study period,
  3. The number of young adults and adolescents in each arm who initiated but did not complete the HPV vaccine series during the study period,
  4. The number of young adults and adolescents in each arm, among all eligible, who completed the HPV vaccine series during the study period,
  5. The number of young adults and adolescents in each arm who completed the HPV vaccine series during the study period, among those who initiated the series at study start, and
  6. The number of young adults and adolescents in each arm who completed the HPV vaccine series among those who initiated the series during the study period.

The implementation of this educational intervention in clinic waiting rooms is intended to assist primary care providers in communicating HPV vaccine awareness and education to parents and patients in a culturally tailored format.

調査の概要

詳細な説明

While HPV infection is nearly ubiquitous among the sexually active population, the morbidity and mortality from HPV-related diseases disproportionately affects minorities and the poor. Hispanic women are at particularly high risk as they have the highest rates of invasive cervical cancer when compared to all other racial or ethnic groups in the U.S. Initiating the 3-dose HPV vaccination series is more common among Hispanic adolescents than whites, but series completion has been lowest among Hispanic populations.

To understand barriers to HPV vaccination and to provide insight into ways in which an existing educational intervention should be modified for a Hispanic population, the investigators conducted focus groups among Hispanic parents and Latina young adults. All groups reported vaccine cost, access to insurance, and a general lack of awareness and/or understanding of either HPV or the vaccine as barriers. All groups also wanted substantially more "general" information about both HPV and the vaccine in order to make informed vaccination decisions. The educational intervention was generally well received but there were universal suggestions from all the groups to provide additional basic information about HPV infection, to add information about the vaccine for boys/young men, and to modify the color scheme and logo to make it more eye-catching and pleasing.

This current phase of the project will be comprised of real world testing of an iPad-based educational intervention about HPV, "Combatting HPV Infection and Cancer" (CHICOS) that has been revised and developed per focus group feedback to target the Hispanic population.

By providing information that patients and parents have clearly indicated they want in a way that is culturally sensitive and meaningful and also individually personalized, the investigators hope to improve HPV vaccination rates.

研究の種類

介入

入学 (実際)

1294

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Colorado
      • Aurora、Colorado、アメリカ、80045
        • University of Colorado Denver

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~75年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Parents of an adolescent between the ages of 9-17; OR a young adult patient between the ages of 18-26;
  2. Adolescent/young adult has not yet received all three doses of the HPV vaccine.
  3. Parent/young adult can read and converse in either English or Spanish

Exclusion Criteria:

  1. Age <18,
  2. Prisoners
  3. Decisionally challenged subjects
  4. Those who cannot read and converse in either English or Spanish
  5. Those who have received all 3 doses of the HPV vaccine

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

  • 主な目的:ヘルスサービス研究
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
他の:Untailored Intervention
Intervention: untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.
The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV "Vaccine Information Sheet" that has been created by the Centers for Disease Control and Prevention.
実験的:Tailored intervention
Intervention: tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.
The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.
他の:Usual Care
Intervention: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.
Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.

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
Number of Young Adults Who Received Any Dose of the HPV Vaccine During the Study Period
時間枠:16 months
This outcome describes the number of young adult participants between the ages of 18-26 who received any dose of the HPV vaccine during the study period.
16 months
Number of Young Adults Who Initiated the HPV Vaccine Series During the Study Period
時間枠:16 months
This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.
16 months
Number of Young Adults Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period
時間枠:16 months
This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.
16 months
Number of Young Adults, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period
時間枠:16 months
This outcome describes the number of young adult participants between the ages of 18-26 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
16 months
Number of Young Adults Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start
時間枠:16 months
This outcome describes the number of young adult participants between the ages of 18-26 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
16 months
Number of Young Adults Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period
時間枠:16 months
This outcome describes the number of young adult participants between the ages of 18-26 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
16 months
Number of Adolescents Who Received Any Dose of the HPV Vaccine During the Study Period
時間枠:16 months
This outcome describes the number of adolescent participants between the ages of 9-17 who received any dose of the HPV vaccine during the study period.
16 months
Number of Adolescents Who Initiated the HPV Vaccine Series During the Study Period
時間枠:16 months
This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and received at least one dose during the study period.
16 months
Number of Adolescents Who Initiated But Did Not Complete the HPV Vaccine Series During the Study Period
時間枠:16 months
This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and did not complete the vaccine series during the study period.
16 months
Number of Adolescents, Among All Eligible, Who Completed the HPV Vaccine Series During the Study Period
時間枠:16 months
This outcome describes the number of adolescent participants between the ages of 9-17 who had 0, 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
16 months
Number of Adolescents Who Completed the HPV Vaccine Series During the Study Period, Among Those Who Initiated the Series at Study Start
時間枠:16 months
This outcome describes the number of adolescent participants between the ages of 9-17 who had 1 or 2 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
16 months
Number of Adolescents Who Completed the HPV Vaccine Series Among Those Who Initiated the Series During the Study Period
時間枠:16 months
This outcome describes the number of adolescent participants between the ages of 9-17 who had 0 doses of the HPV vaccine at study enrollment and completed the vaccine series during the study period.
16 months

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。

捜査官

  • 主任研究者:Amanda F Dempsey, MD, PhD, MPH、University of Colorado, Denver

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

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

2014年6月1日

一次修了 (実際)

2015年12月1日

研究の完了 (実際)

2016年6月1日

試験登録日

最初に提出

2014年5月20日

QC基準を満たした最初の提出物

2014年5月21日

最初の投稿 (見積もり)

2014年5月22日

学習記録の更新

投稿された最後の更新 (実際)

2017年6月26日

QC基準を満たした最後の更新が送信されました

2017年5月30日

最終確認日

2017年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 14-0402
  • PCORI 1455 (その他の助成金/資金番号:Patient Centered Outcomes Research Institute)

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。

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