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临床试验/NCT01901770
NCT01901770
进行中(未招募)
不适用

The Ohio State University Center for Population Health and Health Disparities Community Awareness, Resources and Education (CARE II): Project 4 The PARENT (Parents in Appalachia Receive Education Needed for Teens) Project

Ohio State University Comprehensive Cancer Center1 个研究点 分布在 1 个国家目标入组 624 人2012年1月1日

概览

阶段
不适用
干预措施
educational intervention
疾病 / 适应症
Healthy
发起方
Ohio State University Comprehensive Cancer Center
入组人数
624
试验地点
1
主要终点
Proportion of daughters of participating parents who received their first HPV vaccination
状态
进行中(未招募)
最后更新
3个月前

概览

简要总结

This clinical trial studies an educational intervention for parents and providers in increasing human papillomavirus (HPV) vaccination rates in younger girls in Ohio Appalachia. Educational interventions may be effective in increasing the number of participants whose daughters receive HPV vaccination.

详细描述

PRIMARY OBJECTIVES: I. Implement a multi-level HPV vaccine educational intervention directed at 3 levels within participating 12 Ohio Appalachia counties that includes information about cervical cancer, cervical cancer screening, HPV, the HPV vaccine, communication skills training to improve parent-health care provider conversations about the HPV vaccine, and organizational level components. II. Evaluate the effectiveness of the multi-level HPV vaccine educational intervention in a group randomized controlled trial in 12 Ohio Appalachia counties. OUTLINE: Participants are randomized to 1 of 2 arms. Arm I: Parents and health care providers receive educational materials about HPV vaccination by mail or in-person review with project staff including a culturally tailored HPV and cervical cancer educational video and brochures, a question and answer (Q \& A) fact sheet, and a HPV and cervical cancer resource list. Clinics receive waiting and exam room posters and brochures, tabletop cards, reminder cards to mail to participants, an information resource list, newsletter, vaccine tracking system, and "invitation to be vaccinated" letter to mail to parents. Arm II: Parents and health care providers receive educational materials about influenza vaccination by mail or in-person review with project staff. After completion of study, participants are followed up at 3 and 6 months.

注册库
clinicaltrials.gov
开始日期
2012年1月1日
结束日期
2026年12月31日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Electra Paskett

Principal Investigator

Ohio State University Comprehensive Cancer Center

入排标准

入选标准

  • LEVEL 1: Parents
  • Be able to speak, read, and write English
  • Has a daughter who receives care from or lives in one of 12 Ohio Appalachia counties
  • Be a parent or a guardian of a young girl (age 9 to 17 years) who has not received the HPV vaccine (if a parent has more than one daughter, they will be asked questions about their eldest daughter)
  • Not have a child who has received the HPV vaccine
  • LEVEL 2: Health care providers
  • Practicing in a participating public health department or provider office in Ohio Appalachia
  • Personnel involved in the vaccine process (determined by individual health departments or clinic)
  • Able to speak, read, and write English

排除标准

  • LEVEL 1: Parents
  • Not able to speak, read, and write English
  • Does not have a daughter who receives care from or lives in one of 12 Ohio Appalachia counties
  • Not the parent or a guardian of a young girl (age 9 to 17 years) who has not received the HPV vaccine (if a parent has more than one daughter, they will be asked questions about their eldest daughter)
  • Has a child who has received the HPV vaccine
  • LEVEL 2: Health care providers
  • Does not practicing in a participating public health department or provider office in Ohio Appalachia
  • Personnel that is not involved in the vaccine process (determined by individual health departments or clinic)
  • Not able to speak, read, and write English

研究组 & 干预措施

Arm I-HPV vaccine education

The educational intervention is that parents and providers receive materials about HPV by mail including HPV/ cervical cancer videos and brochures, fact sheets, HPV/cervical cancer resource lists. Clinics receive posters, brochures, tabletop/reminder cards, resource lists, newsletters, and "invitation to be vaccinated" letters for parents.

干预措施: educational intervention

Arm II- Flu vaccine education

The educational intervention is that parents and providers receive materials about Flu by mail including Flu brochures, fact sheets, Flu resource lists. Clinics receive posters and brochures.

干预措施: educational intervention

结局指标

主要结局

Proportion of daughters of participating parents who received their first HPV vaccination

时间窗: Within 3 months of viewing educational material

A logistic random effects model will be used. A t-test of the coefficient for intervention status will be used to determine if there is a difference in the expected proportion of vaccinated patients across treatment arms.

次要结局

  • Proportion of daughters of participants in the intervention arm who received a second and third dose of the HPV vaccine(Up to 6 months)

研究点 (1)

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