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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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 (Other)
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 (Other)
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)
研究者
Electra Paskett
Principal Investigator
Ohio State University Comprehensive Cancer Center