The Parents in Appalachia Receive Education Needed for Teen Project

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy, Human Papilloma Virus Infection

Intervention / Treatment
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* Other: educational intervention
* Other: educational intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I-HPV vaccine education<br>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. | Other: educational intervention<br>* Receive HPV vaccination educational materials<br>* Other names: intervention, educational;|
| Active Comparator: Arm II- Flu vaccine education<br>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. | Other: educational intervention<br>* Receive influenza vaccination educational materials<br>* Other names: intervention, educational;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of daughters of participating parents who received their first HPV vaccination | 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. | Within 3 months of viewing educational material | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of daughters of participants in the intervention arm who received a second and third dose of the HPV vaccine | Separate logistic random effects models will be fit for each vaccination and t-tests of the fixed intervention effect will be used to compare treatment arms. | Up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Ohio Appalachia, HPV vaccine, No evidence of disease