The Parents in Appalachia Receive Education Needed for Teen Project (PARENT)

The Ohio State University

Status: Active, not recruiting

Conditions: Healthy; Human Papilloma Virus Infection

Treatments: Other: educational intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01901770

NCI-2013-01164 (Registry Identifier)

OSU-11115

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 624 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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624 participants in 2 patient groups

Arm I-HPV vaccine education

Experimental group

Description:

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.

Treatment:

Other: educational intervention

Other: educational intervention

Arm II- Flu vaccine education

Active Comparator group

Description:

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.

Treatment:

Other: educational intervention

Other: educational intervention