The Parents in Appalachia Receive Education Needed for Teen Project

NCT ID: NCT01901770

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 624 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2026-12-31

Brief Summary

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

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.

Conditions

Healthy; Human Papilloma Virus Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

educational intervention

Intervention Type: OTHER

Receive HPV vaccination educational materials

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.

Group Type: ACTIVE_COMPARATOR

educational intervention

Intervention Type: OTHER

Receive influenza vaccination educational materials

Interventions

educational intervention

Receive HPV vaccination educational materials

Intervention Type: OTHER

educational intervention

Receive influenza vaccination educational materials

Intervention Type: OTHER

Other Intervention Names

intervention, educational; intervention, educational

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Electra Paskett

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Electra Paskett

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Countries

United States

Related Links

http://cancer.osu.edu

The Jamesline

Other Identifiers

NCI-2013-01164

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-11115

Identifier Type: -

Identifier Source: org_study_id