The Parents in Appalachia Receive Education Needed for Teen Project

Healthy Clinical Trial

— PARENT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01901770
• Other study ID #: OSU-11115
• Secondary ID: NCI-2013-01164
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2012
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 624
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Human Papilloma Virus Infection
• Papilloma
• Papillomavirus Infections

Intervention

Other:
• educational intervention
Receive HPV vaccination educational materials
• educational intervention
Receive influenza vaccination educational materials

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   The Jamesline