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

Primary Purpose

Healthy, Human Papilloma Virus Infection

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
educational intervention
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Healthy focused on measuring HPV, Ohio Appalachia, HPV vaccine, No evidence of disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I-HPV vaccine education

Arm II- Flu vaccine education

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 13, 2013
Last Updated
May 22, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01901770
Brief Title
The Parents in Appalachia Receive Education Needed for Teen Project
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Human Papilloma Virus Infection
Keywords
HPV, Ohio Appalachia, HPV vaccine, No evidence of disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
624 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I-HPV vaccine education
Arm Type
Experimental
Arm 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.
Arm Title
Arm II- Flu vaccine education
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Receive HPV vaccination educational materials
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Receive influenza vaccination educational materials
Primary Outcome Measure Information:
Title
Proportion of daughters of participating parents who received their first HPV vaccination
Description
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.
Time Frame
Within 3 months of viewing educational material
Secondary Outcome Measure Information:
Title
Proportion of daughters of participants in the intervention arm who received a second and third dose of the HPV vaccine
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Electra Paskett
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

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