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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Electra Paskett, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01901770
First received: July 13, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Healthy
Human Papilloma Virus Infection
Other: educational intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Proportion of daughters of participating parents who received their first HPV vaccination [ Time Frame: Within 3 months of viewing educational material ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 624
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: educational intervention
Receive HPV vaccination educational materials
Other Name: intervention, educational
Active Comparator: 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.
Other: educational intervention
Receive influenza vaccination educational materials
Other Name: intervention, educational

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901770

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Electra Paskett Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Electra Paskett, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01901770     History of Changes
Other Study ID Numbers: OSU-11115, NCI-2013-01164
Study First Received: July 13, 2013
Last Updated: April 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
HPV
Ohio Appalachia
HPV vaccine
No evidence of disease

Additional relevant MeSH terms:
Papillomavirus Infections
Virus Diseases
DNA Virus Infections
Tumor Virus Infections

ClinicalTrials.gov processed this record on November 27, 2014