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Active, Not Recruiting

NCT Number: NCT01901770

The Parents in Appalachia Receive Education Needed for Teen Project

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive HPV vaccination educational materials

Other names: intervention, educational

Primary outcomes

  1. Proportion of daughters of participating parents who received their first HPV vaccination

    Time frame: Within 3 months of viewing educational material

    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 outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study 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

Acronym: PARENT

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2013
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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