The Parents in Appalachia Receive Education Needed for Teen Project

NCT01901770 | Active Not Recruiting DMC

• 2 other identifiers: OSU-11115NCI-2013-01164
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Human Papilloma Virus Infection

Keywords

HPV; Ohio Appalachia; HPV vaccine; No evidence of disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of daughters of participants in the intervention arm who received a second and third dose of the HPV vaccine

  Up to 6 months

Study Arms (2)

Arm I-HPV vaccine education

EXPERIMENTAL

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

Arm II- Flu vaccine education

ACTIVE COMPARATOR

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

Interventions

educational intervention OTHER

Receive HPV vaccination educational materials

Also known as: intervention, educational

Arm I-HPV vaccine education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Papillomavirus Infections

Interventions

Early Intervention, Educational; Methods

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Investigative Techniques

Study Officials

• Electra Paskett

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2013
• First Posted: July 17, 2013
• Study Start: January 1, 2012
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)