Clinical trial NCT01901770: The Parents in Appalachia Receive Education Needed for Teen Project
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy
Human Papilloma Virus Infection
Keywords: HPV
Ohio Appalachia
HPV vaccine
No evidence of disease
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-07-17
Enrollment: 624
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Proportion of daughters of participating parents who received their first HPV vaccination
timeFrame: Within 3 months of viewing educational material
Secondary outcomes:
measure: Proportion of daughters of participants in the intervention arm who received a second and third dose of the HPV vaccine
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Electra Paskett
role: PRINCIPAL_INVESTIGATOR
References: