The Parents in Appalachia Receive Education Needed for Teen Project

N/AActive Not RecruitingNCT01901770

Ohio State University Comprehensive Cancer Center624 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

624

Conditions

Healthy Human Papilloma Virus Infection

Interventions

educational interventionOTHER

Receive HPV vaccination educational materials

educational interventionOTHER

Receive influenza vaccination educational materials

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Within 3 months of viewing educational material

Secondary Outcomes

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.

Time frame: Up to 6 months

Data from ClinicalTrials.gov

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