Vax Facts Human Papillomavirus (HPV): Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV

Not Applicable

Completed

• Conditions: Prevention; Human Papillomavirus
• Interventions: Behavioral: Computer-based tailoring system

• Registration Number: NCT01143142
• Lead Sponsor: University of Michigan

Brief Summary

The goal of this study is to determine whether a two-page print brochure that delivers individually tailored educational messages about the Human papillomavirus (HPV) vaccine increases HPV vaccine-hesitant mothers' intentions to have their adolescent daughters vaccinated against HPV.

Detailed Description

This will be a randomized controlled intervention trial for HPV vaccine-hesitant mothers of adolescent (ages 11-15 years old) girls. Mothers will complete a three-item measure that assesses their baseline intentions for having their adolescent daughter vaccinated against HPV. Mothers will then fill out a short, computer-based survey that assesses demographic factors, prior experience with HPV-associated illnesses and views about a variety of potential barriers to HPV vaccination. Following the survey, the intervention group (40 mothers) will receive a two-page print brochure that uses their survey data to generate the brochure such that it addresses each mother's top three concerns about the HPV vaccine. The control group (40 mothers) will receive a generic, two-page brochure that is similar in appearance to the intervention, but contains only untailored, generic information about the vaccine. HPV vaccination intention will be assessed a second time after reading the brochure, using the same three-item measure as before the survey. The vaccine administration records of the adolescent daughters of these mothers will be accessed three months after mothers' participation in the study to assess whether any HPV vaccine doses were provided.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2014-12
• Results First Submitted: 2014-12-08
• Results First Submitted QC: 2014-12-15
• Last Update Submitted: 2014-12-15
• Results First Posted: 2014-12-22
• Last Update Posted: 2014-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• Mother is greater than or equal to 18 years of age
• Mother has a daughter who is between the ages of 11-15 years
• Daughter has not received any doses of the HPV vaccine
• When asked to describe how she feels about getting her daughter vaccinated against HPV in the next six months, mother responds "I don't want her to get vaccinated" or "I'm unsure if I want her vaccinated."

Read More

Exclusion Criteria

• Cannot read/speak English

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailoring	Computer-based tailoring system	Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.
Untailored information	Computer-based tailoring system	Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.

Primary Outcome Measures

Name	Time	Method
Mother's Intention to Vaccinate Daughter Against HPV	Date of intervention (one day)	Mother will rate her intention to have her daughter vaccinated against HPV using a Likert scale before and after the intervention. The scale ranges from 0-11 with higher numbers representing more positive intentions to vaccinate against HPV, and 5 being neutral intentions (i.e. neither positive nor negative). In this assessment we use this 11-point scale to assess vaccination before and after viewing the educational materials. The difference pre and post intervention in vaccination intention is calculated (min 0, max 11) and the mean of these differences are calculated for the control and intervention groups.

Secondary Outcome Measures

Name	Time	Method
Vaccination of Daughter	Less than or equal to three months from the date of the intervention	With mother's consent, daughter's University of Michigan vaccination record will be accessed to determine whether daughter has received any doses of the HPV vaccine. If the University of Michigan vaccination record does not document a visit three months after the intervention, with mother's consent, research staff will call mother at home to determine whether daughter has received any doses of the HPV vaccine.

Trial Locations

Locations (1)

UMHS Outpatient Pediatrics; 🇺🇸 Ann Arbor, Michigan, United States