Overview

This trial is active, not recruiting.

Conditions human papillomavirus, prevention
Treatment computer-based tailoring system
Sponsor University of Michigan
Collaborator Child Health Evaluation and Research Unit
Start date June 2010
End date October 2011
Trial size 70 participants
Trial identifier NCT01143142, 149891, P50CA101451

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.
computer-based tailoring system
Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure.
(Active Comparator)
Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.
computer-based tailoring system
Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure.

Primary Outcomes

Measure
Mother's intention to vaccinate daughter against HPV
time frame: Date of intervention (one day)

Secondary Outcomes

Measure
Vaccination of daughter
time frame: Less than or equal to three months from the date of the intervention

Eligibility Criteria

Female participants at least 18 years old.

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." Exclusion Criteria: - Cannot read/speak English

Additional Information

Official title Vax Facts HPV: Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV
Principal investigator Amanda Dempsey, MD, PhD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by University of Michigan.