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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Amanda Dempsey, University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01143142
First received: June 10, 2010
Last updated: December 15, 2014
Last verified: December 2014

June 10, 2010
December 15, 2014
June 2010
October 2011   (final data collection date for primary outcome measure)
Mother's Intention to Vaccinate Daughter Against HPV [ Time Frame: Date of intervention (one day) ] [ Designated as safety issue: No ]
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.
Mother's intention to vaccinate daughter against HPV [ Time Frame: Date of intervention (one day) ] [ Designated as safety issue: No ]
Mother will rate her intention to have her daughter vaccinated against HPV using a Likert scale before and after the intervention.
Complete list of historical versions of study NCT01143142 on ClinicalTrials.gov Archive Site
Vaccination of Daughter [ Time Frame: Less than or equal to three months from the date of the intervention ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Vax Facts Human Papillomavirus (HPV): Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV
Vax Facts HPV: Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Human Papillomavirus
  • Prevention
Behavioral: 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.
  • Experimental: Tailoring
    Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.
    Intervention: Behavioral: Computer-based tailoring system
  • Active Comparator: Untailored information
    Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.
    Intervention: Behavioral: Computer-based tailoring system

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01143142
149891, P50CA101451
Yes
Amanda Dempsey, University of Colorado, Denver
University of Michigan
National Cancer Institute (NCI)
Principal Investigator: Amanda Dempsey, MD, PhD, MPH Child Health Evaluation and Research Unit
University of Michigan
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP