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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Michigan.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Child Health Evaluation and Research Unit
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01143142
First received: June 10, 2010
Last updated: July 12, 2011
Last verified: June 2010
  Purpose

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.


Condition Intervention
Human Papillomavirus
Prevention
Behavioral: Computer-based tailoring system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Vax Facts HPV: Study of a Computer-based Tailoring System and Mothers' Intentions to Vaccinate Their Daughters Against HPV

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 70
Study Start Date: June 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tailoring
Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.
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.
Active Comparator: Untailored information
Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143142

Locations
United States, Michigan
UMHS Outpatient Pediatrics
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
University of Michigan
Child Health Evaluation and Research Unit
Investigators
Principal Investigator: Amanda Dempsey, MD, PhD, MPH Child Health Evaluation and Research Unit
  More Information

Publications:

Responsible Party: Amanda Dempsey, Child Health Evaluation and Research Unit
ClinicalTrials.gov Identifier: NCT01143142     History of Changes
Other Study ID Numbers: 149891, P50CA101451
Study First Received: June 10, 2010
Last Updated: July 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Human papillomavirus
HPV
Prevention
Tailoring
Persuasive communication
Adolescent

ClinicalTrials.gov processed this record on November 25, 2014