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
Results First Received: December 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Human Papillomavirus
Prevention
Intervention: Behavioral: Computer-based tailoring system

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tailoring

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.

Untailored Information

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.


Participant Flow:   Overall Study
    Tailoring     Untailored Information  
STARTED     36     34  
COMPLETED     36     34  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tailoring

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.

Untailored Information

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.

Total Total of all reporting groups

Baseline Measures
    Tailoring     Untailored Information     Total  
Number of Participants  
[units: participants]
  36     34     70  
Age  
[units: years]
Mean ( Full Range )
  40  
  ( 38 to 55 )  
  40  
  ( 32 to 60 )  
  40  
  ( 32 to 60 )  
Gender  
[units: participants]
     
Female     36     34     70  
Male     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     9     9     18  
White     25     22     47  
More than one race     0     0     0  
Unknown or Not Reported     2     2     4  
Region of Enrollment  
[units: participants]
     
United States     36     34     70  



  Outcome Measures
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1.  Primary:   Mother's Intention to Vaccinate Daughter Against HPV   [ Time Frame: Date of intervention (one day) ]

2.  Secondary:   Vaccination of Daughter   [ Time Frame: Less than or equal to three months from the date of the intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Amanda Dempsey
Organization: University of Colorado
phone: 303-724-6679
e-mail: amanda.dempsey@ucdenver.edu


Publications:


Responsible Party: Amanda Dempsey, University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01143142     History of Changes
Other Study ID Numbers: 149891, P50CA101451
Study First Received: June 10, 2010
Results First Received: December 8, 2014
Last Updated: December 15, 2014
Health Authority: United States: Institutional Review Board