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MeFirst: A Tailored Intervention to HPV Vaccine Decision Making

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vanessa K. Dalton, University of Michigan
ClinicalTrials.gov Identifier:
NCT01769560
First received: January 14, 2013
Last updated: July 21, 2015
Last verified: July 2015
  Purpose
This study will test whether a tailored, online educational intervention increases HPV vaccine uptake and intent among female college students.

Condition Intervention
Human Papillomavirus-Related Carcinoma
Behavioral: MeFirst Tailored Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: MeFirst: A Tailored Intervention to HPV Vaccine Decision Making

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Determine the effect of the MeFirst tool, a tailored, online HPV vaccination decision-making guide, on HPV vaccination intention and/or uptake. [ Time Frame: Immediately post intervention, 3 months and 12 months ] [ Designated as safety issue: No ]
    Intention will be assessed on a five-point scale immediately after and at 3 and 12 months. Uptake will be assessed by yes/no/don't know response to the statement, "I have received at least 1 dose of the HPV vaccine" at 3 and 12 months.


Secondary Outcome Measures:
  • Determine the effect of the MeFirst tool on HPV-related knowledge. [ Time Frame: Immediately post intervention, 3 months and 12 months ] [ Designated as safety issue: No ]
    Comparing 5 or 10-point scales measuring participants' HPV-related knowledge (HPV, HPV vaccination, and cervical cancer) immediately post-intervention and at 3 months and 12 months.


Other Outcome Measures:
  • Determine acceptability of the MeFirst tool to participants. [ Time Frame: Immediately post intervention, 3 months and 12 months ] [ Designated as safety issue: No ]
    Participants answer five 5-point scale questions about the acceptability of the MeFirst tool immediately post intervention, and at 3 months and 12 months.


Enrollment: 661
Study Start Date: January 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Centers for Disease Control and Prevention (CDC) Fact Sheet
Participants will receive the CDC Fact sheet about HPV vaccination while they are taking the survey.
Experimental: MeFirst Intervention
Participants will receive a tailored website regarding their own individualized risk for HPV and information about HPV Vaccination while they are taking the survey as opposed to receiving the CDC fact sheet. This tailored website is generated based on answers provided by each subject in the baseline survey.
Behavioral: MeFirst Tailored Intervention
Participants will be lead through MeFirst, an interactive web-based tool that is tailored to their responses during the survey. This tool provides information regarding HPV Vaccination.

Detailed Description:
MeFirst is the first web-based, online, educational tool designed to promote Human Papillomavirus (HPV) vaccine awareness and understanding in an effort to improve HPV vaccine intent and uptake among female university students. HPV is the most common sexually transmitted infection and causes genital warts and cancer. The HPV vaccine has been recommended for girls ages 11-26 since 2006, yet vaccination rates remain low. Tailored online interventions may be more effective tools to promote behavior change among college students than traditional static interventions. The proposed study is a randomized controlled trial testing the efficacy of the MeFirst tool vs. standard static educational material on increasing HPV vaccination intent and uptake among female university students aged 18-26.
  Eligibility

Ages Eligible for Study:   18 Years to 26 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • enrolled at the University of Michigan

Exclusion Criteria:

  • receipt of any doses of HPV vaccine
  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: NCT01769560

Locations
United States, Michigan
Univeristy of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Vanessa K Dalton, MD, MPH University of Michigan
  More Information

Responsible Party: Vanessa K. Dalton, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01769560     History of Changes
Other Study ID Numbers: HUM00069032 
Study First Received: January 14, 2013
Last Updated: July 21, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
tailored intervention
college aged students
HPV

ClinicalTrials.gov processed this record on September 26, 2016