MeFirst: A Tailored Intervention to HPV Vaccine Decision Making

July 21, 2015 updated by: Vanessa K. Dalton, University of Michigan
This study will test whether a tailored, online educational intervention increases HPV vaccine uptake and intent among female college students.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

661

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Univeristy of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • enrolled at the University of Michigan

Exclusion Criteria:

  • receipt of any doses of HPV vaccine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Immediately post intervention, 3 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the effect of the MeFirst tool on HPV-related knowledge.
Time Frame: Immediately post intervention, 3 months and 12 months
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.
Immediately post intervention, 3 months and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine acceptability of the MeFirst tool to participants.
Time Frame: Immediately post intervention, 3 months and 12 months
Participants answer five 5-point scale questions about the acceptability of the MeFirst tool immediately post intervention, and at 3 months and 12 months.
Immediately post intervention, 3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Vanessa K Dalton, MD, MPH, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

January 14, 2013

First Submitted That Met QC Criteria

January 14, 2013

First Posted (Estimate)

January 16, 2013

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 21, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00069032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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