NCT01769560

Brief Summary

This study will test whether a tailored, online educational intervention increases HPV vaccine uptake and intent among female college students.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
661

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

January 14, 2013

Last Update Submit

July 21, 2015

Conditions

Keywords

tailored interventioncollege aged studentsHPV

Outcome Measures

Primary Outcomes (1)

  • Determine the effect of the MeFirst tool, a tailored, online HPV vaccination decision-making guide, on HPV vaccination intention and/or uptake.

    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 Outcomes (1)

  • Determine the effect of the MeFirst tool on HPV-related knowledge.

    Immediately post intervention, 3 months and 12 months

Other Outcomes (1)

  • Determine acceptability of the MeFirst tool to participants.

    Immediately post intervention, 3 months and 12 months

Study Arms (2)

Centers for Disease Control and Prevention (CDC) Fact Sheet

NO INTERVENTION

Participants will receive the CDC Fact sheet about HPV vaccination while they are taking the survey.

MeFirst Intervention

EXPERIMENTAL

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

Interventions

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.

MeFirst Intervention

Eligibility Criteria

Age18 Years - 26 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • enrolled at the University of Michigan

You may not qualify if:

  • receipt of any doses of HPV vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Vanessa K Dalton, MD, MPH

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 16, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 22, 2015

Record last verified: 2015-07

Locations