MeFirst: A Tailored Intervention to HPV Vaccine Decision Making

Human Papillomavirus-Related Carcinoma Clinical Trial

Official title:

MeFirst: A Tailored Intervention to HPV Vaccine Decision Making

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769560
• Other study ID #: HUM00069032
• Status: Completed
• Phase: N/A
• First received: January 14, 2013
• Last updated: July 21, 2015
• Start date: January 2013
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 661
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 26 Years

Eligibility

Inclusion Criteria:

• enrolled at the University of Michigan

Exclusion Criteria:

• receipt of any doses of HPV vaccine

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Human Papillomavirus-Related Carcinoma

Intervention

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.

Locations

Country	Name	City	State
United States	Univeristy of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determine acceptability of the MeFirst tool to participants.	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	No
Primary	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	No
Secondary	Determine the effect of the MeFirst tool on HPV-related knowledge.	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	No