NCT03337269

Brief Summary

This study aims to assess the effectiveness of targeted educational interventions in increasing the acceptability and knowledge of the HPV vaccine among females ages 12 through 26. Subjects will be randomized to one of three study arms (no intervention, viewing an educational video or reading an educational handout) and then a questionnaire will be administered to assess knowledge and acceptability of the HPV vaccine. Subject charts will be reviewed to assess for initiation of the HPV vaccine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

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

March 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 8, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

September 13, 2017

Last Update Submit

April 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • HPV vaccine acceptability

    Subject reported willingness to accept the HPV vaccination, as assessed through agreement or disagreement to the statement "I would be willing to accept the HPV vaccine today."

    Up to 6 months

Secondary Outcomes (1)

  • HPV vaccine knowledge

    Up to 6 months

Study Arms (3)

Control

OTHER

Subject does not receive an educational intervention

Other: Control

Educational video

OTHER

Subject watches an educational video

Other: Educational video

Educational handout

OTHER

Subject reads an educational handout

Other: Educational handout

Interventions

Approximately 7 minute video on the HPV vaccine

Educational video

One page handout on the HPV vaccine

Educational handout
ControlOTHER

Control

Control

Eligibility Criteria

Age12 Years - 26 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Females ages greater than or equal to 12 years and less than or equal to 26 years
  • Presenting to a gynecology clinic for a routine or problem visit
  • Ability to read and write

You may not qualify if:

  • Women ages less than or greater than 12 years or greater than 26 years
  • Women with known cervical cancer
  • Known pregnancy
  • Prior initiation or completion of the HPV vaccine series

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Cory L, Cha B, Ellenberg S, Bogner HR, Hwang WT, Smith JS, Haggerty A, Morgan M, Burger R, Chu C, Ko EM. Effects of Educational Interventions on Human Papillomavirus Vaccine Acceptability: A Randomized Controlled Trial. Obstet Gynecol. 2019 Aug;134(2):376-384. doi: 10.1097/AOG.0000000000003379.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2017

First Posted

November 8, 2017

Study Start

March 1, 2017

Primary Completion

August 15, 2017

Study Completion

February 15, 2018

Last Updated

April 11, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations