Plain English Summary
Background and study aims
High human papillomavirus (HPV) vaccination rates are key to decreasing the burden of HPV-related diseases. Most messages that promote HPV vaccination to college-aged individuals focus on the long-term consequences of HPV infection. Messages that focus more on short-term consequences of HPV infection may be more effective in this age group. The aim of this study is to see if a message focusing more on the short-term consequences of HPV infection, like genital warts, might increase a person’s intent to receive the HPV vaccine.
Who can participate?
Anyone who is between 18 and 23 years of age, lives in the United States, and has not completed the HPV vaccine series
What does the study involve?
Participation involves completing a short survey (5-10 minutes), viewing of a message with some pictures, and then completing another survey (15-20 minutes). Participants are randomly allocated to view either a message containing an image of a bird on a feeder and a brief description of birdfeeding, or a message containing images of genital warts and a brief description of a Tinder date leading to HPV infection. Intent to receive the HPV vaccine is measured using a survey immediately after the message has been reviewed by the participant.
What are the possible benefits and risks of participating?
The study is not intended to directly benefit participants. The risks in the study are likely to be small. There is a possibility of viewing images of a graphic nature, which some people may find disturbing. There is always a small chance that confidentiality will be broken despite extensive procedures to preserve confidentiality.
Where is the study run from?
The study is being run from Emory University (USA), but all study procedures (questionnaires and messages) take place online.
When is the study starting and how long is it expected to run for?
June 2017 to September 2019 (updated 20/06/2019, previously: June 2019)
Who is funding the study?
Emory University (USA)
Who is the main contact?
Avnika Amin
Trial website
Contact information
Type
Public
Primary contact
Ms Avnika Amin
ORCID ID
Contact details
1518 Clifton Rd
Atlanta
30322
United States of America
Type
Scientific
Additional contact
Dr Saad Omer
ORCID ID
Contact details
-
New Haven
06520
United States of America
-
saad.omer@yale.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IRB00104624
Study information
Scientific title
HPV, genital warts, and purity: college-aged individuals’ perceptions of HPV and intention to receive the HPV vaccine
Acronym
Study hypothesis
Participants who read the interventional message will have a higher intent to receive HPV vaccine than participants who read the control message.
Ethics approval
Emory University Institutional Review Board, 1599 Clifton Road NE, 5th Floor, Atlanta, GA 30322, USA, Tel: +1 (0)404 712 0720, Email: IRB@emory.edu, 11/12/2018, ref: IRB00104624
Study design
This interventional study will randomize participants to receive either a visual message related to birdfeeding (control) or a visual message describing the consequences of HPV infection.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Intent to receive HPV vaccine
Intervention
Participants will be randomized using a Qualtrics algorithm. The algorithm randomly presents either the control or experimental visual message while ensuring that control and experimental group numbers are approximately balanced.
This interventional study will randomize participants to receive either:
Control: a visual message containing an image of a bird on a feeder and a brief description of birdfeeding.
Intervention: a visual message containing images of genital warts and a brief description of a Tinder date leading to HPV infection.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Intent to receive the HPV vaccine, measured once during a post-intervention survey administered immediately after the visual message has been reviewed by the participant. The method of measurement for the primary outcome is a single question asking if the participants intends to initiate (if they have received 0 HPV vaccine doses) or continue (if they have received 1-2 HPV vaccine doses) the HPV vaccine series.
Secondary outcome measures
Clicks on a link helping to locate the nearest vaccine clinic, measured using embedded data in the online survey administered immediately after the visual message has been reviewed by the participant.
Overall trial start date
01/06/2017
Overall trial end date
15/09/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Between 18 and 23 years of age (inclusive)
2. Resident of the United States
3. Has received no more than 2 doses of the HPV vaccine
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
5,049
Participant exclusion criteria
1. Has completed the HPV vaccine series (3 or more doses)
2. Has already completed the survey
Recruitment start date
15/01/2019
Recruitment end date
15/08/2019
Locations
Countries of recruitment
United States of America
Trial participating centre
Emory University Rollins School of Public Health
1518 Clifton Rd
Atlanta
30322
United States of America
Sponsor information
Organisation
Emory University Rollins School of Public Health
Sponsor details
1518 Clifton Rd
Atlanta
30322
United States of America
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study protocol, which contains a brief analysis plan, will be made available. Planned publication of the study results in a high-impact, peer-reviewed journal.
IPD sharing statement
Data will be available upon request from Avnika Amin to legitimate researchers with a brief, methodologically sound proposal. This includes de-identified individual participant data used to generate the results reported. The data will be available within one month of publication of the manuscript. After approval, data will be shared via a link (to be provided) and should only be used for the aims detailed in the approved proposals.
Intention to publish date
15/09/2020
Participant level data
Available on request
Basic results (scientific)
Publication list