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 Yale 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 2020
Who is funding the study?
Yale University (USA)
Who is the main contact?
Erin James
erin.james@yale.edu
Trial website
Contact information
Type
Public
Primary contact
Dr Erin James
ORCID ID
https://orcid.org/0000-0003-0172-5292
Contact details
1 Church St
Suite 340
New Haven
06510
United States of America
+1 2023658826
erin.james@yale.edu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRB2000027459
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
Approved 03/03/2020, Yale University Institutional Review Board (25 Science Park, 150 Munson St, 3rd Floor, New Haven, CT, 06511, USA; +1 203-785-4688; HRPP@yale.edu), ref: 2000027459
Study design
Interventional randomized controlled trial
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 the contact details below to request a patient information sheet
Condition
Intent to receive HP 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.
Immediately after the visual message has been reviewed by the participant, intent to receive the HPV vaccine is measured once during a post-intervention survey. The method of measurement is a single question asking if the participants intend 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.
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
01/09/2020
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
1,672
Participant exclusion criteria
1. Has completed the HPV vaccine series (3 or more doses)
2. Has already completed the survey
Recruitment start date
10/03/2020
Recruitment end date
01/04/2020
Locations
Countries of recruitment
United States of America
Trial participating centre
Yale School of Medicine
One Church St
Suite 340
New Haven
06510
United States of America
Sponsor information
Organisation
Yale School of Medicine
Sponsor details
1 Church St
Suite 340
New Haven
06510
United States of America
+1 2023658826
erin.james@yale.edu
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Yale School of Medicine
Alternative name(s)
YSM
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United States of America
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 Erin James 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
30/09/2022
Participant level data
Available on request
Basic results (scientific)
Publication list