Purity, disgust, and intent to receive the HPV vaccine

ISRCTN ISRCTN81591000
DOI https://doi.org/10.1186/ISRCTN81591000
Secondary identifying numbers IRB2000027459
Submission date
11/02/2020
Registration date
09/03/2020
Last edited
09/03/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Erin James
Public

1 Church St
Suite 340
New Haven
06510
United States of America

ORCiD logoORCID ID 0000-0003-0172-5292
Phone +1 2023658826
Email erin.james@yale.edu

Study information

Study designInterventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleHPV, genital warts, and purity: college-aged individuals’ perceptions of HPV and intention to receive the HPV vaccine
Study objectivesParticipants who read the interventional message will have a higher intent to receive HPV vaccine than participants who read the control message.
Ethics approval(s)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
Health condition(s) or problem(s) studiedIntent to receive HP vaccine
InterventionParticipants 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 typeBehavioural
Primary outcome measureIntent 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 measuresClicks 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 study start date01/06/2017
Completion date01/09/2020

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1,672
Key inclusion criteria1. 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
Key exclusion criteria1. Has completed the HPV vaccine series (3 or more doses)
2. Has already completed the survey
Date of first enrolment10/03/2020
Date of final enrolment01/04/2020

Locations

Countries of recruitment

  • United States of America

Study participating centre

Yale School of Medicine
One Church St
Suite 340
New Haven
06510
United States of America

Sponsor information

Yale School of Medicine
University/education

1 Church St
Suite 340
New Haven
06510
United States of America

Phone +1 2023658826
Email erin.james@yale.edu
Website http://medicine.yale.edu/

Funders

Funder type

University/education

Yale School of Medicine
Private sector organisation / Universities (academic only)
Alternative name(s)
YSM
Location
United States of America

Results and Publications

Intention to publish date30/09/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe 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 planData 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.

Editorial Notes

09/03/2020: Internal review.
04/03/2020: Trial’s existence confirmed by Yale University IRB.