INFORMATION AND CONSENT FORM
STUDY TITLE
LHIVE Healthy: Evaluation of web-based interventions to support people living with HIV in the adoption of health
behaviours
Principal investigator and project director:
José Côté, RN, PhD, Holder of the Research Chair in Innovative Nursing Practices, Université de Montréal
Principal co-investigators:
Sylvie Cossette, RN, PhD, Université de Montréal, Researcher at the Research Centre of the Montreal Heart Institute
Cécile Tremblay, MD, FRCPC, Research Centre of the Centre Hospitalier de l’Université de Montréal (CHUM)
Co-investigators:
Michal Abrahamowicz, PhD; François Boudreau, PhD; Jean-Louis Chiasson, MD; Alexandra De Pokomandy, MD;
Marie-Pierre Gagnon, PhD; Yann-Gaël Guéhéneuc, PhD; Joyal Miranda, RN, PhD; Pilar Ramirez-Garcia, RN, PhD;
Catherine Worthington, PhD
Collaborators:
Ken Monteith, COCQ-SIDA; Laurie Edmiston, CATIE
Vancouver Infectious Diseases Centre investigator:
Dr. Brian Conway
Sponsor: Canadian Institutes of Health Research
Project Number (CHUM): MP-02-2015-5853
IRB Tracking Number (Veritas IRB): 16151-09:09:0525-05-2018
PREAMBLE
You are being invited to take part in a research project because you live with HIV and you would like to exercise
more/eat better/smoke less. Before agreeing to take part in this study, please take the time to read and understand the
information below. If any term or information in this document is unclear to you, do not hesitate to ask the project
director or research staff for explanations.
NATURE AND OBJECTIVES OF STUDY
Long-term use of antiretroviral therapy, normal aging and the presence of certain risk factors are associated with
metabolic disorders that predispose persons living with HIV (PLHIV) to diabetes and cardiovascular disease. By
adopting health behaviours, PLHIV can contribute to prevent the emergence and evolution of these problems.
The main objective of this study is to evaluate web-based interventions to support PLHIV to adopt health behaviours
such as stop smoking, exercise more and eat better.
NUMBER OF STUDY PARTICIPANTS AND LENGTH OF PARTICIPATION
Seven hundred and fifty (750) participants from across Canada will be invited to participate in this study. The research
project will last six months and will be conducted entirely online.
NATURE OF PARTICIPATION REQUESTED AND CONDUCT OF STUDY
If you agree to take part in this research project, your participation will entail, for starters, completing a first online
questionnaire in which you will be asked to choose a health behaviour that you would like to adopt from among the
following: stop smoking OR exercise more OR eat better (duration: 20 minutes).
Then, you will be assigned at random (by chance) to one of two groups. One group will have access to a detailed list
of websites that offer quality information on the health behaviour chosen, the content of which has been validated by
experts (e.g., Government of Canada, Heart and Stroke Foundation, ParticipACTION). The other group will have
access to a web-based tailored intervention in which a virtual nurse proposes a variety of information and strategies
that can help to adopt the chosen behaviour (duration: about 50 minutes).
No matter which group you are assigned to, you will be invited to complete three questionnaires at three different
points in time: at the beginning of the study and three and six months later. The questionnaires should take about 15
minutes to complete online. You will receive an email inviting you to complete the next questionnaire two weeks prior
to the scheduled date. Should you encounter any technical difficulties in the course of your participation preventing
you from completing the questionnaires online, you will be able to contact the project coordinator and complete them
with her over the telephone.
It is very important that you NOT SHARE YOUR PERSONAL INFORMATION (such as user name and password) with
anyone.
RISKS AND INCONVENIENCES
There is no physical risk associated with participating in this study. The only inconvenience associated with it is the
time required for your participation. Moreover, you can choose not to answer any of the questions for any reason
whatsoever.
BENEFITS
You may benefit personally from participating in this study but we cannot guarantee it. What is certain, however, is that
the results obtained will help advance knowledge in the field of e-health interventions.
VOLUNTARY PARTICIPATION AND FREEDOM TO WITHDRAW
Your participation in this study is entirely voluntary. You can choose not to take part in it. If you do choose to
participate, however, bear in mind that you will be free to withdraw from it at any time without having to justify yourself.
All you will need to do is inform the principal investigator or research staff of your decision.
The principal investigator, the CHUM Research Ethics Committee and the project sponsor reserve the right to
withdraw you from the study without your consent, particularly if you fail to comply with the instructions for the study or
if there are administrative reasons to do so.
If you withdraw or are withdrawn from the project, information already collected from you will be held for as long as
required to ensure patient safety and to meet regulatory requirements.
Any new information or discovery that could influence your decision to continue to take part in the study will be
conveyed to you promptly, both verbally and in writing.
CONFIDENTIALITY
In the course of your participation in this project, the project director and research staff will collect information on you
and hold it in a research file. Only information necessary to the research project will be saved. This includes your
name, sex, birth date, and ethnic background, as well as information on your health and lifestyle.
All information collected during this research project will remain strictly confidential within the limits stipulated by law.
In order to protect your identity and the confidentiality of this information, you will be identified only by a numerical
code. The key to the code linking your name to your research file will be held by the project director.
The information collected for research purposes will be used by the project director to achieve the scientific objectives
outlined in the information and consent form. The information could also be used for other data analyses in connection
with the project or to develop other research projects in future.
Data from the research project may be published in specialized journals or shared with other people at scientific
events. However, in no way will it be possible to identify you in scientific publications or presentations of the sort. You
should know, also, that personal information such as your name and contact information will be held by the project
director for five years from the end of the project before being destroyed.
You are entitled to consult your research file to confirm the accuracy of the information contained in it, to amend or
remove obsolete or incorrect entries, and to make copies for as long as the project director or research establishment
holds this information. In order to preserve the scientific integrity of the study, however, you will have access to some
of this information only once the study is completed.
COMPENSATION
You will receive no financial compensation for participating in this research project. However, you could receive up to
three Tim Hortons gift certificates. You will receive a 10$ Tim Hortons gift certificate after the completion of the first
assessment; another 10$ Tim Hortons gift certificate after the completion of the 3 month assessment; a $20 Tim
Hortons gift certificate after the completion of the 6 month assessment. A code will be sent to you by email to redeem
your gift certificate.
RIGHTS OF RESEARCH PARTICIPANTS
By agreeing to take part in this study, you neither give up any of your rights nor do you release the researchers, the
project sponsor or the establishment where the study is being conducted from their civil and professional
responsibilities toward you.
CONTACT RESSOURCES
If you have questions concerning this research project or if you have any problem related to the study, you can contact
the principal investigator and project director, José Côté, at
514-890-8000 extension
15536
and jose.cote@umontreal.ca, as well as the project coordinator, Patricia Auger, at 514-890-8000 extension 17931
If you have questions regarding your rights as a participant in a clinical research project or if you have any complaints
or comments to make, please contact the local associate commissioner for complaints and service quality of the
CHUM at 514-890-8000 extension 12761.
MONITORING ETHICAL ASPECTS OF RESEARCH PROJECT
The CHUM Research Ethics Committee has approved and will monitor this research project.
CONSENT
I have read and had sufficient time to fully understand the above information concerning this study. I am free to ask
questions to the research team at any time.
I understand that by participating in this study I do not give up any of my legal rights or release the researchers,
hospital, or sponsor from their civil and professional responsibilities.
By clicking on the “I agree to participate” button, I agree of my own free will to participate in this study.
(Version Date: 28-Jan-2019)