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
Ontario Research Team:
Sergio Rueda, PhD (Centre for Addiction and Mental Health)
Abigail Kroch, PhD (Ontario HIV Treatment Network)
Tsegaye Bekele (Ontario HIV Treatment Network)
Wesley Oakes (Ontario HIV Treatment Network)
Gordon Arbess, MD (St. Michael’s Hospital)
James
Watson (St. Michael’s Hospital)
Sponsor: Canadian Institutes of Health
Research
Project Number (CHUM): MP-02-2015-5853
RIS
Protocol Number (University of Toronto): 37468
PREAMBLE
You
are being invited to take part in a research project because you are a person living 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 terms or information in this
document is unclear to you, do not hesitate to ask
the
Project Director (José Côté) or research staff for explanations.
STUDY
OBJECTIVES
Long-term use of antiretroviral therapy, normal aging and the presence of
certain risk factors are associated with
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 stopping smoking, exercising more and eating better.
NUMBER OF STUDY PARTICIPANTS AND LENGTH OF PARTICIPATION
Three
hundred and seventy-five fifty (375) participants from across Canada (Quebec, Ontario and
British Columbia)
will
be invited to participate in this study. Your participation will last six months and will be
conducted entirely online.
Following the six month participation period, the online intervention will
remain open for you to access. The study is
expected to be completed in March 2021.
DESCRIPTION OF STUDY PROCEDURES
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: stopping smoking OR exercising more OR eating 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 offers 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). The web-based intervention contains an audio
component that indicates this study is for people living with HIV. If you
are only able to access the web-based
intervention in a non-private setting, please be aware that the audio
component will indicate this study is for people
living with HIV.
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 at three months later, and at
six months later. The questionnaires will ask
you
questions about your demographic information, your health behaviours in the past, your
anticipated health
behaviours in the future, and about your current medical conditions. 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 (Patricia Auger) 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. There may be other, unforeseen risks of which we are not
aware.
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 RIGHT 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 study participant safety. Data collected from this study
has no direct impact on study participant
safety.
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 will be offered a $20
Amazon.ca gift certificate if you complete the second and third
questionnaires at three and six months after entering
the
study. 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.
ALTERNATIVES TO PARTICIPATING IN STUDY
There are alternatives to participating in this research study. Smoking
cessation aid is provided in Ontario. Please
speak to your service provider.
STUDY CONTACTS AND RESEARCH ETHICS BOARD CONTACTS
or
Ontario participants, 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 and
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. Ontario participants can contact the U of T Human Research
Ethics
Program (HREP) at 416-946-3273 and ethics.review@utoronto.ca.
STUDY MONITORING
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-June-2019)