All about IPERGAY

IPERGAY is a clinical trial (or study) in the field of HIV prevention that started in Montréal in the summer of 2013. The acronym stands for: « Intervention Préventive de l'Exposition aux Risques avec et pour les hommes Gays » or Action to Prevent Risk Exposure By and For Gay Men.

IPERGAY was developed in the wake of several research studies concerning HIV/AIDS prevention.  The goal is to evaluate the efficacy of an antiretroviral (medicine used to treat HIV, in this case Truvada) as a form of prevention when used by gay and bisexual seronegative men who are at risk of HIV infection.

This kind of preventive strategy is called pre-exposure prophylaxis (or PrEP for short); pre-exposure referring to before being exposed to an infectious agent and prophylaxis meaning a method of prevention.

Within the framework of IPERGAY, we study men who take Truvada before and after having anal sex, on an as-needed basis, with the goal of preventing infection.  We then compare the results from previous studies that have already tested the efficacy of PrEP when taken continuously (i.e. Truvada taken on a daily basis).

The innovation with PrEP lies in the fact that a seronegative man takes antiretroviral medication as a means of prevention (a prophylaxis) before having anal sex (hence the use of the word pre-exposition), and does so regardless of the role (being a ‘top’ or a ‘bottom’) that they assume when having anal sex.

IPERGAY was launched in France in January 2012 and began in Quebec in July 2013. The study will take place in two phases, the first of which aims to recruit 50 participants in Montréal and 300 in France. Depending on the results from the first phase, a decision may be taken to prolong the study and start phase IIin Quebec and France as well as including new sites in other countries.  The combined objective of phases I and II is to recruit a total of 1900 participants in order to obtain results generating peer recognised scientifically probative data.

The Quebec partners participating in the study are: the Centre hospitalier de l’Université de Montréal (CHUM), the McGill AIDS Centre, the medical clinics Clinique médicale Quartier Latin and Clinique L’Actuel, la Coalition des organismes communautaires québécois de lute contre le sida (COCQ-SIDA, which is a provincial coalition of community based HIV/AIDS service organisations), RÉZO – santé et mieux-être des homes gais ou bisexuels de Montréal (a community based organisation working in the field of health promotion for gay and bisexual men in Montreal) and the Université du Québec à Montréal (UQÀM). The Quebec portion of the study is under the direction of principal investigator Dr. Cecile Tremblay, M.D., CHUM. 

RÉZO is the stakeholder for the community sector in Montreal with the mission to coordinate and disseminate information to the community, to recruit participants and to provide counsellors for the accompaniment of the participants.

 

Dr. Cécile Tremblay, principal investigator for the Quebec portion of the IPERGAY study 

Background information concerning IPERGAY

This study began in Paris, France, in January 2012. In the ensuing months, research teams were established in several other large cities, specifically Lyon, Nantes, Lille, and Nice where study sites have now been set up. Researchers are also preparing a future site in Berlin, Germany.

As previously mentioned, Montreal joined the study in the summer of 2013. Here, as is the case with other European cities where the study is taking place, men who identify as gay, bisexual and more generally men who have sex with men (MSM), are among the populations most affected by HIV infection. Although a strong majority of these men have adopted preventive strategies in order to avoid HIV transmission, some men report experiencing difficulties in using condoms systematically (as in all the time when having anal sex) or in adopting other preventive measures capable of reducing the risks of infection and transmission of HIV.

Given this context, in addition to studying the efficacy of PrEP on demand, (click here for more in-depth information concerning PrEP), the IPERGAY study has been designed to reinforce preventive support, services and care furthering HIV prevention for the study’s participants as well as within the diverse communities of gay and bisexual men in Montreal. This study offers many benefits to its participants (click here to know more about the benefits of participation).

Rigorous ethical rules

In Montreal, as in Paris, the study was approved by ethics review boards which are external committees charged with the responsibility of ensuring that the trial operates within an ethical framework. In addition to the ethics review boards, an independent overview committee meets regularly to review how the study is unfolding with its first priority being the safety of all participants. In each city where there is an established site, members from the community are directly implicated in the study’s implementation and evaluation. They are informed and consulted at every stage of the project. Their principal role is to ensure that the study can serve the best interests of men’s health in our communities. Furthermore, concrete measures have been put into place in order to protect the health and well-being of participants in the study.

The IPERGAY study is financed in France by the Agence nationale de recherches sur le sida et les hépatites virales (ANRS), and in Québec by the Canadian HIV Trials Network of the Canadian Institutes of Health Research