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France’s next PrEP study aims to assess the wider impact of PrEP on the HIV epidemic
Roger Pebody, 2017-07-28 11:30:00
France is launching a new study which will enrol 3000 new
pre-exposure prophylxis (PrEP) users over the next three years, Jean-Michel Molina told the 9th International AIDS Society Conference
on HIV Science (IAS 2017) in Paris this week. Whereas previous
studies, including Molina’s own IPERGAY study, proved the benefit of PrEP to
the individual taking it, the new study has set an ambitious target in relation
to the public health benefit of PrEP. The aim is to show that having an extra
3000 people take PrEP will result in a marked fall in HIV diagnoses among men
who have sex with men in the Paris region.
The demonstration study will also gather data on the best
ways to deliver PrEP and on how to engage migrants and other social groups who
currently have relatively low awareness of PrEP.
France was the first European country to approve PrEP, in
January 2016. It is available through hospitals, HIV testing centres and
general practitioners and its cost is fully reimbursed by the country’s health
system. An analysis of 2774 people taking PrEP up to February 2017 showed that
98% were men who have sex with men (MSM). Significant numbers reported sexually
transmitted infections (36%), chemsex (23%) and prior use of PEP (11%).
The new study, called ‘Prévenir’
(prevent) focuses on Île-de-France, which is the region of Paris and its suburbs. HIV
is concentrated in the capital region – of around 6000 new HIV diagnoses made
in France in 2015, 2500 occurred in Île-de-France. Gay men are particularly affected.
survey found that 16% of men in Parisian gay bars, clubs and sex clubs were
HIV-positive. There has been considerable investment in HIV testing in recent
years and the treatment cascade is strong – in the same survey, 92% of
HIV-positive men were aware of their status and 95% of diagnosed men were
taking treatment. Nonetheless, new HIV diagnoses in gay men have not fallen in
recent years. It seems that it will take something extra – perhaps a greater
use of PrEP – for new infections and diagnoses to fall.
Prévenir is open to people of all genders and sexualities
who are at high risk of acquiring HIV. Nonetheless the researchers are
expecting gay men to make up the vast majority of participants and the study’s
primary outcome measure concerns only men who have sex with men. The
researchers are hoping to demonstrate that the scale up of PrEP, with 3000
additional people taking PrEP, will reduce the rate of new infections in MSM in
Île-de-France by 15%. The analysis will compare incidence (the annual rate of
new infections) in 2020 with current incidence figures, combined with some modelling
of how the epidemic could be expected to evolve over time.
Having most PrEP delivery occur in the context of a study
will ensure that data is collected and the roll-out can be monitored, Stephane
Morel of AIDES told Aidsmap. For example, it will be possible to track the success
of efforts to engage migrants, ethnic minorities, trans people and sex workers
with PrEP. The numbers of people starting PrEP following different kinds of
outreach and promotion activities will be measured.
The researchers will also gather more behavioural data to
give insights into how people fit PrEP into their sexual lives and their risk
reduction strategies. They will collect data from participants on partner
numbers, where they meet partners, use of condoms, sexually transmitted
infections and sexual well-being.
Prévenir is a single-arm study, in which all participants
take PrEP. Nonetheless they will be able to choose whether to follow the ‘on
demand’ or ‘event driven’ dosing schedule for PrEP, which was validated in
France in the IPERGAY study and which over half of current PrEP users follow, or to use daily dosing, as is more typically used in other parts of
Helping participants work out which dosing schedule works
best for them and how they can put it into practice will be peer counsellors
from AIDES. This is similar to the IPERGAY study, in which community-based
sexual health coaches were readily and frequently available to study
participants, to help with understanding of PrEP, adherence, the trial design
and sexual health more broadly. However in Prévenir counselling will be
provided less frequently and one of the aims of the study is to assess whether
this has any impact on adherence and the effectiveness of PrEP.
The demonstration project will be able to examine whether
differences in the way that PrEP is provided have an impact on its success.
While many of the PrEP providers are hospital departments with experience of
providing antiretrovirals to people living with HIV, others are testing centres
for HIV and STIs. Some of these are community based and take a broad, holistic
approach to sexual health. At a number of study sites, the counselling will not
be provided by the AIDES’ peer counsellors, but by medical staff such as nurses
or psychiatrists. Will these differences like these have an impact on participant
satisfaction, retention in the study, or HIV infections?
The study is being conducted by the ANRS, the French agency
for research on AIDS and viral hepatitis, in partnership with the community
organisation AIDES. The collaboration builds on the close working relationships
already developed in IPERGAY. Daniela Rojas Castro, director of research at the
community network Coalition PLUS and one of the study’s principal
investigators, told Aidsmap that having community stakeholders closely involved
in the research process was important to ensure that new models of HIV
prevention fit with people’s lives.
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Find details of HIV services in France, the latest news from the country, and a selection of resources from local organisations.
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