A
large study looking at HIV infections in gay men who are within
long-term relationships with HIV-positive partners is about to start
in Australia, the International Microbicides Conference in Sydney heard today.
This Opposites Attract study will look at the risk of HIV acquisition by
the HIV-negative parter within different-status relationships and
hopes to make an estimate of the comparative risks of HIV
transmission from HIV-positive partners who are, and are not, on
antiretroviral therapy (ART). Initially starting in Sydney,
Melbourne, Brisbane and Adelaide, it is planned that the study will
expand to other Australian cities and to Thailand.
Calculations
of study size and expected loss to follow-up are being informed by
findings from a large study of HIV risk in gay male relationships,
the HIM study (Bavinton).
Background
The
need for a study of HIV transmission risk and the influence of viral
suppression in gay men has existed ever since the Swiss
Statement in 2008. This said that within certain parameters people
with an undetectable viral load could not sexually transmit HIV, but
the authors later emphasised that evidence for this was only strong
in studies of vaginal sex. The need for further evidence became stronger when the HPTN
052 study found that treating the HIV-positive partner in
heterosexual different-status relationships reduced their chance of
transmitting HIV by 96%. Since then both the British
HIV Association and the US Department
for Health and Human Services have recommended ART for prevention
purposes in some patients, but both emphasise that the assumption
that this will work for gay men is an extrapolation of the data for
heterosexuals, and another
study recently found that up to a quarter of gay men with no
detectable HIV in their blood may have detectable levels in semen.
A
study looking at whether treatment works as prevention is thus badly
needed in gay men. While a randomised controlled study of immediate
versus delayed treatment like HPTN 052 will be difficult to do in the
future, given changes in the criteria of ART initiation, an
observational study of risk within different-status relationships
could be done. The challenge, however, will be that gay male
relationships are less likely to be monogamous, and HIV more likely
to be transmitted during casual sex, than in heterosexuals. A study
was therefore undertaken of different-status and same-status gay male
relationships to assess whether a transmission study would be
feasible.
The HIM Study findings
The
Health in Men (HIM) study is a cohort of 1427 initially HIV-negative
gay men recruited in 2001 to 2004 to look at risk factors for HIV, which
has provided useful
data on risk behaviours in other studies.
In
this study, an analysis was done of data originally collected in
2007. HIM subjects completed annual interviews and were asked whether
they were in a primary relationship, how long it had lasted, whether
their partner had HIV and, if so, whether the subject knew their viral
load. Characteristics of different-status and same-status
relationships were collected.
Two-thirds
of HIM subjects reported being in a primary relationship of which
8.4% (79 individuals) reported that their partner had HIV. This is
roughly the same as the proportion of gay men estimated to have HIV
in New South Wales (see Prestage). Another 21% of the subjects,
however, reported that they did not know their partner's HIV status.
Within
the 79 different-status partnerships, two-thirds of HIV-negative men
knew their partner's HIV viral load, and 58% said it was
undetectable.
In
terms of contrast between different-status and same-status
relationships, some factors were similar, such as age of the HIM
subject and their partner, the length of the relationship (roughly
50% had lasted longer than two years) and whether sex was permitted
with people outside the relationship.
The
rate of relationship breakup was similar too: each year, 29% of
different-status relationships and 26% of same-status relationships
broke up. Different-status relationships were less likely to break up
if they had been going for more than two years, if the HIM subject
was over 44, and if the relationship involved 'serospositioning'
(i.e. the HIV-negative partner was only ever 'top' if they had sex
without a condom).
Other
things were different, though. HIM subjects in different-status
relationships were more likely than other subjects to report having
sex outside the relationship, having unprotected sex with casual
partners, and having tested for HIV in the last three months, and
were 2.5 times more likely to report that they were in an open
relationship.
Conversely,
they were less likely to report having unprotected sex within the
relationship, to have 'negotiated safety' agreements about no
condomless sex outside the relationship, and to be the receptive
partner.
There
were eight new HIV infections in the 79 men in different-status
relationships during the average 3.9 years of follow-up. HIV
incidence among men in different-status relationships was 2.2% a year
and 0.7% in same-status relationships (hazard ratio: 3.12). HIV
acquisition was three times more likely if the HIM subject had been
'bottom' with their partner in unprotected sex, and over 15 times
more likely if their partner had ejaculated inside them. HIV
transmission was six times more likely to occur within the first year
of a relationship than after that point and was 4.7 times more likely
if the HIM subject was under 35 than if they were over 44.
Conclusions
Presenter
Benjamin Bavinton said that these findings posed challenges for the
designers of the forthcoming Opposites Attract study. Firstly, the
high break-up rate meant that recruitment had to be ongoing throughout
the relationship in order to replace attrition due to break-ups.
Secondly, high rates of sex outside the primary relationship meant
that phylogenetic testing of all HIV infections was essential to
establish which were transmissions from the primary partner (results
would not be released to participants). Thirdly, Australian criminal
law meant that sexual risk behaviour data could only be collected
from HIV-negative participants. Fourthly, because infection was so
much more common in the first year of relationships, men in new,
tentative and not necessarily committed relationships would have to
be recruited. And finally, most of the blood tests would have to be
done with the initially HIV-negative partner, including when the
relationship might have just broken up or just after they had
received the news that they had acquired HIV: retention in these
circumstances might be a big problem.
Nonetheless,
recruitment is about to start: for would-be subjects and
professionals interested in the study, there is more information at
www.oppositesattract.net.au.