Original content from the Mapping Pathways blog team
This is the second
part of a two-part blog series on highlights and discussions from the
Microbicides 2012 conference that recently concluded in Sydney. Here, Jim
Pickett re-emphasizes the importance of adherence in clinical trials (a big
topic of discussion at the conference) and his optimism about the future of the
HIV prevention and treatment landscape. Read Part I here.
MP: Can you give us
some examples that illustrate the issues surrounding adherence?
JP: The Partners
PrEP trial and the FEM-PrEP
trial are good case studies to illustrate the issues surrounding adherence in
an HIV prevention clinical trial. Partners PrEP reported very high levels of
adherence while the FEM-PrEP trial had to be stopped in April 2011 due to “futility.”
Studies later indicated that while many of the FEM-PrEP participants said they
adhered to the medication schedule, blood tests indicated that many did not.
A built-in support system and the risk perception of
participants are the key here. In Partners PrEP, serodiscordant couples were
enrolled together into the trial. One partner was HIV positive while the other
was negative. The HIV risk of the HIV-negative partner was not theoretical; it
was real. HIV was in their life and they were in it together.
FEM-PrEP involved women recruited on their own, with no
consideration whether they were in a serodiscordant relationship – or any
relationship for that matter. The risk of HIV was not present in the form of a
partner who already had it, but it was, in fact, present in their environment
where there was very high HIV incidence. It is interesting that many of these women did not believe
themselves to be at a high risk of HIV, despite this high incidence.
Human beings are very good at rationalizing risks and saying
“it can never happen to us.” I can drive fast and will never get into a car
accident. If I feel a certain behavior is not risky, or that I can “get away
with it”, I will not take steps to protect myself.
We don’t want to create tools where only people who are
married or in a relationship are able to use the tools successfully. That would
be crazy. But we do have to think about how important those social
relationships are and use the lessons learned to devise new tools and new
trials that give us answers – and develop things that work for all kinds of
people, regardless of relationship status, sexual orientation, or whether their
potential HIV exposure comes from unprotected vaginal intercourse, unprotected
anal intercourse, or from the sharing of syringes during injection drug use.
MP: Are there any
trials coming up that you are excited about?
JP: I’m very
excited by the upcoming MTN-017 rectal
microbicide safety and acceptability trial that will enroll approximately 186
gay men, other men who have sex with men, and transgender women at trial sites
in South Africa, Peru, Thailand, and the United States. Participants will go
through three eight-week cycles: One cycle of having a daily Truvada tablet,
another cycle of applying a “rectal friendly” reformulated tenofovir gel every
day, and a cycle of applying the gel before and after having sex.
What impresses me is the level of community involvement
sought and obtained to help design this trial. The trial team, and advocates
such as myself, visited each of the sites mentioned, had day-long meetings with
community members, captured all their observations, and made adjustments to the
trial design from the input received. We have to listen to the voices of the
communities. We can’t just show up and conduct trials.
MP: What are your
other thoughts on the HIV prevention and treatment landscape?
JP: I always like
to compare the HIV prevention and treatment landscape to the evolution of
computers and phones. Years ago, computers were the size of a house. It took
time for the computer to evolve from its clunky beginnings to its current look
where we can carry it around in our pocket and it can do more things than we
ever could have imagined. Now we have phones and computers that are completely
intuitive and easy to use.
Similarly, the HIV landscape has evolved over the years.
Before 1996, we had a handful of drugs that didn’t always work great. They were
toxic and had to be taken multiple times a day. When protease
inhibitors came out in 1996, people near death’s door were brought back to
life. But they also had to suffer through a whole host of side effects like
nausea, diarrhea, and body disfigurements.
Now, new-age
ARV medication can combine three drugs into one pill that has to be taken
just once a day. The side effects are minimal and you don’t have to worry about
requirements like eating it on a full or empty stomach, or having it
refrigerated.
We are now in the clunky computer stage of ARV-based
prevention. But, things will keep getting better. We can’t get to the
streamlined phase before going through the clunky phase. We have to learn to
crawl before we can run. Someday, our ARV prevention tools will be as sexy as
the iPhone.
Jim Pickett is the
Director of Prevention Advocacy and Gay Men's Health at the AIDS Foundation of
Chicago. He is chair of IRMA (International Rectal Microbicide Advocates), and
a member of the Mapping Pathways team. Read Part I of Jim’s interview here.
[Content that is linked from other sources is for informational purposes and should not construe a Mapping Pathways position.]
