Microbicides 2012 Conference: “Someday, our ARV-prevention tools will be as sexy as the I-Phone!”

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 incidenceIV HIV . 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.

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