December 4, 2012
It's a very thorough and rigorous process. You said you took almost a year to decide. What were your fears and reservations?
At first, for me, I was annoyed that they were calling it a phase-2 study and calling it an efficacy trial. I felt that it should be called an experimental efficacy trial because with most phase-2 trials, if you see positive signs, then you take that product to licensure. In this case, we weren't trying to take a product to licensure. They're trying to find out if we can answer a question, which actually gets back to the root of the science.
What we learned from the previous study was that we don't actually know enough about HIV and about how things work. So we're doing this study to figure out, can we make an impact originally on viral set point? And can we lower that initial point where the virus replication starts to happen? And if we can lower that initial peak, we could lower how long it would take someone to have to use antiretrovirals or even use them at all, which would be a huge breakthrough. But we wouldn't take that to licensure right away because it's a very hard message to sell and it's not necessarily the message we want to sell.
But we're trying to see if we can impact this particular thing and then we learned in the midst of this trial, RV144 hits. We learn that maybe there are some other things that could mean this product could actually prevent infection and not just lower viral set point. So we increased the size of people in the trial. One of the interesting things, being on a CAB [community advisory board] during this, recruitment for the trial was very slow at first. We almost closed the trial for futility. We were wracking our brains about how we could tell more people about the study, how we could get more people involved.
People were asking me, since I had such a lengthy process and I was able to talk about it. I talked about my process in a number of places and I think it was really important for me to make that informed decision because I think it really comes down to: people have to make an informed decision for themselves. Sometimes that informed decision is an informed no. And sometimes it is an informed yes. But we need to give them the information in a way that they can understand it. For me, there were questions that I wanted to know for myself before I would do something that would require me to say yes to participating in a five-year study.
Because at first it does sound like it has a huge impact on your life. And now having been in it for two years, I realize that it didn't really have a big impact on my life, in terms of time and commitment. The study team I work with and the vaccine research center was amazingly flexible. They were able to schedule around a lot of things. I always got the first appointment, so I'd only be an hour late to work, which I was able to work out with my boss. So it was really helpful for me to have gone through my process, even though my process is not the typical process.
But I think the things that were very typical were the ways the site team handled me, dealt with me and engaged me, even with my awkward questions like, "Why are you asking about blood products? Why do you promote these types of lubricants, which don't have the same high safety profile as these other lubricants for anal sex?" Since you know people are having unprotected anal sex to be in the study, you had to have had two incidences, which I always laughed at them for. Because it was like, "Oh yeah, I had two incidences, but still not the same as most people's two incidences are. But sure, we'll call that the same level of risk."
So it's overall been a really good process. It's funny now though, because when you're in the study you can't get your HIV test done anywhere but in the study, so you don't accidentally unblind yourself. So I have to call them to schedule my HIV testing, which is a little annoying, but sometimes you're like, "Yeah, the government takes care of my HIV." I never have anything I really worry about. I know a lot about HIV. I've powered up my sex life and sexual habits. And they'll follow up with me once a year, for the next three years.
Do you let your potential partners know that you're in this trial?
Mm hmm. For those who ask. A couple asked about joining. One or two of them have enrolled. It's really kind of if I'm in the position that you want to ask. My enrollment in the study has zero effect on them basically. The condom use, the one person I don't use condoms with knows all about the study. We have a long complicated story about why we made the decision we made and how we negotiated this decision. But the others, almost 99-percent condom usage, so those people won't be affected.
There's nothing in the study that would affect them, nothing from the study product that I'm getting. And these are questions I had to know before I enrolled. If I do produce an immune response, does that transfer in any way shape or form? "No." Explaining what this vaccine-induced seropositivity is: the goal of a vaccine is to produce antibodies and so the older HIV test that we have, the rapid test that we all take, looks for antibodies. So there's a chance that if a vaccine is doing what it's supposed to do, you will produce antibodies. So on a rapid test, you could be antibody positive, but virus negative, which is why you have follow up with the PCR test or even the western blot. What most people do to confirm once you do produce a positive test is to go back and do those others. So that's something that could happen and I want to know more about the interaction of this, just in case. But none of that has really affected me.
One of the things they constantly ask in the study is, "Have you had any negative social outcomes or results of being in the study or telling people you're in the study?" I'm actually like, "No." For me, it's really been a chance to talk to people about HIV vaccine research. So many people are like, "What? What's that? HIV vaccine research? You do what now?" And it gives me an opportunity to talk and discuss. So I haven't really had negative responses from the study. The partners I've told about it, like most things in most people's sex lives, they don't really care. If it's not really going to affect them, I don't actually need to disclose every bit of my sexual health history to them. But those who ask, care. And if there was going to be an effect on them, I would definitely tell them.