Matthew Rose: Confessions of an HIV Vaccine Trial Participant
Matthew Rose is an HIV advocate and a strong voice for young black gay men in the United States. Based in Washington D.C., Matthew does independent consulting on HIV/AIDS policy. He also works at AVAC (AIDS Vaccine Advocacy Coalition), where he is the Policy Chair for the Young Black Gay Men's Leadership Initiative. He himself is currently enrolled in an HIV vaccine trial. I had the pleasure of meeting Matthew at AIDS Vaccine 2012, where he was a presenter and journalist fellow. There he told me about his experience being part of a vaccine trial.
Matthew, you're a participant for a vaccine trial. Tell us about that.
Yeah, it's been about two years now. I've been enrolled in the HIV Vaccine Trials Network (HVTN) 505 trial, which recruits men who have sex with men (MSM) and transgender women into an HIV vaccine trial to test a new product.
Why did you choose to get into that?
It's interesting. Unlike most trial participants, it took me about a year to decide. I had reviewed the protocol. I had started as an advocate in the field before I could enroll. What it came down to was that I had the means and the ability to and I felt like it was something I can give, so I chose to give.
How did you hear about it?
In 2009, I started a fellowship with AVAC doing HIV biomedical research prevention advocacy. Actually, that was when 505 was just rolling out and we had all the criticism about its community engagement and the whole recruitment process. So going through that process, working with the researchers and being on the community advisory board of the vaccine research center, we went through it all. I talked about it, heard about it, learned a whole about the study, probably more than any community person needs to know. Then I made my decision.
What's the process like?
Generally what happens is you either call in or book one of their appointments, and then they give you a phone screen. They ask a little bit about your sexual behavior. They ask you about your circumcision, which they'll verify later. If you check all the things off in the phone screen, they'll bring you in. You can go and meet someone at the mobile unit, which is what I ended up doing.
So I went and they drew a little blood. They have to confirm that you're HIV negative. And they need to test this for adenovirus 5 to make sure that you're adenovirus-5 negative as well. Then they talk to you a little bit more about the trial. They give you the consent, so that you can read about the trial, which I had already read about before. Then they send you away.
If they call, you come back in to get your HIV test results and your adenovirus-5 test results. If both of those are negative, you can go into a trial. They'll do a full physical and at that point, they'll have a nurse practitioner or doctor verify that you are indeed circumcised, and fully circumcised, by the definition that they use for it. From there, you get to go consent with them. They have a whole process. You take a little test in the end to make sure you are fully consented and understand it. Then they schedule a date for you to come into the clinic.
You have what's about a four-hour visit your first time, in which you go in, they draw blood, they do vitals and then they order vaccine product. They have you take a digital survey about your sexual behavior practices. Then they give you the first injection, which is via biojector. Biojector is a needleless syringe process that basically activates the product into your body faster than you would with needle and syringe. Then they hold you for an hour, just to make sure you don't have any adverse reactions, and they send you on your way.
They send you home with this little booklet and a thermometer to take your own temperature every morning. And you need to see if the site they did the injection on gets big or not, or if it's decreasing from swelling, because it will swell originally. About five days later from that, they'll call you and check in to see what your results were and if you were having any adverse events. They schedule you in for a blood draw, which is usually about two weeks later. When you show up two weeks later, they draw a whole bunch of blood. I say a whole bunch, but it's actually less than when you donate blood, which is always funny to me because they're like, "Don't donate blood products while you're in the study." And I'm like, "It's a study for men who have sex with men. I can't donate blood products, but OK, whatever."
So you then chill out for three months, come back in and rinse and repeat that whole process again. The second time you go in for biojector though, it's a lot shorter because they just have you fill out the ACASI [audio computer-assisted self-interview]. Of course during the blood draw, I should say, they do some risk-reduction counseling. They talk about what are your risk behaviors, what are you doing. They give you more condoms and lube than you can shake a stick at. Then you wait three more months and do it one more time.
You come in six months later and they give you another shot with a needle and syringe. Then they have a really big blood draw, which is still less than what you'd donate, but it just seems like a lot of vials. But they're really good to you. They'll lay you down. They talk about anything that happens. With me, they gossiped about what's going on in the field. Then they say, "We're done with injections. From now on you're going to come in every three months, where you'll get a blood draw, smaller or bigger blood draw on alternating visits every three months."
Two weeks later, you come back and get your results. They always give you your results in person. They'll never tell you over the phone, no matter what your results are. Obviously, if your results are positive, they'll link you to care. If not, they'll give you risk reduction counseling. Then every third time you come in, you do the ACASI to do kind of like a, "What are your sexual practices? What are your risk behaviors? What's your drug use? Who are your sexual partners?"
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.
It's great to hear you haven't had any negative outcomes. Finally, after the five years is up, what do you hope to get out of this?
I'll be interested to be unblinded. People are always like, "What arm do you think you're in?" I have no idea. I have never felt any sort of reaction to any of my vaccinations. But I didn't feel any reaction to any of the vaccinations I took before I went abroad either, except for the typhoid pills but that was a whole different story. Those are known to give you crazy dreams and stuff. But it'll be nice just to know I participated.
Over the time I've been involved with this field, I've really become close friends to all the researchers. I think that's another piece that helped influenced my decision to be in the study as well. Seeing these people work so hard and needing numbers, there's nothing stopping me from helping them, so why don't I? So I'll just be happy to know that I contributed. If I was in the placebo, I have a number of recent friends who are ready to enroll me in the next study of theirs. We'll see where I go in this field. But if the opportunity to enroll in another trial comes, there's a good chance I would do it.
Any last advice for others thinking about enrolling?
I think people need to really read the information that's available. Ask the questions that they think are relevant. There's no such thing as a stupid question, especially when it comes to a decision about your health. If the decision is right for you, then it's a great decision to make. It's been very rewarding for me.
This transcript has been lightly edited for clarity.
Follow Matthew on Twitter: @MTKRose.