Thomas J. Villa

Of Trials and Trust

When I volunteer to participate in early-phase clinical trials, I see myself not as some hapless test subject but as a co-investigator, one whose role necessarily differs from those of the Principal Investigator and scientific team but is nonetheless essential to the research. One who believes the research is of sufficient value that I am willing to put some skin in the game, so to speak. And we all know that many clinical trials involve more than mere skin. As a result, I do not take the decision to participate lightly but rather approach it in a deliberate manner similar to that for any weighty decision.

What hypothesis and intervention will be tested, and are these worth my commitment of blood (likely lots of it), “sweat” and perhaps some tears?

In addition to meeting the eligibility criteria to participate, what do I have to offer to this study? What do I bring to the (exam) table?

With whom will I be working for the duration of the trial – – the Principal Investigator and other researchers, the study team, the folks with whom I’ll share my disappointment over my steadily increasing weight or my fluctuating blood pressure as they check my vital signs each study visit? The phlebotomists who expertly draw countless tubes of blood and who never put me on the spot to explain the self-inflicted scars from years-ago insertions into the very same veins from which they seek to extract today? The doctors, nurses and technicians to whom I will grant permission to poke and prod, to examine, measure and record every detail of Me – – body, mind and behavior, some of which I may never have shared with another living soul?

I know they’re competent professionals, but do I trust them? Will they be as open and honest with me about the trial as I am with them about Me? Will they treat me as a teammate so we learn together through this process? (Trust me, I’m going to pick every brain every visit.) More importantly, how likely are they to reach a level of comfort with me over time that they’ll not only laugh at my early morning jokes but perhaps even respond in kind? I mean who wants to spend two hours in the endoscopy suite on an otherwise beautiful autumn day if you can’t at least share a few laughs with the two persons who are doing things back there that most men would not want to acknowledge?

I struggled for many years to accept myself as a gay man and many more years to understand and accept what it means to live with HIV. Having done that, I am determined to put “my virus” to good use, to make it work as hard as I do. Participation in clinical trials is one way I do that. So I need to know: Will you use Me wisely?

As explained earlier, I do not take lightly the decision to participate in a clinical trial. While it is possible that I am unique in my approach, that I am other than (not for the first time!) or in some way an outlier (again!), I do not think this is the case. The early years of this ongoing HIV pandemic were filled with courageous souls whose sacrifices enabled development of the therapies that enable us to live long and healthy lives today. My experience with peers, fellow study participants, and community advocates during more than two decades of living with this virus has shown me that many research participants today are motivated by a similar fierce determination to spare future generations from this virus, this plague.

TMI (“Too Much Information”)! you may be thinking. (In my mind’s eye I see my best friend Victor urgently sending our personal hand signal to stop beating around the bush. Get to the point!) What does any of this, you may ask, have to do with HIV cure-directed clinical trials, with responsibility for partner protection during an analytic treatment interruption (ATI)? How does this relate to our relative responsibility to consider the safety of study participants during the Covid-19 pandemic? These questions bring us back to where we started, to the process of deciding whether or not to participate in a specific Phase 1 trial. Now it’s your turn. Do you trust me?

You’ve been entrusted to conduct a clinical trial that may represent a scientist’s (your?) life’s work as well as the hopes of countless people affected by HIV. So ask yourself: Would I be a capable and trustworthy teammate? Are we – – the research team, the study itself, and I – – a good fit for each other? Are you confident of my understanding of the protocol and its potential risks? Of my ability and willingness to adhere to study guidelines? To be truthful about all of this? If not, then I may not be an appropriate candidate for one of the several participant slots you are trying to fill.

If you do trust me, then we assume together responsibility to discuss available options to ensure the safety of my sexual partner(s) while I am undergoing ATI. I trust you to help me understand my options, access any resources or services I may need, and to hold me accountable to our agreed plan, making adjustments as warranted. If as part of my commitment to the success of the trial I commit to abstain from sex of any kind during an ATI, you need to be able to trust that I will indeed abstain (or proactively contact you to discuss options if I am unable to do so). In joining this study, I volunteered my time, my body (such as it is), and my sincere commitment to the success of our team. I trust you to use me wisely.

Thomas J. Villa (Tom) works to help end the HIV epidemic as a writer, Community Advisor to and serial participant in HIV clinical research.