Prepping for a PrEP Trial

Critical Observations Before the Study Even Begins

Keith Green I recently accepted a position as Project Director for a research study designed to assess the initial acceptability and feasibility of a pre-exposure prophylaxis (PrEP) trial among young men who have sex with men (YMSM) in Chicago.

The concept of PrEP, in a nutshell, involves administering medications used in the treatment of HIV (particularly Viread or Truvada at this point) to "high risk" HIV-negative individuals, in hopes of preventing transmission of the virus. Several PrEP trials are currently underway across the globe, many of which will likely demonstrate the efficacy of both Viread and Truvada as biomedical interventions for the prevention of HIV.

I asked him how he addressed homosexuality during his church prevention work. His response made my head spin.

Though young men who have sex with men, particularly those of color, continue to contract HIV at alarming rates, these current trials ironically have very few young men enrolled in them. Therefore, if in fact these studies are able to prove the effectiveness of PrEP, we will know very little about its implementation within the population that could benefit most from this technology. The PrEP study that I am involved with seeks to provide some insight into this.

For this study, we will attempt to recruit 99 YMSM between the ages of 18 and 22, and to follow them over the course of two years.

There are three separate arms in the study. All participants will go through an intensive evidence-based behavioral intervention and then be randomized to one of three groups. One group will receive once-daily Truvada, another group will receive a placebo (or sugar pill), and yet another group will receive nothing. Participants will be regularly monitored for HIV seroconversion, behavioral disinhibition (getting buck wild sexually because they feel that they are protected by PrEP), and any adverse effects (among a host of other things).

Aware of my search to hire research assistants who will largely be responsible for recruiting and retaining participants, a close friend recommended a friend of his for one of the positions. Trusting the judgment of my friend, I followed up on his recommendation and called his friend to arrange an interview.

I didn't expect him to be knowledgeable about PrEP. The average person wouldn't be. His sexual orientation and racial identity were also of no concern to me. I simply needed him to be able to connect to the population that we have committed to engage in order to recruit and retain them in the study.

I asked him what kind of experience he had with HIV prevention, and he mentioned that he had done some work within his church. Knowing that he was African American, and curious about the position that his church takes on homosexuality, I asked him how he addressed this when it came up during his prevention work there. His response made my head spin.

He told me that he does not condone homosexuality, but that he doesn't knock anybody for their choice. He said that everybody has to answer to God for their own sins, and that all he can do is help to steer people in the right direction.

As taken aback as I was by this response, that wasn't actually the part that did me in. Unfortunately, I've come to expect this type of mentality from people who make an effort to do HIV prevention work in the church (though I must point out that I have been pleasantly surprised at times). What got me was that while telling me about this friend of his who might be a good fit for this position, my friend who'd recommended him inadvertently told me that he was somebody he "got down with every now and then." Of course, I didn't mention that during our conversation, but listening to him dissociate himself from his own sexual behaviors made me sick to my stomach.

There was no way in hell I could trust him with the potentially vulnerable members of the population that our study intends to enroll. To do so would be like throwing the whole "do no harm" clause of ethical research out the door. The young people who choose to participate in this study deserve to have someone working with them who will support and encourage them to lead healthier lives -- physically, mentally, and spiritually. I immediately thanked him for his interest, but assured him that he was not the man for this job. I then called my friend back and chewed him out for wasting my time by not screening this guy before giving me his number, but also to thank him for helping me to put some things into perspective.

Could this mentality be partially to blame for why the existing PrEP studies (and many other types of studies related to HIV for that matter) lack participation from young people, and young people of color specifically? We continue to hear that people are more likely to become engaged in research and services if they feel that they have some connection to the researcher or service provider. But just because a provider looks like you and may even engage in some of the same behaviors as you do, it doesn't necessarily equate to a connection between the two of you. And, even if it does, there is no guarantee that such a connection will be a healthy one. That person's negative or judgmental feelings about themselves and their own behaviors will most certainly have a negative impact on you, especially if you are already vulnerable.

This observation is not one that will be included in the results of our study, because it deviates from the objectives that we have set out to measure. However, it has everything to do with the implementation of PrEP as an acceptable and feasible HIV prevention intervention among young men who have sex with men. We talk a lot about cultural sensitivity and inclusiveness within research and prevention, but self-awareness and radical acceptance are often careless whispers.

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