Prepping for a PrEP trial
Critical observations before the study even begins

via Positively Aware, by Keith R. Green

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

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.

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 for six months.

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.

Read the rest.