Research to Rollout: PrEP in the Real World
The first PrEP proof-of-concept data came from the iPrEx PrEP trial in November 2010, which showed that daily TDF/FTC can reduce HIV risk in MSM and transgender women—the following July data from Partners PrEP and TDF2 showed that the same regimen can reduce the risk of HIV in heterosexual men and women.
As promising as PrEP may be, significant questions remain unanswered, chief among them being whether the efficacy that was demonstrated within the confines of a clinical trial—where people were not certain whether they were taking drug or placebo, were told that the safety and efficacy of PrEP was unknown, and in which they received extensive monitoring and support—can be translated into effectiveness in practice.
Such clinical translation efforts are not unique to PrEP and can be expected with the introduction of any new biomedical advance for any disease. But, in particular, this translation effort is needed now in order to achieve the public health benefit for which PrEP is so promisingly suited—progress in reducing HIV infections.
A new option exists but who needs it, wants it and how can it be delivered for maximum impact? There are a number of different research initiatives ongoing to help answer these questions: open-label extension studies, demonstration projects and bridging studies.
Demonstration Projects and Implementation Pilots
TDF/FTC as PrEP has proven effective in the context of a controlled clinical trial environment—it’s not clear yet how it might work in the real world, without the intensive support and monitoring available in a clinical trial setting.
Demonstration project and implementation pilots are designed to better understand how to optimize PrEP programming in a real-world setting. These projects will focus on what PrEP implementation looks like when it is actually delivered in a clinic setting and will collect data.