Pre-exposure prophylaxis: primary prevention of HIV in at-risk populations
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It is estimated that 50,000 individuals become newly infected with human immunodeficiency virus (HIV) every year in the United States. HIV is a lentivirus that is primarily spread through sexual contact. If left untreated, this viral infection can lead to decreased CD4+ T cells, increased susceptibility to opportunistic infections, and eventually progression to acquired immunodeficiency syndrome (AIDS) and death. HIV viral loads can be decreased to undetectable levels with the use of combination antiretroviral therapy (cART). In 2012 the Food and Drug Administration approved cART therapy, Truvada (tenofovir/emtricitabine), for safe use as pre-exposure prophylaxis (PrEP). When detectable levels of drug are present in the blood stream of patients, there is up to a 92% relative risk reduction in HIV infection compared to placebo. The implementation of PrEP has the potential to decrease the incidence of new HIV infections in at-risk populations worldwide. Because PrEP treatment is relatively new (2012), there are many barriers to administration to patients. Increased risky sexual behavior, known as risk compensation, is one of the concerns providers cite as a reason against prescribing PrEP. Most publications on PrEP have described randomized controlled trials that focused on safety, efficacy, and to a lesser extent, risk compensation behaviors. Now that Truvada is widely available, researchers are starting to elucidate patients’ sexual habits while using PrEP in the outpatient settings. However, there is a need for more longitudinal research regarding the behaviors of individuals using PrEP, specifically to determine how often risk compensation occurs and under what conditions. This study will initiate a PrEP clinic at Boston Medical Center and run a 3 year, open-label randomized controlled trial of eligible men who have sex with men (MSM) patients, who either start PrEP immediately or are delayed by one year. It is hypothesized that condom usage will decrease among immediate PrEP participants compared to the delayed participants. The study aims to determine if risk compensation occurs in these patients by following condom usage, development of sexually transmitted infections, number of sexual partners, and number/type of sexual encounter. Secondary outcomes will include measurements of medication adherence and number of HIV-seroconverters. These data will be collected through surveys and laboratory testing. The resulting information will help medical professionals better understand the risks and benefits of PrEP and also how to implement it most effectively in the fight to reduce the worldwide HIV burden.