High interest in preexposure prophylaxis among men who have sex with men at risk for HIV infection: baseline data from the US PrEP demonstration project.

In the United States (US), an estimated 50,000 new human immunodeficiency virus (HIV) infections occur each year 1, highlighting the urgent need for new prevention strategies. Men who have sex with men (MSM) account for approximately two-thirds of new HIV infections and are the only group in whom HIV incidence has been rising 2. Transgender women (TGW) also have elevated infection rates; over a quarter in the US are HIV-positive 3-5 . Pre-exposure prophylaxis (PrEP) is the first biomedical intervention with proven efficacy to reduce HIV acquisition in MSM and TGW. iPrEx, a randomized, controlled trial, demonstrated a 44% reduction in HIV incidence among MSM and TGW who received once daily emtricitabine/tenofovir (FTC/TDF), and an estimated >90% efficacy among those with detectable blood drug levels 6,7. Based on compelling data from iPrEx and other PrEP trials 8,9, the US Food and Drug Administration approved FTC/TDF for the prevention of sexually acquired HIV infection in July 2012 10,11. The Centers for Disease Control and Prevention (CDC) published PrEP clinical practice guidelines in May 2014 12. Modeling studies suggest PrEP could substantially reduce HIV incidence among MSM in the US, and may be cost effective if targeted to the highest risk populations 13-15. However, little is known about levels of interest and characteristics of individuals who elect to take PrEP in clinical settings. An analysis of pharmacy claims found that between January 2012 and September 2013, only 2319 people filled prescriptions for FTC/TDF PrEP in the US and almost half were women 16. Several factors, including perceived low demand for PrEP 17-19, inadequate access to insurance or healthcare 20, lack of provider knowledge or willingness to prescribe PrEP 21-24, and concerns about adherence 25, HIV resistance 26, risk compensation 27, and cost 20,28 may explain why there has not been rapid dissemination of this innovation. Demonstration projects have been recommended to address implementation issues and help determine if appropriate and how best to scale-up PrEP 29,30. The US PrEP Demonstration Project (The Demo Project) is the first study assessing the feasibility, acceptability and safety of delivering PrEP to MSM and TGW in sexually transmitted disease (STD) clinics and a community health center. In this article, we describe the proportion of potentially eligible participants who elected to enroll in the study (PrEP uptake) and correlates of uptake, and describe baseline demographic and risk characteristics among participants who enrolled.