![]() Concerns have been raised regarding PrEP implementation, including risk compensation, 9, 10 poor adherence, 11 drug resistance, 12 and safety and toxic effects. 7 Clinics that treat sexually transmitted infections (STIs) and community-based clinics serving MSM are promising clinical sites for PrEP delivery, 8 yet little is known about PrEP use in these settings. Men who have sex with men account for more than two-thirds of new HIV infections in the United States and are the only risk group in whom infection rates are rising. 4 Two recent studies of daily or intermittent PrEP among MSM 5, 6 confirmed high PrEP efficacy. 1 After 2 additional randomized clinical trials demonstrated safety and efficacy, 2, 3 this PrEP formulation was approved in the United States for the prevention of sexually acquired HIV infection in 2012. In 2010, the Pre-exposure Prophylaxis Initiative (iPrEx) trial of preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection used a combination of daily oral tenofovir disoproxil fumarate and emtricitabine to demonstrate an overall 44% reduction in HIV acquisition among men who have sex with men (MSM) and transgender women receiving PrEP and greater than 90% efficacy among those with detectable drug levels in blood samples. Interventions that address racial and geographic disparities and housing instability may increase the impact of PrEP. Adherence was higher among those participants who reported more risk behaviors. Two individuals became HIV infected during follow-up (HIV incidence, 0.43 infections per 100 person-years) both had tenofovir diphosphate levels consistent with fewer than 2 doses/wk at seroconversion.Ĭonclusions and Relevance The incidence of HIV acquisition was extremely low despite a high incidence of STIs in a large US PrEP demonstration project. ![]() Overall STI incidence was high (90 per 100 person-years) but did not increase over time. The mean number of anal sex partners declined during follow-up from 10.9 to 9.3, whereas the proportion engaging in condomless receptive anal sex remained stable at 65.5% to 65.6%. African American participants (56.8% of visits P = .003) and those from the Miami site (65.1% of visits P < .001) were less likely to have protective levels, whereas those with stable housing (86.8% P = .02) and those reporting at least 2 condomless anal sex partners in the past 3 months (88.6% P = .01) were more likely to have protective levels. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ≥4 doses/wk) at follow-up visits. Results Overall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Main Outcomes and Measures Concentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition. All participants received HIV testing, brief client-centered counseling, and clinical monitoring. Interventions A combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. Data were analyzed from December 18, 2014, through August 8, 2015. Objective To assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States.ĭesign, Setting, and Participants Demonstration project conducted from October 1, 2012, through Febru(last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM). Importance Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition.
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