Over-the-counter human immunodeficiency virus self-test kits: time to explore their use for men who have sex with men in Brazil

Human immunodeficiency virus (HIV) testing is the primary gateway into HIV/AIDS prevention and treatment, making increased access and frequency of HIV testing critical to ∗ Corresponding author. E-mail address: (B. Grinsztejn). stemming the spread of the epidemic. People with HIV who are aware of their status can begin lifesaving treatment, which in turn decreases HIV infectiousness1,2 and may decrease risk behaviors following diagnosis.3–7 Furthermore, modeling studies in the U.S. suggest that a substantial proportion of new infections are spread by persons unaware of their HIV /© 2014 Elsevier Editora Ltda. © 2014 Elsevier Editora Ltda. Este é um artigo Open Access sob a licença de CC BY-NC-ND Este é um artigo Open Access sob a licença de CC BY-NC-ND 240 b raz j inf e c t di s . 2 0 1 4;18(3):239–244 infection,8,9 and that increased testing alone could optimally reduce new infections by as much as 1/3 in one year.10 Testing remains a high priority and must be made as widely accessible as possible, particularly to populations most at risk of infection. Brazil’s HIV epidemic is concentrated among men who have sex with men (MSM) and transsexual/transgender populations, with elevated prevalence also occurring among sex workers and injection drug users.11 As compared to the general population, whose prevalence is stable at around 0.4–0.6%, HIV prevalence among MSM in Brazil is estimated to be between 13.6% and 14.4%.11–13 Nevertheless, studies have demonstrated that only about half of Brazilian MSM report any history of testing,13–15 and that only 30% report testing in the past year.16 Currently the US Centers for Disease Control and Prevention recommend that testing for most-at-risk MSM be conducted every 3–6 months.14 In a recently conducted national respondent driven sampling study, nearly 50% of MSM who tested seropositive were unaware of their infection.13 Late diagnosis continues to be pervasive in Brazil, particularly for men.17 Strategies to increase testing uptake and frequency among MSM are needed. On July 3 2012,the United States Food and Drug Administration (US FDA) approved Over-the-Counter (OTC) licensing for the saliva-based OraQuick In-Home HIV testTM (OraSure Technologies, Inc., Bethlehem, PA).18 These tests are now available in US pharmacies, and a number of European nations are not far behind. In late 2013 the French Health Ministry announced that self-testing kits for HIV will be commercially available in 2014;19 the United Kingdom recently lifted the ban on HIV home test kits, which should become available through commercial channels by April 2014.20 The hope of OTC HIV self-testing kits is that they will both facilitate testing for communities at high risk of HIV transmission, particularly those communities which are reticent to test, and increase testing frequency and thus early detection and treatment. This technology is particularly promising for MSM and transgender populations, for whom negative experiences in the public health system, including long queues and discrimination (related to sexual orientation, gender identity, or a positive HIV test), may reduce their likelihood of clinic attendance. As OTC HIV testing expands, the time to engage the scientific community, government, and civil society in a dialog around how to best utilize this technology in Brazil has come. We provide a brief review of recent research on utilization and acceptability of HIV self-testing for MSM, raise potential implications of the OTC tests, and suggest potential strategies for implementation of self-testing and also a research agenda moving forward. How to target OTC testing? Since the idea of OTC HIV testing emerged in the nineties, much of the early debate centered on the issue of the quality (sensitivity and specificity) of the kits and the risk profile of populations targeted for test use. There is both the potential for false-negative results shortly after infection (the window period) and an increased burden of false-positive results if self-testing is adopted by low prevalence populations, such as the “worried well” of repeat testers.21,22 However, selfconducted HIV tests have generally performed quite well: a recently published systematic review of both oral fluid and finger stick self-conducted rapid HIV tests documented a very high specificity in supervised (with a health care worker present) and unsupervised (with a phone line for questions) settings. The findings on sensitivity varied from 93% to 100% in unsupervised environments.23 Targeting home testing to particularly high-risk populations can mitigate poor predictive values. If the OTC tests currently approved in the U.S. were targeted to MSM in Brazil, both the positive and negative predictive values of the test would be approximately 99% (assuming HIV prevalence of 10% and OraSure sensitivity at 92% and specificity at 99.98% in the home environment).18 The extended ‘window period’ for antibody detection of up to three months remains an unfortunate reality. There is hope that the performance characteristics of the rapid tests will improve in coming years; however, the antibody tests will always have a window period and this limitation will always require careful orientation, particularly for those with recent infections. Of course, the issue of the window period exists for clinic-conducted rapid tests as well as self-conducted tests; community education around the testing window remains a priority whether tests are conducted alone or in clinics. It also must be made clear to consumers that self-tests cannot be used as a confirmatory testing mechanism; the test is not licensed for t