To the Editors:
On December 1, 2016, the World Health Organization released a new Guideline recommending that HIV self-testing (HIVST) should be offered as an additional approach to HIV testing services.1 This recommendation was based on accumulating evidence on the effectiveness of HIVST delivered through health services in promoting knowledge of their status among people living with HIV.2 HIVST kits are also available directly to consumers through pharmacies in the United States, the United Kingdom, and France and since December 1, 2016, also in Italy (Autotest VIH; Mylan, Canonsburg, PA). However, little is known about the relative contribution of HIVST sold directly to consumers in favoring access to HIV testing.
We analyzed data prospectively collected on new HIV diagnoses observed in the first 6 months after marketing of HIVST kits in Italy (December 1, 2016–May 31, 2017) in the largest public HIV counseling and testing centre of the city of Rome, accounting approximately for 50% of the newly diagnosed HIV infections reported during the past decade in our region (Regional Infectious Diseases Surveillance Unit, written communication, June 15, 2017). In particular, data were collected in the context of an ongoing regional multicenter observational study on adults newly diagnosed with HIV infection, conducted in public HIV counseling and testing sites of the Lazio Region, Italy since January 2004.3 Briefly, for all enrolled patients, the following information are collected: sociodemographic characteristics, laboratory data, HIV exposure category, previous HIV tests, and clinical history, including information on other sexually transmitted infections.
In the considered period, 9 of 39 (23%) new HIV diagnoses observed in the center had a first positive result with HIVST. These 9 persons were all men who have sex with men, born in Italy, had a median age of 29 years, and their first CD4 cells count within 1 month from diagnosis, available for 7 of them, was in all instances above 350 cells/mmc. Six of them reported no previous HIV testing. The characteristics of individuals newly diagnosed with HIV through self-testing compared with those diagnosed through conventional, facility-based testing during the same 6-month period of the current and previous year are shown in Table 1.
Of the 9 persons diagnosed through HIVST, 5 were observed during the first 2 months after marketing, 4 in the following 2 months, and none in the final 2 months of the study period. Interestingly, sales data for HIVST kits in Italy, available for the first 5 months after marketing, show a progressive decline from 6347 kits sold in December 2016 to 3049 in April 2017 (QuintilesIMS, Sell-out Volumes–Multichannel View–December–April 2017). During this period, no public health program on HIVST was in place in Italy.
Based on this preliminary observation, we may hypothesize that availability of HIVST trough pharmacies may favourably impact on access to testing, especially for some subpopulations of persons living with HIV who may otherwise not test. However, we may also speculate that to maximize the benefits of HIVST it is important, also in countries where kits are available directly to consumers, to implement programs that promote access to HIVST of persons at high risk for HIV and of key populations. Studies addressing these issues are urgently needed.
The authors thank Dr. Elisabetta Schifano for data management.
1. WHO. Guidelines on HIV Self-Testing and Partner Notification: Supplement to Consolidated Guidelines to HIV Testing Services. Geneva, Switzerland: World Health Organization; 2016.
2. Frye V, Koblin BA. HIV self-testing in high-risk populations. Lancet HIV. 2017;4:e232–e233.
3. Scognamiglio P, Chiaradia G, De Carli G, et al. The potential impact of routine testing of individuals with HIV indicator diseases in order to prevent late HIV diagnosis. BMC Infect Dis. 2013;13:473.