Pharmacists to play crucial role in promoting HIV self-testing kits
Council has adopted the United Nations’ ambitious project to bring the HIV epidemic under control by 2020 through universal testing and treating. Pharmacists are regarded as ideally placed to educate their communities and increase the number of people diagnosing their status through an HIV self-screening test.
On 6 June 2017, Council published Board Notice 434 relating to good pharmacy practice (GPP) rules: Minimum standards for the selling of HIV self-screening test kits for comment by 6 July 2017. The minimum standards for the sale of HIV self-screening test kits provides guidance on how to address pertinent issues and concerns relating to HIV self-screening.
The World Health Organization (WHO) defines human immunodeficiency virus self-testing (HIVST) as the process whereby an individual collects their own specimen (blood or oral fluid), performs HIV testing using an HIV rapid diagnostic test, and interprets the result themselves, either assisted or unassisted. Self-testing may also be termed self-screening.
South Africa has adopted the 90-90-90 targets of the United Nations Programme on HIV/AIDS (UNAIDS), which is a set of treatment targets intended to help bring the acquired immune deficiency syndrome (AIDS) epidemic under control by 2020. These targets are:
- 90% of all people living with HIV will know their HIV status
- 90% of all people with diagnosed HIV infection will receive sustained antiretroviral therapy (ART)
- 90% of all people on ART will have viral suppression.
The South African HIV self-testing policy and guidance considerations, published by the Southern African HIV Clinicians Society, reports that “in South Africa, the proportion of people who have had an HIV test and are aware of their status has increased from 50% in 2008 to 66.5% in 2014. There still remains a testing gap for the country and new approaches must be considered.”
HIVST has the potential to impact the first 90 by increasing access and acceptability for traditionally under-tested populations, including key at-risk populations that may require frequent or routine testing. A reactive or positive test result with an HIVST kit must be confirmed by a facility-based HIV test to diagnose an HIV infection. HIVST is a complementary approach to existing HIV-testing services, with the benefit of reaching previously untested, hard-to-reach, and test-averse populations.
Most HIV kits for self-testing are based on the HIV Rapid Diagnostic Test (RDT) for professional use that has been modified and repackaged for an untrained layperson. Professional-use HIV RDTs should not be used as an HIVST kit for the layperson without some level of modification, as there is a risk of misunderstanding or misinterpreting the instructions for use and/or test results. These tests should be validated for self-testing prior to use as such.
The medical devices regulatory framework, which came into effect on 1 June 2017, has a classification system for medical devices and in vitro diagnostic devices (IVDs), as per the regulations of Act 101 of 1965. All HIV self-test kits will be classified according to this risk-based and intended-use assessment which will stipulate conditions of sale, marketing and use of the kits.
The overarching goal of introducing HIVST in SA is to ensure that high-quality, safe and effective products are readily available and accessible in the market through channels that can support the user, such as pharmacies.
HIVST is an important addition to the basket of preventative measures aimed at achieving the first 90 of the 90-90-90 targets and pharmacy will play a key role in supporting the HIV self-testing initiative by promoting access, education, support, linkage to care and uptake reporting whilst protecting confidentiality and anonymity.