Introduction
South Africa is the country with the most severe burden of HIV infections worldwide, with an estimated 7.8 million people living with HIV (PLHIV) and AIDS-related deaths that account for over 23% of all reported deaths in 2019.1 Further reductions of AIDS-related deaths and HIV transmission can be facilitated by identifying PLHIV who are unaware of their HIV status, early diagnosis and engagement with antiretroviral therapy (ART).2 Although the last HIV household survey, in 2017, showed that 85% of all HIV-positive individuals aged between 15 and 64 years had already been diagnosed, gaps remain, for example, in reaching men, with just below 80% being diagnosed, compared with 89% of their female counterparts.3 As such, the need to intensify HIV testing remains a critical step in achieving the Joint United Nations Programme on HIV/AIDS (UNAIDS) target to diagnose 95% of PLHIV by 2030.4
The South African National Department of Health has, in recent years, developed and implemented an array of innovative HIV testing strategies, such as community-based approaches, to complement provider-initiated HIV testing services offered at healthcare facilities in order to expand HIV testing service (HTS). HIV self-testing (HIVST), a process in which a person collects their own specimen (blood or oral fluid), performs HIV testing using an HIV rapid diagnostic test, generally in private, and interprets the result themselves either assisted or unassisted,5 has become the latest addition to the growing list of HIV testing options, with recent studies having shown it as a strategy that is acceptable, feasible and effective in maximising HIV testing uptake.6–8 More importantly, HIVST offers a much needed alternative that allows men in particular to overcome socio-structural barriers associated with perceived stigmatisation of using a clinic, a possibly unwelcoming attitude by mostly female clinic staff and by other clients, and clinic access being restricted to normal working hours.9 A recent model analysis by our team showed that, based on preliminary cost data and effectiveness data from other settings, HIVST combined with home-based testing would have the greatest impact towards the UNAIDS 95 target of all 10 testing modalities analysed, increasing the fraction of diagnosed PLHIV to 96.5% by 2030, and would be highly cost-effective compared with currently funded HIV interventions.10
In 2017, the second phase of the Unitaid-funded Self-Testing AfRica (STAR) Initiative began to conduct HIVST implementation research in Eswatini, Lesotho and South Africa through different models of distribution which include workplace-based distribution, facility-based distribution and community-based distribution. Over 3 million HIVST kits were distributed between 2017 and 2020 across all three countries. In South Africa, HIVST distribution was mainly targeted at men given their lower historical uptake of HIV testing services; previous analysis by our team showed that the workplace model in particular was effective in reaching men who had not been tested before, or not in the last 12 months.11 Previous work by our team evaluated the cost of community-based HIVST distribution through STAR to be, in 2019 US$, between US$8.91 and US$9.66 per kit distributed in Malawi, US$17.70 in Zambia, US$14.91 in Zimbabwe and US$14.03 in Lesotho, comparable with the cost of standard HIV testing services in each country. These estimates however did not take onward linkage and the cost of confirmatory testing for people screening positive with HIVST into account, making direct comparisons with existing.12–14 This study adds to this by presenting the cost and intermediary cost-effectiveness of distributing oral fluid-based HIVST and onward linkage to confirmatory testing and treatment services through 11 distribution models in South Africa in an effort to provide evidence for governments making decisions regarding the further scale up of self-testing after the end of the STAR initiative.