Should Digital Interventions for HIV Self-Testing Be Regulated with World Health Organization Prequalification?

Abstract HIV self-testing (HIVST) allows people to test for HIV outside traditional health facilities, but this presents challenges around pre- and posttest counseling, reporting results, and linking to care. Digital interventions for HIVST, a type of Software as a Medical Device (SaMD), have been shown to address these challenges, but there is currently no standardized system for regulating or approving these interventions. The World Health Organization Prequalification Program (WHOPQ) is an international regulatory body that approves vaccines, medications, and in vitro diagnostics (IVDs) for low- and middle-income countries that do not have the capacity to do their own approvals. This paper explores whether WHOPQ could be used to prequalify digital interventions for HIVST. Over half the World Health Organization (WHO) member states have national regulatory bodies for medical devices, but low- and middle-income countries, especially in Africa, do not have the capacity to regulate medical devices, let alone SaMD. This gap parallels the gap in vaccine regulation that initially led to the development of WHOPQ, and while sophisticated artificial intelligence (AI)–enabled SaMD are being developed, digital interventions for HIVST could be used as a low-risk test case for prequalification of SaMD. The WHOPQ already has a strong history with HIV; over half the WHOPQ funding is from HIV-related funders and half of all prequalified medicines and IVDs are for treatment and diagnosis of HIV; however, only 2% are manufactured in Africa. If digital interventions for HIVST become prequalified, this could improve interoperability and ensure quality, accelerating their adoption at scale. However, care must be taken to remove barriers for African developers and ensure that prequalification does not delay access to people testing for HIV.