Fischer Alex Emilio, Lalla-Edward Samanta Tresha, Edward Vinodh, Abrahams Musaed, Shankland Luke, de Wit John
Department of Interdisciplinary Social Science, Public Health, Utrecht University, Heidelberglaan 1 3584 CS, Utrecht, The Netherlands, 31 302538252.
Aviro Health, Cape Town, South Africa.
JMIR Mhealth Uhealth. 2025 Aug 22;13:e60276. doi: 10.2196/60276.
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.
艾滋病毒自我检测（HIVST）使人们能够在传统医疗机构之外进行艾滋病毒检测，但这在检测前和检测后咨询、报告结果以及与护理衔接方面带来了挑战。针对HIVST的数字干预措施，作为一种医疗设备软件（SaMD），已被证明可以应对这些挑战，但目前尚无用于监管或批准这些干预措施的标准化系统。世界卫生组织预认证计划（WHOPQ）是一个国际监管机构，为没有能力自行审批的低收入和中等收入国家批准疫苗、药物和体外诊断试剂（IVD）。本文探讨了WHOPQ是否可用于对HIVST的数字干预措施进行预认证。超过一半的世界卫生组织（WHO）成员国设有医疗器械国家监管机构，但低收入和中等收入国家，尤其是非洲国家，没有能力监管医疗器械，更不用说医疗设备软件了。这一差距与最初促使WHOPQ发展的疫苗监管差距相似，而且在开发复杂的人工智能（AI）驱动的医疗设备软件的同时，HIVST的数字干预措施可作为医疗设备软件预认证的低风险测试案例。WHOPQ在艾滋病毒方面有着悠久的历史；超过一半的WHOPQ资金来自与艾滋病毒相关的资助者，所有预认证药品和IVD中有一半用于艾滋病毒的治疗和诊断；然而，只有2%是在非洲生产的。如果HIVST的数字干预措施获得预认证，这将提高互操作性并确保质量，加速其大规模采用。然而，必须注意消除非洲开发者面临的障碍，并确保预认证不会延误艾滋病毒检测者获得检测的机会。
