Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.
Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine.
Curr Opin Infect Dis. 2018 Feb;31(1):14-24. doi: 10.1097/QCO.0000000000000426.
HIV self-testing (HIVST) can provide complementary coverage to existing HIV testing services and improve knowledge of status among HIV-infected individuals. This review summarizes the current technology, policy and evidence landscape in sub-Saharan Africa and priorities within a rapidly evolving field.
HIVST is moving towards scaled implementation, with the release of WHO guidelines, WHO prequalification of the first HIVST product, price reductions of HIVST products and a growing product pipeline. Multicountry evidence from southern and eastern Africa confirms high feasibility, acceptability and accuracy across many delivery models and populations, with minimal harms. Evidence on the effectiveness of HIVST on increased testing coverage is strong, while evidence on demand generation for follow-on HIV prevention and treatment services and cost-effective delivery is emerging. Despite these developments, HIVST delivery remains limited outside of pilot implementation.
Important technology gaps include increasing availability of more sensitive HIVST products in low and middle-income countries. Regulatory and postmarket surveillance systems for HIVST also require further development. Randomized trials evaluating the effectiveness and cost-effectiveness under multiple distribution models, including unrestricted delivery and with a focus on linkage to HIV prevention and treatment, remain priorities. Diversification of studies from west and central Africa and around blood-based products should be addressed.
HIV 自我检测（HIVST）可以为现有的 HIV 检测服务提供补充，并提高 HIV 感染者对自身状况的了解。本综述总结了撒哈拉以南非洲地区当前 HIVST 的技术、政策和证据现状，以及在这一快速发展领域中的优先事项。
HIVST 正朝着规模化实施的方向发展，世界卫生组织发布了指南、将首个 HIVST 产品列入预认证、HIVST 产品价格降低以及产品管线不断扩大。来自南部和东部非洲的多国证据证实，在许多提供模式和人群中，HIVST 具有很高的可行性、可接受性和准确性，且危害极小。HIVST 对提高检测覆盖率的有效性的证据确凿，而关于其对后续 HIV 预防和治疗服务的需求产生以及成本效益传递的证据也正在出现。尽管有这些进展，但 HIVST 的提供仍仅限于试点实施之外。
重要的技术差距包括在中低收入国家增加更敏感的 HIVST 产品的供应。HIVST 的监管和上市后监测系统也需要进一步发展。在多种分发模式下评估有效性和成本效益的随机试验，包括不受限制的分发，并侧重于与 HIV 预防和治疗的联系，仍然是优先事项。应当解决来自西非和中非以及血液制品相关研究的多样化问题。
