Sandbulte Matthew R, Gautney Brad J, Maloba May, Wexler Catherine, Brown Melinda, Mabachi Natabhona, Goggin Kathy, Lwembe Raphael, Nazir Niaman, Odeny Thomas A, Finocchario-Kessler Sarah
1Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS USA.
Global Health Innovations, Dallas, TX USA.
Pilot Feasibility Stud. 2019 Jan 25;5:18. doi: 10.1186/s40814-019-0402-0. eCollection 2019.
Infant HIV diagnosis by HIV DNA polymerase chain reaction (PCR) testing at the standard 6 weeks of age is often late to mitigate the mortality peak that occurs in HIV positive infants' first 2-3 months of life. Kenya recently revised their early infant diagnosis (EID) guidelines to include HIV DNA PCR testing at birth (pilot only), 6 weeks, 6 months, and 12 months postnatal and a final 18-month antibody test. The World Health Organization (WHO) approved point-of-care (POC) diagnostic platforms for infant HIV testing in resource-limited countries that could simplify logistics and expedite infant diagnosis. Sustainable scale-up and optimal utility in Kenya and other high-prevalence countries depend on robust implementation studies in diverse clinical settings.
We will pilot the implementation of birth testing by HIV DNA PCR, as well as two POC testing systems (Xpert HIV-1 Qual [Xpert] and Alere q HIV-1/2 Detect [Alere q]), on specimens collected from Kenyan infants at birth (0 to 2 weeks) and 6 weeks (4 to < 24 weeks) postnatal. The formative phase will inform optimal implementation of birth testing and two POC testing technologies. Qualitative interviews with stakeholders (providers, parents of HIV-exposed infants, and community members) will assess attitudes, barriers, and recommendations to optimize implementation at their respective sites. A non-blinded pilot study at four Kenyan hospitals ( = 2 Xpert, = 2 Alere q platforms) will evaluate infant HIV POC testing compared with standard of care HIV DNA PCR testing in both the birth and 6-week windows. Objectives of the pilot are to assess uptake, efficiency, quality, implementation variables, user experiences of birth testing with both POC testing systems or with HIV DNA PCR, and costs.
This study will generate data on the clinical impact and feasibility of adding HIV testing at birth utilizing POC and traditional PCR HIV testing strategies in resource-limited settings. Data from this pilot will inform the optimal implementation of Kenya's birth testing guidelines and of POC testing systems for the improvement of EID outcomes.
ClinicalTrials.gov, NCT03435887. Registered 26 February 2018.
通过在标准6周龄时进行HIV DNA聚合酶链反应（PCR）检测来诊断婴儿HIV，往往为时已晚，无法缓解HIV阳性婴儿在出生后最初2至3个月出现的死亡高峰。肯尼亚最近修订了其早期婴儿诊断（EID）指南，将出生时（仅试点）、出生后6周、6个月和12个月的HIV DNA PCR检测以及最后的18个月抗体检测纳入其中。世界卫生组织（WHO）批准了在资源有限国家用于婴儿HIV检测的即时检测（POC）诊断平台，这可以简化后勤工作并加快婴儿诊断。在肯尼亚和其他高流行国家实现可持续扩大规模和最佳效用，取决于在不同临床环境中进行有力的实施研究。
我们将对出生时（0至2周）和出生后6周（4至<24周）从肯尼亚婴儿采集的标本，试点实施通过HIV DNA PCR进行出生检测，以及两种POC检测系统（Xpert HIV-1 Qual [Xpert]和Alere q HIV-1/2 Detect [Alere q]）。形成阶段将为出生检测和两种POC检测技术的最佳实施提供信息。对利益相关者（提供者、HIV暴露婴儿的父母和社区成员）进行定性访谈，将评估他们在各自场所进行优化实施的态度、障碍和建议。在四家肯尼亚医院（=2个Xpert平台，=2个Alere q平台）进行的非盲法试点研究，将在出生和6周窗口期将婴儿HIV POC检测与HIV DNA PCR检测的护理标准进行比较。该试点的目标是评估接受程度、效率、质量、实施变量、使用两种POC检测系统或HIV DNA PCR进行出生检测的用户体验以及成本。
本研究将生成关于在资源有限环境中利用POC和传统PCR HIV检测策略在出生时添加HIV检测的临床影响和可行性的数据。该试点的数据将为肯尼亚出生检测指南和POC检测系统的最佳实施提供信息，以改善EID结果。
ClinicalTrials.gov，NCT03435887。2018年2月26日注册。
