Research, Department of Pediatrics, Baylor College of Medicine, Houston, Texas, USA
The University of North Carolina Gillings School of Global Public Health, Chapel Hill, North Carolina, USA.
BMJ Open. 2024 Jan 22;14(1):e077706. doi: 10.1136/bmjopen-2023-077706.
Index case testing (ICT) is an evidence-based approach that efficiently identifies persons in need of HIV treatment and prevention services. In Malawi, delivery of ICT has faced challenges due to limited technical capacity of healthcare workers (HCWs) and clinical coordination. Digitisation of training and quality improvement processes presents an opportunity to address these challenges. We developed an implementation package that combines digital and face-to-face modalities (blended learning) to strengthen HCWs ICT skills and enhance quality improvement mechanisms. This cluster randomised controlled trial will assess the impact of the blended learning implementation package compared with the standard of care (SOC) on implementation, effectiveness and cost-effectiveness outcomes.
The study was conducted in 33 clusters in Machinga and Balaka districts, in Southern Malawi from November 2021 to November 2023. Clusters are randomised in a 2:1 ratio to the SOC versus blended learning implementation package. The SOC is composed of: brief face-to-face HCW ICT training and routine face-to-face facility mentorship for HCWs. The blended learning implementation package consists of blended teaching, role-modelling, practising, and providing feedback, and blended quality improvement processes. The primary implementation outcome is HCW fidelity to ICT over 1 year of follow-up. Primary service uptake outcomes include (a) index clients who participate in ICT, (b) contacts elicited, (c) HIV self-test kits provided for secondary distribution, (d) contacts tested and (e) contacts identified as HIV-positive. Service uptake analyses will use a negative binomial mixed-effects model to account for repeated measures within each cluster. Cost-effectiveness will be assessed through incremental cost-effectiveness ratios examining the incremental cost of each person tested.
The Malawi National Health Science Research Committee, the University of North Carolina and the Baylor College of Medicine Institutional Review Boards approved the trial. Study findings will be disseminated through peer-reviewed journals and conference presentations.
NCT05343390.
索引病例检测（ICT）是一种基于证据的方法，可有效地确定需要艾滋病毒治疗和预防服务的人员。在马拉维，由于医疗保健工作者（HCWs）的技术能力有限以及临床协调方面的挑战，ICT 的提供面临挑战。培训和质量改进流程的数字化为解决这些挑战提供了机会。我们开发了一个实施包，该实施包结合了数字和面对面模式（混合学习），以增强 HCWs 的 ICT 技能并增强质量改进机制。这项集群随机对照试验将评估与标准护理（SOC）相比，混合学习实施包对实施、效果和成本效益结果的影响。
该研究于 2021 年 11 月至 2023 年 11 月在马拉维南部的马钦加和巴拉卡区的 33 个集群中进行。集群以 2:1 的比例随机分配到 SOC 与混合学习实施包。SOC 由以下组成：简短的面对面 HCW ICT 培训和 HCW 的常规面对面设施指导。混合学习实施包包括混合教学、角色扮演、实践和提供反馈，以及混合质量改进流程。主要实施结果是 HCW 在 1 年随访期间对 ICT 的保真度。主要服务利用结果包括：（a）参与 ICT 的索引客户，（b）引出的联系人，（c）提供用于二次分发的 HIV 自我检测试剂盒，（d）测试的联系人，（e）被确定为 HIV 阳性的联系人。服务利用分析将使用负二项式混合效应模型来解释每个集群内的重复测量。成本效益将通过增量成本效益比进行评估，以检查每个接受测试的人的增量成本。
马拉维国家卫生科学研究委员会、北卡罗来纳大学和贝勒医学院机构审查委员会批准了该试验。研究结果将通过同行评审期刊和会议演讲进行传播。
NCT05343390。
