MDA + IRS trial in Katakwi, Uganda

These datasets are from the prospective controlled community trial described in "Impact of population based indoor residual spraying with and without the mass drug administration with dihydroartemisinin-piperaquine on malaria prevalence in a high transmission setting: a controlled trial in northeastern Uganda." <br>Abstract<br>BackgroundDeclines in malaria burden in Uganda have slowed. Modelling predicts that indoor residual spraying (IRS) and mass drug administration (MDA), when co-timed, have synergistic impact. This study investigated additional protective impact of population-based MDA on malaria prevalence, if any, when added to IRS, as compared with IRS alone and with standard of care (SOC).<br><br>MethodsThe 32-month prospective controlled community trial enrolled an open cohort of residents (46,765 individuals, 1st enumeration and 52,133, 4th enumeration) in Katakwi District in northeastern Uganda. Consented participantswere assigned to three arms based on residential subcounty: MDA+IRS, IRS, and SOC (insecticide treated bednets and case management). IRS with pirimiphos methyl and MDA with dihydroartemisinin- piperaquine were delivered in 4co-timed campaign-style rounds 8 months apart. The primary endpoint was population prevalence of malaria, estimated by 6 cross-sectional surveys, starting at baseline and preceding each subsequent round. <br>ResultsComparing malaria prevalence by qPCR <br>in MDA+IRS and IRS only arms over all 6surveys (intention-to-treat analysis), roughly every 6 months,post-interventions, a geostatistical model found a significantadditional 15.5% (95% confidence interval (CI): [13.7%, 17.5%], Z=9.6, p= 5e-20) decrease in the adjusted odds ratio (aOR) due to MDA for all ages, a 13.3% reduction in under5’s (95% CI: [10.5%, 16.8%], Z=4.02, p= 5e-5), and a 10.1% reduction in children 5-15 (95% CI: [8.5%, 11.8%], Z=4.7, p= 2e-5). All ages residents of the MDA + IRS arm enjoyed an overall 80.1% reduction (95% CI: [80.0%,83.0%, p¡.0001] in odds of qPCR confirmed malaria compared with SOC residents. Secondary difference-in-difference analyses comparing surveys at different timepoints to baseline showed aOR (MDA + IRS vs IRS) of qPCR positivity between 0.28 and 0.66 (p<br>ConclusionsDespite being assessed at long timepoints 5-7 months post-round, MDA plus IRS provided significant additional protection from malaria infection over IRS alone. Future cohort studies of impact on incidence recommended.<br>Trial registrationThis trial was retrospectively registered July 7th, 2018 with the Pan African Clinical Trials Registry (PACTR 201807166695568).<br>Datasets shared here include: (a) CompleteEnumerationR1toR4: De-identified enumeration dataset of all subjects enrolled in the open cohort of this prospective controlled community trial from Q4 2016 to Q2 2019; (b) MDACoverageR1toR4: 4 rounds of MDA coverage data; and (c) Surveys1to6_Mar2022: malaria prevalence and LLIN data for all 6 cross-sectional population surveys from November 2016 to April 2019.

本数据集来源于发表于"基于人群的室内残留喷洒（Indoor Residual Spraying, IRS）联合/不联合双氢青蒿素哌喹（dihydroartemisinin-piperaquine）大规模药物给药（Mass Drug Administration, MDA）对高传播场景疟疾患病率（malaria prevalence）的影响：乌干达东北部一项对照试验"的前瞻性对照社区试验（prospective controlled community trial）。

摘要
背景 乌干达疟疾负担的下降趋势已趋缓。模型预测，同步实施室内残留喷洒（IRS）与大规模药物给药（MDA）可产生协同效应。本研究旨在探究在IRS基础上加用基于人群的MDA，相较于单纯IRS与标准诊疗（Standard of Care, SOC），是否能为疟疾患病率带来额外保护效应。

方法 这项为期32个月的前瞻性对照社区试验，在乌干达东北部卡塔奎区招募了开放队列居民（首次普查人数为46765人，第四次普查人数为52133人）。经知情同意的参与者按居住的分区被分为三组：MDA+IRS组、单纯IRS组与标准诊疗组（标准诊疗包括经杀虫剂处理的蚊帐和病例管理）。采用甲基嘧啶磷的IRS与采用双氢青蒿素哌喹的MDA以每8个月1轮的节奏，共开展4轮同步的运动式干预。本研究的主要终点为人群疟疾患病率，通过6次横断面调查进行估算，调查始于基线，且在每一轮后续干预前开展。

结果 对6次全部调查中MDA+IRS组与单纯IRS组的定量聚合酶链反应（quantitative polymerase chain reaction, qPCR）检测疟疾患病率进行意向治疗分析（intention-to-treat analysis）后发现，在干预后约每6个月的时点，地理统计模型（geostatistical model）显示：全人群中，MDA可使校正后比值比（adjusted odds ratio, aOR）显著额外降低15.5%（95%置信区间（confidence interval, CI）：[13.7%, 17.5%]，Z=9.6，p=5×10^-20）；5岁以下儿童组降低13.3%（95%CI：[10.5%,16.8%]，Z=4.02，p=5×10^-5）；5-15岁儿童组降低10.1%（95%CI：[8.5%,11.8%]，Z=4.7，p=2×10^-5）。与标准诊疗组居民相比，MDA+IRS组全人群的qPCR确诊疟疾校正比值比整体降低80.1%（95%CI：[80.0%,83.0%]，p<0.0001）。次级双重差分分析（difference-in-difference analysis）将不同时间点的调查与基线调查进行比较，结果显示MDA+IRS组与单纯IRS组的qPCR阳性校正比值比介于0.28至0.66之间（原文本p值未完整标注）。

结论 尽管干预后评估时点距每轮干预间隔长达5-7个月，MDA联合IRS仍较单纯IRS为疟疾感染提供了显著的额外保护。建议未来开展针对发病影响的队列研究。

试验注册 本试验于2018年7月7日在泛非临床试验注册平台（PACTR 201807166695568）进行了回顾性注册。

本次共享的数据集包括：(a) CompleteEnumerationR1toR4（R1至R4完整普查数据集）：本前瞻性对照社区试验开放队列中2016年第四季度至2019年第二季度入组的所有受试者的去标识化普查数据集；(b) MDACoverageR1toR4（R1至R4 MDA覆盖数据集）：4轮MDA的覆盖数据；(c) Surveys1to6_Mar2022（2022年3月更新的1至6次调查数据集）：2016年11月至2019年4月开展的全部6次横断面人群调查的疟疾患病率与经长效杀虫剂处理的蚊帐（long-lasting insecticidal net, LLIN）数据。