Contact tracing versus facility-based screening for active TB case finding in rural South Africa: A pragmatic cluster-randomized trial (Kharitode TB)
Contact tracing versus facility-based screening for active TB case finding in rural South Africa: A pragmatic cluster-randomized trial (Kharitode TB)
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南非农村地区基于接触者追踪与基于机构筛查用于活动性结核病病例发现的比较：一项实用的整群随机试验（卡里托德结核病研究）
DOI：
10.1371/journal.pmed.1002796
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发表时间：
2019-04-01
期刊：
影响因子：
15.8
通讯作者：
Dowdy, David W.
中科院分区：
文献类型：
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作者：
Hanrahan, Colleen F.;Nonyane, Bareng A. S.;Dowdy, David W.
背景目前缺乏比较有效性的研究来检查不同策略的实施情况，以发现活动性结核病（TB）病例，特别是在占撒哈拉以南非洲人口60%的农村地区。两种结核病发现策略的随机整群效果比较在南非林波波省的两个主要农村地区的56个公共初级保健诊所进行了基于设施的筛查和接触者追踪。在基于机构的筛选组中，对28家研究诊所的所有（出于任何原因）出现TB症状的患者进行痰液Xpert MTB/RIF检测，未进行接触者追踪。在接触者追踪组中，确定了活动性结核病患者的接触者（通过14家诊所的家庭追踪和其他14家诊所的小额货币奖励），筛查了结核病症状，并提供了Xpert MTB/RIF检测。主要结果是新发现的结核病患者开始接受治疗的人数。该分析采用多变量泊松回归，根据历史临床水平结核病例量和地区进行调整。试验注册于ClinicalTrials.gov（NCT 02808507）。从2017年7月18日到2019年1月17日，在18个月的时间里，共有3，755人在56个研究诊所开始结核病治疗。两组的临床特征和患者特征的临床水平平均值相似：40/56（71%）诊所位于农村地区，2，136/3，655（58%）患者为男性，2，243（61%）为HIV阳性。将基于机构的治疗组与接触者追踪组开始治疗的结核病患者的治疗率进行比较，治疗开始率为1.04（95%置信区间[CI] 0.83-1.30，p = 0. 73）。在接触者追踪组中，对788名新的结核病指标患者的1 677名接触者进行了筛查，产生了12名新的结核病患者。预先规定的亚组分析得出了相似的结果，在历史较小和历史较大的诊所中，估计的治疗开始比率分别为0.96（95% CI 0.64-1.27; p = 0.78）和1.23（95% CI 0.87-1.59; p = 0.29）。Vhembe和Waterberg区的该比率分别为1.02（95% CI 0.66-1.37; p = 0.93）和1.08（95% CI 0.74-1.42; p = 0.68）。在敏感性分析中，排除了24例TB登记号无法验证的记录（1.03，95% CI 0.82-1.29; p = 0.78）和排除了转入（1.02，95% CI 0.80-1.29; p = 0.71），估计的治疗开始率保持不变。研究的局限性包括由于集水区人口随着时间的推移而发生变化以及无法区分两种接触调查策略的独立影响而导致的集群大小不平衡的可能性。结论在该农村地区，相对于资源密集程度较低的基于设施的筛查方法，基于症状筛查和Xpert MTB/RIF检测的接触者追踪并没有增加结核病治疗的启动率。撒哈拉背景。
Background There is a dearth of comparative effectiveness research examining the implementation of different strategies for active tuberculosis (TB) case finding, particularly in rural settings, which represent 60% of the population of sub-Saharan Africa.Methods and findings We conducted a pragmatic, cluster-randomized comparative effectiveness trial of two TB case finding strategies (facility-based screening and contact tracing) in 56 public primary care clinics in two largely rural districts of Limpopo Province, South Africa. In the facility-based screening arm, sputum Xpert MTB/RIF was performed on all patients presenting (for any reason) with TB symptoms to 28 study clinics, and no contact tracing was performed. In the contact-tracing arm, contacts of patients with active TB were identified (via household tracing in 14 clinics and using small monetary incentives in the other 14 clinics), screened for TB symptoms, and offered Xpert MTB/RIF testing. The primary outcome was the number of newly identified patients with TB started on treatment. The analysis used multivariable Poisson regression adjusted for historical clinic-level TB case volumes and district. The trial was registered with ClinicalTrials.gov (NCT02808507). From July 18, 2017, to January 17, 2019, a total of 3,755 individuals started TB treatment across 56 study clinics in the 18-month period. Clinic characteristics and clinic-level averages of patient characteristics were similar across the two arms: 40/56 (71%) clinics were in a rural location, 2,136/3,655 (58%) patients were male, and 2,243 (61%) were HIV positive. The treatment initiation ratio comparing the yield of TB patients started on treatment in the facility-based arm compared to that from the contact-tracing arm was 1.04 (95% confidence interval [CI] 0.83-1.30, p = 0. 73). In the contact-tracing arm, 1,677 contacts of 788 new TB index patients were screened, yielding 12 new patients with TB. Prespecified subgroup analyses resulted in similar results, with estimated treatment initiation ratios of 0.96 (95% CI 0.64-1.27; p = 0.78) and 1.23 (95% CI 0.87-1.59; p = 0.29) among historically smaller and historically larger clinics, respectively. This ratio was 1.02 (95% CI 0.66-1.37; p = 0.93) and 1.08 (95% CI 0.74-1.42; p = 0.68) in the Vhembe and Waterberg districts, respectively. The estimated treatment initiation ratio was unchanged in sensitivity analyses excluding 24 records whose TB registration numbers could not be verified (1.03, 95% CI 0.82-1.29; p = 0.78) and excluding transfers-in (1.02, 95% CI 0.80-1.29; p = 0.71). Study limitations include the possibility of imbalance on cluster size owing to changes in catchment population over time and the inability to distinguish the independent effects of the two contact investigation strategies.Conclusions Contact tracing based on symptom screening and Xpert MTB/RIF testing did not increase the rate of treatment initiation for TB relative to the less resource-intensive approach of facility-based screening in this rural sub-Saharan setting.