Control of latent tuberculosis infection (LTBI) is a priority in the World Health Organization strategy to eliminate TB. Many high-income, low TB incidence countries have prioritised LTBI screening and treatment in recent migrants. We tested whether a novel model of care, based entirely within primary care, was effective and safe compared to secondary care.

This was a pragmatic cluster-randomised, parallel group, superiority trial (ClinicalTrials.gov: NCT03069807) conducted in 34 general practices in London, UK, comparing LTBI treatment in recent migrants in primary care to secondary care. The primary outcome was treatment completion, defined as taking ≥90% of antibiotic doses. Secondary outcomes included treatment acceptance, adherence, adverse effects, patient satisfaction, TB incidence and a cost-effectiveness analysis. Analyses were performed on an intention-to-treat basis.

Between September 2016 and May 2019, 362 recent migrants with LTBI were offered treatment and 276 accepted. Treatment completion was similar in primary and secondary care (82.6% versus 86.0%; adjusted OR (aOR) 0.64, 95% CI 0.31–1.29). There was no difference in drug-induced liver injury between primary and secondary care (0.7% versus 2.3%; aOR 0.29, 95% CI 0.03–2.84). Treatment acceptance was lower in primary care (65.2% (146/224) versus 94.2% (130/138); aOR 0.10, 95% CI 0.03–0.30). The estimated cost per patient completing treatment was lower in primary care, with an incremental saving of GBP 315.27 (95% CI 313.47–317.07).

The treatment of LTBI in recent migrants within primary care does not result in higher rates of treatment completion but is safe and costs less when compared to secondary care.

控制潜伏性结核感染 （LTBI） 是世界卫生组织消除结核病战略的重点。许多高收入、低结核病发病率国家已优先考虑近期移民的 LTBI 筛查和治疗。我们测试了与二级保健相比，完全基于初级保健的新型保健模式是否有效和安全。

这是一项实用的整群随机、平行组、优效性试验 （ClinicalTrials.gov： NCT03069807） 在英国伦敦的 34 家全科诊所进行，比较了初级保健和二级保健中近期移民的 LTBI 治疗。主要结局是治疗完成，定义为服用 ≥90% 的抗生素剂量。次要结局包括治疗接受度、依从性、不良反应、患者满意度、结核病发病率和成本效益分析。分析是在意向性治疗的基础上进行的。

在 2016 年 9 月至 2019 年 5 月期间，362 名最近患有 LTBI 的移民接受了治疗，其中 276 人被接受。初级和二级保健的治疗完成率相似（82.6% 对 86.0%;校正 OR （aOR） 0.64,95% CI 0.31-1.29）。初级和二级保健机构在药物性肝损伤方面没有差异（0.7% vs 2.3%;aOR 0.29,95% CI 0.03-2.84）。初级保健机构的治疗接受度较低 （65.2% （146/224） 对 94.2% （130/138）;aOR 0.10,95% CI 0.03-0.30）。在初级保健机构，每名患者完成治疗的估计成本较低，增加了 315.27 英镑 （95% CI 313.47–317.07）。

初级保健中新移民的 LTBI 治疗不会导致更高的治疗完成率，但与二级保健相比，它是安全的并且成本更低。