Background People with recurrent or drug-resistant TB require long courses of intramuscular injections. We evaluate a novel system in which patient-nominated lay carers were trained to deliver intramuscular injections to patients in their own homes. Methods A pragmatic, individually randomised non-inferiority trial was conducted at two hospitals in Malawi. Adults starting TB retreatment were recruited. Patients randomised to the intervention received home-based care from patient-nominated lay people trained to deliver intramuscular streptomycin. Patients receiving standard care were admitted to hospital for 2 months of streptomycin. The primary outcome was successful treatment (alive and on treatment) at the end of the intervention. Results Of 456 patients screened, 204 participants were randomised. The trial was terminated early due to futility. At the end of the intervention, 97/101 (96.0%) in the hospital arm were still alive and on treatment compared with 96/103 (93.2%) in the home-based arm (risk difference −0.03 (95% CI −0.09 to 0.03); p value 0.538). There were no differences in the proportion completing 8 months of anti-TB treatment; or the proportion experiencing 2-month sputum culture conversion. The mean cost of hospital-based management was US$1546.3 per person, compared to US$729.2 for home-based management. Home-based care reduced risk of catastrophic household costs by 84%. Conclusions Although this trial failed to meet target recruitment, the available data demonstrate that training patient-nominated lay people has potential to provide a feasible solution to the operational challenges associated with delivering long-term-injectable drugs to people with recurrent or drug-resistant TB in resource-limited settings, and substantially reduce costs. Further data under operational conditions are required. Trial registration number ISRCTN05815615.

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非专业护理人员提供结核病长效注射剂：实用的随机试验

背景 患有复发性或耐药结核病的人需要长时间的肌肉注射。我们评估了一种新系统，在该系统中，患者指定的非专业护理人员接受培训，可以在自己家中为患者提供肌肉注射。方法 在马拉维的两家医院进行了一项实用的、单独随机的非劣效性试验。招募了开始结核病再治疗的成年人。随机分配到干预组的患者接受了由患者指定的接受过肌内链霉素输送培训的非专业人员提供的家庭护理。接受标准治疗的患者入院接受为期 2 个月的链霉素治疗。主要结果是干预结束时的成功治疗（存活和接受治疗）。结果 在筛选的 456 名患者中，204 名参与者被随机分组​​。由于无效，试验提前终止。在干预结束时，住院组中有 97/101 (96.0%) 人仍然活着并正在接受治疗，而在家组中有 96/103 (93.2%) 人（风险差异 -0.03（95% CI -0.09至 0.03）；p 值 0.538）。完成 8 个月抗结核治疗的比例没有差异；或经历 2 个月痰培养转化的比例。以医院为基础的管理的平均成本为每人 1546.3 美元，而以家庭为基础的管理为 729.2 美元。以家庭为基础的护理将灾难性家庭成本的风险降低了 84%。结论 尽管该试验未能达到招募目标，现有数据表明，培训患者指定的外行人员有可能为在资源有限的环境中向复发性或耐药结核病患者提供长期注射药物相关的操作挑战提供可行的解决方案，并大幅降低成本. 需要运行条件下的更多数据。试用注册号 ISRCTN05815615。