Rai Bhola, Dixit Kritika, Dhital Raghu, Rishal Poonam, Gurung Suman Chandra, Paudel Puskar Raj, Mishra Gokul, Bonnett Laura, Siqueira-Filha Noemia, Khanal Mukti Nath, Lonnroth Knut, Squire S Bertel, Caws Maxine, Wingfield Tom
Research, Birat Nepal Medical Trust, Kathmandu, 44600, Nepal.
WHO Collaborating Centre on Tuberculosis and Social Medicine, Karolinska Institute, Stockholm, 171 77, Sweden.
Wellcome Open Res. 2022 Dec 13;7:141. doi: 10.12688/wellcomeopenres.17669.3. eCollection 2022.
The World Health Organization's End TB (tuberculosis) Strategy advocates social and economic support for TB-affected households but evidence from low-income settings is scarce. We will evaluate the feasibility and acceptability of a locally-appropriate socioeconomic support intervention for TB-affected households in Nepal. We will conduct a pilot randomised-controlled trial with mixed-methods process evaluation in four TB-endemic, impoverished districts of Nepal: Pyuthan, Chitwan, Mahottari, and Morang. We will recruit 128 people with TB notified to the Nepal National TB Program (NTP) and 40 multisectoral stakeholders including NTP staff, civil-society members, policy-makers, and ASCOT (Addressing the Social Determinants and Consequences of Tuberculosis) team members. People with TB will be randomised 1:1:1:1 to four study arms (n=32 each): control; social support; economic support; and combined social and economic (socioeconomic) support. Social support will be TB education and peer-led mutual-support TB Clubs providing TB education and stigma-reduction counselling. Economic support will be monthly unconditional cash transfers during TB treatment with expectations (not conditions) of meeting NTP goals. At 0, 2, and 6 months following TB treatment initiation, participants will be asked to complete a survey detailing the social determinants and consequences of TB and their feedback on ASCOT. Complementary process evaluation will use focus group discussions (FGD), key informant interviews (KII), and a workshop with multi-sectoral stakeholders to consider the challenges to ASCOT's implementation and scale-up. A sample of ~100 people with TB is recommended to estimate TB-related costs. Information power is estimated to be reached with approximately 25 FGD and 15 KII participants. The ASCOT pilot trial will both generate robust evidence on a locally-appropriate, socioeconomic support intervention for TB-affected households in Nepal and inform a large-scale future ASCOT trial, which will evaluate the intervention's impact on catastrophic costs mitigation and TB outcomes. The trial is registered with the ISRCTN ( ISRCTN17025974).
世界卫生组织的终结结核病战略倡导为受结核病影响的家庭提供社会和经济支持，但来自低收入地区的证据很少。我们将评估在尼泊尔为受结核病影响的家庭提供因地制宜的社会经济支持干预措施的可行性和可接受性。我们将在尼泊尔四个结核病高发贫困地区——皮乌坦、奇特旺、马霍塔里和莫朗——开展一项试点随机对照试验，并进行混合方法的过程评估。我们将招募128名向尼泊尔国家结核病规划（NTP）报告的结核病患者以及40名多部门利益相关者，包括NTP工作人员、民间社会成员、政策制定者和解决结核病社会决定因素及后果（ASCOT）团队成员。结核病患者将按1:1:1:1随机分配到四个研究组（每组n = 32）：对照组；社会支持组；经济支持组；社会和经济（社会经济）联合支持组。社会支持将包括结核病教育以及由同伴主导的互助结核病俱乐部，提供结核病教育和减少耻辱感咨询。经济支持将是在结核病治疗期间每月进行无条件现金转移，并期望（而非附加条件）实现NTP目标。在开始结核病治疗后的0、2和6个月，将要求参与者完成一项调查，详细说明结核病的社会决定因素和后果以及他们对ASCOT的反馈。补充性过程评估将采用焦点小组讨论（FGD）、关键信息提供者访谈（KII）以及与多部门利益相关者举办的研讨会，以探讨ASCOT实施和扩大规模面临的挑战。建议抽取约100名结核病患者样本以估算与结核病相关的成本。估计约25名FGD参与者和15名KII参与者可达到信息饱和。ASCOT试点试验将为尼泊尔受结核病影响家庭提供因地制宜的社会经济支持干预措施生成有力证据，并为未来大规模的ASCOT试验提供信息，该试验将评估该干预措施对减轻灾难性成本和结核病结局的影响。该试验已在国际标准随机对照试验编号注册平台（ISRCTN）注册（ISRCTN17025974）。
