Addressing the Social Determinants and Consequences of Tuberculosis (ASCOT): a pilot randomised controlled trial and process evaluation in Nepal

背景。结核病导致的死亡人数超过任何感染。低收入国家的穷人受到结核病的影响尤为严重。结核病患者一旦患病，将面临严重的心理、社会和经济（社会经济）挑战，包括精神疾病、歧视、收入损失和获得结核病治疗的灾难性费用。这些挑战降低了患者治愈的机会，使家庭更深地陷入贫困，并阻碍了全球结核病控制工作。为解决这一问题，世界卫生组织（世卫组织）倡导为受结核病影响的家庭提供社会经济支持。相关的工作。在秘鲁这个中等收入国家，我们的团队成员先前表明，为受结核病影响的家庭提供社会经济支持可提高结核病治愈率并降低灾难性成本。然而，在结核病负担严重的低收入国家，如尼泊尔，没有相关证据。在过去两年中，在威康信托基金种子奖的资助下，我们的团队与社区、结核病患者和尼泊尔国家结核病规划合作，解决了这一知识缺口。我们确定了在尼泊尔获得结核病服务的障碍，包括结核病知识低、感知到的耻辱、孤立和接受治疗的高旅行成本。然后，我们提出了可行的和适合当地的社会经济支持方案来克服这些障碍，包括现金转移和同伴支持。我们准备对这些包装进行实地测试，并选择最有希望进行大规模试验评价。1 .为受结核病影响的家庭实地测试社会经济支助方案，以确定尼泊尔最可行和最可接受的方案；为一项确定的大规模试验的设计和实施提供信息，以评估选定的一揽子支持方案对尼泊尔受结核病影响家庭的健康、财务和耻辱的影响；说谎。巩固与社区、尼泊尔国家结核控制项目和世卫组织的伙伴关系，以确保未来的试验能够实现，作为其他低收入国家的典范，并为结核病政策和实践提供信息。尼泊尔四个结核病和贫困高发地区：Chitwan、Mahottari、Morang和pyyuthan。为受结核病影响的家庭提供一揽子社会经济支持的随机对照试点试验。人口。在研究地点的国家结核控制项目诊所诊断的100名结核病患者（每个地点连续诊断25名参与者）。干预措施。计算机软件将随机分配参与者接受：i)没有额外社会经济支持的控制标准护理；ii)通过家庭互助小组提供社会支持，以减少耻辱感；iii)提供经济支持，每月提供现金转移，以降低成本并使治疗依从性得以实现；社会经济支持将社会和经济支持相结合。干预措施将由Birat尼泊尔医疗信托基金（BNMT）提供，这是一个成熟的尼泊尔非政府组织。干预措施将是灵活的，以根据需要调整现金或支助小组的规模或频率。研究活动。将对参与者进行结核病知识、耻辱、心理健康、生活质量、贫困水平、结核病成本以及对所接受干预措施的满意度等方面的调查。焦点小组和对选定参与者、项目和BNMT团队成员以及NTP工作人员的访谈将与项目成本数据相结合，以评估干预措施的可行性。主要的结果。评估干预措施的可行性和可接受性，以选择最有希望的干预措施进行大规模试验评估。二次结果。探讨干预措施对结核病治愈的影响以及受结核病影响家庭的灾难性成本。好处和应用。这项研究将确保为尼泊尔受结核病影响的家庭提供最具资金、可实现和影响力的大规模社会经济支持试验的确定设计，其结果将是低收入国家中首次此类试验，并将为区域和国际结核病政策和实践提供信息。

BACKGROUND. Tuberculosis (TB) kills more people than any infection. Poorer people in low income countries (LICs) are disproportionately affected by TB. Once ill, people with TB face severe psychological, social, and economic (socioeconomic) challenges, including mental illness, discrimination, income loss, and catastrophic costs of accessing TB care. These challenges reduce patients' chances of cure, push households deeper into poverty, and impede global TB control efforts. To combat this, the World Health Organization (WHO) advocates socioeconomic support for TB-affected households. RELATED WORK. In Peru, a middle-income country, members of our team previously showed that socioeconomic support for TB-affected households increases TB cure rates and reduces catastrophic costs. However, no related evidence exists in LICs with significant TB burden, like Nepal. Over the past two years funded by a Wellcome Trust Seed Award, our team worked with communities, people with TB, and the National TB Program (NTP) of Nepal to address this knowledge gap. We identified barriers to accessing TB services in Nepal including low TB knowledge, perceived stigma, isolation, and high travel costs to receive care. We then suggested feasible and locally-appropriate socioeconomic support packages to overcome these barriers, including cash transfers and peer support. We are ready to field-test these packages and select the most promising for large-scale trial evaluation.OBJECTIVES1. Field-test socioeconomic support packages for TB-affected households to identify which is most feasible and acceptable in Nepal;2. Inform design and delivery of a definitive, large-scale trial to evaluate the impact of the selected support package on health, finances, and stigma of TB-affected households in Nepal; and3. Consolidate partnerships with communities, the Nepal NTP, and WHO, to ensure the future trial is achievable, act as a model for other LICs, and informs TB policy and practice.SETTING. Four districts of Nepal with high TB and poverty: Chitwan, Mahottari, Morang, and Pyuthan.DESIGN. A randomised-controlled pilot trial of socioeconomic support packages for TB-affected households. POPULATION. 100 people with TB diagnosed in NTP clinics in the study sites (25 consecutively diagnosed participants per site). INTERVENTIONS. Computer software will randomly allocate participants to receive:i) Control standard of care with no additional socioeconomic support; ii) Social support through home-based peer-led mutual support groups to reduce stigma; iii) Economic support with monthly cash transfers to mitigate costs and enable treatment adherence ; oriv) Socioeconomic support integrating social and economic support. Interventions will be delivered by Birat Nepal Medical Trust (BNMT), a well-established, Nepalese non-governmental organisation. Interventions will be flexible to refine size or frequency of cash or support groups where needed.STUDY ACTIVITIES. Participants will be surveyed on TB knowledge, stigma, mental health, quality of life, poverty level, costs of TB, and satisfaction with interventions received. Focus groups and interviews with selected participants, project and BNMT team members, and NTP staff will be combined with project costs data to evaluate the feasibility of the interventions. PRIMARY OUTCOME. To evaluate the feasibility and acceptability of the interventions in order to select the most promising intervention for large-scale trial evaluation.SECONDARY OUTCOMES. To explore the impact of interventions on TB cure and catastrophic costs of TB-affected households.Benefits and applications. This research will ensure the most fundable, achievable, and impactful design of a definitive, large-scale trial of socioeconomic support for TB-affected households in Nepal, the findings of which will be the first of their kind in a LIC and will inform regional and international TB policy and practice.