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

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. OBJECTIVES

1. 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; and

3. 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 ; or iv) 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.