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Protocol for the Addressing the Social Determinants and Consequences of Tuberculosis in Nepal (ASCOT) pilot trial.

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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, Bertie ORCID: https://orcid.org/0000-0001-7173-9038, Caws, Maxine ORCID: https://orcid.org/0000-0002-9109-350X and Wingfield, Tom ORCID: https://orcid.org/0000-0001-8433-6887 (2022) 'Protocol for the Addressing the Social Determinants and Consequences of Tuberculosis in Nepal (ASCOT) pilot trial.'. Wellcome Open Research, Vol 7, e141.

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Official URL: https://doi.org/10.12688/wellcomeopenres.17669.3

Abstract

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). [Abstract copyright: Copyright: © 2022 Rai B et al.]

Item Type:

Article

Subjects:

WA Public Health > WA 30 Socioeconomic factors in public health (General)
WF Respiratory System > Tuberculosis > WF 200 Tuberculosis (General)

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