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• W4310437974 abstract "<ns3:p><ns3:bold>BACKGROUND: </ns3:bold>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.</ns3:p><ns3:p> </ns3:p><ns3:p> <ns3:bold>METHODS: </ns3:bold>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.</ns3:p><ns3:p> </ns3:p><ns3:p> <ns3:bold>CONCLUSIONS:</ns3:bold> 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.</ns3:p><ns3:p> The trial is registered with the ISRCTN (<ns3:ext-link xmlns:ns4=http://www.w3.org/1999/xlink ext-link-type=uri ns4:href=https://protect-us.mimecast.com/s/vu8uCyP6mEt7ZLQoZSZCcaj?domain=doi.org>ISRCTN17025974</ns3:ext-link>).</ns3:p>" @default.
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• W4310437974 date "2022-11-30" @default.
• W4310437974 modified "2023-09-26" @default.
• W4310437974 title "Protocol for the Addressing the Social Determinants and Consequences of Tuberculosis in Nepal (ASCOT) pilot trial" @default.
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• W4310437974 doi "https://doi.org/10.12688/wellcomeopenres.17669.2" @default.
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