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

Autor:	Rai B; Research, Birat Nepal Medical Trust, Kathmandu, 44600, Nepal., Dixit K; Research, Birat Nepal Medical Trust, Kathmandu, 44600, Nepal.; WHO Collaborating Centre on Tuberculosis and Social Medicine, Karolinska Institute, Stockholm, 171 77, Sweden., Dhital R; Research, Birat Nepal Medical Trust, Kathmandu, 44600, Nepal., Rishal P; Research, Birat Nepal Medical Trust, Kathmandu, 44600, Nepal., Gurung SC; Research, Birat Nepal Medical Trust, Kathmandu, 44600, Nepal., Paudel PR; Research, Birat Nepal Medical Trust, Kathmandu, 44600, Nepal., Mishra G; Research, Birat Nepal Medical Trust, Kathmandu, 44600, Nepal.; Planning, Monitoring, Evaluation, Surveillance, and Research, Nepal Tuberculosis Control Centre, Kathmandu, 44600, Nepal., Bonnett L; Institute of Population Health, University of Liverpool, Liverpool, L69 3GF, UK., Siqueira-Filha N; Health Sciences, University of York, UK, York, YO10 5DD, UK., Khanal MN; Planning, Monitoring, Evaluation, Surveillance, and Research, Nepal Tuberculosis Control Centre, Kathmandu, 44600, Nepal., Lonnroth K; WHO Collaborating Centre on Tuberculosis and Social Medicine, Karolinska Institute, Stockholm, 171 77, Sweden., Squire SB; Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK., Caws M; Research, Birat Nepal Medical Trust, Kathmandu, 44600, Nepal.; Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK., Wingfield T; Research, Birat Nepal Medical Trust, Kathmandu, 44600, Nepal.; WHO Collaborating Centre on Tuberculosis and Social Medicine, Karolinska Institute, Stockholm, 171 77, Sweden.; Clinical Sciences and International Public Health, Liverpool School of Tropical Medicine, Liverpool, L3 5QA, UK.; Tropical and Infectious Diseases Unit, Liverpool University Hospital NHS Foundation Trust, Liverpool, UK.
Jazyk:	angličtina
Zdroj:	Wellcome open research [Wellcome Open Res] 2022 Nov 30; Vol. 7, pp. 141. Date of Electronic Publication: 2022 Nov 30 (Print Publication: 2022).
DOI:	10.12688/wellcomeopenres.17669.2
Abstrakt:	BACKGROUND:  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. METHODS:  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. CONCLUSIONS:  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). Competing Interests: No competing interests were disclosed. (Copyright: © 2022 Rai B et al.)
Databáze:	MEDLINE
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