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


Rai, Bhola, Dixit, Kritika, Dhital, Raghu, Rishal, Poonam, Gurung, Suman Chandra, Paudel, Puskar Raj, Mishra, Gokul, Bonnett, Laura ORCID: 0000-0002-6981-9212, Siqueira-Filha, Noemia, Khanal, Mukti Nath et al (show 4 more authors) (2022) Protocol for the Addressing the Social Determinants and Consequences of Tuberculosis in Nepal (ASCOT) pilot trial. Wellcome Open Research, 7. p. 141.

[img] XML Word Processing Document (DOCX)
wellcomeopenres-7-141-V2 TW 07122022.docx - Author Accepted Manuscript
Download (63kB)

Abstract

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 ).

Item Type: Article
Uncontrolled Keywords: Infectious Diseases, Clinical Trials and Supportive Activities, Rare Diseases, Tuberculosis, Prevention, Clinical Research, Behavioral and Social Science, 3 Prevention of disease and conditions, and promotion of well-being, 3.1 Primary prevention interventions to modify behaviours or promote wellbeing, Infection, 3 Good Health and Well Being
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Infection, Veterinary and Ecological Sciences
Faculty of Health and Life Sciences > Institute of Population Health
Depositing User: Symplectic Admin
Date Deposited: 09 Jan 2023 09:17
Last Modified: 12 Apr 2024 03:32
DOI: 10.12688/wellcomeopenres.17669.3
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3166876
Dimensions
Altmetric
CORE (COnnecting REpositories)