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. 2024 Jan 19;24(1):107.
doi: 10.1186/s12879-023-08876-8.

Study protocol: a pragmatic, cluster-randomized controlled trial to evaluate the effect of implementation of the Truenat platform/MTB assays at primary health care clinics in Mozambique and Tanzania (TB-CAPT CORE)

V N Leukes #  1 , J Hella #  2 , I Sabi #  3 , M Cossa #  4 , C Khosa #  5 , B Erkosar  1 , C Mangu  3 , E Siyame  3 , B Mtafya  3 , A Lwilla  3 , S Viegas  5 , C Madeira  5 , A Machiana  5 , J Ribeiro  5 , A L Garcia-Basteiro  4   6 , F Riess  7 , D Elísio  4 , M Sasamalo  2 , G Mhalu  2 , C M Denkinger  8 , M D M Castro  8 , S Bashir  8 , S G Schumacher  1 , E Tagliani  9 , A Malhotra  10 , D Dowdy  10 , C Schacht  11 , J Buech  11 , D Nguenha  4 , N Ntinginya  3 , M Ruhwald  1 , A Penn-Nicholson #  12 , K Kranzer #  13   14 ; TB-CAPT Consortium
Affiliations

Study protocol: a pragmatic, cluster-randomized controlled trial to evaluate the effect of implementation of the Truenat platform/MTB assays at primary health care clinics in Mozambique and Tanzania (TB-CAPT CORE)

V N Leukes et al. BMC Infect Dis. .

Abstract

Background: In 2020, the WHO-approved Molbio Truenat platform and MTB assays to detect Mycobacterium tuberculosis complex (MTB) and resistance to rifampicin directly on sputum specimens. This primary health care center-based trial in Mozambique and Tanzania investigates the effect of Truenat platform/MTB assays (intervention arm) combined with rapid communication of results compared to standard of care on TB diagnosis and treatment initiation for microbiologically confirmed TB at 7 days from enrolment.

Methods: The Tuberculosis Close the Gap, Increase Access, and Provide Adequate Therapy (TB-CAPT) CORE trial employs a pragmatic cluster randomized controlled design to evaluate the impact of a streamlined strategy for delivery of Truenat platform/MTB assays testing at primary health centers. Twenty-nine centers equipped with TB microscopy units were selected to participate in the trial. Among them, fifteen health centers were randomized to the intervention arm (which involves onsite molecular testing using Truenat platform/MTB assays, process process optimization to enable same-day TB diagnosis and treatment initiation, and feedback on Molbio platform performance) or the control arm (which follows routine care, including on-site sputum smear microscopy and the referral of sputum samples to off-site Xpert testing sites). The primary outcome of the study is the absolute number and proportion of participants with TB microbiological confirmation starting TB treatment within 7 days of their first visit. Secondary outcomes include time to bacteriological confirmation, health outcomes up to 60 days from first visit, as well as user preferences, direct cost, and productivity analyses.

Ethics and dissemination: TB-CAPT CORE trial has been approved by regulatory and ethical committees in Mozambique and Tanzania, as well as by each partner organization. Consent is informed and voluntary, and confidentiality of participants is maintained throughout. Study findings will be presented at scientific conferences and published in peer-reviewed international journals.

Trial registration: US National Institutes of Health's ClinicalTrials.gov, NCT04568954. Registered 23 September 2020.

Keywords: Clinical trial; Diagnostics; Efficacy; Implementation; Truenat; Tuberculosis.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
TB-CAPT consortium partners contributing to the TB-CAPT CORE trial
Fig. 2
Fig. 2
Geographical locations of Recruiting institutions and their associated primary health centers. Clinics assigned to the control and intervention arm are indicated in blue and red, respectively. A Centro de investigação de Saúde de Manhiça (CISM), Manhica, Mozambique. B Instituto Nacional de Saúde (INS), Maputo, Mozambique. C The National Institute for Medical Research (NIMR), Mbeya, Tanzania. D Ifakara Health Institute (IHI), Dar es Salaam, Tanzania
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