Sustainability and impact of an intervention to improve initiation of tuberculosis preventive treatment: results from a follow-up study of the ACT4 randomized trial.

Autor: Menzies D; McGill International TB Centre, Montreal Chest Institute and Research Institute of the MUHC, Canada.; Department of Epidemiology & Biostatistics, McGill University, Canada., Obeng J; Komofo Anokye Teaching Hospital, Kumasi, Ghana., Hadisoemarto P; Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia., Ruslami R; Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia., Adjobimey M; Centre National Hospitalier Universitaire de Pneumo-Phtisiologie de Cotonou, Benin., Fisher D; Department of Medicine, Cumming School of Medicine, University of Calgary, Canada., Barss L; Department of Medicine, Cumming School of Medicine, University of Calgary, Canada., Bedingfield N; Department of Medicine, Cumming School of Medicine, University of Calgary, Canada., Long R; Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Canada., Paulsen C; Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Canada., Johnston J; British Columbia Centre for Disease Control, Vancouver, Canada.; Department of Medicine, University of British Columbia, Vancouver, Canada., Romanowski K; Department of Medicine, University of British Columbia, Vancouver, Canada., Cook VJ; British Columbia Centre for Disease Control, Vancouver, Canada.; Department of Medicine, University of British Columbia, Vancouver, Canada., Fox GJ; Faculty of Medicine and Health, The University of Sydney, Sydney, Australia., Nguyen TA; Faculty of Medicine and Health, The University of Sydney, Sydney, Australia., Valiquette C; McGill International TB Centre, Montreal Chest Institute and Research Institute of the MUHC, Canada., Oxlade O; McGill International TB Centre, Montreal Chest Institute and Research Institute of the MUHC, Canada.; School of Population and Global Health, McGill University, Canada., Fregonese F; McGill International TB Centre, Montreal Chest Institute and Research Institute of the MUHC, Canada., Benedetti A; McGill International TB Centre, Montreal Chest Institute and Research Institute of the MUHC, Canada.; Department of Epidemiology & Biostatistics, McGill University, Canada.
Jazyk: angličtina
Zdroj: EClinicalMedicine [EClinicalMedicine] 2024 Mar 28; Vol. 71, pp. 102546. Date of Electronic Publication: 2024 Mar 28 (Print Publication: 2024).
DOI: 10.1016/j.eclinm.2024.102546
Abstrakt: Background: In a cluster randomized trial (clinicaltrials.gov: NCT02810678) a flexible but comprehensive health system intervention significantly increased the number of household contacts (HHC) identified and started on tuberculosis preventive treatment (TPT). A follow-up study was conducted one year later to test the hypotheses that these effects were sustained, and were reproducible with a simplified intervention.
Methods: We conducted a follow-up study from May 1, 2018 until April 30, 2019, as part of a multinational cluster randomized trial. Eight sites in 4 countries that had received the intervention in the original trial received no further intervention; eight other sites in the same countries that had not received the intervention (control sites in the original trial) now received a simplified version of the intervention. This consisted of repeated local evaluation of the Cascade of care for TB infection, and stakeholder decision making. The number of HHC identified and starting TPT were repeatedly measured at all 16 sites and expressed as rates per 100 newly diagnosed index TB patients. The sustained effect of the original intervention was estimated by comparing these rates after the intervention in the original trial with the last 6 months of the follow-up study. The reproducibility was estimated by comparing the pre-post intervention changes in rates at sites receiving the original intervention with the pre-post changes in rates at sites receiving the later, simplified intervention.
Findings: With regard to the sustained impact of the original intervention, compared to the original post-intervention period, the number of HHC identified and treated per 100 newly diagnosed TB patients was 10 more (95% confidence interval: 84 fewer to 105 more), and 1 fewer (95% CI: 22 fewer to 20 more) respectively up to 14 months after the end of the original intervention. With regard to the reproducibility of the simplified intervention, at sites that had initially served as control sites, the number of HHC identified and treated per 100 TB patients increased by 33 (95% CI: -32, 97), and 16 (-69, 100) from 3 months before, to up to 6 months after receiving a streamlined intervention, although differences were larger, and significant if the post-intervention results were compared to all pre-intervention periods.
Interpretation: Up to one year after it ended, a health system intervention resulted in sustained increases in the number of HHC identified and starting TPT. A simplified version of the intervention was associated with non-significant increases in the identification and treatment of HHC. Inferences are limited by potential bias due to other temporal effects, and the small number of study sites.
Funding: Funded by the Canadian Institutes of Health Research (Grant number 143350).
Competing Interests: Dr Fox reports receiving peer reviewed grants as PI for operating funds for other TB research projects from the Australian Medical Research Council (paid to institution), and receipt of a $50,000 in-kind donation of Rifapentine from Sanofi Inc, for a study outside of the scope of work of the current trial. Dr Menzies reports receiving peer reviewed grants as PI for operating funds for other TB research projects from the Canadian Institutes of Health Research, and from the TB Trials Consortium of Centres for Disease Control (USA) (paid to institution). Dr TA Nguyen reports receiving peer reviewed grants as PI for operating funds for other TB research projects from the Australian Medical Research Council (paid to institution), Dr Ruslami reports receiving honoraria from the Indonesian Pediatric Society. All other authors declare no competing interests relevant to this study. All other authors declare no relevant Conflicts of interest.
(© 2024 The Authors.)
Databáze: MEDLINE