期刊
CONTEMPORARY CLINICAL TRIALS
卷 32, 期 3, 页码 382-392出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2010.12.008
关键词
Tuberculosis; South Africa; Cluster randomised; Isoniazid
资金
- National Union of Mineworkers
- Solidarity and United Unions of South Africa
- Anglogold Ashanti
- Gold Fields and Harmony mining companies
- South African Chamber of Mines
- Mine Health and Safety Council
- South African government Departments of Minerals and Resources, Health and Labour
- Consortium to Respond Effectively to the AIDS TB Epidemic
- Bill and Melinda Gates Foundation
- South African Mine Health and Safety Council
- Foundation for Innovative New Diagnostics, Switzerland
- Sanofi Aventis
- National Institutes of Health/National Institutes of Allergy and Infectious Diseases [AI077486]
- UK Department of Health
- MRC [G0700837] Funding Source: UKRI
- Medical Research Council [G0700837] Funding Source: researchfish
- National Institute for Health Research [PHCS/03/01] Funding Source: researchfish
Background: South Africa has the third highest annual number of new tuberculosis (TB) cases globally. The resurgence of TB which has particularly affected gold miners in South Africa, is attributed to occupational risk factors for TB including silica dust exposure and high HIV prevalence. Isoniazid preventive therapy (IPT) is recommended for individuals at high risk to prevent both HIV-related TB and silicotuberculosis, but global uptake has been poor. We describe the design of a cluster randomised study, Thibela TB, which compares routine IPT targeted to those identified as at higher risk of TB (due to HIV infection or silicosis) against a community-wide approach in which IPT is offered to all employees. The trial is registered with the Current Controlled Trials: Registration number ISRCTN63327174. Methods: We describe the rationale for the intervention of community-wide IPT, drawing on studies conducted in 1950-1960s in the pre-HIV era. The design of the study, including the definition of the cluster, is presented and advantages and limitations of such a design are discussed. Conclusion: If successful in reducing TB incidence and prevalence, this trial has potential to make a major contribution to TB control policy in high HIV settings, providing evidence concerning efficacy, and additionally safety and population-level effects on drug susceptibility patterns. Such rigorous evaluation is essential to provide policy makers with an evidence base to guide community-level TB prevention strategies. (C) 2010 Elsevier Inc. All rights reserved.
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