Effect of community-wide isoniazid preventive therapy on tuberculosis among South African gold miners. A project of Consortium to Respond Effectively to the AIDS-TB Epidemic (CREATE)
Thibela means prevent in Sotho, the predominant language of the gold miners of South Africa. Thus, the study''s name, Thibela TB, describes the study''s purpose: to measure the maximum possible benefit of community-wide isoniazid preventive therapy (IPT) on TB incidence and prevalence at a community level in a population with a high prevalence of HIV. Mine shafts (clusters) rather than individuals will be randomized to the intervention. The study will include 70,000 miners. The Thibela TB Study Centre is centrally located on the TauTona Mine campus and is housed in office space and containers pleasantly decorated with "Thibela Man", the cartoon miner who has become the trademark for the study.
This is an open cluster-randomized study. Clusters consist of a mine shaft/shafts and an associated hostel where the miners reside. Mine shafts have been randomized to receive either community-wide (IPT) or the standard of care that includes IPT targeted to high risk individuals (miners with silicosis and/or HIV infection). The expected reduction in TB incidence in the mines receiving massive IPT is 60%, or from 4,000 per 100,000 cases annually in the control mines to less than 800 per 100,000 cases annually, or more simply put, more than 1,000 cases of TB should be prevented in the mines using massive preventive therapy.