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Study of factors associated with acceptance of, adherence to, and toxicity from treatment for latent tuberculosis infection

To better understand the scope of treatment of latent tuberculosis infection (LTBI) in the United States and Canada and to elucidate factors associated with acceptance and completion of treatment, a human subjects research study will be undertaken by the TB Epidemiologic Studies Consortium (TBESC). The study is being conducted in three phases.

Phases 1 and 2 will describe the scope of treatment being offered in the United States and Canada. Phase 1 involves the selection of target catchment areas by the TBESC sites and enumeration of clinics providing treatment in those areas. Phase 2 is a retrospective chart review of persons who were offered or received treatment in the catchment areas during calendar year 2002. The chart review provides demographic and limited clinical information on large, representative samples of patients offered treatment and of patients treated. It will be the first description of the overall population being offered and given treatment in the U.S. and Canada. This database will allow us to examine demographic factors associated with acceptance - and completion of treatment.

Phase 3 of the study is a prospective cohort study of patients who have been offered treatment in the United States and Canada. Phase 3 will consist of a survey among persons offered treatment to assess the factors affecting patients’ interest and ability to initiate and complete treatment and to identify potentially modifiable factors related to acceptance and completion of treatment. The range of factors that will be assessed is complex and includes knowledge, attitudes, culture-specific beliefs about treatment, toxicity and tolerability, social and economic factors, and issues associated with the health care delivery system.