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.