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Tuberculosis Epidemiologic Studies Consortium (TBESC)
Task Order 13: Factors associated with acceptance of, adherence
to and toxicity from treatment for LTBI and pilot study of treatment
for LTBI effectiveness
Task Order 13, Phase 3 is a prospective cohort study focused on
identifying potentially modifiable factors associated with
acceptance/non-acceptance and completion/non-completion of LTBI
treatment. The underlying premise of this study is that a complex
interplay of cultural, social, economic, structural, clinical, and
interpersonal factors influences rates of acceptance and completion
of treatment. This project has a total sample size of 1800-2040
participants across 12 sites.
Sites
12 TBESC sites are involved in TO13 Phase 3: American Lung
Association of Metropolitan Chicago, California Department of Health
Services, Charles P. Felton National TB Center at Harlem, New York,
Denver Public Health and Hospitals Authority, Emory University,
Atlanta GA, Hawaii Department of Health, Maryland Department of
Health and Mental Hygiene, Massachusetts Department of Public
Health, New York State Department of Health, Tennessee Department of
Health, University of North Texas Health Science Center at Fort
Worth, and University of British Columbia, Vancouver, British
Columbia, Canada
Primary Study Objectives
1. Identify potentially modifiable factors associated with
acceptance/non-acceptance of LTBI treatment
2. Identify potentially modifiable factors related to
completion/non-completion of treatment.
Study Design
Task Order 13, Phase 3 is the third of three phases. Phase 1
involved the selection of target catchment areas by the TBESC sites
and enumeration of clinics providing LTBI treatment in those areas.
Phase 1 data were published in the American Journal of Critical Care
Medicine in January 2006. Phase 2 is a retrospective chart review of
persons who were offered or received LTBI treatment in the catchment
areas during calendar year 2002. Phase 2 is in the final data
analysis phase. Preliminary data were presented at ATS in May 2007,
and a manuscript is being drafted. Phase 3 is a prospective study of
treatment initiation and completion and the issues associated with
these two outcomes. Applied across 11 U.S. sites and one Canadian
site, the study design consists of an interviewer-administered
interview with persons who were recommended LTBI treatment. The
interview assesses knowledge, attitudes and beliefs about TB and
LTBI treatment, as well as perceptions of service delivery,
communication with staff, and facilitators and barriers associated
with care-seeking and treatment adherence. Study participants will
complete an interview upon treatment initiation and upon treatment
completion or cessation. Half of the treatment initiators will be
randomized to an interval follow-up group, who will be followed at
periodic intervals and administered a brief interview. Data will
also be collected on clinic characteristics and practices.
Study Progress
Data collection for Phase 3 began in March 2007 and is scheduled
to be completed in July 2009. As of June 13, 2007, 179 participants
have been enrolled across 10 study sites.
Last Modified: 07/25/2007
Last Reviewed: 05/18/2008 Content Source: Division of Tuberculosis Elimination
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
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