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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.


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 is complete and analysis is underway.

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