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Home / The International Journal of Tuberculosis and Lung Disease, Volume 21, Number 3

Factors associated with non-completion of follow-up: 33-month latent tuberculous infection treatment trial

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SETTING: A post-hoc exploratory analysis of a randomized, open-label clinical trial that enrolled 8053 participants from the United States, Canada, Brazil, and Spain.

OBJECTIVE: To assess factors associated with non-completion of study follow-up (NCF) in a 33-month latent tuberculous infection treatment trial, PREVENT TB.

DESIGN: Participants were randomized to receive 3 months of weekly directly observed therapy vs. 9 months of daily self-administered therapy. NCF was defined as failing to be followed for at least 993 days (33 months) from enrollment. Possible factors associated with NCF were analyzed using univariate and multivariate regression via Cox proportional hazard model.

RESULTS: Of 7061 adults selected for analysis, 841 (11.9%) did not complete study follow-up. Homelessness, young age, low education, history of incarceration, smoking, missing an early clinic visit, receiving isoniazid only, and male sex were significantly associated with NCF. Similar results were found in the North American region (United States and Canada) only. In Brazil and Spain, the only significant factor was missing an early clinic visit.

CONCLUSIONS: Study subjects at higher risk for NCF were identified by characteristics known at enrollment or in early follow-up. Evaluation of follow-up in other trials might help determine whether the identified factors consistently correlate with retention.

Keywords: LTBI; adherence; compliance; loss to follow-up; retention

Document Type: Research Article

Affiliations: 1: Centers for Disease Control and Prevention (CDC), Atlanta, CDC Foundation Research Collaboration, Atlanta, Georgia 2: Vanderbilt University School of Medicine, Nashville, Tennessee 3: Boston University Schools of Public Health and Medicine, Boston, Massachusetts 4: Centers for Disease Control and Prevention (CDC), Atlanta 5: Johns Hopkins University School of Medicine, Baltimore, Maryland 6: Duke University School of Medicine, Durham, Family Health International 360, Durham, North Carolina, USA

Publication date: 01 March 2017

This article was made available online on 13 January 2017 as a Fast Track article with title: "Factors associated with non-completion of follow-up: 33-month latent tuberculous infection treatment trial".

More about this publication?

  • The International Journal of Tuberculosis and Lung Disease (IJTLD) is for clinical research and epidemiological studies on lung health, including articles on TB, TB-HIV and respiratory diseases such as COVID-19, asthma, COPD, child lung health and the hazards of tobacco and air pollution. Individuals and institutes can subscribe to the IJTLD online or in print – simply email us at [email protected] for details.

    The IJTLD is dedicated to understanding lung disease and to the dissemination of knowledge leading to better lung health. To allow us to share scientific research as rapidly as possible, the IJTLD is fast-tracking the publication of certain articles as preprints prior to their publication. Read fast-track articles.

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