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

R. N. Moro, T. R. Sterling, J. Saukkonen, A. Vernon, C. R. Horsburgh, R. E. Chaisson, C. D. Hamilton, M. E. Villarino, S. Goldberg

Research output: Contribution to journalArticlepeer-review

Abstract

S E T T ING: A post-hoc exploratory analysis of a randomized, open-label clinical trial that enrolled 8053 participants from the United States, Canada, Brazil, and Spain. OBJE CTIVE : To assess factors associated with noncompletion 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. RESULT S : 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. CONCLUS IONS : 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.

Original languageEnglish (US)
Pages (from-to)286-296
Number of pages11
JournalInternational Journal of Tuberculosis and Lung Disease
Volume21
Issue number3
DOIs
StatePublished - Mar 1 2017

Keywords

  • Adherence
  • Compliance
  • LTBI
  • Loss to follow-up
  • Retention

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Infectious Diseases

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