title: Factors associated with non-completion of follow-up: 33-month latent tuberculous infection treatment trial.
abstract: A post-hoc exploratory analysis of a randomized, open-label clinical trial that enrolled 8053 participants from the United States, Canada, Brazil, and Spain.
  
  
  
  To assess factors associated with non-completion of study follow-up (NCF) in a 33-month latent tuberculous infection treatment trial, PREVENT TB.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Centers for Disease Control and Prevention (CDC), Atlanta, CDC Foundation Research Collaboration, Atlanta, Georgia.
authors.forename: R N
authors.initials: RN
authors.lastname: Moro
authors.affiliation: Vanderbilt University School of Medicine, Nashville, Tennessee.
authors.forename: T R
authors.initials: TR
authors.lastname: Sterling
authors.affiliation: Boston University Schools of Public Health and Medicine, Boston, Massachusetts.
authors.forename: J
authors.initials: J
authors.lastname: Saukkonen
authors.affiliation: Centers for Disease Control and Prevention (CDC), Atlanta.
authors.forename: A
authors.initials: A
authors.lastname: Vernon
authors.affiliation: Boston University Schools of Public Health and Medicine, Boston, Massachusetts.
authors.forename: C R
authors.initials: CR
authors.lastname: Horsburgh
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: R E
authors.initials: RE
authors.lastname: Chaisson
authors.affiliation: Duke University School of Medicine, Durham, Family Health International 360, Durham, North Carolina, USA.
authors.forename: C D
authors.initials: CD
authors.lastname: Hamilton
authors.affiliation: Centers for Disease Control and Prevention (CDC), Atlanta.
authors.forename: M E
authors.initials: ME
authors.lastname: Villarino
authors.affiliation: Centers for Disease Control and Prevention (CDC), Atlanta.
authors.forename: S
authors.initials: S
authors.lastname: Goldberg
mesh_terms: D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage*; D023801:Directly Observed Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006703:Ill-Housed Persons / Q000706:statistics & numerical data; D006801:Humans; D007538:Isoniazid / Q000008:administration & dosage; D055985:Latent Tuberculosis / Q000188:drug therapy*; D008297:Male; D055118:Medication Adherence; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D012307:Risk Factors; D012737:Sex Factors; D013997:Time Factors
chemical_list: D000995:Antitubercular Agents; D007538:Isoniazid