TABLE 1.
Schedule of data collection
| Data collection point | Data | Method |
|---|---|---|
| Baseline | Patient characteristics: Demographics (including sex, age, education, marital status, housing, employment, income, and legal status), injection drug use history, medical and psychiatric history, HCV transmission risk factors history, physical characteristics, medication use, and treatment motivation | Semistructured interview |
| Clinical characteristics: HCV genotype, alanine aminotransferase, aspartate aminotransferase, bilirubin, albumin, thyroid stimulating hormone, complete blood count including absolute neutrophil count, and international normalized ratio; liver biopsy grade and stage for patients who completed a liver biopsy | Laboratory test results | |
| Baseline and every 4 weeks throughout treatment | Beck Depression Inventory score (Version: BDI), a 21-question multiple choice self-report inventory used to measure the severity of depression. | Semistructured interview |
| Addiction Severity Index (Version: ASI-Lite), an interview-administered research assessment instrument to rate the extent to which treatment for addiction is needed. | Semistructured interview | |
| Weekly throughout prescribed treatment or until treatment was stopped | All baseline clinical characteristics | Laboratory test results |
| Urine toxicological screening for illicit drugs | High-performance liquid chromatography (Gamma Dynacare Medical Laboratories, London, Ontario) | |
| Prescribed psychotropic and nonpsychotropic medication | Abstracted from patient’s chart | |
| Ribavirin compliance | Semistructured interview | |
| Exposure to HCV transmission risk factors | Semistructured interview | |
| Treatment week 4 | Rapid virological response | Laboratory test results |
| Treatment week 12 | Early virological response | Laboratory test results |
| Treatment week 24 | End of treatment response for patients infected with HCV genotype 2 or 3 | Laboratory test results |
| Treatment week 48 | End of treatment response for patients infected with HCV genotype 1 | Laboratory test results |
| 24 weeks after completion of treatment | Sustained virologicial response | Laboratory test results |
HCV Hepatitis C virus