Rationale, design, and methodology of a trial evaluating three models of care for HCV treatment among injection drug users on opioid agonist therapy

Table 2 Schedule of research visits

Data Sources	Pre-Baseline	Baseline	Wk0	Wk4	Wk8	Wk12	Wk24	Final Tx Wk	FU Wk4	FU Wk12	FU Wk24
Blood Tests
HCV Viral Load	X			X	X	X	X	X	X	X	X
Resistance Tests (NS3/4A, NS5A, NS5B Assays)		X		X				X	X	X	X
Other Clinical Measures
Urine Toxicology (amphetamine, benzos, cocaine, methadone, opiates, oxycodone)		X		X	X	X	X	X	X	X	X
Methadone dose		X		X	X	X	X	X
Chart Abstraction	X									X
Blister Pack			X	X	X	X	X
Questionnaires (ACASI)
Demographics		X
Adherence [32, 66, 67]				X	X	X	X	X
ACTG for Interferon if used [31]				X	X	X	X	X
Awareness of Viral Load questions				X	X	X	X	X		X	X
Quality of Life: EQ-5D-3 L [38, 68], HCV QoL [69, 70]		X		X	X	X	X	X		X	X
Depression: BDI-II [71, 72]		X		X	X	X	X	X		X	X
Healthcare Service Utilization (NMOS) [73]		X		X	X	X	X	X		X	X
Alcohol: AUDIT [74]		X		X	X	X	X	X		X	X
Drug and Alochol Use: ASI-Lite [75, 76]		X		X	X	X	X	X		X	X
Tobacco Questionnaire [77]		X									X
Social Support: Norbeck Social Support Questionnaire [78], MOS [79]		X				X	X	X		X	X
IMB Questions [80, 81]		X			X
HCV Beliefs		X									X
Common Sense Model Questions [82]		X			X
Psychiatric comorbidities: MINI [83]		X
Trust in physician [84]		X
Distrust in Health Care System [85]		X
Trust in Health Care Provider [86]		X
Subjective Opiate Withdrawal Scale [87]		X		X	X	X	X	X		X	X
Side Effects Survey		X		X	X	X	X	X

ISSN: 1471-2334