. Author manuscript; available in PMC: 2020 Dec 1.

Published in final edited form as: Contemp Clin Trials. 2019 Oct 24;87:105859. doi: 10.1016/j.cct.2019.105859

Table 1.

Core assessment measures.

Research visit activities	Time (minutes)	Pre-treatment			Treatment visits			Post-treatment visits
Research visit activities	Time (minutes)	Pre-screening	Enrollment	Baseline	Week 4, ± 1 wk	Week 8, ± 1 wk	Week 12, ± 1 wk	Week 24, ± 2wks	Week 36, ± 2 wks	Week 48, ± 2 wks
Visit number			0	1	2	3	4	5	6	7
TIME (in minutes)			40	70	37	22	90	70	20	65
Release of information		X	X
Informed consent	30		X
Randomization			X
Instruments
Socio-demographic survey	10		X
Short socio-demographic survey	5							X
Behavioral risk assessment	10			X	X		X	X	X	X
Depression (PHQ-9)	5			X			X	X		X
Anxiety (GAD-7)	4			X			X	X		X
Alcohol use (AUDIT-C)	3			X			X	X		X
Modified ASI - baseline	10			X
Modified ASI - follow-up	5				X	X	X	X
Substance use treatment	3			X	X	X	X	X		X
Quality of life (EQ-5D)	8			X			X	X		X
Adherence (visual analogue scale)	2				X	X	X
Medical outcomes social support scale	5			X			X			X
Brief revised working alliance (PN arm only)	5						X
Stigma scale	5			X
Shame scale	2			X					X
Health efficacy scale	3			X			X
Satisfaction scale	1						X
Peer support	1			X	X	X	X	X
Labs
HCV antibody		MC		MC
HCV viremia		MC		MC	MC	MC	MC	MC	X	X
HCV genotype/subtype				MC	MC
HIV test				MC
HIV viral load^*				MC	MC	MC	MC
HIV CD4^*				MC	MC	MC	MC
AST/ALT/Platelets/FIB-4 calculation		MC		MC	MC	MC	MC	MC
Total bilirubin				MC
Albumin				MC
Prothrombin time				MC
FibroSure/Fibroscan/Liver biopsy				MC	MC^**	MC^**
Imaging study^**		MC		MC
Child-Pugh score (exclude B,C)				MC	MC	MC	MC
Pregnancy test^*				MC
Archiving sample				X				X	X	X
HCV GenoSure NS5A/NS5B Assay^*								X
HBV panel				MC
HAV status				MC
Urine toxicology POC assay				X	X	X	X	X		X

Research visit activities	Post-treatment visits
Research visit activities	Week 60, ± 2 wks	Week 72, ± 2 wks	Week 84 ± 2 wks	Week 96, ± 2 wks	Week 108, ± 2 wks	Week 120, ± 2 wks	Week 132, ± 2 wks	Week 144, ± 2 wks	Week 156, ± 2 wks	Week 168, ± 2 wks
Visit number	8	9	10	11	12	13	14	15	16	17
TIME (in minutes)	15	45	15	25	15	90	15	25	15	90
Release of information
Informed consent
Randomization
Instruments
Socio-demographic survey
Short socio-demographic survey		X				X				X
Behavioral risk assessment	X	X	X	X	X	X	X	X	X	X
Depression (PHQ-9)						X				X
Anxiety (GAD-7)						X				X
Alcohol use (AUDIT-C)		X		X		X		X		X
Modified ASI - baseline
Modified ASI - follow-up		X				X				X
Substance use treatment						X				X
Quality of life (EQ-5D)						X				X
Adherence (visual analogue scale)
Medical outcomes social support scale						X				X
Brief revised working alliance (PN arm only)
Stigma scale
Shame scale						X				X
Health efficacy scale
Satisfaction scale
Peer support
Labs
HCV antibody
HCV viremia	X	X	X	X	X	X	X	X	X	X
HCV genotype/subtype
HIV test
HIV viral load^*
HIV CD4^*
A ST/ALT/Pla te 1 ets/FIB-4 calculation
Total bilirubin
Albumin
Prothrombin time
FibroSure/Fibroscan/Liver biopsy
Imaging study^**
Child-Pugh score (exclude B,C)
Pregnancy test^*
Archiving sample	X	X	X	X	X	X	X	X	X	X
HCV GenoSure NS5A/NS5B Assay^*
HBV panel
HAV status
Urine toxicology POC assay		X		X		X		X		X

Note: MC = Medical chart;

= if applicable;

^**

= if available.