Integrated treatment of hepatitis C virus infection among people who inject drugs: study protocol for a randomised controlled trial (INTRO-HCV)

BMC Infectious Diseases

Table 1 Flow chart of the study outlining follow-up visits and assessments at each visit

	Screening 1 (part 1)	Screening 2 (part 2)	Treatment initiation or referral to standard treatment (physician)	Treatment follow-up (4 weeks after initiation)	Treatment follow-up (8 weeks after initiation)	Treatment follow-up (12 weeks after initiation)	Effect assessment (12 weeks after completion)	Annual follow-up
Acceptable time shift (days)				± 7	± 7	± 7	± 14	± 60
Physician assessment			X				X	X
Research nurse assessment	X	X					X	X
- Informed consent	X
- Eligibility assessment	X	X	X
- Follow-up by staff delivering treatment and providing information (several times weekly)			X	X	X	X
- Clinical assessment	X	X	^b	^b	^b	^b		X
- Counselling on prevention			X	X	X	X	X	X
Elastography^a		X					(X)	X
Lab tests
- Viral testing	X						X	X
Full blood count and transaminases	X			^b	^b	^b	X	X
HSCL-10 (mental health)	X						X	X
FAS (fatigue symptoms)	X						X	X
EQ-5D-5 L (quality of life)	X						X	X
Infection risk behaviour	X						X	X
Substance use patterns	X						X	X
HCV genotyping and viral load	X						X	X

^aElastography after treatment will be assessed in Bergen and not in Stavanger due to elastography availability only in hospital clinic and not outpatient clinic
^bAdditional tests will be taken on clinical indication