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 | ||
Elastographya | 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 |