Visit window | Â | Â | +/- 2Â days | ||||||
---|---|---|---|---|---|---|---|---|---|
Weeks | -4 (Screen) | 0 (Baseline) | 4 | 8 | 12 | 16 | 24 | 36 | 48 |
Informed consent | X | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history | X | Â | Â | Â | Â | Â | Â | Â | Â |
Inclusion/exclusion criteria | X | X | Â | Â | Â | Â | Â | Â | Â |
Drug, alcohol and smoking history | X | Â | Â | Â | Â | Â | Â | Â | Â |
Pregnancy testa | X | Xa | Â | Â | Â | Â | Â | Â | Â |
Medication review | X | X | X | X | X | X | X | X | X |
FibroScan®b | X | X |  |  | X |  | X | X | X |
Physical examinationc and vital signs | X | Xc | Xc | Xc | Xc | Xc | Xc | Xc | Xc |
Hepatitis B serologyd | X | Â | Â | Â | Â | Â | Â | Â | Â |
HCV RNA viral loade | Xe | X | X | X | X | X | X | X | X |
HCV genotyped | Â | X | Â | Â | Â | Â | Â | Â | Â |
HIV viral loadd,e (as per SOC) | Xe | X | Â | Â | X | Â | X | X | X |
CD4 counte (as per SOC) | X5 | X | Â | Â | X | Â | X | X | X |
Hematologyf and chemistryg | X | X | X | X | X | X | X | X | X |
HbA1c | X | X | Â | Â | X | Â | X | X | X |
Fasting insulin and glucose | X | X | X | X | X | X | X | X | X |
Fasting lipidsh | Â | X | Â | Â | X | Â | X | X | X |
Inflammatory markers/research blood | Â | X | X | X | X | X | X | X | X |
TSH | Â | X | Â | Â | Â | X | X | Â | X |
AFP levels | Â | X | Â | Â | X | Â | X | X | X |
2-hr OGTT | Â | X | Â | Â | Â | Â | Â | Â | X |
Adverse events | Â | Â | X | X | X | X | X | X | X |
Anthropometric measuresi | Xi | X | Â | Â | X | Â | X | X | X |
Counselling on lifestyle modification | Â | X | Â | Â | Â | Â | X | Â | X |
Block food frequency questionnaire | Â | X | Â | Â | Â | Â | X | Â | X |
International physical activity questionnaire | Â | X | Â | Â | Â | Â | X | Â | X |
Audit-C and illicit drug use questionnaires | Â | X | Â | Â | X | Â | X | X | X |
TSQM for patient acceptability (arm 1) | Â | Â | Â | X | Â | Â | X | Â | X |
Study drug accountability/dispensation (arm 1) | Â | X | X | X | X | Â | X | X | X |
Birth control review | X | X | X | X | X | Â | X | X | X |