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Table 1 Schedule of events and data collection

From: Improving treatment and liver fibrosis outcomes with metformin in HCV-HIV co-infected and HCV mono-infected patients with insulin resistance: study protocol for a randomized controlled trial

Visit window    +/- 2 days
Weeks -4 (Screen) 0 (Baseline) 4 8 12 16 24 36 48
Informed consent X         
Medical history X         
Inclusion/exclusion criteria X X        
Drug, alcohol and smoking history X         
Pregnancy testa X Xa        
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         
HCV RNA viral loade Xe X X X X X X X X
HCV genotyped   X        
HIV viral loadd,e (as per SOC) Xe X    X   X X X
CD4 counte (as per SOC) X5 X    X   X X X
Hematologyf and chemistryg X X X X X X X X X
HbA1c X X    X   X X X
Fasting insulin and glucose X X X X X X X X X
Fasting lipidsh   X    X   X X X
Inflammatory markers/research blood   X X X X X X X X
TSH   X     X X   X
AFP levels   X    X   X X X
2-hr OGTT   X        X
Adverse events    X X X X X X X
Anthropometric measuresi Xi X    X   X X X
Counselling on lifestyle modification   X      X   X
Block food frequency questionnaire   X      X   X
International physical activity questionnaire   X      X   X
Audit-C and illicit drug use questionnaires   X    X   X X X
TSQM for patient acceptability (arm 1)     X    X   X
Study drug accountability/dispensation (arm 1)   X X X X   X X X
Birth control review X X X X X   X X X
  1. HCV hepatitis C, HIV human immunodeficiency virus, HbA1c glycated hemoglobin, TSH thyroid-stimulating hormone, AFP alpha-fetoprotein, OGTT oral glucose tolerance test, TSQM Treatment Satisfaction Questionnaire for Medication
  2. aIf randomization occurs > = 4 weeks from last pregnancy test, perform pregnancy test at baseline
  3. bFibroScan® can be done at screening if necessary for inclusion; baseline test can be done on different day than rest of visit if necessary (within 4 weeks of baseline). FibroScan® window can be +/− 7 days of the week 12 visit, +/− 21 days of week 24 and 36 visits, and up to 21 days before the week 48 visit
  4. cTargeted physical exam: vitals, cardiac, respiratory and abdominal exams; exam as pertinent to patient complaints
  5. dTests to be done if not already in participant medical records [hepatitis B (HBV) needs to be within 6 months of screening visit; HIV needs to be within 1 month of screening]
  6. eIf results available within 1 month of screening visit, no need to retest
  7. fHematology: complete blood count (CBC) with differential, platelets, international normalized ratio (INR)
  8. gChemistry: electrolytes, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), lipase, albumin, direct bilirubin, lactate, creatinine, estimated glomerular filtration rate (eGFR)
  9. hLipids: total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides
  10. iAnthropometric measures: height, weight, body mass index (BMI), waist circumference, hip circumference, waist-to-hip ratio. At screening, only height and weight documented
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Trials

ISSN: 1745-6215