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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

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+/- 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