Table 3 Trial procedures and Timelines

Informed consent

X

Demographic data and medical history including full ART history

X

Eligibility criteria

X

X

Review of historical drug resistance tests

X

Adverse events

X

X

X

X

X

X

X

X

X

Concomitant medications

X

X

X

X

X

X

X

X

X

X

HIV-SI

X

X

X

X

PSQI

X

X

X

X

HIV associated conditions

X

X

X

X

X

X

X

X

X

X

Randomisation

X

e-Case Report Forms

X

X

X

X

X

X

X

X

X

X

Vital signs (Blood Pressure, Pulse, temperature, weight)

X

X

X

X

X

X

X

Complete/^asymptom directed physical examination

X

X^a

X^a

X^a

X^a

X^a

X^a

X^a

X^a

Height

X

Weight, BMI & waist circumference

X

X

X

X

X

X

X

12 Lead ECG

X

X

X

X

Urinalysis

X

X

X

X

X

X

X

Urine Pregnancy Test

X

X

X

X

X

X

X

CD4/CD8 T cell count

X

X

X

X

HIV-1 RNA viral load (& resistance testing if > 50 copies/mL)

X

X

X

X

X

X

X

X

X

Whole blood for Proviral DNA

X

Haematology

X

X

X

X

X

X

X

Urea, electrolytes, creatinine, phosphate, glucose, calcium, amylase

X

X

X

X

X

X

X

Estimated GFR

X

X

X

X

X

X

X

UPCR

X

X

X

X

X

X

X

HBV & HCV serology

X

Liver function tests

X

X

X

X

X

X

X

Lipids (Fasting Cholesterol, LDL, HDL, Triglycerides)

X

X

X

X

HbA1c

X

X

X

X

Pill count adherence

X

X

X

X

X

X

X

X

Self-reported adherence

X

X

X

X

X

X

X

X

Study drug dispensation

X

X

X

X

X

X

Study drug accountability

X

X

X

X

X

X

X