Multi-arm, non-randomized, quality of life
This is a prospective, longitudinal, observational study, performed at a Co-morbidities clinic for PLWH. PLWH with one or more co-morbidities receiving anti-retroviral therapy (ART) will be analyzed for their prevalence and incidence of developing renal, metabolic, hepatic and bone diseases. All participants will be assessed at baseline and followed up for one year, or until change in ART regimen, whichever earlier.
Study Type
OBSERVATIONAL
Enrollment
300
Prince of Wales Hospital
Shatin, Hong Kong
RECRUITINGRenal diseases
Renal disease is defined as glomerular filtration rate (GFR) \<60 mL/min/1.73m2, or presence of albuminuria, defined as urine albumin:creatinine \>3 mg/mmol, according to Kidney Disease Improving Global Outcomes (KDIGO) categorization of chronic kidney disease. Blood will be taken for creatinine and urine for creatinine and albumin levels.
Time frame: Baseline
Dyslipidemia
Dyslipidemia is defined as total cholesterol \>5.17 mmol/l, triglyceride \>1.7 mmol/l, HDL cholesterol \<1.03 mmol/l in men and \<1.29 mmol/l in women, or LDL cholesterol \>4.1 mmol/l, or a history of taking anti-hyperlipidemic drugs, according to the National Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (ATP III) guidelines. Fasting blood sample will be taken to measure total, LDL and HDL cholesterol and triglyceride levels.
Time frame: Baseline
Cardiovascular risk
High cardiovascular disease risk is defined as QRISK3 \>10%. QRISK3 will be calculated from QRISK 3 risk calculator at qrisk.org.
Time frame: Baseline
Liver steatosis and fibrosis
Liver steatosis is defined as Controlled Attenuated Parameter (CAP) \>248 dB/m and significant fibrosis is defined as liver stiffness \>9.0 kPa, as measured by transient elastography. Transient elastography will be performed to measure CAP and liver stiffness.
Time frame: Baseline
Low bone mineral density
Low bone mineral density is defined as T score \<-1.0 in men 50 years and in post-menopausal women at either lumbar spine or femoral neck, and Z score \<-2.0 in men younger than 50 years and pre-menopausal women, as measured by dual energy X-ray absorptiometry (DXA). DXA scan will be performed to measure bone mineral density at lumbar spine and femoral neck.
Time frame: Baseline
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Health-related quality of life
any severity of problem in the five dimensions of EQ-5D-5L, EQ-5D-5L index and EQ-VAS EuroQol 5 level EQ-5D version will be performed to measure the above parameters.
Time frame: Baseline
Incidences of Comorbidities
All the above endpoints will be determined at 1 year follow up or at the time of change of ART regimen
Time frame: 12 months or at the time of change of ART regimen