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Table 1 Procedures for cross-sectional cohort of age- and sex-matched HIV-negative participants (n = 750), plus the newly enrolled HIV-positive, ART-treated adults (on ART for < 24 months) (n = 500)

From: Etiology of Persistent Microalbuminuria in Nigeria (P_MICRO study): protocol and study design

Visit 1

Visit 2 (4–8 weeks after Visit 1)

– Screening, informed consent

– HIV testing (HIV-negative participants only)

– Blood pressure measurement

– Diabetes screeninga

– Enrollment (if meet eligibility criteria)

– Participant to provide urine specimen at study clinic on day of visit (for 1st uACR and for urine albumin-to-protein ratio (uAPR) (if HIV-positive))

– Participant to provide urine specimen at study clinic on day of visit (for 2nd uACR)

– Specimen collection (~ 6 tubes; ~ 30 mL total)

i) Genotyping (Two DBS cards)

ii) Serum creatinine (3 mL gold top tube)

iii) HBVb and HCV testingc (Two 3.5 mL gold top tubes)

iv) CMV testingd (One 3.5 mL gold top tube)

v) Additional specimens to store (Two urine aliquots: Two 3 mL EDTA tubes; toenail/hair samples from consenting patients)

  1. aScreen for diabetes (if symptomatic, e.g., polyuria, polydipsia, weight loss), perform fasting/random glucose test (point-of-care device) and if ≥ 6.1 mmol/L (110 mg/dL), then patient has possible diabetes, and is referred to medical provider/clinic for further evaluation
  2. bScreen initially with hepatitis B surface antigen, and if positive, perform hepatitis B e Ag and hepatitis B DNA (viral load)
  3. cScreen initially with hepatitis C antibody (due to anticipated low prevalence (< 1%), we will test a random sample of 200 HIV-positive adults and perform additional screening (stored samples) only if prevalence > 2%)
  4. dScreen for Cytomegalovirus (CMV) using IgG antibody tests