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Table 6 Procedures for longitudinal cohort of HIV-positive (n = 1,000) and HIV-negative (n = 500) participants with normoalbuminuria to be followed for 30 months (n = 1500 total)

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

Procedure / Visit (month (mo))

Enrollment

6 mo

12 mo

24 mo

30 mo

Seated blood pressure check

X

X

X

X

X

Diabetes mellitus screening (perform fasting blood glucose if any signs/symptoms suggestive of underlying diabetes)

X*

X

X

X

X

uACRa (No urine protein testing necessary for enrolled Aim 2 HIV-positive adults with normoalbuminuria as all HIV-positive ART-treated adults from Aim 1 will have one uAPR measurement) (We will have stored urine at 3 timepoints to go back and perform uAPR testing in patients with incident microalbuminuria)

X# (We will use Aim 1 uACR as participants baseline value)

 

X

 

X

Serum creatinine (SCr)b

X (We will use Aim 1 SCr as their baseline value)

 

X

 

X

Parasite screening

     

Complete blood count (CBC) with differentialc

X

X

X

X

X

Urine dipstick (spun for all patients with hematuria followed by urine microscopy (S. haematobium)

X

X

X

X

X

Malaria testing (rapid diagnostic test) at point-of-care (POC) using fingerprick specimen

X

X

X

X

X

Filariasis POC testing for Wuchereria bancroftid

X

   

X

Onchocerciasis testing (bilateral skin snips)e

X

   

X

Stool for ova and parasite (stool O&P)f

X

X

X

X

X

Daytime thick blood smear for Loa loa (10 AM–2 PM)

X

   

X

Strongyloides IgG serology (plasma)g

X

   

X

Tuberculosis screeningh

X

X

X

X

X

Inflammatory biomarkers (urine and plasma)i

X

   

X

CD4 cell count

X

   

X

Viral load (plasma HIV RNA)

X

   

X

Social and Behavioral data

X

 

X

 

X

Additional tubes for storagej

X

 

X

 

X

  1. *All potentially eligible Aim 2 participants will undergo fasting blood glucose testing to evaluate for diabetes (and if ≥ 6.1
  2. mmol/L (110 mg/dL), then patient may have diabetes, is ineligible, and is referred to medical provider/clinic for evaluation
  3. #All participants will use their recent uACR measurement (obtained in Aim 1) for their baseline
  4. aTwo 3 mL sterile universal containers taken for uACR testing (Urine protein testing only for HIV-positives)
  5. bTwo 3 mL gold top tubes taken to measure serum creatinine (SCr)
  6. cCBC with differential—looking for eosinophilia (common with Filariasis (especially Loa loa) and Schistosomiasis)
  7. dPOC testing for W. bancrofti antigen by Filariasis Test Strip (FTS), followed by obtaining nocturnal thick blood smears for
  8. microfilaria [between 10 pm—2 am] in FTS-positive persons. Brugia spp. are not endemic to Africa, so testing for W
  9. bancrofti will be sufficient
  10. eOnchocerca volvulus ELISA is not sensitive enough to rule out infection. Physical exam findings are also not sensitive. No one
  11. will want to be snipped every 6 months, but since filarial worms are long-lived (> 5 years), snipping at the beginning and end
  12. of study should capture anyone who is infected at study onset or becomes infected during the study
  13. fStool for O&P to be done screening for S. mansoni and soil transmitted helminths (e.g., Ascaris, Trichuris, Hookworm)
  14. gStrongyloides IgG ELISA at baseline in ALL participants & test all persons testing NEG at enrolment again at 30 months
  15. hSputum specimens (5 mL) to be collected and sent for Gene Xpert testing and/or microscopy (acid fast bacilli staining)
  16. iTwo 3 mL purple top tubes for plasma biomarkers and one 5–7 mL urine specimens for urine biomarkers (and stored)
  17. jTwo 3 mL purple top EDTA tubes and one 5–7 mL urine specimen to be obtained and stored for future/approved testing
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BMC Infectious Diseases

ISSN: 1471-2334

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