Skip to main content

Table 2 Components of same-day ART initiation in the VIBRA trial

From: VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho

Component Description Remarks
Medical history The study nurse assesses the patient’s medical history using a checklist; if necessary the nurse may refer the patient to a health facilty and may choose not to initiate same-day ART. In case of doubt, the nurse will contact the study physician See checklist in Additional file 1 (eForm title “Medical history”)
Physical examination The study nurse conducts a structured physical examination using a checklist; if necessary the nurse may refer the patient to a health facilty and may choose not to initiate same-day ART. In case of doubt, the nurse will contact the study physician See checklist in Additional file 1 (eForm title “Physical exam”)
WHO stage The study nurse assigns a clinical WHO stage according to the physical examination and medical history  
CD4 measurement The study team performs a point-of-care CD4 count, using PIMA Alere™ (a finger-prick test), which gives results within 20 min.
 ▪ If CD4 count < 350 cells/mcL: co-trimoxazole prophylaxis, 960 mg once daily orally, 1 tablet
  ◦ If participant < 14 years: 1/2 tablet once daily orally
 ▪ If CD4 count < 200 cells/mcL: cryptococcal antigen (CrAg) point-of-care measurement (lateral flow assay, IMMY©)
  ◦ If CrAg positive: immediate referral to a nearby district hospital by the study team and no same-day ART initiation
Although baseline CD4 counts are no longer used according to national guidelines to establish ART eligibility, the baseline CD4 count remains a strong indicator of early outcomes on ART and is, therefore, (a) an important variable for the study analysis and (b) an important clinical monitoring measurement for the prevention of opportunistic infections
The national guidelines suggest screening for CrAg only if CD4 count < 100 cells/mcL. However, data are scarce, so we will extend screening to those with CD4 count < 200 cells/mcL
For CrAg-positive patients, preventive or therapeutic antifungal treatment is indicated and a lumbar puncture is required. Thus, referral to the hospital is needed. Due to evidence that early ART initiation should be avoided if there is cryptococcal meningitis, same-day ART will not be initiated in CrAg-positive individuals until cryptococcal meningitis has been excluded
Creatinine measurement The study team performs a point-of-care creatinine measurement, using StatSensor Creat™ Nova™ Biomedical (finger-prick test), which gives results within 2 min.
 • If estimated creatinine glomerular filtration rate according to the Cockroft–Gault equation < 50 mL/min: substitution of tenofovir disoproxil fumarate (TDF) with abacavir or zidovudine depending on the hemoglobin result
 • If estimated creatinine glomerular < 30 mL/min: the nurse may refer the patient to a health facility and may choose not to initiate same-day ART
According to national guidelines, a baseline creatinine measurement is needed before initiating standard first-line ART including TDF
Hemoglobin measurement The study nurse performs a point-of-care hemoglobin measurement, using HemocueTM, HB301 (a finger-prick test), which gives results within 2 min.
 • If hemoglobin < 8 g/dL: zidovudine is contraindicated and the nurse may refer the patient to a health facility and may choose not to initiate same-day ART
According to national guidelines, hemoglobin must be measured before initiating an ART regimen containing zidovudine
Adherence counseling and education session The study nurse conducts a structured education and adherence session, which is delivered using a leaflet, one-on-one, in approximately 5–10 min. A condensed version of the education and counseling typically provided over the course of the former pre-ART visits was developed for and successfully tested in the previous trial (CASCADE trial)
Readiness assessment Before dispensing ART, the study nurse will confirm the patient’s readiness and will answer all remaining questions, using a checklist
 • If the patient is not ready, they are referred to a health facility and same-day ART is not initiated
See checklist in Additional file 1 (eForm title “Readiness”)
Dispensing of ART The study nurse prescribes a 1-month supply of the standard first-line ART according to national guidelines: TDF/lamivudine/efavirenz as a fixed-dose combination, once daily
 • If TDF is contraindicated, it is substituted with abacavir or zidovudine depending on the hemoglobin level
 • If the patient has an uncontrolled mental disease (e.g., active psychosis), they are referred to a health facility and same-day ART is not initiated
 • Depending on CD4 count, additionally 1 month’s supply of co-trimoxazole will be dispensed
The study nurses, like other qualified nurses in Lesotho, are authorized to write prescriptions for ART. We include only patients aged 10 years and older and weighing 35 kg or above (see the eligibility criteria). Thus, TDF/lamivudine/efavirenz is the standard treatment, which everybody will receive unless we discover they have renal impairment
Before dispensing ART, the study nurse will re-test the patient again for HIV as per national ART guidelines
Follow-up visit The study nurse provides a follow-up date in 12–16 days, either at the health facility (VIBRA control) or with the VHW (VIBRA intervention, if the participant agrees), as their next ART visit The study nurse documents the entire process in the patient booklet (“bukana”), including drugs prescribed and follow-up date, and fills in all government documents (patient file and registers) at the health facility responsible for the catchment area
  1. ART antiretroviral therapy, CrAg cryptococcal antigen, HIV human immunodeficiency virus, TDF tenofovir disoproxil fumarate, VHW village health worker, WHO World Health Organization