TABLE 3

Randomized controlled trials assessing clinical impacts of POC HIV viral load testing

Clinical trialLocationStudy populationInterventionsOutcomesEstimated completion date
STREAM, NCT03066128 (49)Single site, South Africa390 nonpregnant adults on ART who are due a viral load test at 6 mo after initiationPOC monitoring including Xpert HIV-1 viral load testing, combined with task shifting to enrolled/auxiliary nurses, versus standard of carePrimary:
(i) Proportion of patients who are retained in care with viral suppression at <200 copies/ml at 12 mo after enrollment (18 mo on ART)
Secondary:
(i) Proportion of patients with viral load of <1,000 copies/ml 12 mo from enrollment
(ii) Costs per patient virologically suppressed and retained in care
(iii) Time to detection of virological failure, subsequent intensive adherence counseling, and initiation of second-line regimen
(iv) Proportion of patients entered appropriately into differentiated ART delivery programs and time to appropriate entry into these programs
Q4 2018
NCT03288246 (189)Single site, Haiti150 persons aged 10–24 yrs on ART for >6 moPOC HIV viral load testing at enrollment, 3 and 6 mo compared to standard laboratory testing at the same time pointsPrimary:
(i) Number of steps in the HIV viral load cascade
Secondary:
(i) Comprehension of the relationship between ART adherence and HIV viral load assessed 1 mo after receiving viral load result
(ii) Viral suppression at <1,000 copies/ml at 6 mo from enrollment
Q4 2018
UltraHIV NCT03187964 (47)Single site, South Africa1,500 adults on ART who are due annual HIV viral load testing (another component of the study assesses Xpert Ultra for TB in a separate group of 1,500 adults)POC Xpert HIV-1 viral load testing at site versus standard laboratory viral load testingPrimary:
(i) Related to TB component of the study.
Secondary:
(i) Proportion of patients diagnosed with viremia by 8 wks
(ii) Of those with viremia, the proportion who are identified to require adherence counselling and/or HIV resistance testing by 1 wk, are referred for adherence counselling and/or second-line ART by 8 wks, and do not successfully start adherence counseling, HIV resistance testing, or second-line ART by 12 wks
Q4 2019
NCT03533868 (48)Two sites, Nigeria794 adults being initiated on ARTPOC Xpert HIV-1 Viral Load monitoring at 6 and 12 mo from enrollment versus standard laboratory viral loadPrimary:
(i) Proportion of patients with viral suppression at <1,000 copies/ml at 12 mo on ART
Secondary:
(i) Average adherence from pharmacy refill data
(ii) Loss to follow-up at 12 mo
(iii) Time to adherence counselling, confirmation of virological failure and switch to second-line ART
(iv) Time from specimen collection to result availability and communication to patient
(v) HIV drug resistance patterns
(vi) Patient and health care worker satisfaction
Q4 2019
RAPID-Viral Load NCT03553693 (190)20 sites, Uganda2,440 children, adolescents, and adults on ART, including pregnant women and patients with unsuppressed HIV viral loadsRAPID-Viral Load study intervention testing and counselling package, which includes near-point-of-care HIV viral load testing at local testing hubs, structured viral load counseling, and forms to track viral load ordering and testing, with feedback and performance evaluations at regular intervalsPrimary:
(i) Proportion of patients with HIV viral load ordered when indicated by country guidelines
(ii) Mean time to delivering HIV viral load result to patient
Secondary:
(i) HIV viral load suppression at 12 mo from enrollment
(ii) HIV viral load suppression
(iii) Proportion switched to second-line ART
(iv) Proportion of results present in Uganda’s Central Public Health Laboratory system
Q4 2019