Abstract
BackgroundThe benefit of routine HIV-1 viral load (VL) monitoring of patients on antiretroviral therapy (ART) in resource-constrained settings is uncertain because of the high costs associated with the test and the limited treatment options. We designed a cluster randomized controlled trial to compare the use of routine VL testing at ART-initiation and at 3, 6, 12, and 18 months, versus our local standard of care (which uses immunological and clinical criteria to diagnose treatment failure, with discretionary VL testing when the two do not agree).MethodologyDedicated study personnel were integrated into public-sector ART clinics. We collected participant information in a dedicated research database. Twelve ART clinics in Lusaka, Zambia constituted the units of randomization. Study clinics were stratified into pairs according to matching criteria (historical mortality rate, size, and duration of operation) to limit the effect of clustering, and independently randomized to the intervention and control arms. The study was powered to detect a 36% reduction in mortality at 18 months.Principal FindingsFrom December 2006 to May 2008, we completed enrollment of 1973 participants. Measured baseline characteristics did not differ significantly between the study arms. Enrollment was staggered by clinic pair and truncated at two matched sites.ConclusionsA large clinical trial of routing VL monitoring was successfully implemented in a dynamic and rapidly growing national ART program. Close collaboration with local health authorities and adequate reserve staff were critical to success. Randomized controlled trials such as this will likely prove valuable in determining long-term outcomes in resource-constrained settings.Trial RegistrationClinicaltrials.gov NCT00929604
Highlights
The rapid expansion of access to antiretroviral therapy (ART) in sub-Saharan Africa has led to dramatic drops in AIDS-related mortality in a variety of settings, [1,2,3,4,5] but a tremendous unmet need for HIV care remains
The measurement of HIV-1 RNA levels is recommended to monitor the response to ART in developed countries. [9,10] The World Health Organization (WHO) does not recommend routine viral load (VL) testing in resource-constrained settings, in part due to the cost and complex infrastructure needed for reliable results
Given the lack of third-line ART regimens in much of sub-Saharan Africa and the high cost, sophisticated laboratory equipment, and technical training necessary to perform VL testing, the widespread adoption of this technology must be informed by solid evidence
Summary
A large clinical trial of routing VL monitoring was successfully implemented in a dynamic and rapidly growing national ART program. Close collaboration with local health authorities and adequate reserve staff were critical to success. Randomized controlled trials such as this will likely prove valuable in determining long-term outcomes in resourceconstrained settings
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