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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
A cluster randomized trial of routine HIV-1 viral load monitoring in Zambia: Study design, implementation, and baseline cohort characteristics
PLoS ONE, Volume 5, No. 3, Article e9680, Year 2010
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Description
Background: The 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). Methodology: Dedicated 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 Findings:From 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. Conclusions: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 resource-constrained settings. Trial Registration: Clinicaltrials.gov NCT00929604. © 2010 Koethe et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC2837376/bin/pone.0009680.s001.doc
https://efashare.b-cdn.net/share/pmc/articles/PMC2837376/bin/pone.0009680.s002.doc
Authors & Co-Authors
Koethe, John Robert
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
United States, Nashville
Vanderbilt University School of Medicine
Westfall, Andrew O.
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
Luhanga, Dora K.
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
Clark, Gina M.
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
Goldman, Jason D.
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
Mulenga, Priscilla Lumano
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
Cantrell, Ronald A.
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
Chi, Benjamin H.
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
United States, Birmingham
Heersink School of Medicine
Zulu, Isaac S.
Zambia, Lusaka
University Teaching Hospital Lusaka
Saag, Michael S.
United States, Birmingham
Heersink School of Medicine
Stringer, Jeffrey S.A.
Zambia, Lusaka
Centre for Infectious Disease Research in Zambia
United States, Birmingham
Heersink School of Medicine
Statistics
Citations: 18
Authors: 11
Affiliations: 4
Identifiers
Doi:
10.1371/journal.pone.0009680
e-ISSN:
19326203
Research Areas
Health System And Policy
Infectious Diseases
Study Design
Randomised Control Trial
Cohort Study
Case-Control Study
Study Approach
Quantitative
Study Locations
Zambia