Abstract
BackgroundProspective clinical trial data regarding routine HIV-1 viral load (VL) monitoring of antiretroviral therapy (ART) in non-research clinics of Sub-Saharan Africa are needed for policy makers.Methods CLinic-based ART Diagnostic Evaluation (CLADE) is a randomized, controlled trial (RCT) evaluating feasibility, superiority, and cost-effectiveness of routine VL vs. standard of care (clinical and immunological) monitoring in adults initiating dual nucleoside reverse transcriptase inhibitor (NRTI)+non-NRTI ART. Participants were randomized (1:1) at 7 predominately rural, non-research, district-level clinics of western Kenya. Descriptive statistics present accrual patterns and baseline cohort characteristics.ResultsOver 15 months, 820 adults enrolled at 7 sites with 86–152 enrolled per site. Monthly site enrollment ranged from 2–92 participants. Full (100%) informed consent compliance was independently documented. Half (49.9%) had HIV diagnosed through voluntary counseling and testing. Study arms were similar: mostly females (57.6%) aged 37.6 (SD = 9.0) years with low CD4 (166 [SD = 106]) cells/m3). Notable proportions had WHO Stage III or IV disease (28.7%), BMI <18.5 kg/m2 (23.1%), and a history of tuberculosis (5.6%) or were receiving tuberculosis treatment (8.2%) at ART initiation. In the routine VL arm, 407/409 (99.5%) received baseline VL (234,577 SD = 151,055 copies/ml). All participants received lamivudine; 49.8% started zidovudine followed by 38.4% stavudine and 11.8% tenofovir; and, 64.4% received nevirapine as nNRTI (35.6% efavirenz).ConclusionsA RCT can be enrolled successfully in rural, non-research, resource limited, district-level clinics in western Kenya. Many adults presenting for ART have advanced HIV/AIDS, emphasizing the importance of universal HIV testing and linkage-to-care campaigns.Trial RegistrationClinicalTrials.gov NCT01791556
Highlights
Both CD4+ T-cell count (CD4 count) and plasma HIV-1 RNA are standard of care assessments of immune function and HIV viremia in patients receiving antiretroviral therapy (ART) in resource-rich settings.[1, 2] In resource-limited settings such as sub-Saharan Africa where marked advancements have been made in ART roll-out, ART monitoring has been primarily based upon clinical (i.e. World Health Organization [WHO] Stage) and immunological (i.e. CD4 count) evaluations.[3]
Many adults presenting for ART have advanced HIV/AIDS, emphasizing the importance of universal HIV testing and linkage-to-care campaigns
With marked advances in ART roll-out in sub-Saharan Africa planned, it is important to evaluate the role of routine viral load (VL) monitoring.[12,13,14]
Summary
Jackson Foundation for the Advancement of Military Medicine, Inc., and the U.S Department of Defense (DOD). Funding was received through a cooperative agreement (W81XWH-07-2-0065) between the Kenya Medical Research Institute and CLinic-based ART Diagnostic Evaluation (CLADE) is a randomized, controlled trial (RCT) evaluating feasibility, superiority, and cost-effectiveness of routine VL vs standard of care (clinical and immunological) monitoring in adults initiating dual nucleoside reverse transcriptase inhibitor (NRTI)+non-NRTI ART. Participants were randomized (1:1) at 7 predominately rural, non-research, district-level clinics of western Kenya. Descriptive statistics present accrual patterns and baseline cohort characteristics
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