Evaluation (CLADE): Design, Accrual, and Baseline Characteristics of a Randomized Controlled Trial Conducted in Predominately Rural, District-Level, HIV Clinics of Kenya

Abstract

Background Prospective clinical trial data regarding routine HIV-1 viral load (VL) monitoring of antiretro-viral 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 transcrip-tase inhibitor (NRTI)+non-NRTI ART. Participants were randomized (1:1) at 7 predominate-ly rural, non-research, district-level clinics of western Kenya. Descriptive statistics present accrual patterns and baseline cohort characteristics. Results Over 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 in

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oai:CiteSeerX.psu:10.1.1.769.9982Last time updated on 10/30/2017

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