Kericho CLinic-based ART Diagnostic Evaluation (CLADE): design, accrual, and baseline characteristics of a randomized controlled trial conducted in predominately rural, district-level, HIV clinics of Kenya

PLoS One. 2015 Feb 23;10(2):e0116299. doi: 10.1371/journal.pone.0116299. eCollection 2015.

Abstract

Background: Prospective 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.

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 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).

Conclusions: A 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 registration: ClinicalTrials.gov NCT01791556.

Publication types

  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adult
  • Anti-HIV Agents / therapeutic use*
  • Cost-Benefit Analysis
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / virology*
  • HIV-1
  • Humans
  • Kenya
  • Male
  • Middle Aged
  • Nevirapine / therapeutic use
  • Prospective Studies
  • Research Design
  • Reverse Transcriptase Inhibitors / therapeutic use*
  • Treatment Outcome
  • Viral Load*
  • Zidovudine / therapeutic use

Substances

  • Anti-HIV Agents
  • Reverse Transcriptase Inhibitors
  • Zidovudine
  • Nevirapine

Associated data

  • ClinicalTrials.gov/NCT01791556

Grants and funding

The Clinic-based ART Diagnostic Evaluation (CLADE) trial is sponsored by the U.S. Office of the Global AIDS Coordinator (#KE-07-0044). This work was also supported by a cooperative agreement (W81XWH-07-2-0067) between the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and the U.S. Department of Defense (DOD). Funding was also received through a cooperative agreement (W81XWH-07-2-0065) between the Kenya Medical Research Institute and the U.S. Department of Defense (DOD). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.