title: 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.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01791556.
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, United States of America; Henry M. Jackson Foundation for the Advancement of Military Medicine, Rockville, MD, United States of America.
authors.forename: Fredrick K
authors.initials: FK
authors.lastname: Sawe
authors.affiliation: Kericho District Hospital, Kenya Ministry of Public Health and Sanitation, Kericho, Kenya.
authors.forename: Eunice
authors.initials: E
authors.lastname: Obiero
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; HJF Medical Research International, Inc., Kericho, Kenya.
authors.forename: Peter
authors.initials: P
authors.lastname: Yegon
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; HJF Medical Research International, Inc., Kericho, Kenya.
authors.forename: Rither C
authors.initials: RC
authors.lastname: Langat
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; HJF Medical Research International, Inc., Kericho, Kenya.
authors.forename: Appolonia
authors.initials: A
authors.lastname: Aoko
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; HJF Medical Research International, Inc., Kericho, Kenya.
authors.forename: Jemutai
authors.initials: J
authors.lastname: Tarus
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya.
authors.forename: Ignatius
authors.initials: I
authors.lastname: Kiptoo
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; HJF Medical Research International, Inc., Kericho, Kenya.
authors.forename: Raphael K
authors.initials: RK
authors.lastname: Langat
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; HJF Medical Research International, Inc., Kericho, Kenya.
authors.forename: Jonah
authors.initials: J
authors.lastname: Maswai
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; HJF Medical Research International, Inc., Kericho, Kenya.
authors.forename: Margaret
authors.initials: M
authors.lastname: Bii
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; HJF Medical Research International, Inc., Kericho, Kenya.
authors.forename: Samoel
authors.initials: S
authors.lastname: Khamadi
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya.
authors.forename: Kibet P
authors.initials: KP
authors.lastname: Shikuku
authors.affiliation: EmpiriStat, Mt Airy, MD, United States of America.
authors.forename: Nicole
authors.initials: N
authors.lastname: Close
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; HJF Medical Research International, Inc., Kericho, Kenya.
authors.forename: Samuel
authors.initials: S
authors.lastname: Sinei
authors.affiliation: Kenya Medical Research Institute/Walter Reed Project, Kericho, Kenya; U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, United States of America.
authors.forename: Douglas N
authors.initials: DN
authors.lastname: Shaffer
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology*; D015497:HIV-1; D006801:Humans; D007630:Kenya; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000627:therapeutic use; D011446:Prospective Studies; D012107:Research Design; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load; D015215:Zidovudine / Q000627:therapeutic use
chemical_list: D019380:Anti-HIV Agents; D018894:Reverse Transcriptase Inhibitors; D015215:Zidovudine; D019829:Nevirapine