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Randomized Controlled Trial
. 2015 Feb 23;10(2):e0116299.
doi: 10.1371/journal.pone.0116299. eCollection 2015.

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

Fredrick K Sawe  1 , Eunice Obiero  2 , Peter Yegon  3 , Rither C Langat  3 , Appolonia Aoko  3 , Jemutai Tarus  3 , Ignatius Kiptoo  4 , Raphael K Langat  3 , Jonah Maswai  3 , Margaret Bii  3 , Samoel Khamadi  3 , Kibet P Shikuku  4 , Nicole Close  5 , Samuel Sinei  3 , Douglas N Shaffer  6
Affiliations
Randomized Controlled Trial

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

Fredrick K Sawe et al. PLoS One. .

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.

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Conflict of interest statement

Competing Interests: The team commits to following PLOS ONE policy and assures PLOS ONE the authors have no competing interests. Empiristat is often contracted by the United States Military HIV Research Program for technical data support. For CLADE, Dr. Close (of Empiristat) provided analytical support and validation of analyses as part of capacity development to Mr. Yegon (as outlined in the original submitted manuscript, page 12, paragraph 3). This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Participating Sites in the Clinic-based ART Diagnostic Evaluation (CLADE) Trial.
Map data courtesy of Kenya Open Data (https://opendata.go.ke).
Fig 2
Fig 2. Participant Enrollment by Month in the CLinic-based ART Diagnostic Evaluation (CLADE) Trial (n = 820).
See this image and copyright information in PMC

References

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