克里乔基于诊所的抗逆转录病毒治疗诊断评估（CLADE）：在肯尼亚主要为农村地区的区级艾滋病毒诊所进行的一项随机对照试验的设计、病例收集及基线特征
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.
作者信息
Sawe Fredrick K, Obiero Eunice, Yegon Peter, Langat Rither C, Aoko Appolonia, Tarus Jemutai, Kiptoo Ignatius, Langat Raphael K, Maswai Jonah, Bii Margaret, Khamadi Samoel, Shikuku Kibet P, Close Nicole, Sinei Samuel, Shaffer Douglas N
机构信息
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.
Kericho District Hospital, Kenya Ministry of Public Health and Sanitation, Kericho, Kenya.
出版信息
PLoS One. 2015 Feb 23;10(2):e0116299. doi: 10.1371/journal.pone.0116299. eCollection 2015.
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.
背景
撒哈拉以南非洲地区非研究型诊所中关于抗逆转录病毒疗法（ART）的常规HIV-1病毒载量（VL）监测的前瞻性临床试验数据对政策制定者来说是必要的。
方法
基于诊所的ART诊断评估（CLADE）是一项随机对照试验（RCT），评估在开始接受双核苷类逆转录酶抑制剂（NRTI）+非NRTI ART治疗的成年人中，常规VL监测与标准治疗（临床和免疫学监测）相比的可行性、优越性和成本效益。参与者在肯尼亚西部7家主要位于农村的非研究型区级诊所中被随机分组（1:1）。描述性统计呈现了入组模式和基线队列特征。
结果
在15个月的时间里，7个地点共有820名成年人入组，每个地点入组86 - 152人。每月各地点的入组人数在2 - 92名参与者之间。独立记录了完全（100%）知情同意的依从情况。一半（49.9%）通过自愿咨询和检测确诊感染HIV。研究组相似：大多为女性（57.6%），年龄37.6（标准差 = 9.0）岁，CD4细胞计数较低（166 [标准差 = 106] 个/立方毫米）。相当比例的人处于世界卫生组织III期或IV期疾病（28.7%），BMI <18.5千克/平方米（23.1%），有结核病病史（5.6%）或在开始接受ART时正在接受结核病治疗（8.2%）。在常规VL监测组中，407/409（99.5%）接受了基线VL检测（234,577，标准差 = 151,055拷贝/毫升）。所有参与者都接受了拉米夫定；49.8%开始使用齐多夫定，随后38.4%使用司他夫定，11.8%使用替诺福韦；64.4%接受奈韦拉平作为非核苷类逆转录酶抑制剂（nNRTI）（35.6%接受依非韦伦）。
结论
在肯尼亚西部农村、非研究型、资源有限的区级诊所中可以成功开展一项随机对照试验。许多前来接受ART治疗的成年人患有晚期HIV/AIDS，这凸显了普遍HIV检测和护理联系活动的重要性。
试验注册
ClinicalTrials.gov NCT01791556。
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