Randomized Controlled Trials of HIV/AIDS Prevention and Treatment in Africa: Results from the Cochrane HIV/AIDS Specialized Register
Randomized Controlled Trials of HIV/AIDS Prevention and Treatment in Africa: Results from the Cochrane HIV/AIDS Specialized Register
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DOI：
10.1371/journal.pone.0028759
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发表时间：
2011-12-15
期刊：
影响因子：
3.7
通讯作者：
Siegfried, Nandi
中科院分区：
文献类型：
--
作者：
Zani, Babalwa;Pienaar, Elizabeth D.;Siegfried, Nandi
导言：为了有效地解决非洲的艾滋病毒/艾滋病问题，需要有证据证明预防新感染和提供有效治疗。理想情况下，关于哪些干预措施有效的决定应该基于随机对照试验(RCT)的证据。我们之前的研究描述了1987至2003年间报告的非洲艾滋病毒/艾滋病随机对照试验。本研究更新了2004-2008年间发表的随机对照试验。目的：描述在非洲开展的、2004-2008年间报道的HIV/AIDS随机对照试验。方法：检索Cochrane HIV/AIDS专科登记库，检索时间为2009年9月。两名研究人员独立评估了纳入研究的情况，并使用标准化表格提取数据。详细信息包括试验的地点、干预措施、方法质量、主要研究人员和基金的地点。结果：我们的搜索确定了834项随机对照试验，其中68项在非洲进行。43项经评估的预防干预措施和25项治疗干预措施。43项预防性随机对照试验中有15项侧重于预防艾滋病毒母婴传播。25项治疗试验中有13项集中在机会性感染上。试验在16个国家进行，其中南非(20个)、赞比亚(12个)和津巴布韦(9个)最多。中位数样本量为628(范围33-9645)。用于生成分配序列和隐藏分配序列的方法分别在38个和32个试验中是足够的，58个报告包括Conort推荐的流程图。29名首席调查员居住在美利坚合众国(美国)，18名来自非洲国家。试验由不同机构共同资助，大部分资金来自美国政府和非政府机构。19家制药公司向15个随机对照试验提供了部分资金，非洲机构共同资助了17个随机对照试验。在65个试验中报告了伦理批准，在61个试验中报告了知情同意。结论：预防试验在非洲占主导地位。值得注意的是，很少有主要研究人员和资助者来自非洲。这些发现反映了我们以前的工作，并继续表明有必要加强非洲的试验研究能力。
Introduction: To effectively address HIV/AIDS in Africa, evidence on preventing new infections and providing effective treatment is needed. Ideally, decisions on which interventions are effective should be based on evidence from randomized controlled trials (RCTs). Our previous research described African RCTs of HIV/AIDS reported between 1987 and 2003. This study updates that analysis with RCTs published between 2004 and 2008.Objectives: To describe RCTs of HIV/AIDS conducted in Africa and reported between 2004 and 2008.Methods: We searched the Cochrane HIV/AIDS Specialized Register in September 2009. Two researchers independently evaluated studies for inclusion and extracted data using standardized forms. Details included location of trials, interventions, methodological quality, location of principal investigators and funders.Results: Our search identified 834 RCTs, with 68 conducted in Africa. Forty-three assessed prevention-interventions and 25 treatment-interventions. Fifteen of the 43 prevention RCTs focused on preventing mother-to-child HIV transmission. Thirteen of the 25 treatment trials focused on opportunistic infections. Trials were conducted in 16 countries with most in South Africa (20), Zambia (12) and Zimbabwe (9). The median sample size was 628 (range 33-9645). Methods used for the generation of the allocation sequence and allocation concealment were adequate in 38 and 32 trials, respectively, and 58 reports included a CONSORT recommended flow diagram. Twenty-nine principal investigators resided in the United States of America (USA) and 18 were from African countries. Trials were co-funded by different agencies with most of the funding obtained from USA governmental and non-governmental agencies. Nineteen pharmaceutical companies provided partial funding to 15 RCTs and African agencies co-funded 17 RCTs. Ethical approval was reported in 65 trials and informed consent in 61 trials.Conclusion: Prevention trials dominate the trial landscape in Africa. Of note, few principal investigators and funders are from Africa. These findings mirror our previous work and continue to indicate a need for strengthening trial research capacity in Africa.