Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial
Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial
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DOI：
10.1016/s0140-6736(07)60950-7
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发表时间：
2007-07-21
期刊：
影响因子：
168.9
通讯作者：
McIntyre, James
中科院分区：
文献类型：
--
作者：
Padian, Nancy S.;van der Straten, Ariane;McIntyre, James
研究背景迫切需要女性控制的艾滋病预防方法。我们评估了提供乳胶隔膜，润滑剂凝胶，避孕套（干预）的效果，与避孕套单独（控制）在南非和Zimbabwei.Methods的妇女艾滋病毒seroincidence，我们做了一个开放标签，随机对照试验，在艾滋病毒阴性，性活跃的妇女从诊所和社区为基础的组织，谁是每季度随访12-24个月（中位数21个月）。所有参与者都收到了艾滋病毒预防一揽子计划，其中包括关于艾滋病毒和性传播感染的检测前和检测后咨询、检测、可治愈性传播感染的治疗以及减少风险的强化咨询。主要结局为HIV感染事件。这项研究在ClinicalTrials.gov注册，编号NCT 00121459。结果总体HIV发病率为4.0%/100女性-年：干预组（n= 2472）为4.1%，对照组（n=2476）为3.9%，对应的相对危险度为1.05（95%CI 0.84-1.32，意向治疗分析）。干预组使用避孕套的妇女比例明显低于对照组（54% vs 85%，p < 0.0001）。报告不良事件的参与者比例（60% [1523] vs 61% [1529]）和严重不良事件（5% [130] vs 4% [101]）在两组之间相似。我们的观察表明，避孕套使用率较低的妇女提供了隔膜并没有导致感染增加值得进一步研究。虽然干预似乎是安全的，但我们的研究结果并不支持将隔膜添加到当前的艾滋病毒预防策略中。
Background Female-controlled methods of HIV prevention are urgently needed. We assessed the effect of provision of latex diaphragm, lubricant gel, and condoms (intervention), compared with condoms alone (control) on HIV seroincidence in women in South Africa and Zimbabwe.Methods We did an open-label, randomised controlled trial in HIV-negative, sexually active women recruited from clinics and community-based organisations, who were followed up quarterly for 12-24 months (median 21 months). All participants received an HIV prevention package consisting of pre-test and post-test counselling about HIV and sexually transmitted infections, testing, treatment of curable sexually transmitted infections, and intensive risk-reduction counselling. The primary outcome was incident HIV infection. This study is registered with ClinicalTrials.gov, number NCT00121459.Findings Overall HIV incidence was 4.0% per 100 woman-years: 4.1% in the intervention group (n=2472) and 3.9% in the control group (n=2476), corresponding to a relative hazard of 1.05 (95% CI 0.84-1.32, intention-to-treat analysis). The proportion of women using condoms was significantly lower in the intervention than in the control group (54% vs 85% of visits, p < 0.0001). The proportions of participants who reported adverse events (60% [1523] vs 61% [1529]) and serious adverse events (5% [130] vs 4% [101]) were similar between the two groups.Interpretation We observed no added protective benefit against HIV infection when the diaphragm and lubricant gel were provided in addition to condoms and a comprehensive HIV prevention package. Our observation that lower condom use in women provided with diaphragms did not result in increased infection merits further research. Although the intervention seemed safe, our findings do not support addition of the diaphragm to current HIV prevention strategies.