Impact of an Adherence Intervention on the Effectiveness of Tenofovir Gel in the CAPRISA 004 Trial
Impact of an Adherence Intervention on the Effectiveness of Tenofovir Gel in the CAPRISA 004 Trial
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DOI：
10.1007/s10461-014-0752-9
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发表时间：
2014-05-01
影响因子：
4.4
通讯作者：
Karim, Salim S. Abdool
中科院分区：
文献类型：
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作者：
Mansoor, Leila Essop;Karim, Quarraisha Abdool;Karim, Salim S. Abdool
高依从性在杀微生物剂试验中很重要，但迄今为止，没有依从性干预措施证明杀微生物剂依从性或有效性的经验性改善。大约在CAPRISA 004试验的中途，我们实施了一种新的依从性干预（依从性支持计划-ASP），基于信息-动机-行为技能模型，并结合动机访谈方法。我们使用前后比较评估了ASP对依从性和替诺福韦凝胶有效性的影响。在试验中的889名女性中，774名提供了486.1女性-年的ASP前随访，828名提供了845.7女性-年的ASP后随访。中位依从性从ASP前的53.6%上升至ASP后的66.5%。在64名具有配对替诺福韦药物样本的妇女中，可检测的替诺福韦水平从ASP前的40.6%增加到ASP后的62.5%。ASP后凝胶有效性改善;替诺福韦凝胶组的HIV发病率在ASP前降低24%，而在ASP后降低47%。实施ASP后，杀微生物剂依从性改善，同时替诺福韦凝胶的有效性增加。
High adherence is important in microbicide trials, but no adherence interventions to date have demonstrated empiric improvements in microbicide adherence or effectiveness. Approximately midway during the CAPRISA 004 trial, we implemented a novel adherence intervention (Adherence Support Program-ASP), based on an Information-Motivation-Behavioral Skills model and incorporating a Motivational Interviewing approach. We assessed the impact of the ASP on adherence and tenofovir gel effectiveness using a before-and-after comparison. Of the 889 women in the trial, 774 contributed 486.1 women-years of follow-up pre-ASP and 828 contributed 845.7 women-years of follow-up post-ASP. Median adherence rose from 53.6 % pre-ASP to 66.5 % post-ASP. Detectable tenofovir levels increased from 40.6 % pre-ASP to 62.5 % post-ASP in 64 women who had paired tenofovir drug samples. Gel effectiveness improved post-ASP; HIV incidence in the tenofovir gel arm was 24 % lower pre-ASP compared to 47 % lower post-ASP. Following implementation of the ASP, microbicide adherence improved with a concomitant increase in the effectiveness of tenofovir gel.