Evaluation of Microbicide Gel Adherence Monitoring Methods
Evaluation of Microbicide Gel Adherence Monitoring Methods
复制标题
DOI：
10.1097/olq.0b013e31824790bb
复制
发表时间：
2012-05-01
影响因子：
3.1
通讯作者：
Cone, Richard A.
中科院分区：
文献类型：
--
作者：
Moench, Thomas R.;O'Hanlon, Deirdre E.;Cone, Richard A.
背景：在临床试验中，一种客观准确的方法来测量阴道杀微生物剂凝胶方案的依从性，可以更准确地估计杀微生物剂的疗效，帮助定位依从性促进资源，并使依从性促进策略的客观评估成为可能。方法：采用4种方法评价阴道是否插入凝胶涂抹器。在研究现场，50名妇女通过聚丙烯阴道涂抹器插入羟乙基纤维素万能安慰剂凝胶并处理，但没有插入第二个“假插入”涂抹器。涂抹器被丢弃到一个装有医疗事件监控系统（MEMS）的容器中，该系统记录了打开的时间和日期。另外15名参与者在两次研究现场访问中也做了同样的事情，并在家中进行了6天的凝胶治疗。通过环境光、紫外线（UV）光、阿利新蓝染色和阴道细胞碘染色的显微镜检测，对涂抹器是否插入进行评分。结果：紫外法、阿利新蓝法、环境光法和碘法3个检测阅读器2个读数的平均灵敏度/特异度分别为84/ 83,79 / 83,76 /63和65/80%。所有方法的灵敏度在一次或多次预先插入凝胶后插入的涂药器中都显着更高，其中紫外法的灵敏度最高（95%）。MEMS帽准确记录涂抹器处理时间。结论：在没有事先使用凝胶的情况下，所有4种方法的准确性都不高，这可能限制了它们监测性方案的准确性。然而，对于每日给药方案，MEMS监测和紫外线检查应该提供快速、可靠和定量的依从性评估。
Background: An objective and accurate method that measures adherence to vaginal microbicide gel regimens during clinical trials could provide more accurate estimates of microbicide efficacy, aid in targeting adherence promotion resources, and enable objective assessment of adherence promotion strategies.Methods: We evaluated 4 methods to assess whether or not gel applicators had been vaginally inserted. At the study site, 50 women inserted hydroxyethylcellulose universal placebo gel through a polypropylene vaginal applicator and handled, but did not insert a second "sham-inserted" applicator. Applicators were discarded into a container capped with a medical event monitor system (MEMS) that recorded the time and date of opening. Fifteen additional participants did likewise at 2 study site visits, and administered gel on 6 intervening days at home. Applicators were scored as inserted, or not, by direct inspection under ambient light, ultraviolet (UV) light, staining with Alcian blue, and microscopic detection of vaginal cells stained with iodine.Results: Mean sensitivity/specificity of 2 readings each by 3 test readers for UV, Alcian blue, ambient light, and iodine methods were 84/83, 79/83, 76/63, and 65/80%, respectively. Sensitivity of all methods was significantly higher in applicators inserted after one or more prior insertions of gel, with the highest sensitivity (95%) obtained with UV. MEMS caps accurately recorded applicator disposal time.Conclusions: The modest accuracy of all 4 methods for applicator insertions without prior gel applications may limit their accuracy in monitoring coital regimens. However, for daily dosing regimens, MEMS monitoring and UV inspection should provide a rapid, reliable, and quantitative assessment of adherence.