van der Straten Ariane, Panther Lori, Laborde Nicole, Hoesley Craig J, Cheng Helen, Husnik Marla J, Horn Stephanie, Nel Annalene, Soto-Torres Lydia, Chen Beatrice A
Women's Global Health Imperative (WGHI), RTI International, 351 California St., Suite, 500, San Francisco, CA, 94104, USA.
Department of Medicine, Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA.
AIDS Behav. 2016 Nov;20(11):2644-2653. doi: 10.1007/s10461-016-1299-8.
We evaluated the adherence and acceptability of a vaginal ring containing dapivirine, maraviroc, or both drugs for 28 days during a Phase I placebo-controlled trial in 48 HIV-negative sexually abstinent U.S. women aged 18-40. Adherence was assessed weekly by clinical interview and computer-assisted self-interviewing; acceptability assessment occurred at the last product-use visit. Study retention was 98 % (47/48); 94 % (45/48) reported being fully adherent with ring use during the 28-day period. Two participants experienced the ring partially coming out. Analysis was blinded and behavioral data were combined across study groups. Most women reported being very comfortable having the ring in their vagina; 44 % preferred continuous use, whereas 51 % had no preference compared to episodic use. Although a range of minor ring concerns were expressed, few were actually experienced. High adherence to and acceptability of this vaginal ring in this Phase I trial contributes to its promise as a sustained mechanism for multidrug vaginal microbicide delivery.
在一项针对48名年龄在18至40岁、性禁欲的美国HIV阴性女性的I期安慰剂对照试验中，我们评估了含有达匹韦林、马拉维若或两种药物的阴道环28天的依从性和可接受性。通过临床访谈和计算机辅助自我访谈每周评估一次依从性；在最后一次产品使用访视时进行可接受性评估。研究保留率为98%（47/48）；94%（45/48）的人报告在28天期间完全依从阴道环的使用。两名参与者的阴道环出现部分脱出。分析是盲法进行的，行为数据在各研究组中合并。大多数女性报告称，阴道内放置阴道环感觉非常舒适；44%的女性倾向于持续使用，而与间歇性使用相比，51%的女性没有偏好。尽管表达了一系列对阴道环的轻微担忧，但实际经历的很少。在这项I期试验中，这种阴道环的高依从性和可接受性使其有望成为一种持续的多药阴道杀菌剂给药机制。
