Rebecca Giguere, Iván C Balán, Cody Lentz, Curtis Dolezal, Alex Carballo-Diéguez, Edward J Fuchs, Peter Anton, Ian McGowan, Ken Ho, Ethel Weld, Craig W Hendrix
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引用次数: 0
Abstract
Objectives: DREAM-01 was an open label, dose-escalation and variable osmolarity study to identify a tenofovir HIV-prevention douche/enema that could achieve protective colon tissue cell concentrations and high acceptability. To assess impact on sexual enjoyment, iso-osmolar and hypo-osmolar placebo douches were provided for at-home use before receptive anal sex (RAS).
Methods: Eighteen HIV-uninfected men who have RAS were administered three tenofovir douches at the research clinic: Product A, an iso-osmolar dose; Product B, an iso-osmolar escalation dose; and Product C, a hypo-osmolar escalation dose. Following Products A and C, participants were given a saline douche of matching osmolarity to use at home before RAS. Participants reported acceptability via a computer-assisted self-interview and in-depth interview in this mixed-methods study.
Results: All three products were rated acceptable by 17 (95%) of the participants. A majority (94%) would be likely or very likely to use any of the three products before RAS. Of those who used the saline douches before RAS and then rated their sexual enjoyment, most reported that their sexual enjoyment was not affected. Interview data revealed that participants found the product easy to incorporate into their regular routine, but would prefer to use more liquid for cleansing.
Conclusions: These findings indicate that the hypo-osmolar Product C, which also provides the most rapid delivery of tenofovir for HIV prevention, is acceptable for future safety trials and that our sample reports high likelihood of using a rectal microbicide douche for HIV prevention. Our findings support continued pursuit of a tenofovir rectal microbicide douche.
研究目的DREAM-01是一项开放标签、剂量递增和可变渗透压研究,旨在确定一种能达到保护性结肠组织细胞浓度和高可接受性的替诺福韦艾滋病预防冲洗剂/灌肠剂。为了评估对性快感的影响,提供了等渗透压和低渗透压安慰剂冲洗液,供接受性肛交(RAS)前在家使用:方法:18 名未感染艾滋病毒的肛交男性在研究诊所使用了三种替诺福韦冲洗液:产品 A 是等摩尔剂量;产品 B 是等摩尔递增剂量;产品 C 是低摩尔递增剂量。在使用产品 A 和产品 C 后,参与者将获得与渗透压相匹配的生理盐水冲洗液,以便在 RAS 前在家使用。在这项混合方法研究中,参与者通过计算机辅助自我访谈和深度访谈报告了接受程度:结果:17 名参与者(95%)认为所有三种产品均可接受。大多数人(94%)可能或非常可能在进行 RAS 之前使用这三种产品中的任何一种。在使用生理盐水冲洗后对性快感进行评分的参与者中,大多数人表示他们的性快感没有受到影响。访谈数据显示,参与者认为该产品很容易融入他们的日常工作中,但他们更希望使用更多的液体进行清洁:这些研究结果表明,低渗透性产品 C 也能最快速地输送替诺福韦用于预防艾滋病,可用于未来的安全试验,而且我们的样本报告称使用直肠杀菌冲洗剂预防艾滋病的可能性很高。我们的研究结果支持继续研究替诺福韦直肠杀菌冲洗剂:NCT02750540。
期刊介绍:
Sexually Transmitted Infections is the world’s longest running international journal on sexual health. It aims to keep practitioners, trainees and researchers up to date in the prevention, diagnosis and treatment of all STIs and HIV. The journal publishes original research, descriptive epidemiology, evidence-based reviews and comment on the clinical, public health, sociological and laboratory aspects of sexual health from around the world. We also publish educational articles, letters and other material of interest to readers, along with podcasts and other online material. STI provides a high quality editorial service from submission to publication.