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Australian men's experiences during a microbicide male tolerance study.

机译:澳大利亚男性在杀菌剂男性耐受性研究中的经历。

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Microbicides currently in development have the potential to provide new options for the prevention of sexually transmitted infections if proven safe and efficacious. We examined the experiences of healthy male volunteers in a male tolerance study in Victoria, Australia in relation to trial participation and product use. Men (N=36) enrolled in a seven-day, phase 1 clinical safety trial of SPL7013 were interviewed pre and post-use of the gel using a semi-structured interview guide. Interviews were digitally recorded and transcribed verbatim, and transcripts were analysed using a framework approach. All but one man completed the trial. The median age was 34 years (range 22-67 years). Most men had little pre-study knowledge of microbicides and almost all participated for altruistic or personal reasons. Men expressed few concerns about product safety during the trial and indicated trust in the information received through the consent process and from study staff. Three men were non-adherent to the request to be abstinent and an additional two did not refrain from masturbation. Most were positive about the gel, although they described it as "sticky" and found that it stuck to clothes, bed sheets and pubic hair. The type of applicator used was unfamiliar to the men, and some found it "clinical" in appearance. Men are willing to participate in male tolerance studies, often for altruistic reasons. However, counseling about ways to maintain abstinence and further research to inform anticipatory guidance regarding the "sticky" quality of gels, may be important.
机译:如果被证明是安全有效的,目前正在开发的杀菌剂有可能为预防性传播感染提供新的选择。我们在澳大利亚维多利亚州的一项男性耐受性研究中研究了健康男性志愿者在试验参与和产品使用方面的经验。男性(N = 36)参加了为期7天的SPL7013的1期临床安全性试验,使用了半结构化访谈指南,对使用该凝胶前后的人进行了访谈。对访谈进行数字记录并逐字记录,并使用框架方法分析成绩单。除一名男子外,其他所有人都完成了审判。中位年龄为34岁(范围为22-67岁)。大多数男人对杀微生物剂的研究都很少,几乎所有参加者都是出于利他或个人原因。在试验期间,男性几乎没有对产品安全性表示担忧,并表示对通过同意过程和研究人员所收到的信息的信任。三名男子不遵守节欲的要求,另有两名男子没有自慰。大多数人对这种凝胶都持肯定态度,尽管他们称其为“粘性”,并发现它粘在衣服,床单和阴毛上。男性不熟悉所使用的涂抹器类型,有些人在外观上认为它是“临床的”。男人通常出于利他的原因愿意参加男性的耐受性研究。但是,就保持禁欲的方法进行咨询以及进一步研究以告知有关凝胶“粘性”质量的预期指导可能很重要。

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