Acceptability of a bioadhesive nonoxynol-9 gel delivered by an applicator as a rectal microbicide

Acceptability of a bioadhesive nonoxynol-9 gel delivered by an applicator as a rectal microbicide
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DOI:
10.1097/00007435-199911000-00006
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发表时间:
1999-11-01
影响因子:
3.1
通讯作者:
Chesney, MA
Chesney, MA
中科院分区:
医学4区
文献类型:
--
作者:
Gross, M;Celum, CL;Chesney, MA

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背景和目的:直肠杀微生物剂作为避孕套预防艾滋病/性病的辅助手段,以前没有研究过。本研究的目的:优势24(TM) (1.5 ml含52.5 mg壬苯醇醚-9的生物胶粘剂凝胶,由一次性涂抹器给药)作为阴道杀菌剂进行研究,评估男性夫妇的可接受性。研究设计:25对hiv阴性和10对hiv阳性男性夫妇参加了频率升级试验。日记和自我管理的问卷评估了产品的使用、可接受性、性行为以及胃肠道和泌尿系统的副作用。结果:排除那些认为不需要HN预防方法的参与者,58%的人表示,如果批准用于直肠,他们将使用Advantage 24;69%的接受者在插入凝胶后报告直肠充血和相关的副作用,68%的人报告与涂抹器相关的不适;59%的参与者认为凝胶太粘了。结论:可接受性仍不确定,需要进一步研究重新设计的涂药器和减少直肠副作用的方法。
Background and Objectives: Potential rectal microbicides, as an adjunct to condoms for HIV/STD prevention, have not been studied previously.Goal of This Study: advantage 24(TM) (1.5 ml bioadhesive gel containing 52.5 mg nonoxynol-9 administered by single-use applicator)-under investigation as a vaginal microbicide-was evaluated for acceptability among male couples,Study Design: Twenty-five HIV-negative and 10 HIV-positive male couples participated in a frequency use escalation trial. Diaries and self-administered questionnaires assessed product use, acceptability, sexual behavior, and gastrointestinal and urologic side effects.Results: Excluding participants who felt no need for an HN prevention method, 58% said they would use Advantage 24 if approved for rectal use; 69% of receptive users reported rectal fullness and related side effects after insertion of the gel, and 68% reported applicator-related discomfort; 59% of insertive participants found the gel too sticky.Conclusions: Acceptability remains inconclusive and warrants further study of redesigned applicators and ways to minimize rectal side effects.