Ramjee Gita, Morar Neetha S, Braunstein Sarah, Friedland Barbara, Jones Heidi, van de Wijgert Janneke
Medical Research Council, P O Box 70380, Overport, 4067, Kwazulu-Natal, South Africa.
AIDS Res Ther. 2007 Sep 27;4:20. doi: 10.1186/1742-6405-4-20.
When on the market, microbicides are likely to be used by individuals who do not know their HIV status. Hence, assessment of safety and acceptability among HIV positive men and women is important. Acceptability of Carraguard, the Population Council's lead microbicide candidate was assessed in a Phase I safety study among healthy HIV-positive sexually abstinent women and men, and sexually active women (20 per group), in Durban, South Africa. Participants were randomized to use Carraguard gel, placebo gel, or no product. All women in the gel arms applied 4 ml gel vaginally every evening for 14 intermenstrual days (women in the sexually active group inserted gel within 1 hour prior to sex on days when sex occurred), and sexually abstinent men applied gel directly to the penis every evening for 7 days. Acceptability was assessed by face-to-face structured questionnaires and semi-structured in-depth interviews with all participants. Gel use questions were applicable to participants in the gel arms only (13 sexually abstinent women, 14 sexually active women, and 13 abstinent men).
Overall, 93% of the women liked the study gel (Carraguard or placebo) very much, 4% disliked it somewhat, and 4% were neutral. 15% of men and women disliked the gel's color, smell, or packaging. Most women and men reported never experiencing pain or irritation during or after gel application. Although over two thirds of the women preferred some lubrication during sex, some of the women felt that the gel was frequently too wet. Twenty-one percent of women and 42% of men said they felt covert use of a microbicide would be acceptable. Over 60% of women and men would prefer to use a microbicide alone instead of using it with a condom.
Acceptability of Carraguard among HIV-positive women and men in Durban was good. The wetness experienced by the women may be attributed to the delivery of gel volume. The applicator was designed to deliver 4 mls whereas in fact between 4 ml to 5 mls were actually dispensed. Condom migration in the event of a partially effective product is of concern.
杀微生物剂上市后，很可能会被那些不知道自己艾滋病毒感染状况的人使用。因此，评估艾滋病毒阳性男女对其安全性和可接受性很重要。在南非德班对健康的艾滋病毒阳性禁欲男女以及性活跃女性（每组20人）进行了一项一期安全性研究，评估了人口理事会主要杀微生物剂候选产品卡拉胶避孕凝胶（Carraguard）的可接受性。参与者被随机分配使用卡拉胶避孕凝胶、安慰剂凝胶或不使用任何产品。凝胶组的所有女性在月经周期的14天里每晚阴道内使用4毫升凝胶（性活跃组的女性在发生性行为前1小时内插入凝胶），禁欲男性每晚将凝胶直接涂抹在阴茎上，持续7天。通过对所有参与者进行面对面的结构化问卷调查和半结构化深入访谈来评估可接受性。凝胶使用问题仅适用于凝胶组的参与者（13名禁欲女性、14名性活跃女性和13名禁欲男性）。
总体而言，93%的女性非常喜欢研究用凝胶（卡拉胶避孕凝胶或安慰剂），4%的女性有点不喜欢，4%的女性态度中立。15%的男性和女性不喜欢凝胶的颜色、气味或包装。大多数女性和男性报告在涂抹凝胶期间或之后从未经历过疼痛或刺激。虽然超过三分之二的女性在性行为时更喜欢一些润滑，但一些女性觉得凝胶经常太湿。21%的女性和42%的男性表示他们认为秘密使用杀微生物剂是可以接受的。超过60%的女性和男性更愿意单独使用杀微生物剂而不是与避孕套一起使用。
在德班，艾滋病毒阳性男女对卡拉胶避孕凝胶的接受性良好。女性感受到的凝胶湿润可能归因于凝胶的挤出量。涂抹器设计为挤出4毫升凝胶，而实际上挤出量在4毫升至5毫升之间。如果产品部分有效，避孕套移位是一个令人担忧的问题。
