Morgan Stanley Children's Hospital, 3959 Broadway, 1st Floor, Room 101 Central, New York, NY 10032, USA.
Sex Transm Infect. 2010 Feb;86(1):71-3. doi: 10.1136/sti.2009.038158. Epub 2009 Dec 3.
Clinical trials of microbicides should include adolescent participants. There may be unique challenges including obtaining informed consent, meeting eligibility criteria and adherence to study demands. We report on our experience enrolling young adolescents in a microbicide surrogate acceptability study and the implication of our experience for other types of clinical trials.
Adolescent females were enrolled in a microbicide surrogate acceptability study for 6 months which required parental consent. They were asked to use the product every time they had coitus. They had face-to-face interviews at intake, 3 and 6 months, and completed weekly phone diaries.
Of the 208 enrolled, 95 participants were between 14 and 17 years. Ten were pregnant at intake, and 15 did not have sex during the study. Of the remaining 70 adolescents, 46 (66%) used the product at least once during the 6-month period, and all but seven attended a face-to-face interview after intake.
It will be possible to include young adolescents in clinical studies, even if parental consent is required. However, there will be challenges, and researchers need to anticipate those challenges and reduce barriers to enrolling young adolescents.
临床试验应该包括青少年参与者。可能存在一些独特的挑战，包括获得知情同意、符合入选标准以及遵守研究要求。我们报告了在一项杀微生物剂替代物可接受性研究中招募青少年参与者的经验，以及这些经验对其他类型临床试验的意义。
招募了 208 名青春期女性参加为期 6 个月的杀微生物剂替代物可接受性研究，需要获得家长同意。要求她们每次发生性行为时都使用该产品。在入组时、第 3 个月和第 6 个月进行面对面访谈，并完成每周电话日记。
在入组的 208 名参与者中，有 95 名年龄在 14 至 17 岁之间。10 人在入组时怀孕，15 人在研究期间没有发生性行为。在其余 70 名青少年中，有 46 人（66%）在 6 个月期间至少使用过一次该产品，除了 7 人外，所有人都在入组后参加了面对面访谈。
即使需要获得家长同意，也可以将青少年纳入临床试验。然而，这将存在一些挑战，研究人员需要预测这些挑战，并减少招募青少年的障碍。
