Competence to Consent to Oral and Injectable PrEP Trials Among Adolescent Males Who Have Sex with Males.

Competence to Consent to Oral and Injectable PrEP Trials Among Adolescent Males Who Have Sex with Males.
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DOI:
10.1007/s10461-020-03077-9
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发表时间:
2021-05
期刊:
影响因子:
4.4
通讯作者:
Mustanski B
Mustanski B
中科院分区:
医学2区
文献类型:
--
作者:
Fisher CB;Puri LI;Macapagal K;Feuerstahler L;Ahn JR;Mustanski B

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坚持口服暴露前预防(PrEP)对于与男性发生性关系的青少年男性(AMSM)具有挑战性。一旦完成比较口服和更持久的注射PrEP的成人试验,将需要进行青少年研究。然而,缺乏关于青少年同意能力的数据可能会维持监护人许可要求,这被认为是AMSM参与之前PrEP试验的障碍。这项在线研究评估了AMSM(14 - 17岁)对这些试验的同意能力,并将其与不需要监护人许可的MSM(18 - 19岁)进行了比较。应用MacCAT-CR,参与者(N = 214)观看了视频和模拟同意书,然后是开放式和是/否项目。认知诊断模型和手段测试分析支持AMSM同意这些试验的能力:16 - 17岁和大多数14 - 15岁的人,表现出同意理解,欣赏和推理在18 - 19岁的水平。数据还确定了在知情同意过程中需要注意的弱点。
Adherence to oral pre-exposure prophylaxis (PrEP) is challenging for adolescent males who have sex with males (AMSM). Once adult trials comparing oral to longer lasting injectable PrEP are completed, there will be a need for adolescent studies. However, lack of data on adolescent consent capacity may sustain guardian permission requirements identified as a barrier to AMSM participation in prior PrEP trials. This online study assessed AMSM’s (14 – 17 years) consent capacity for these trials, comparing performance to MSM (18 – 19 years) for whom guardian permission is not required. Applying the MacCAT-CR, participants (N = 214) viewed a video and mock consent form followed by open-ended and yes/no items. Cognitive diagnostic models and means testing analyses supported AMSM capacity to consent to these trials: 16 – 17 and most 14 – 15 year-olds, demonstrated consent understanding, appreciation and reasoning at 18 – 19 year-old levels. Data also identified vulnerabilities requiring attention during informed consent.
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