Population Council, Washington, DC.
Population Council, New York, New York.
J Adolesc Health. 2014 Jun;54(6):654-62. doi: 10.1016/j.jadohealth.2014.01.014. Epub 2014 Mar 29.
This article explores the ethics and feasibility of enrolling adolescent females in microbicide trials using data from 16- to 17-year-old participants of the Phase 3 trial of the candidate vaginal microbicide, Carraguard.
Secondary analysis was conducted to compare health, behavioral, and operational outcomes between 16- to 17-year-olds and 18- to 19-year-olds screened for and enrolled in the trial. Analytical approaches included Kaplan-Meier survival analysis, Cox proportional hazards modeling, and generalized estimating equations for nonsurvival end points.
Results reveal no significant differences between the two age groups for health (sexually transmitted infection, adverse event), risk behavior, or operational (adherence, follow-up) outcomes. However, data suggest that after 1 year of trial participation, human immunodeficiency virus (HIV) and pregnancy incidence were higher and increased more rapidly for the 16- to 17-year-olds than for 18- to 19-year-olds; this finding is entirely consistent with other incidence data for HIV infection among South African youth and cannot be attributed to study participation without a comparison outside the trial.
Data from the Carraguard trial provide no evidence that inclusion of 16- to 17-year-olds in the trial had any detrimental effect on trial participants or on the conduct of research. These data provide an argument motivating the inclusion of sexually active adolescents aged 16-17 years into future trials in order to avoid delaying access to an effective product for adolescents at high risk of HIV acquisition. Careful support for adolescent-inclusive protocols (including appropriate counseling) must be incorporated into study design.
本文利用 Carraguard 候选阴道杀微生物剂 3 期试验中 16 至 17 岁参与者的数据，探讨招募少女参加杀微生物剂试验的伦理和可行性。
对数据进行二次分析，比较参加试验筛查和入组的 16 至 17 岁和 18 至 19 岁青少年的健康、行为和操作结果。分析方法包括 Kaplan-Meier 生存分析、Cox 比例风险模型和非生存终点的广义估计方程。
结果显示，两组在健康（性传播感染、不良事件）、风险行为或操作（依从性、随访）结果方面没有显著差异。然而，数据表明，在试验参与 1 年后，艾滋病毒（HIV）和妊娠发生率在 16 至 17 岁组中更高，且增加速度更快，而在 18 至 19 岁组中则较低；这一发现与南非青年 HIV 感染的其他发病率数据完全一致，不能归因于没有与试验之外的比较就进行研究参与。
Carraguard 试验的数据没有证据表明招募 16 至 17 岁的青少年参加试验对试验参与者或研究的进行有任何不利影响。这些数据为将性活跃的 16-17 岁青少年纳入未来试验提供了论据，以避免延迟为处于 HIV 高感染风险的青少年提供有效的产品。必须在研究设计中纳入对青少年包容性方案（包括适当的咨询）的精心支持。
