Adolescent and Parent Willingness to Participate in Microbicide Safety Studies

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• 作者：Marina Catallozzi ; MD ; MSCE¹ ; ² ; ³ ; ^{mc2840@cumc.columbia.edu} ; Ariel M. de Roche ; BS¹ ; Mei-Chen Hu ; PhD⁴ ; Carmen Radecki Breitkopf ; PhD⁵ ; Jane Chang ; MD⁶ ; Lisa S. Ipp ; MD⁶ ; Jenny K.R. Francis ; MD ; MPH¹ ; ² ; Susan L. Rosenthal ; PhD¹ ; ² ; ⁴
• 关键词：Adolescent research participation ; Topical microbicides ; Clinical trials ; Sexually transmitted infections
• 刊名：Journal of Pediatric and Adolescent Gynecology
• 出版年：2017
• 出版时间：February 2017
• 年：2017
• 卷：30
• 期：1
• 页码：82-87
• 全文大小：135 K
• 卷排序：30

文摘

To understand adolescents' and parents' willingness to participate (WTP) in a hypothetical phase I prevention study of sexually transmitted infections, discordance within adolescent-parent dyads, and expectations of each other during decision-making.Design and SettingAdolescent-parent dyads were recruited to participate in a longitudinal study about research participation attitudes.ParticipantsAdolescents (14-17 years old) and their parents (n = 301 dyads) participated.InterventionsNone.Main Outcome MeasuresIndividual interviews at baseline assessed WTP on a 6-level Likert scale. WTP was dichotomized (willing/unwilling) to assess discordance.ResultsWTP was reported by 60% (182 of 301) of adolescents and 52% (156 of 300) of parents. In bivariate analyses, older adolescent age, sexual experience, and less involvement of parents in research processes were associated with higher level of WTP for adolescents; only sexual experience remained in the multivariable analysis. For parents, older adolescent age, perceived adolescent sexual experience, and conversations about sexual health were significant; only conversations remained. Dyadic discordance (44%, 132 of 300) was more likely in dyads in which the parent reported previous research experience, and less likely when parents reported higher family expressiveness. Adolescents (83%, 248 of 299) and parents (88%, 263 of 300) thought that the other would have similar views, influence their decision (adolescents 66%, 199 of 300; parents 75%, 224 of 300), and listen (adolescents 90%, 270 of 300; parents 96%, 287 of 300). There were no relationships between these perceptions and discordance.ConclusionInclusion of adolescents in phase I clinical trials is necessary to ensure that new methods are safe, effective, and acceptable for them. Because these trials currently require parental consent, strategies that manage adolescent-parent discordance and support adolescent independence and parental guidance are critically needed.