Department of Community and Health Systems, Indiana University School of Nursing, Indianapolis, Indiana.
Department of Community and Health Systems, Indiana University School of Nursing, Indianapolis, Indiana.
J Adolesc Health. 2023 May;72(5):703-711. doi: 10.1016/j.jadohealth.2022.11.241. Epub 2023 Jan 14.
Minor adolescents are often excluded from HIV prevention clinical trials due to unresolved ethical issues. Their under-representation in research leads to delayed access to new HIV prevention approaches. We examine the relationship between consent procedures, trial features, demographic and social characteristics, and minor adolescents' willingness to participate (WTP) in biomedical HIV prevention research.
We recruited 14-17-year-olds at risk of HIV for this quasi-experimental study. Adolescents were randomly assigned to (1) self-consent, (2) adult permission required, or (3) parental permission required and underwent simulated consent procedures for two types of HIV prevention trials. They rated likelihood of participating in each study if offered the opportunity and completed a survey with demographic, social, and behavioral measures.
One hundred and twenty nine adolescents with diverse identities and socioeconomic status enrolled. Among the 58% of participants who identified as lesbian, gay, bisexual, transgender, or queer (LGBTQ), 76% were out to at least one parent/guardian (outness). Mean WTP was 3.6 (of 5; 5 = definitely would participate) across all participants and both trial types. We found no evidence of an association between WTP and consent condition, LGBTQ identity, or outness. However, medical mistrust, communication with parents, and concern about HIV were associated with WTP.
Our results suggest adolescents are willing to participate in HIV prevention trials and parental involvement in the consent process may not be the most important deciding factor. However, variation in WTP within consent groups, and variation in other significant variables, underscores the need for individualized approaches to recruitment and consent for these trials.
由于尚未解决的伦理问题，未成年青少年通常被排除在 HIV 预防临床试验之外。他们在研究中的代表性不足导致新的 HIV 预防方法无法及时获得。我们研究了同意程序、试验特征、人口统计学和社会特征与未成年青少年参与（WTP）生物医学 HIV 预防研究之间的关系。
我们招募了处于 HIV 风险中的 14-17 岁青少年进行这项准实验研究。青少年被随机分配到（1）自我同意、（2）需要成人同意或（3）需要父母同意，并对两种 HIV 预防试验进行了模拟同意程序。他们评估了如果有机会参加每项研究的可能性，并完成了一份包含人口统计学、社会和行为措施的调查。
129 名具有不同身份和社会经济地位的青少年参与了研究。在 58%的自我认同为女同性恋、男同性恋、双性恋、跨性别或 queer（LGBTQ）的参与者中，有 76%至少向一位父母/监护人出柜（出柜）。所有参与者和两种试验类型的平均 WTP 为 3.6（满分 5；5=肯定会参加）。我们没有发现 WTP 与同意条件、LGBTQ 身份或出柜之间存在关联的证据。然而，对医疗的不信任、与父母的沟通以及对 HIV 的担忧与 WTP 相关。
我们的结果表明，青少年愿意参与 HIV 预防试验，父母参与同意过程可能不是最重要的决定因素。然而，同意组内 WTP 的差异以及其他重要变量的差异，凸显了这些试验需要采取个性化的招募和同意方法。
