Ethics of HIV-Related Research Involving Adolescents in Kenya

描述（由申请人提供）：尽管撒哈拉以南非洲青少年艾滋病预防研究具有很高的社会价值，但由于对青少年参与风险的伦理考虑，研究人员不愿意让青少年参与艾滋病毒检测和结果披露的研究。本研究探讨了青少年艾滋病毒研究中必不可少的四个相互关联的伦理问题：披露艾滋病毒检测结果对青少年心理社会健康、寻求健康或风险行为的影响；尽量减少招募青少年的危害；了解家长、儿童和18岁及以上青少年的知情同意；并适当使用青少年和家长参与的补偿费。研究地点是肯尼亚艾滋病毒感染率最高的尼扬扎省的Siaya区。本研究的具体目的是：(1)在一项研究的背景下，检验艾滋病毒检测和信息披露对青少年行为和心理健康的影响。约1500名15-19岁的在校和失学青少年（500名女性和1000名男性）将被招募参加一项关于艾滋病毒检测和按护理标准披露的实证研究，以告知道德准则。艾滋病毒阳性参与者（N=40-50: 20-25名女性，20-25名男性）将在测试后2-4个月和12-15个月接受访谈，以检查益处和意外后果，包括艾滋病毒护理、风险行为以及对耻辱或痛苦/幸福的看法。还将对检测呈阴性的随机抽样（N=40-50: 20-25名女性，20-25名男性）进行访谈，以检查艾滋病毒风险行为。所有80-100名青少年参与者和15-17岁青少年的父母将被问及他们对艾滋病毒检测的看法，并在研究背景下被告知结果。(2)调查利益相关者对青少年艾滋病研究方法的看法，包括招募、知情同意、艾滋病毒检测和结果披露，以及参与研究的补偿/诱因。这一目标将分三个阶段进行。在第一阶段，将建立一个成人社区咨询委员会（CAB）和青年咨询委员会（YAB），以协助确定可能影响青少年参与研究的因素，并完善第一阶段研究的招募、艾滋病毒检测和结果披露以及参与补偿的程序。在第二阶段，将评估青少年和家长对知情同意的理解。在第三阶段，青少年和家长将被问及他们对研究招募方法和参与研究补偿的看法。(3)制定青少年艾滋病毒研究的道德行为准则，并与主要利益相关者协商完善这些准则。目标1和目标2的研究结果将用于制定开展合乎伦理的青少年艾滋病毒研究的初步指导方针。将分析肯尼亚CAB和YAB对准则的看法，以及来自另外两个撒哈拉以南国家的可比较焦点小组参与者和当地伦理学家对准则的看法，并利用这些看法来完善准则并评估其普遍性。最终准则将通过同行评议的出版物和有针对性的通讯广泛传播。

DESCRIPTION (provided by applicant): Despite the high social value of adolescent HIV prevention research in sub-Saharan Africa, investigators are reluctant to involve adolescents in studies with HIV testing and disclosure of results because of ethical concerns about the risks of their participation. This study examines four inter-related ethical issues essential to adolescent HIV research: the effects of disclosure of HIV test results on adolescent psychosocial well-being, health-seeking, or risk behavior; minimizing harms in the recruitment of adolescents; comprehension of informed consent among parents, children, and adolescents 18 years and older; and the appropriate use of compensatory payments for youth and parent participation. The study setting is Siaya District in Nyanza Province, which has the highest HIV prevalence in Kenya. The specific aims for the study are: (1) To examine the effects of HIV testing and disclosure on adolescent behavior and psychosocial well-being in the context of a research study. About 1,500 school-going and out-of-school adolescents (500 female & 1000 male) aged 15-19 will be enrolled to participate in an empirical study of HIV testing and disclosure per the standard of care to inform ethical guidelines. HIV positive participants (N=40-50: 20-25 females, 20-25 males) will be interviewed at 2-4 months and 12-15 months post-testing to examine benefits and unintended consequences, including HIV care, risk behavior, and perceptions of stigma or distress/well-being. A random sample of those testing negative (N=40-50: 20-25 females, 20-25 males) will also be interviewed to examine HIV risk behavior. All 80-100 adolescent participants and parents of youth aged 15-17 will be queried on their perceptions about HIV testing and being told results in a research study context. (2) To examine stakeholder perceptions about adolescent HIV research methods for recruitment, informed consent, HIV testing and disclosure of results, and compensation/inducements for study participation. This aim will be conducted in three phases. In Phase 1, an adult Community Advisory Board (CAB) and Youth Advisory Board (YAB) will be established to assist in identifying factors that may impact adolescent research participation, and to refine Aim 1 study procedures for recruitment, HIV testing and disclosure of results, and compensation for participation. In Phase 2, adolescent and parent comprehension of informed consent will be assessed. In phase 3, adolescents and parents followed for Aim 1 will be queried about their perceptions of study recruitment methods and compensation for study participation. (3) To develop guidelines for the ethical conduct of adolescent HIV research and to refine them in consultation with key stakeholders. Findings from Aims 1 and 2 will be used to develop preliminary guidelines for conducting ethical adolescent HIV research. Perceptions about the guidelines from the Kenya CAB and YAB, and from comparable focus group participants and local ethicists from two additional sub- Saharan countries will be analyzed and used to refine the guidelines and assess their generalizability. Final guidelines will be disseminated widely through peer-reviewed publications and targeted communications.