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毒预防研究具有很高的社会价值，但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，因为他们参与的风险存在伦理问题。本研究探讨了四个相互关联的伦理问题至关重要的青少年艾滋病毒的研究：披露艾滋病毒检测结果对青少年的社会心理健康，寻求健康，或风险行为的影响;尽量减少伤害招募青少年;理解父母，儿童和青少年之间的知情同意18岁及以上;和适当使用补偿金的青年和父母的参与。该研究的背景是尼扬扎省的锡亚亚区，该地区是肯尼亚艾滋病毒流行率最高的地区。本研究的具体目的是：（1）在一项研究的背景下，探讨艾滋病毒检测和披露对青少年行为和心理社会健康的影响。大约1,500名15-19岁的在校和校外青少年（500名女性和1000名男性）将参加一项艾滋病毒检测和披露的经验研究，按照护理标准，为道德准则提供信息。HIV阳性受试者（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个月接受采访，以检查益处和意外后果，包括HIV护理、风险行为以及对耻辱或痛苦/福祉的看法。还将对检测阴性的随机样本（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)检查利益相关者对青少年HIV研究方法的看法，包括招募、知情同意、HIV检测和结果披露以及研究参与的补偿/激励。这一目标将分三个阶段实现。在第一阶段，将成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，并完善目标1的招募、艾滋病毒检测和结果披露以及参与补偿的研究程序。在第2阶段，将评估青少年和父母对知情同意书的理解。在第3阶段，将询问目标1随访的青少年和家长对研究招募方法和参与研究的补偿的看法。(3)制定青少年艾滋病毒研究的道德行为准则，并与主要利益攸关方协商完善这些准则。目标1和2的结果将用于制定开展青少年艾滋病毒伦理研究的初步准则。将分析肯尼亚CAB和YAB以及来自另外两个撒哈拉以南国家的可比焦点小组参与者和当地伦理学家对指南的看法，并用于完善指南和评估其普遍性。最后准则将通过同行审查的出版物和有针对性的通信广泛传播。

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.