Ethics of HIV-Related Research Involving Adolescents in Kenya

肯尼亚青少年涉及艾滋病毒相关研究的伦理

• 批准号: 9241095
• 负责人: Winfred K Luseno
• 金额: $ 17.62万
• 依托单位: PACIFIC INSTITUTE FOR RES AND EVALUATION
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9241095
• 关键词: 18 year old; AIDS prevention; Adolescent; Adolescent Behavior; Adult; Africa South of the Sahara; African; Age; Behavioral; Benefits and Risks; Bioethics Consultants; Biological; Biological Markers; Caring; Child; Clinical; Communication; Communities; Comprehension; Conflict (Psychology); Consent; Consultations; Country; Data; Democratic Republic of the Congo; Developing Countries; Disclosure; Distress; Effectiveness; Enrollment; Ethical Issues; Ethicists; Ethics; Ethics Committees; Familiarity; Female; Financial compensation; Focus Groups; Gender; Guidelines; HIV; HIV Seropositivity; HIV prevention trial; HIV risk; Health; Human immunodeficiency virus test; Informed Consent; Interview; Kenya; Lead; Life; Measures; Methods; Outcome; Parents; Participant; Peer Review; Perception; Personal Satisfaction; Phase; Prevalence; Prevention Research; Preventive Intervention; Procedures; Protocols documentation; Province; Publications; Qualitative Methods; Recommendation; Research; Research Methodology; Research Personnel; Risk; Risk Behaviors; Sampling; Schools; Scientist; Social Values; Structure; Test Result; Testing; Youth; Zimbabwe; adolescent HIV prevention; aged; base; design; experience; innovation; male; payment; psychosocial; research study; social; social stigma; standard of care; teenage parents; young man; young woman; 18 year old; AIDS prevention; Adolescent; Adolescent Behavior; Adult; Africa South of the Sahara; African; Age; Behavioral; Benefits and Risks; Bioethics Consultants; Biological; Biological Markers; Caring; Child; Clinical; Communication; Communities; Comprehension; Conflict (Psychology); Consent; Consultations; Country; Data; Democratic Republic of the Congo; Developing Countries; Disclosure; Distress; Effectiveness; Enrollment; Ethical Issues; Ethicists; Ethics; Ethics Committees; Familiarity; Female; Financial compensation; Focus Groups; Gender; Guidelines; HIV; HIV Seropositivity; HIV prevention trial; HIV risk; Health; Human immunodeficiency virus test; Informed Consent; Interview; Kenya; Lead; Life; Measures; Methods; Outcome; Parents; Participant; Peer Review; Perception; Personal Satisfaction; Phase; Prevalence; Prevention Research; Preventive Intervention; Procedures; Protocols documentation; Province; Publications; Qualitative Methods; Recommendation; Research; Research Methodology; Research Personnel; Risk; Risk Behaviors; Sampling; Schools; Scientist; Social Values; Structure; Test Result; Testing; Youth; Zimbabwe; adolescent HIV prevention; aged; base; design; experience; innovation; male; payment; psychosocial; research study; social; social stigma; standard of care; teenage parents; young man; young woman

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.

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的社会价值很高，但由于对参与风险的道德关注，研究人员不愿意让青少年参与艾滋病毒测试和披露结果的研究。这项研究研究了青少年艾滋病毒研究至关重要的四个相互关联的道德问题：HIV测试结果披露对青少年社会心理健康，寻求健康或风险行为的影响；最大程度地减少招募青少年的危害；理解18岁及以上父母，孩子和青少年之间知情同意；以及适当使用补偿性付款来为青年和父母参与。研究环境是尼亚扎省的Siaya区，肯尼亚的HIV患病率最高。该研究的具体目的是：（1）研究研究研究中艾滋病毒测试和披露对青少年行为和社会心理健康的影响。根据标准，将招募约1,500名上学和校外青少年（500名女性和1000名男性）15-19岁的男性，以参加艾滋病毒测试和披露的经验研究，以告知道德准则。 HIV阳性参与者（n = 40-50：20-25位女性，20-25名男性）将在测试后2-4个月和12-15个月接受采访，以检查福利和意外的后果，包括艾滋病毒护理，风险行为以及对污名或困扰/福祉的看法。还将采访那些测试阴性的人的随机样本（n = 40-50：20-25位女性，20-25名男性），以检查HIV风险行为。所有80-100名青少年参与者和15-17岁青年的父母将在他们对艾滋病毒测试的看法中询问，并在研究研究环境中被告知结果。 （2）检查利益相关者对青少年艾滋病毒研究方法的看法，用于招募，知情同意，艾滋病毒测试和结果披露以及研究参与的赔偿/诱因。这个目标将分为三个阶段。在第1阶段，将建立成人社区顾问委员会（CAB）和青年顾问委员会（YAB），以协助识别可能影响青少年研究参与的因素，并完善目标1的研究程序，以招募和披露结果，并披露结果以及参与赔偿。在第2阶段，将评估青少年和父母的理解知识同意。在第3阶段，将询问青少年和父母遵循的AIM 1，以查询他们对研究招聘方法的看法和对研究参与的补偿。 （3）制定青少年艾滋病毒研究道德行为的准则，并与主要利益相关者协商。目标1和2的发现将用于制定进行道德青少年艾滋病毒研究的初步准则。将对肯尼亚出租车和YAB的准则以及可比焦点小组参与者和当地伦理学家的看法进行分析，并将分析并用来完善指南并评估其普遍性。最终指南将通过同行评审的出版物和有针对性的通信广泛传播。