Ethics of HIV-Related Research Involving Adolescents in Kenya

点击翻译按钮获取中文摘要

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.