Abstract
BACKGROUND: Involving children and adolescents (youth) living with HIV (YLWH) in research is critical for developing appropriate HIV care services and interventions. However, this vulnerable population may not adequately weigh risks against benefits when participating in research, forming an ethical concern, yet little is known about how YLWH perceive these risks and benefits. To inform research-related policies and procedures, we sought perspectives of Kenyan YLWH, their caregivers and subject matter experts (SMEs) on risks and benefits of participation in research in a setting with a high burden of youth HIV infection. METHODS: We conducted a qualitative inquiry on identifying, enrolling, and protecting YLWH (age 10-24 years) in research using semi-structured interviews with YLWH involved in research, their caregivers, YLWH with no prior research experience, and other SMEs at the AMPATH care and research sites in western Kenya. Transcripts were thematically analyzed and emerging themes derived to characterize perspectives of each group on risks and benefits of engaging YLWH in research. RESULTS: Interviews were conducted with 40 YLWH (50% female; median age 17.5 years), 20 caregivers (70% female), and 39 SMEs [healthcare providers (N = 10), community leaders (N = 10) community advisory board members (N = 4), IRB experts (N = 5), clinical researchers (N = 6), social science researchers (N = 4) and laboratory experts (N = 1).] Participants in all groups identified accidental disclosure of HIV status, stigma and discrimination, risks of blood draws, mental health effects, and coercion due to study compensation as risks of research involvement. Benefits fell into 5 categories: clinical, informational, personal, future and community or household benefits. Benefits included access to health care, learning about HIV, gaining hope and community, improving HIV care, and reducing stigma. All participant groups largely held similar views; however, caregivers were the only group to identify misuse of study compensation as a risk, and YLWH less frequently cited clinical benefits. CONCLUSION: These findings suggest that participants commonly cite indirect risks and benefits of research participation, yet these are often excluded from institutional guidelines for consent documentation. Researchers should consider including indirect risks and benefits, such as the risk of stigma or the benefit of gaining knowledge and community, to study documentation.