Electronic adherence monitoring (EAM) is widely used in HIV research;however, our understanding of the ethics of EAM is limited. The proposed study will investigate theoretical and user perspectives on EAM to ensure optimal protection for participants in EAM-based HIV research and care. Innovation: The proposed study is innovative for several reasons: 1) it is the first study to thoroughly examine ethical issues surrounding the use of EAM technology;2) it will leverage insights from non-electronic adherence monitoring and other fields to develop a normative framework for EAM;3) it will involve empiric data collection on EAM use through an ongoing longitudinal cohort study of adherence to HIV antiretroviral therapy in rural Uganda, which will be fused with philosophical research;and 4) it will translate ethics insights into practical recommendations for HIV research (and derivatively care) in Uganda and potentially in other settings. Approach: We will first consult the ethics literature and develop a preliminary sense of potential ethical concerns about EAM use in HIV research and care, including confidentiality, privacy, data security, autonomy, trust, respect, and ancillary care obligations. Our focus will be on resource-limited settings where possible. We will then collect primary data from multiple perspectives through an ongoing longitudinal, observational cohort of HIV-infected adults who are monitored with Wisepill in rural Uganda (R01MH054907, PI: Bangsberg). These data will highlight those ethical concerns that loom largest in rural Uganda and enrich our preliminary understanding. We will then develop ethical recommendations for use of EAM in HIV research and care in rural Uganda and similar settings. We propose the following aims: 1. Develop a preliminary normative framework (i.e., general ethical recommendations subject to modification and specification per empiric data) for the use of EAM in HIV research. 2. Empirically assess patient, researcher, institutional review board, clinician, and community perspectives about EAM use in HIV research in rural Uganda. 3. Use empirical data (Aim 2) to enrich the normative framework (Aim 1) and prepare model ethical recommendations for EAM-based HIV research in rural Uganda and similar settings, with potential applications for clinical care. Investigators: Dr. Haberer (PI) is the emerging academic leader of real-time ART adherence monitoring, particularly in resource-limited settings. Dr. Eyal (PI) is a bioethicist with extensive experience addressing topics in global health and adherence, and provides essential insight into modern philosophical and ethical issues related to electronic monitoring. Dr. Musiimenta (Site PI) provides key experience in mixed method evaluation of HIV/AIDS-related information systems in rural Uganda.
Adherence remains a key challenge to effective HIV treatment. Electronic adherence monitoring (EAM) is emerging as a central component of HIV antiretroviral therapy adherence research and clinical care. However, EAM raises a unique set of ethical challenges, ranging from privacy to autonomy to the burden of collecting enormous amounts of potentially clinically relevant data. These issues have not been thoroughly explored, and no ethical recommendations exist at this time. The proposed research will create culturally informed recommendations for guidelines that will help ensure that EAM-based HIV research and clinical care are carried out in an ethically appropriate manner.
