Optimizing the ethical research engagement for pregnant women living with HIV and their children

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PROJECT SUMMARY Research involving pregnant women living with HIV (PWLHIV) and their children has increased in recent years to better understand the health outcomes related to new antiretroviral regimens within the antenatal period and outcomes related to being born to a mother living with HIV. While some insights have been reached regarding the issues faced by these populations when engaging in research, very little is known about what potential harms arise from their participation and their preferred method for communication of study results. Therefore, there is a critical need for an empiric, person-centered approach to understand the ethical issues that can arise from research involving PWLHIV and their young children due to the intersectionality of multiple vulnerabilities within these populations. By providing more empirical evidence to inform ethical research activities, research programs will gain critical guidance on how to engage this population in future studies. The proposed activities will occur within the context of our ongoing Tabiri Study (R01HD104552), which is currently enrolling 1000 Kenyan women (half of whom live with HIV) who are pregnant or immediately post-partum and following them and their children for 24 months. The specific objectives of this application are to: (1) provide an evidentiary basis to guide the ethical and equitable conduct of biomedical research involving PWLHIV and their young chil- dren, and (2) create and disseminate a stakeholder-informed bioethics toolkit to support investigators engaging in research with similar populations. Within the first aim, we will evaluate perspectives on research participation from key stakeholders, including PWLHIV who are actively enrolled in ongoing maternal-child health outcomes research in Kenya. To do this, we will recruit key stakeholders, including PWLHIV and their partners, village elders, healthcare workers, research assistants, community health workers, and research ethics committee members, for in-depth, qualitative interviews to understand a myriad of topics related to research participation. Within the second aim, we will create and disseminate a bioethical toolkit for engaging PWLHIV and their chil- dren in research. The results from the key stakeholder interviews from the first part of our study will inform the creation of ethical guidelines for research engaging PWLHIV and their young children. We will then utilize a series of participatory design workshops, including PWLHIV, university ethics committee members, and key stakeholders, guided by an international ethics framework, to develop a bioethical toolkit. The toolkit will outline key aspects of research, from study design to dissemination of results. We will then disseminate the toolkit us- ing three strategies: (1) a local symposium, inviting ethics committee members from across Kenya; (2) the re- search networks of the International epidemiological Databases to Evaluate AIDS Regional Consortium and the Academic Model Providing Access to Healthcare (AMPATH) consortium; and (3) an exhibition booth at an international HIV conference. Through these aims, we will gain critical insights to develop the evidence-based resources needed to optimize stakeholder-engaged, ethical research focused on PWLHIV and their children.