Project Summary This is a supplemental application under NOT-OD-24-031 to conduct bioethics research related to inclusion of pregnant people in tuberculosis clinical trials. Women bear a large proportion of the global tuberculosis burden, and 250,000 pregnant women develop tuberculosis annually. Millions more pregnant people need tuberculosis preventive therapy and/or vaccines. Despite this, almost all clinical trials of new tuberculosis therapeutics and vaccines have excluded pregnant people from participating, resulting in a lack of evidence to inform clinical guidelines and practice. Over the past year, our team at the Johns Hopkins TB Research Advancement Center, working under the aegis of the USAID-funded SMART4TB Consortium, has led an initiative to increase access for pregnant people to TB clinical trials. In collaboration with the World Health Organization (WHO) and the IMPAACT Network, we sponsored a global consensus meeting in October 2023 to research equity for pregnant people. Over the coming year we are working with the WHO and other partners to gain stakeholder input and develop guidance documents for inclusion of pregnant people in research. In this supplemental application to our TRAC, we request support to conduct outreach to clinical trialists and clinicians to identify barriers to inclusion of pregnant people in TB trials. Input from other stakeholders is being collected by the WHO, SMART4TB, and advocacy groups. We propose to conduct in- depth interviews with key informants from the TB research and treatment community to identify the most important barriers to inclusion of pregnant people in trials, then use the themes that emerge to design and implement a larger stakeholder survey for up to 300 clinicians and triallists. We will employ methods previously used in the PHASES Project, which addressed a lack of equity for women in HIV research. Our research team includes experts in clinical trials, bioethics, TB in women, survey research, and community advocacy. The results of this work will support development of global guidance by the WHO, research networks, and funders.