Culturally Engaged REcovery - MOms connected through Native CommunitY (CEREMONY): An Implementation Study to Evaluate the Adaptation and Implementation of an Integrated Perinatal SUD Clinical Model for Pregnant and Postpartum Native People.

Deaths related to substance use disorders and mental health concerns are leading causes of maternal mortality, particularly in the postpartum period. Integrated perinatal substance use care that streamlines substance use disorders (SUD) treatment and prenatal care into a single setting improves perinatal outcomes, including postpartum follow-up and engagement in treatment for SUD, which may ultimately reduce maternal mortality. Native pregnant and postpartum people have identified a lack of culturally responsive care, as well as stigma, bias, and racism, as barriers to entry into SUD care and prenatal care. Through a partnership between the University of Utah Health and Sacred Circle Healthcare, the Culturally Engaged Recovery - MOms connected through Native communitY (CEREMONY) project aims to adapt and test the clinical and implementation effectiveness of integrated perinatal SUD care for Native pregnant people. The protocol for this 7-year, NIH-funded project centers on a bidirectional partnership and acknowledges Native sovereignty, data safety, and ethics of research with Native and Indigenous communities. Within this ethical and community-engaged framework, we rely on the ADAPT-ITT model, human-centered design, and the Implementation Research Logic Model to map the adaptation and iteration of a culturally responsive integrated perinatal SUD care model. Following adaptation, our protocol outlines a Hybrid Type 1 implementation science study to evaluate the clinical and implementation effectiveness of the adapted intervention. The work of CEREMONY has the potential to create implementation protocols for use in other settings as well as to reduce maternal morbidity among Native pregnant people in Utah.The CEREMONY study is registered in ClinicalTrials.Gov under NCT06747442.