DESCRIPTION (provided by applicant): This IRSDA K01 resubmission advances the Fogarty mission of facilitating global health research through building partnerships between research institutions in the U.S. and abroad, and training new global health scientists. Dr. Cristian Meghea is an Assistant Professor in the College of Human Medicine, at Michigan State University (MSU) and an Associated Researcher at Babes-Bolyai University (BBU), in Cluj-Napoca, Romania where he was born and raised. This award will prepare Dr. Meghea to establish himself as an independently- funded global health researcher with capacity to develop, evaluate, and implement effective, culturally-tailored, and sustainable interventions to prevent and reduce smoking in families during the reproductive years in resource limited settings such as Central and Eastern Europe. Pregnancy smoking and postnatal relapse are highly prevalent in Romania and Central and Eastern Europe, with lifetime negative health effects for the women and their children. There are higher odds of female smoking persistence during pregnancy, and of relapse once pregnant women quit, when the male partner also smokes. It is critically important to address the smoking behavior of couples at the beginning of reproductive life. Building on ongoing pilot work led by Dr. Meghea in Cluj-Napoca, Romania, the overall objective of the proposed research, conducted through BBU in the same clinic as the ongoing pilot, is to adapt, enhance, and test the implementation feasibility and preliminary efficacy of an evidence-based pregnancy and postnatal couple intervention for smoking cessation that begins early in pregnancy and has a postnatal component. The intervention will be based on the motivation and problem solving (MAPS) approach, successful in preventing smoking relapse postpartum in the US, which will be enhanced by targeting the couples' smoking behavior by focusing on dyadic efficacy for smoking cessation. The target population is primigravida pregnant women and their partners in Cluj-Napoca, Romania. The specific aims are: (1) To develop an adapted and enhanced couple intervention to reduce pregnancy smoking and postpartum relapse in Romania based on the MAPS approach. (2) To conduct a pilot randomized controlled trial to test the fidelity of the culturally adapted MAPS intervention enhanced for couples smoking prevention during pregnancy and postpartum. (3) To examine in the pilot the implementation feasibility and initial efficacy in increasing maternal pregnancy smoking cessation and reducing postnatal relapse, with secondary hypotheses regarding maternal smoking reduction and spousal cessation, relapse, and reduction. This study proposed in this award will form the basis for a larger, multicenter clinical trial that will be submitted by Dr. Meghea as an R01 application by the end of the 4th year of this award to evaluate the effectiveness of the proposed smoking prevention intervention. If proven effective in the subsequent R01 trial, the intervention has a high potential for broad spectrum population impact and sustainability. The long-term goal is the adoption in the national Romanian health system as a proactive extension of the existing STOP SMOKING national program which includes a quitline. To pursue this long-term research agenda, Dr. Meghea will enroll in courses, trainings, and work with an outstanding team of mentors to refine and develop five areas of expertise: (1) Global health and tobacco control; (2) Behavioral health, intervention adaptation, dissemination, and implementation research; (3) Tobacco and drug dependence epidemiology; (4) Perinatal epidemiology; (5) Advanced biostatistics. Dr. Voice, the primary US mentor, will provide mentorship on conducting international research in resource limited settings, and will be an important source for networking with other colleagues. For over 15 years, he has lead a Fogarty D43 training and research program in Romania and the neighboring Balkans. Dr. Adriana Baban, the primary Romania mentor in Cluj-Napoca at BBU, is an expert in health psychology, prevention, and qualitative research. Dr. Kristie Foley, US Co-Mentor, with expertise in behavioral health and tobacco research rounds out this 3-member core mentoring team. The current and future interactions with Dr. Foley, the Fogarty R01 she currently leads building tobacco research capacity in Romania since 2012, and her collaborators in the region are extraordinary opportunities for Dr. Meghea's career development and research. Scientific advisors include: Dr. Adrian Blow (couples and family health interventions), Dr. William Wadland (smoking cessation and tobacco dependence), Dr. Jim Anthony (tobacco and drug dependence epidemiology), Dr. Nigel Paneth (perinatal epidemiology), Dr. David Wetter, one of the original MAPS developers, and Dr. Teodora Ciolompea, the national coordinator of the STOP SMOKING program in Romania. Dr. Ciolompea will have a key advisory role in the intervention adaptation, implementation and sustainability by facilitating the future adoption of the intervention in the national Romanian health system. The access to a true conception cohort with prenatal and postnatal care, delivery, and repeat pregnancies in the same clinics, and the high smoking rate and rare polydrug use, have the potential to advance health discoveries faster, cheaper, and more efficiently than we could in the US. This award addresses tobacco use, a key Fogarty and NIH priority in global health research and will provide Dr. Meghea the opportunity to engage in and maintain a strong research program with a major impact.

PUBLIC HEALTH RELEVANCE: The proposed research is relevant to public health because the findings will have a system wide sustainable impact on the prevention of prenatal and postnatal family smoking in Romania and in Central and Eastern Europe, with applications to the US and other populations. The research is also expected to have an important impact on the methodology and design of clinical and public health interventions during the reproductive years with lifelong potential implications. Thus, the proposed research is relevant to the part of NIH's mission that pertains to developing fundamental knowledge that will help enhance health and reduce the burdens of human illness.