Resources and Support for Implementation Science and Tobacco Control at NIH. cancercontrol.cancer.gov/brp

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1 Resources and Support for Implementation Science and Tobacco Control at NIH cancercontrol.cancer.gov/brp

2 NIH Fogarty International Center

3 NIH Fogarty International Center

4 NIH Office of Behavioral and Social Science Research (OBSSR)

5 National Cancer Institute

6 National Heart, Lung and Blood Institute

7 NIH Resources Dissemination and Implementation Science Training programs Training Institute for Dissemination and Implementation Research in Health NCI Implementation Science Team Masters Courses and Webinar Series Conferences Conference in the Science of Dissemination and Implementation in Health, December 4-5, 2017 Online courses and materials FIC Toolkit Overcoming Barriers to Implementation in Global Health Research to Reality online forum for cancer control researchers and practitioners

8 NIH D&I Funding Opportunity Open to Foreign Institutions Three different mechanisms R01, R21, R03 Studies of strategies to implement health promotion, prevention, screening, early detection, and diagnostic interventions, as well as effective treatments, clinical procedures, or guidelines in existing care systems.

9 Current Tobacco Control Funding Initiatives at NCI cancercontrol.cancer.gov/brp

10 Tobacco Control as a Global Cancer Research Priority November 2012 Research leaders from 15 countries came to NIH to discuss priorities in global cancer research. 䇾With respect to modifiable lifestyle risk factors for cancer, there is a consensus that tobacco use remains, by far, the most important at a global level.䇿 Measures that can already be taken to control tobacco use include removing tobacco products from trade agreements, increasing taxes on tobacco products, controlling tobacco industry marketing, and building support among health professionals. Source: H. Varmus, H. S. Kumar, Addressing the growing international challenge of cancer: A multinational perspective. Sci. Transl. Med. 5, 175cm2 (2013). 10

11 TCRB International Research Webpage 11

12 NCI International Tobacco Control Grants NCI has supported tobacco control research grants in more than 40 countries around the world 12

13 NCI Global Tobacco Control Grants Areas of Research Percent of Total FY 2002 Present (N=56)* 13

14 NIH International Tobacco and Health Research and Capacity Building Program

15 The International Tobacco and Heath Research and Capacity Building Program (TOBAC) Country Collaborators, Co-funded by FIC, NCI and NIDA Source: 15

16 Features of the TOBAC Program: Special Requirements Collaboration: Requires both PI from US/HIC and PI from LMIC. Relevant Research Priorities: Demonstrate how proposed research reflects the priorities of the collaborating LMIC Dissemination: Dissemination plan should describe how results will support tobacco control in the host country. Continued Collaboration: Plan for continued collaboration and mentoring after initial training period Network meetings: Budget for periodic grantee network meetings Evaluation: Track long term impact of training and capacity building efforts and use of research findings in country.

17 Translating evidence and building capacity to support waterpipe control in the Eastern Mediterranean (PI: Maziak, W.) Rationale: Growth in waterpipe smoking in Eastern Mediterranean region and other parts of the world, especially among young adults, combined with widespread misperceptions that waterpipe smoking is less harmful and addictive than cigarette smoking. Specific Aims: Develop health warning labels specific to waterpipe tobacco smoking using focus groups in Lebanon and Tunisia Evaluate warning labels with 400+ young adults (18 25 years) in each country assessing reaction, harm perception, quit intentions, and perceived effectiveness Key informant interviews with government officials and NGOs to assess capacity and possible barriers to implementation

18 NCI DCCPS Organizational Structure Division of Cancer Control and Population Sciences (DCCPS) Healthcare Delivery Research Program Behavioral Research Program Epidemiology and Genomics Research Program Surveillance Research Program The Behavioral Research Program (BRP) initiates, supports, and evaluates a comprehensive program of research including basic behavioral and psychological science as well as the development, testing, and dissemination of interventions in cancer control areas such as tobacco use, diet and energy balance, and sun protection. cancercontrol.cancer.gov/brp/ 18

19 How We Fund Grants Although most of our portfolio consists of investigator-initiated (unsolicited) grants, BRP also supports grant applications in specific areas of interest Requests for Applications (RFA) Identifies the specific receipt date(s), the estimated amount of funds earmarked for the initiative, the number of awards likely to be funded, and any specific criteria for scientific peer review; applications re ei ed in response to a parti ular RFA are re ie ed y an Institute s S ientifi Re ie Group Program Announcements (PA) Most PA applications are submitted with a standing receipt date and are reviewed with all other applications received at that time using standard peer-review processes Program Announcement (PAR) Program announcements with special receipt, referral, and/or review considerations For more information: cancer.gov/grants-training/grants-process/grants-process.pdf 19

20 Grant Recipients A grant provides federal financial assistance, including money, property, or both to an eligible entity to perform approved scientific activities with little or no government involvement Nonprofit organizations For-profit organizations Institutions of higher education Hospitals Research foundations State, local, and tribal governments Federal institutions Foreign institutions and international organizations (varies by announcement) Other organizations (e.g., school districts, faith-based, public housing) See each FOA for scientific disciplines of interest and transdisciplinary considerations For more information: cancer.gov/grants-training/grants-process/grants-process.pdf 20

21 Grant Mechanisms R01 and R21 NIH Research Project Grant (R01) NIH Exploratory/Developmental Grant (R21) Used to support a discrete, specified, and circumscribed research project Encourages new, exploratory, and developmental research projects by providing support for early stages of project development NIH's most commonly used grant program No specific dollar limit unless specified in Funding Opportunity Announcement (FOA) Advance permission required for $500K or more (direct costs) in any year Generally awarded for 3-5 years Sometimes used for pilot and feasibility studies Limited to up to two years of funding Combined budget for direct costs for the two-year project period usually may not exceed $275,000 No preliminary studies are required For more information: grants.nih.gov/grants/funding/funding_program.htm#rseries 21

22 Tobacco Use and HIV in Low and Middle Income Countries (LMICs) Contact: Mark Parascandola PAR (R01) & PAR (R21) 22

23 Funding Announcements Tobacco Use and HIV in Low and Middle Income Countries (LMICs) PAR [R01] PAR [R21] National Institute on Drug Abuse (NIDA) is participating with NCI Grants can be submitted to either NIDA or NCI, and either Institute can be named as a secondary assignment

24 Goals of Funding Announcement Encourage research focused on tobacco use and HIV/AIDS in low and middle income countries (LMICs). In particular, applications are encouraged that focus on the development and evaluation of tobacco cessation interventions tailored to HIV positive populations, including those with co-morbidities such as tuberculosis (TB), in low-resource settings. Novel, transdisciplinary nature of addressing tobacco use in context of HIV in LMICs Bring together investigators from diverse disciplines and research foci to pool their efforts on this syndemic Encourage sharing of research strategies and data across disciplines and geographic regions Dedicated review group with experience in LMICs and both tobacco and HIV PAR = no set aside funding

25 Background: Tobacco and HIV/AIDS Smoking prevalence higher among PLHIV compared with general population PLHIV who smoke tobacco suffer greater morbidity and mortality than non-smoking counterparts PLHIV who smoke have higher risk of infection, greater progression from HIV to AIDS, and weaker response to anti-retroviral therapy (ART) Introduction of ART has led to decline in AIDS mortality and increased life expectancy for PLHIV, increasing risk for NCDs and related behavioral risk factors Existing HIV and TB prevention and treatment guidelines do not include a focus on tobacco use

26 Opportunities and Challenges HIV and TB treatment context provides opportunity to intervene around tobacco use Existing infrastructure for community interventions Diagnosis of HIV/AIDS or TB provides teachable moment However, smoking cessation interventions for PLHIV present additional challenges Lower cessation rates Complications with other substance abuse, mental illness, socio-economic status Bulk of the evidence base for tobacco cessation comes from HICs LMICs may have limited access to pharmacologic treatments, fewer trained health professionals, weaker tobacco control policies Need for tailored interventions in LMIC context

27 Sample of Example Research Questions What types of tobacco cessation interventions are most effective in persons with HIV, with or without TB co-infection, to achieve improved tobacco abstinence as well as disease treatment outcomes in low-resource environments? What are the barriers to integrating tobacco control interventions into the existing HIV and TB prevention and treatment context in LMICs? What is the cost-effectiveness of integrating smoking cessation within HIV and TB treatment? What interventions can be effectively introduced to low-resource settings in LMICs? How does the social and behavioral context of tobacco use in PLHIV in LMICs, including the use and abuse of other substances, influence tobacco use behavior and cessation outcomes? What policy interventions could be embedded in HIV and TB control programs that would serve to improve the outcomes of cessation or prevention efforts at both a clinical and population level?

28 Evaluation Criteria Standard Review Criteria: Significance, Investigator(s), Innovation, Approach, Environment Specific to this FOA: Is the study or intervention appropriate for LMIC settings? Can the intervention be scaled up and implemented in the setting in which it is being studied? Does the project provide a well-developed plan for dissemination of research results to the LMIC countries where the research is taking place? 28

29 Other Important Information Applications will be evaluated by reviewers with relevant expertise in HIV/AIDS, tobacco control, and global health R01s are 3-5 year grants, which require preliminary studies R21s are 2-year grants, which are considered exploratory and do not require preliminary studies Non-domestic (non-u.s.) Entities (Foreign Institutions) are eligible to apply. Grants ith dire t osts $500,000 in any year require Program approval for submission Submit materials to Program Director at least 8 weeks prior to receipt

30 Improving Smoking Cessation in Socioeconomically Disadvantaged Populations via Scalable Interventions Contact: Yvonne Hunt PAR (R01) & PAR (R21) 30

31 Improving Smoking Cessation R01/R21 Background Smoking in the U.S. is increasingly concentrated among socioeconomically disadvantaged (SED) populations, leading to marked smoking-related health disparities SED populations have less access to empirically validated treatments, face more obstacles to engage in and maintain behavior change, and are less likely to use treatments PAR Purpose Develop and test scalable smoking cessation interventions with the potential to improve cessation outcomes among socioeconomically disadvantaged populations 31

32 Improving Smoking Cessation R01/R21 Emphasis: Interventions that have the potential to be scalable, implementable, and sustainable in real-world settings General Research Approaches: Test enhancements of interventions currently scaled or ready to scale Evaluation of existing interventions which could be scaled if evidence supports Requirements: Justify how the intervention can be scaled and packaged for broad use Propose a testable hypothesis related to the scalability of the intervention 32

33 Improving Smoking Cessation R01/R21 Example Research Questions: In what ways can scalable interventions be developed or modified to increase engagement with treatment and enhance long-term behavioral change? What strategies might be used to systematically increase access to and utilization of cessation services in socioeconomically disadvantaged populations? How might available infrastructures that provide services to socioeconomically disadvantaged populations be utilized to also deliver smoking cessation interventions? 33

34 Improving Smoking Cessation R01/R21 Targeted Subpopulations SED smokers (e.g., low income, low educational attainment, un- or underemployed, un- or underinsured, racial/ethnic groups living in low-resource communities, other disadvantaged groups such as veterans, incarcerated) Transdisciplinary Approach Teams may include public health, clinical, behavioral, and social scientists, statisticians, economists, technology developers, researchers with expertise in dissemination and implementation Not Intended to Support: Observational studies describing factors that influence cessation behavior, treatment engagement, implementation or dissemination in real-world contexts; studies for which smoking cessation is not an end-point; studies to test interventions for cessation of non-combustible tobacco products 34

35 Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21) Contact: Mark Parascandola PAR (R21) 35

36 Mobile Health: Technology and Outcomes in Low and Middle Income Countries (R21) Background Enormous potential for mobile technology to transform health care, personal health management, and basic health research. The potential of mhealth is especially relevant to LMICs, where cell phone ownership is rising rapidly, but access to health care and providers is often limited. While there has been a large increase in interventions that use mobile phones, research on these interventions is often lacking. Definition of mhealth The use of mobile and wireless devices (cell phones, tablets, etc.) to improve health outcomes, health care services, and health research. 36

37 Research Objectives This FOA encourages research projects that study the development/adaptation of mhealth interventions for the prevention, diagnosis, management, and treatment of specific health conditions. Applicants are encouraged to propose research projects that have the potential to provide an understanding of principles underlying effective mhealth interventions or tools that are generalizable to the field. This initiative aims to support projects that adapt or develop technologies that are appropriate for LMIC settings. A plethora of mhealth applications and devices have been developed in highincome countries, however, these technologies are not necessarily suitable for the needs of individuals in LMICs. 37

38 Special Requirements All projects are required to involve partnerships between U.S. and LMIC researchers and to develop mhealth research capacity at LMIC institutions that can continue beyond the period of the grant. Applicants should consider appropriate collaborations with researchers from diverse disciplines such as behavioral science, engineering, computer science, business, medicine, public health, and/or other relevant fields. In addition, applicants should consider partnering with individuals in public or private organizations, including health system entities, which could enable future research or implementation efforts within the relevant LMIC. 38

39 Other Important Information Non-domestic (non-u.s.) Entities (Foreign Institutions) are eligible to apply. Participating NIH Institutes and Centers include: Fogarty International Center, National Cancer Institute, National Institute on Deafness and Other Communication Disorders, National Institute of Mental Health, National Institute of Biomedical Imaging and Bioengineering FIC Contact: Laura Povlich, Ph.D. Fogarty International Center (FIC ( Telephone: NCI Contact: Vidya Vedham, Ph.D. National Cancer Institute (NCI ( Telephone:

40 Questions Tobacco and HIV in Low and Middle Income Countries (LMICs)

41 Are these funding opportunities only offered to interventions conducted in the U.S.? Are projects conducted overseas going to be funded? Do you have to be a U.S. citizen or have a green card to apply for funds? 41

42 Can a new investigator receive special accommodation in review? 42

43 Resources for New Funding Announcements Funding Opportunities, Webinars and list of FAQs for funding announcements: There, you can also find links to FOAs and Program Director contact information Connect with any BRP staff member via contact information listed on: questions to BRP anytime at Subscribe or unsubscribe from NCI/BRP updates at 43

44 U.S. Department of Health & Human Services National Institutes of Health National Cancer Institute cancercontrol.cancer.gov/brp CANCER Produced February 2017