Revised December 2018
About the Study
Q: What is the purpose of the study?
A: The HEALing Communities Study will test the immediate impact of implementing an integrated set of evidence-based interventions to prevent and treat opioid misuse and Opioid Use Disorder (OUD) within communities affected by the opioid crisis. The integrated set of evidence-based prevention and treatment interventions across healthcare, behavioral health, justice, and other community-based settings will be designed to achieve the following goals: reduce overdose fatalities (by 40% in a 3-year period), and events; decrease the incidence of OUD; and increase the number of individuals receiving medication to treat OUD, retained in treatment beyond 6 months, and receiving recovery support services.
Q: Who is running the study?
A: The study is a cooperative agreement funded and supported by the National Institute on Drug Abuse, a component of the National Institutes of Health, in partnership with the Substance Abuse and Mental Health Services Administration.
Q: Who can apply?
A: Any qualified researcher can apply to be the principal investigator for a research site or data coordinating center. However, special consideration will be given to investigators whose applications demonstrate linkages with multiple different communities and partners. Applicants should provide letters of support and demonstrated linkages with communities, treatment centers, primary and emergency care providers, state and local government, and faith-based and community organizations.
Special consideration will be given to applications within states that are burdened with higher than average rates of overdose mortality and opioid-related morbidity. Recognizing the impact the opioid crisis has had on rural America, 30% of the communities must come from rural areas.
Q: How many grants and research sites are planned?
A: One data coordinating center and up to three research sites are planned as part of the study. Each research site will encompass at least 15 communities to measure at the local level the impact of integrating evidence-based prevention, treatment, and recovery interventions for opioid misuse, opioid use disorder, opioid-related overdose events and fatalities across primary care, behavioral health, and justice settings. Only one award for research sites will be made per state.
Q: How will communities within the sites and between the sites connect?
A: The principal investigators and co-investigators at the research site will coordinate linkages among the communities within each research site and the state-wide and community-wide partners that make up each individual site. A coordinating body of communities and study leadership will be established and convened by NIH to ensure that the data collected and study design are consistent across the multiple research sites.
Q: How can partners (community, private sector, etc) get engaged?
A: Community, private-sector, faith-based, and other partners are essential to this effort. Community based organizations are encouraged to reach out to local academic and other research institutions to express interest in partnering to develop an application for a HEALing Communities research site. Interested parties can reach out to NIH/NIDA for further information.
Q: What can we expect to learn through the study? When will we know if it’s working to lower overdose death?
A: The HEALing Communities Study will generate important information to help communities enhance their strategic response to the opioid crisis and drive down overdose deaths. Specifically, the study will guide development of an integrated, cost-effective framework across multiple settings including healthcare, behavioral health, and justice systems. The study is set to launch in 2019, and will begin gathering data immediately on strategies aimed at reducing opioid overdose fatalities by 40% over three years.
FOA Questions and Answers
Q: Can one institution apply to both Funding Opportunity Announcements (FOAs), provided the PIs are different?
A: Yes, a single institution can apply to both the Research Site and Data Coordinating Center (DCC) FOAs.
Q: Can an organization apply for the Data Coordinating Center (DCC) and subcontract with one of the awarded research sites?
A: Yes, an applicant can apply for the DCC and subcontract with one of the awarded research sites.
Q: Can an organization be a subcontractor for more than one research site?
A: Yes, an organization can be a subcontractor for more than one research site.
Q: Must the applicant organization be located within the same state as the partnering communities?
A: No, the FOA does not require the applicant organization be located within the same state as partnering communities. However, all the partnering communities must be located within a single state. In addition, the application should provide an in-depth understanding of the opioid crisis and strong collaboration with the state where partnering communities reside.
Q: Is there a specific reporting structure and process for the role and responsibilities of the high-ranking government official?
A: The intent of the FOA is to include a high-ranking governmental official with the ability to influence the provision of opioid prevention, treatment, and recovery services. The Research Site FOA does not prohibit any specific type of reporting structure. However, if more than one person is sharing this role, the application would need to specify roles and responsibilities, along with a specific process that would be used to make decisions in an efficient and timely manner.
Q: How can a community-based or small research organization join a network and participate in the study?
A: We are encouraging community-based and small research organizations and other entities interested in the HEALing Communities Study to reach out to universities, academic medical centers and other large research organizations in their area to state their interest in collaborating on an application. Since the FOA requires participation of a high-level government official, the state government office responsible for opioid prevention, treatment, and recovery services may also be aware of academic and research organizations that intend to develop an application.
Q: Does the government have a preference for the type of proposer, e.g., non-profit organization vs. for-profit organization?
A: No, the government does not have a preference. If an applicant has the scientific expertise and ability to meet all the requirements listed in either Funding Opportunity Announcement (FOA), that applicant is eligible to apply.
Q: In identifying rural communities, are applicants required to use the Am I Rural? feature of the Rural Health Information website cited in several places in the FOA?
A: The link was provided as a resource. Applicants are asked to provide the definition they are using for rural, the justification for the definition, and data indicating how communities meet that definition.
Q: How many applications for a Research Site may an organization submit?
A: We will only accept one application per organization for RFA-DA-19-016.
Q: How many applications for the Data Coordinating Center may an organization submit?
A: We will only accept one application per organization for RFA-DA-19-017.
Q: Can my organization submit applications for both a Research Site and the Data Coordinating Center?
A: Yes, that is allowed.
Q: Are multiple PIs allowed in applications submitted in response to the FOA DA-19-016?
A: Yes, multiple PIs are allowed for both the Research Site and DCC FOAs. However, the contact PI must fulfill the obligation for level of effort per year, which is a minimum of 5 months over the life of the grant award. This is a requirement in each of the FOAs.
Q: If there are 2 co-PIs, does 2.5 months commitment per PI satisfy the requirement?
A: No, the contact PI must fulfill the minimum commitment requirement in the FOA. The time commitment may not be split among multiple people. The FOAs state that the contact PI of the research site and DCC application must commit a minimum of 5 months annually over the life of the grant award.
Q: Can there be more than one Research Site in a state?
A: No, NIDA will only fund one Research Site per state.
Q: Can you explain the requirement that 15 percent of the fatalities must have occurred in rural communities?
A: The FOA requires that applicants demonstrate that there have been at least 150 opioid-related overdose fatalities combined in the communities participating in the research site. Of these, at least 15 percent (22 deaths) must have occurred in rural communities. Once at least 22 deaths in rural areas have been documented, the applicant has met this 15% requirement (i.e., the 15 percent requirement does not apply proportionally to the total number of opioid-related overdose).
Q: With respect to the primary outcome (i.e., 40 percent reduction in opioid mortality in 3 years), is this from baseline or would a randomized controlled trial (RCT) comparing intervention and control communities, adjusting for baselines be acceptable?
A: The FOA states the 40 percent reduction in opioid fatalities is compared to baseline. The FOA provides ideas about the type of trial design that will be acceptable. The application should propose a study design and justify the design proposed, including how a reduction in the primary outcome would be measured and determined.
Q: The FOA states "there is special interest in funding applications from states ranking in the top third of per capita age-adjusted drug overdose death rates in 2016, based on mortality data from the Centers for Disease Control and Prevention." Are applications from states not meeting this condition considered nonresponsive?
A: As stated, these locations are of "special interest", but it is not a requirement for this FOA. Applications from all states are welcomed and considered competitive if a rationale for being highly affected by the opioid crisis is clearly articulated. In addition, although the FOA requires certain thresholds for opioid overdose-related fatalities, age-adjusted rates are not required. Therefore, crude rates would be acceptable, particularly in situations where these are the only data available.
Q: Some data sources (including determination of the primary outcome of overdose deaths) have a lag in reporting. This lag following a three-year period may bump up against the four-year time frame of the study. Has this been considered?
A: Yes. The FOA provides some guidance. Applicants are expected to put forward their best ideas for accomplishing the aims of the research, including study timeframe and data collection. The FOA outlines requirements and expectations for the collection of data, including both de novo data collection and improving the quality and frequency of existing data.
Q: What other research programs or resources should research sites link to?
A: Applicants are encouraged to leverage NIDA's Clinical Trials Network (http://www.henanqingdian.com/about-nida/organization/cctn/ctn), the Clinical and Translational Science Award Program funded by the National Center for Advancing Translational Sciences (https://ncats.nih.gov/ctsa/about), and the Institutional Development Award Program Infrastructure for Clinical and Translational Research (IDeA-CTR), funded by the National Institute of General Medical Sciences (https://www.nigms.nih.gov/Research/DRCB/IDeA/Pages/IDeA-CTR.aspx).
Q: How might faith-based organizations get involved in the study?
A: Potential applicants with questions regarding faith-based organizations as implementing partners in their research collaboratives may contact the HHS Center for Faith and Opportunity Initiatives for resources. Email: Partnerships@HHS.gov; Telephone: (202) 358-3595.
Q: What data need to be sent by the sites to the DCC?
A: The research site FOA states very clear data requirements related to primary and secondary outcomes. Please see sub-section D of the FOA.
Q: Will the research site applicants be expected to include and describe the plans for a data safety monitoring board or similar?
A: The FOA does not require a data safety monitoring board. However, if the specifics of the study suggest that a data safety monitoring board is necessary then the plans for this level of monitoring should be described in the application.
Q: Does the study need an overall community advisory board (CAB)? Does each control community need a CAB?
A: The FOA requires a single CAB per research site. Please refer to sub-section C in the FOA.
Q: What is meant by developing a data-driven strategic plan to implement evidence-based prevention and treatment interventions?
A: Please see the FOA. The Communities That Care framework is provided as an example, see link: www.communitiesthatcare.net. This conceptually driven approach consists of multiple steps to help communities understand, from a data-driven perspective, what is happening with the opioid crisis in their communities, assess resources and needs, and come together to develop a strategic plan to address those needs, evaluate the impact of the strategic plan, and make adjustments as needed.
Q: Is there a page limit for the number of support letters that can be submitted?
A: No, there is no page limit for the number of support letters. Please submit the number of letters necessary to support the application.
Q: RFA-DA-19-016 (Research Sites) requires two community data tables as part of the "Other Project Information." Is there a required format for these tables?
A: No, there is no required format nor standard form for the submission of this required information. That said, below is a sample format for reporting this information. Applicants might consider these sample formats to detail the Community Data Part One and Community Data Part Two (separate tabs in the linked file).
Worksheet (Excel, 39KB)
Q: Are we required to have contracts with all organizations we will engage in a community/county or is the letter of support acceptable for the proposal?
A: A letter of support is sufficient for the application. Please include all budget requirements in the application. If the application is successful and awarded, negotiation of a contractor consortium agreement is expected at the time of award.
Q: The FOA mentioned using a Results Based Accountability approach. Are there expectations that evaluation and site data will include the measures that are aligned with this specific approach?
A: The FOAs state that awardees shall work with other awardees, NIH/NIDA, SAMHSA, and the DCC to develop, implement, monitor, and display a dashboard of metrics related to the study and performance of each research site.
Q: Does our integrated care model have to include all components listed, including both prevention and increased access to treatment?
A: The integrated community-based model must include all components listed in the FOA including prevention, treatment, and recovery support for opioid misuse, opioid use disorder, and opioid-related overdose fatalities.
Q: Do research sites or the DCC need to obtain OMB clearance under the Paperwork Reduction Act (PRA) for any data collection?
A: No, as a grant mechanism neither the DCC nor the research sites will need to obtain an OMB information collection request clearance under the Paperwork Reduction Act.
Q: Is all health economic research envisioned as residing in the DCC, or could a research site propose its own cost and cost-effectiveness study?
A: The research site can propose its own cost and cost-effectiveness study. A research site could provide an optional subcomponent to propose an economic study for communities collaborating on their proposal. All research sites are required to provide information on how they would interface with the DCC to develop and collect data related to the economic research that includes all research sites.
Q: Should the research sites also provide their own analysis of the primary and secondary outcomes and health economics?
A: The research sites are asked to propose how they will work with the DCC to address research questions related to the primary and secondary outcomes and health economics research. The DCC FOA articulates the data related and analytic responsibilities of the DCC for overarching research questions that include data from all the research sites. Research sites may also propose to conduct analyses from data collected across their collaborating communities.
Q: Is there a maximum budget request?
A: There is no maximum budget, per se; however, the FOA outlines the anticipated funds available for the project. NIDA intends to commit up to $89.5 M in FY 2019, $96.5 M in FY 2020 and 2021 and $48.5 M in FY 2022 for the research sites. We plan to fund up to 3 research sites, subject to availability of funds. For the DCC, NIDA intends to commit up to $6.5 M each year from FY 2019 through FY 2022 to fund one DCC, subject to the availability of funds.
Q: Can a research site use funds to enhance the infrastructure in control communities after the intervention is done?
A: All requested funds must be related to the proposed research project and must be spent during the proposed project period. Funding that continues after a study is complete is not typically an allowable cost. Applicants with budget questions should contact the grant management point of contact listed on the FOAs to inquire about allowable costs.
Q: Can you explain what type of funding is available for the section H optional module?
A: Section H is an opportunity to support additional activities necessary to support the research requested in the FOA or to expand upon research activities outlined in the FOA. As an optional component of a research application, significance, need, and a strong justification for the activities and budget will be needed. Funding for these optional modules will come from the committed dollars for this project.
Q: Do the budget numbers listed in the FOAs include direct and indirect cost?
A: Yes, the budget numbers listed in the FOAs are total funds available.
Q: Do applicants need to include the steering committee chair institution's indirect costs in the proposed budget?
A: Per the FOAs, the steering committee chair will be an outside person and will be selected by NIDA and SAMHSA. This person will have significant scientific expertise in the areas of research conducted by the cooperative, but will not be affiliated with any research site, DCC, or Federal participants. The budget for the DCC should include travel expenses and an honorarium to cover level of effort included in the FOA, but does not need to consider indirect costs specific to the chair's institution.
Q: How is the application being reviewed? Will the reviewers review all sections, or will the different sections be individually reviewed?
A: Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened by NIDA, in accordance with NIH peer review policy and procedures, using the stated review criteria. It is important to note that the application will be reviewed in its entirety by a peer review panel.
Q: Will the review be conducted by NIH/CSR or at NIDA? Will the applications be reviewed by a special emphasis panel?
A: The applications will be reviewed at NIDA by a special emphasis panel.
Q: November 11, 2018, is the due date for the Letter of Intent, but that is a Sunday. Should Letters of Intent be submitted by November 9, 2018?
A: When the due date for Letters of Intent falls on a Sunday, the due date is extended to the next business day. In this case, Monday, November 12, 2018, is a federal holiday, so Letters of Intent will be accepted until Tuesday, November 13th. Early letters are certainly welcome and encouraged.
Q: How can the earliest start date be listed as February 2019 if the anticipated Advisory Council Review Date on the FOAs is listed as May 2019?
A: The February start date is the earliest possible start date. At the time of publication, NIH's goal is to make a funding decision in February, which would yield a February start date. While the NIDA Advisory Council meeting is scheduled for May 2019, these applications will receive expedited review by Council prior to the May meeting, allowing for the grants to be awarded closer to the earliest possible start date.
Q: The Research Site application includes a PHS Inclusion Enrollment Report that must be completed for the individuals we plan to enroll. Since we are enrolling communities and not individuals, how do we complete this section?
A: Applicants should complete the table with the expected enrollment demographics based on the communities where the study will be conducted.
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