HEAL Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16-30) Technical Assistance Webinar 2019

Definitions

• Q: How is prevention defined?                  
  A: “Prevention” is defined as interventions that occur prior to the onset of OUD and are intended to prevent or reduce risk for opioid misuse and OUD. See the funding opportunities for further information.
• Q: How are older adolescents and young adults defined?
  A:  For this RFA older adolescents and young adults are defined as individuals ages 16-30.

Funding Opportunity Requirements

• Q: ­Is the UG3/UH3 only for primary prevention? 
  A: Three levels of prevention interventions are appropriate for this funding opportunity – universal, selective, and indicated. See  RFA-DA-19-035 for definitions.
• Q: Can projects include populations that extend below or above the identified age range?
  A: Projects should include populations within the specified age range of 16-30.
• Q: Does the entire age range need to be addressed?
  A: No, the entire age range does not need to be included.
• Q: Are applications that intervene to engage older adolescents or young adults in OUD treatment considered responsive?
  A: No. The funding opportunities are focused on prevention for individuals prior to development of an OUD.
• Q: Are studies that include pharmacological treatments (e.g., MAT) considered responsive?
  A: The funding opportunities call for studies to develop and test interventions to prevent opioid misuse and OUD. The definition of prevention is included in the funding opportunities. Studies of Interventions and treatments for individuals with OUD or who need treatment are not considered prevention and are not responsive.
• Q: Are settings other than those identified in the funding opportunity acceptable?
  A: Other settings that are opportune for accessing and engaging at-risk older adolescent and young adult populations (ages 16-30) are acceptable.
• Q: Do all research projects need to focus on all five objectives specified in RFA-DA-19-035?
  A: Yes, research projects are expected to address all five objectives identified in the  RFA-DA-19-035. The objectives are listed below:
  1) Develop strategies to identify, reach, and engage older adolescent and young adult populations at risk for opioid misuse and OUD in prevention interventions and services,
  2) develop and adapt interventions and strategies to prevent initiation of opioid misuse, escalation from initiation to misuse, and escalation from misuse to OUD,
  3) test the effect of prevention strategies and interventions on initiation of opioid use, opioid misuse, OUD and other opioid related outcomes,
  4) develop and test strategies to facilitate implementation and sustainability of prevention interventions and strategies in health care, justice and other systems and settings opportune for accessing and engaging at-risk older adolescents and young adults, and, 5) conduct an economic evaluation (e.g., to quantify programmatic costs and cost-effectiveness of interventions and strategies).
• Q: Does a milestone of the UG3 phase need to be a demonstration of intervention efficacy?
  A: It is expected that recruitment, feasibility, preliminary pilot data, and demonstrated readiness to launch into the clinical trial phase (UH3) will be demonstrated by completion of the UG3 phase.
• Q: As the application covers both the UG3 and UH3 phases, should the application include sets of aims for both phases? Should the aims be described in one page?
  A: Yes. The research project applications should include aims and propose research to be conducted in both phase 1 (UG3) and phase 2 (UH3). The aims for both phase 1 and phase 2 should be described on one page.
• Q: How should research projects work with the Coordinating Center, RFA-DA-19-034?
  A: Projects funded under this funding opportunity are expected to work collaboratively toward core data collection measures and methods, as appropriate, that will enable the construction of data sets that are harmonized and facilitate progressive data sharing models.  Consistent with achieving the goals of the program, finished, de-identified datasets are expected to be made available for the research community at the close of the study through deposit at the National Addiction and HIV Data Archive Program: https://www.icpsr.umich.edu/icpsrweb/content/NAHDAP/about.html or another site to be determined by the Steering Committee of the cooperative agreement. See RFA-DA-19-034 for details on the Coordinating Center’s responsibilities and the support it will provide to research projects.
• Q: What are the requirements for letters of support from end-users?
  A: It is expected that applications will include letters of support indicating commitment from end users to implement the intervention or strategies studied if the outcomes are favorable.  
• Q: For research project applications, should both the UG3 and UH3 phases be described within the 12-page limit?
  A: Yes

Implementation research and economic evaluation

• Q: Are research projects required to include implementation aims and analyses?
  A: Research projects are expected to address all five objectives specified in the funding opportunity. Applications should describe how the objective pertaining to implementation will be addressed in coordination with the Coordinating Center.
• Q: Are research projects required to include economic aims and analyses?
  A: Research projects are required to address all five objectives specified in the funding opportunity. Applications should describe how the objective pertaining to economic evaluation will be addressed in coordination with the Coordinating Center.
• Q: Are research project applications required to include implementation research expertise on the research team?
  A: Research projects should have the expertise needed to address all objectives in the funding opportunity. Research project teams will be expected to include expertise to conduct and coordinate with the Coordinating Center the implementation research activities proposed in the application.
• Q: Are research project applications required to include economic research expertise on the research team?
  A: Research projects should have the expertise needed to coordinate economic evaluation activities with the coordinating center.
• Q: Given that there is a Coordinating Center, do all research project (UG3/UH3) applications need to include personnel for data analyses and cost evaluation?
  A: The UG3/UH3 research project applications are expected to include personnel who have the expertise to carry out all aspects of the research projects and coordinate research activities with the Coordinating Center. It is expected that the research projects will include on the team personnel to conduct data analyses. For the economic evaluation, the research projects are expected to include personnel who have the expertise needed to coordinate economic evaluation activities with the Coordinating Center.
• Q: As compared to the UG3 phase, should the UH3 phase have a greater focus on implementation research?
  A:  The application should propose an approach based on the research proposed. It is permissible for implementation research questions to be included in both the UG3 and the UH3 phases.

Budget

• Q: Can a year be split between UG3 and UH3 efforts?
  A:  No. The UG3 and UH3 budgets should use 12-month increments.
• Q: Is there an upper budget limit for the research projects?
  A: Application budgets are limited to $500,000 per year in direct cost for UG3 (phase 1), and $1,000,000 per year in direct costs for UH3 (phase 2). 
• Q: Does the initial application need to include detailed budgets for both the UG3 and UH3 phases? 
  A: Yes.
• Q: Are consortium indirect costs included in the $500K/$1million yearly direct cost limit?
  A: No.

Miscellaneous

• Q: Are the webinar slides available online?
  A: Yes, the webinar slides and a recording are posted at: www.nida.nih.gov/news-events/meetings-events/2019/01/heal-preventing-opioid-use-disorder-in-older-adolescents-young-adults-ages-16-30-foa-technical
• Q: Can an institution receive more than one UG3/UH3 award under this funding opportunity? 
  A: Nothing prohibits this. Each application submitted by an institution in response to the funding opportunity needs to be distinct.
• Q: Can a team submit applications for both the Coordinating Center (U24) RFA-DA-034 and the Research Project (UG3/UH3) RFA-DA-19-035?
  A: Yes, nothing prohibits an applicant from submitting applications for both the Coordinating Center U24 RFA and the Research Projects UG3/UH3 RFA.
• Q: Can the PI and the stakeholder co-Investigator come from the same organization/institution?
  A: Yes
• Q: If 501(c)(3) eligibility is pending, can the application be submitted?
  A: This must be in place prior to award.
• Q: Is a minimum effort required for project PIs?
  A: A minimum effort is not specified in the RFAs.  Effort should be appropriate for the work and responsibilities proposed.
• Q: What is the project period for the UG3/UH3 awards?
  A: The maximum project period is 5 years. This includes up to 2 years for the UG3 (phase 1) and up to 4 years for the UH3 (phase 2) with the total project period for both the UG3 and UH3 phases not to exceed 5 years.
• Q: How many awards will be awarded in the UH3 phase?
  A: This depends on achieving milestones during the UG3 phase and available funds.