Pre-Application Webinar Interventions to Prevent Adolescent Electronic Nicotine Delivery Systems Use

NIDA pre-application webinar for RFA-DA-21-009, Interventions to Prevent Electronic Nicotine Delivery Systems (ENDS) Use Among Adolescents (R01, Clinical Trial Optional). This webinar was recorded on August 17, 2020.

Video length: 42:17

Transcript

[Belinda Sims speaking] Okay, I can hear that some phones are not on mute. Some connections are not muted. Please make sure your connection is muted. I will ask again, please make sure you are on mute. Thank you. Okay, good afternoon. This is the Pre application for RFA twenty-one zero zero, nine interventions to prevent electronic nicotine delivery systems use among adolescents. This FOA is an R01 clinical trial optional. And my name is Belinda Sims from the National Institute on Drug Abuse. I'm a program officer there and I just want to note that there are other program staff from NIH who are participating in this FOA that I'll just mention now. We have Rachel Grana from the National Cancer Institute, Liz Ginexi from the Office of Behavioral and Social Sciences Research. Kay Wanke from the Office of Disease Prevention.  And Dharmendar Rathore from the NIDA review office, Carol Alderson from NIDA grants management and Garlin Hallas from NIDA grants management. Crystal Wolfrey from NCI grants management and then also assisting with the meeting today Jorge Vizcaino-Rios from NIDA and Jamar Ali from NIDA. And there are other. NIDA program staff on, I believe Aria Crump who's the deputy director of the prevention research branch is on and Amy Goldstein who's the chief of the prevention research branch at NIDA is on as well. 

Okay, the objective for the webinar is to provide submission information or the FOA, and there are several participating components in the FOA.

The National Institute on Drug Abuse, the National Cancer Institute, the Office of Disease Prevention and the Office of Behavioral and Social Sciences Research. The purpose of the funding opportunity is to seek support on research to test the efficacy or effectiveness of intervention. I can hear someone typing. Please everyone. If you could mute your phones.  The purpose of the FOA is to support research to test. The efficacy or effectiveness of interventions to prevent initiation. And or escalation of electronic nicotine delivery systems use among adolescents, or to support research on the impact of tobacco control policies, including ENDS specific policies on ENDS use behavior. Particularly for prevention intervention research, collaboration with stakeholders and likely program adopters is required to ensure feasibility for implementation scalability, dissemination and sustainability. For this particular FOA individuals as young as twelve and as old as eighteen encompass the core target age range for adolescents. Justification for the specific age, or age range of the target population is required, including studies that propose targeting youth outside the core age range. And this slide here shows you a little bit about NIDA's interest areas for the FOA, and they include, but are not limited to research on interventions to prevent initiation and escalation of ENDS use among adolescents, or example, studies testing, the efficacy or effectiveness of novel, social network strategies that leverage peer leaders or other social influencers. Interventions to prevent the escalation of ENDS use among adolescents already experimenting with E-cigarettes or other ENDS devices. Studies that leverage digital technology and social media for prevention of adolescent ENDS use.

Research on the impact of tobacco control and ENDS specific policies on adolescent ENDS use outcomes, for example, studies examining the impact of tobacco control and ENDS specific policies on ENDS use behaviors. For NIDA studies may focus on prevention of ends containing nicotine, THC, flavorings or other substances independently or their co-use. Now I'm going to turn it over to Rachel Grana to talk about NCI's interests. 

[Rachel Grana speaking] Thanks so much, Belinda.

Hi, everybody NCI's interest areas also include, but are not limited to studies that develop and test prevention, interventions, addressing determinants of risk and also protective factors, for perceptions of risks or benefits of the products parent, peer influences media and advertising influences. We are also interested in intervention research to prevent initiation, but also escalation of ENDS use among youth and also ENDS use alone or in the context of multi tobacco products use often called dual use or poly tobacco product use. We are interested in studies, investigating, effective approaches for the digital health technologies and harnessing social media to prevent ENDS use interventions based in those digital realms.

We're also very interested in research to understand the impact of ENDS specific policies on prevention of initiation and escalation of youth ENDS use, and some examples here are smoke free policies, ENDS free policies, point of sale restrictions, retail and pricing policies and interactive effects with the other tobacco control policies that may be in the same context. And then finally studies investigating healthcare providers, advice and practice aimed at youth and prevention.


[Belinda Sims speaking] Thank you, Rachel I'm going to turn it over to Liz Ginexi to talk about OBSSR and ODP interests.
We can't hear you Liz if you are speaking already. 


[Liz Ginexi speaking] Sorry about that. Thanks. So much. This is Liz Ginexi, and I'm representing the NIH offices of the director, ODP and OBSSR, and my colleague K Wanke is on the call as well. though we are listed on the RFA, you'll see both of our offices there, we are asking applicants to focus their questions to the program staff at NCI and NIDA, because you should tailor your aims to what they have stated in the RFA as their goals.

Our role is simply to help at the backend to play a co-funding role. And we're not therefore going to really be directing your interest, nor will you want to try and tailor to try and get our money. At the end we're gonna have conversations with the NIDA and NCI staff, and we will intend to supplement the set aside money that they have listed on the RFA with some additional funds to help them reach as many Meritorious grants as possible at the end of the day, so we are not going to be taking requests from anybody for, for possible consideration, except from NIDA and NCI.
And so, for the purposes of this RFA, we do urge you to contact the program staff at NIDA and NCI for all of your questions. Thanks. 

[Belinda Sims speaking] Thank you Liz. Okay, so, for the FOA, for this process, it goes without saying, I know many of you are seasoned applicants for NIH, goes without saying that you should review the FOA for all specific details and instructions and you will be expected to follow all of those details. And instructions, and, as you see here on this slide, just pointing out that there are eight major sections of the, and each section pertains to particular information, for example, section three on eligibility. You want to make sure that your institution is eligible to apply as well as you as an individual PI. Agency contacts are listed in section seven. There were some key dates want to be aware of. We have requested a letter of intent, which would be due thirty days in advance of the submission date September nineteenth two thousand and twenty. The application due date is October nineteenth, and I just made a note here that this is a Monday just FYI.  AIDA application due dates do not apply to this FOA. The review for FOA, we expect it to occur in March, two thousand, twenty-one and applications submitted and response to this FOA will go to the May two thousand and twenty one Council.
Thus, the earliest start date for any project would be July, 2021. And in terms of award and eligibility information, the FOA will support new applications. It's clinical trial optional.
So, we're accepting applications that are proposing or that do not propose clinical trials as specified in the FOA. In terms of funds available at NIDA we committed one million dollars, to support one to three awards. The National Cancer Institute also has committed one million dollars to fund one to three awards. Application budgets are limited to five hundred thousand dollars, direct five hundred thousand dollars, direct cost per year. And the maximum project period is five years and again for eligibility.
I refer you to the FOA for specific information on eligible applicants, eligible individuals, required registrations and other eligibility information. Now I'm going to turn it over to Dharm Rathore to talk about review.  


[Dharm Rathore speaking] Thanks Belinda.
So, as we received the applications, we are going to create a special emphasis panel here within the scientific review branch at NIDA to evaluate the applications as Belinda mentioned. We will do the review. Sometimes around March, and just like any other FOA at NIH there are five standard review criteria which are significance investigator, innovation, approach and environment. Now, as you, you know, let me give you a a little bit of a background about how things will go once the applications are received.
So, once the applications are in we will evaluate the applications for completeness as well as for responsiveness any application that is deemed to be incomplete and are non-responsive will be return without review. So, here are the criteria mentioned that will make an application non responsive.
So, please make sure that your application includes the study timeline as a milestone plan, and the applications that do not propose research to test the efficacy or effectiveness of interventions to prevent initiation and or escalation of ENDS use among adolescents. That's one thing. And then any application that does not propose research on the impact of tobacco control and ENDS specific policies, and adolescent ENDS use outcomes. They will be considered non-responsive and will be returned without review.
I do want to give a few quick points about, you know, how a good application really looks so, a really strong application is well written. It has clearly laid out backup plans. If your initial plan doesn't work out, the aims are not interdependent, but are other independent.  There is adequate level of effort by the principle investigator as well as the key personnel.
Let's run the application in a timeline is proposed. And then there are adequate details in there in the time, in both the timeline as well as the milestone plan and for applications that are proposing clinical trials, very important, that aspects of human subjects protection as well as inclusion are addressed.  One of the really common weaknesses we see which really things the application is about the consent form. So, if you're in all likelihood, there's a very high chance that you'll be recruiting minors for a clinical trial for clinical trial were to happen. If that's the case.
You know, please make sure that you are clearly addressing how you're going to get consent from those subjects because you will most likely need to involve the parents, and then this is a very tricky topic to include parents.  And so those are some of the weaknesses we commonly see in applications which do impact the scores and I just wanted to share those with you. So that you're well aware about it.

[Belinda Sims speaking]
Thank you for those great pointers.
Okay, so we're gonna start moving into our question and answer phase and here on this slide
I just have some initial questions that we received and answers that were provided. 
One question was, do we need to submit a letter of intent is that required? And the letter of intent is requested thirty days in advance of the application due date. But it's not required, it's not binding and it does not enter into the review of the subsequent application. The information really allows the staff or program staff and reviews staff to estimate the potential review workload and plan the review.
Question, is a focus of the RFA on the development or evaluation of a prevention program or both? And the answer for that is, for intervention research, the RFA is interested in studies to test the efficacy or effectiveness of the intervention. So, this could include testing the efficacy of a novel intervention.
Question is there more interest in school-based interventions? And the answer for that question is, the RFA is not specific to school-based research. 
Okay, so now we're going to, let me see if I can escape from this screen. Okay, and I believe if. We have a chat box available and if you think there's an option to raise your hand, although I don't see it here. If you have a question, we can respond that way.
Maybe easiest to start entering your questions in the chat to everyone.
And we can see it and respond that way or if you unmute yourself and say, excuse me, and your name, we can hear your question. Okay. Liz says you can raise your hand if you open the participant participant box. 
The hand is located next to your name. And I'm just scrolling down the participant list. I don't see any hands raised.
And I'm monitoring the chat here, and I don't see any questions. Okay. Here's the question.
Does the proposal, does the proposal have to address any potential challenges that can occur due to COVID nineteen quarantine. That is not specifically stated in the FOA.
So, I would leave that up to you as the applicant based on the work that you're proposing. If you think that would be a particular challenge you want to raise and address. I would leave that to the applicant raise.
Okay, here we have another question. Can you say more about or explain studies to adapt or optimize evidence-based substance use prevention approaches to prevent ENDS use are allowed but must be well justified.


Yes. So, is it, alright, if I answer that one and Rachel, you may want to jump in after me, if you want to add on or modify something.
But for, for NIDA for example, there are already existing studies, or existing interventions that address prevention of substance use broadly speaking that may not have specifically focused on prevention of ENDS use, or be able to tell or be able to determine whether or not the intervention will have an impact on ENDS use specifically.  So, a project may want to adapt an existing evidence-based intervention or optimize an intervention.But if so we would like for you to really provide a strong justification for why that's a focus of your project.
Rachel, did you want to add anything? 


[Rachel Grana speaking]
Thanks, Belinda. Yeah, I think that covers it. I agree with your response. And I'd also just emphasize that a primary outcome needs to be the ENDS use.
Yeah. You know, prevention of ENDS use initiation, escalation, et cetera.  But the strategy that's adapted is acceptable as long as it's adapted adequately and that's the primary outcome.


[Belinda Sims speaking]
Thank you another question, what did you suggest for addressing unknown timelines and changes in school or community or related to COVID?
So, again, I would say as you're proposing your work, you may want to take that into consideration and address it as you see fit, related to what you're actually proposing to do based on the, the timeline, expecting that the earliest start date would be July, two thousand and twenty one.


[Rachel Grana speaking]
Yeah, and I think that Belinda, I could add a, in my opinion, you know, it was brought up by doctor Rathore of including backup plans and alternative approaches is always important. It's probably important in this context. But, of course up to you, what kind of strategies you would prefer. 


[Belinda Sims speaking]
Okay. We have another question here.
Will, applications looking at use of cannabis, THC ENDS products, or co-use be considered responsive?
I think that was addressed as an area of interest.


So, depending on the scope of work overall, and that, the contents of the application, that topic area would potentially be responsive to this FOA.  
Would biological endpoints in the clinical trial, be considered important relevant for this RFA or are patient reported outcomes, data, sufficient.
Rachel I think we've had a discussion about this before. So, do you mind taking this one?


[Rachel Grana speaking]
Sure, happy to.  This is Rachel from NCI.  I think, again, this is, of course, to the discretion of the, PI and in the context of the feasibility of the research you're proposing as always, I think that, you know, biomarkers or biological endpoints in many cases, you know, can be justified appropriate but that is to be decided by the applicant in the context of what you're really proposing, and the way your mode administration of your intervention, et cetera.


[Belinda Sims speaking]
Thank you. Okay. Here's an interesting question.
Funding seems very limited in terms of NIDA and NCI. What is the total funds available for this FOA.  The total funds committed to this one million dollars from NIDA, one million dollars from NCI and OBSSR and ODP are participating as potential Co-founders. And so I would encourage you to review that section of the FOA. And that those are the limits as stated.  At a minimum two million dollars.


[Liz Ginexi speaking]
And this is Liz, from OBSSR how much we're gonna throw into the pot really depends on the quality of the applications and the desire to fund more of them on the part of and NIDA and NCI who will then work with us.


So, we don't have unlimited funds. But at this point, we have not specified a priori how much we will spend. It's really going to depend on need and funding highly scored applications.


[Belinda Sims speaking]
Thank you Liz.


There's a question here, I realize that the mechanism is an R01 is there a possibility that other mechanisms like an R twenty-one would open up for a similar topic?
Well, there are a number of existing funding opportunity announcements that you could pursue.
For example, at NIDA we have a NOSI that outlines our areas, our broad areas of interest in the prevention research branch and that NOSI links to the R01, R 21 and RO3.
And so, if you wanted to do other investigator-initiated work in this area, there are our other opportunities for that.

[Dharm Rathore speaking]
I just want to add two quick things, so it's really trying times and I'm just trying to be as flexible as we can with respect to application submission.
So, two things that I just want to share with potential applicants are number one. We are in a being liberal with late applications.
So, if you think you will need you have a little bit more time to submit an application, you can avail the late application option. Which gives you up to two weeks of additional time to put an application together.
And as long as you think it's related to COVID.


And then the second thing is NIH is also giving some flexibility with respect to preliminary data. So, if you think, you will not be able to develop your preliminary data on time to put a submission together.
And you would still like to come in with an application you'll have up to once that of your meeting, it's set, you'll have.
Time to submit your preliminary data as, you know, as a one-page document, at least thirty days before the review meeting. So, let's say if the review meeting is happening in early March.
You will have the opportunity to submit preliminary data up to early February to us and we'll include it with the review. So, feel free to use as much flexibility as we are offering as you develop your application.


[Belinda Sims speaking]
Thank you Dharm that's great advice. Okay.


I have another question here regarding the priority that collaboration with stakeholders and likely program adopters is required to ensure feasibility for implementation, scalability, dissemination and sustainabilityis required, to dissemination sustainability.  Is including implementation and dissemination outcomes in addition to the initiation escalation outcomes would that be considered responsive to this FOA? The primary focus will be on outcomes related to ENDS use and ENDS use behaviors.  If you want to include dissemination, implementation and sustainability for example, if you were proposing a hybrid trial, you would need to also include as your primary outcome ENDS use behaviors.  And please follow up if you have further questions about that in the chat.


Is it required that the primary outcome is ENDS use or could it be some other related outcome, such as provider intervention rates or patient perceptions?
I think and Rachel, you can please join in on this one. But the intent of this RFA is to support research that will examine as a primary outcome ENDS use outcomes.
Would you like to add anything to this? 


[Rachel Grana speaking]
Hi, Belinda. Yeah, this is Rachel. I would agree with that that we're focusing the primary outcome on the ENDS use prevention.
I think what, I think another thing I would just say here is that if you have some questions in this realm, where you think you're in a gray area of whether your outcome qualifies in that vein, then definitely reach out to one of us program officials with those specific kind of questions and draft aims and things like that.
So, we can discuss what you're really proposing, but I would agree with Belinda's answer.

 
[Belinda Sims speaking]
Thanks. Okay. And I'm not seeing any other questions in the chat right now.
And here for the raised hands. Okay, let's see there's a question.
The target age range is noted as twelve to eighteen years. Justification for the specific age is required, including studies that propose targeting youth outside of the core age range.  Would an intervention including college students, age, eighteen to twenty-four, be responsive to this call?
Potentially, I think as stated in the FOA the primary focus is on adolescence, but if you do propose a study at the upper at the upper age range of eighteen and beyond please include a strong justification for that.
And we're just gonna pause here. See if other questions come in and I'm scanning for raised hands or.
Okay, could you clarify the definition of preventing ENDS escalation? Is quitting vaping among not establish vapers considered responsive to the FOA? And I'll give a reply and then Rachel, you want to please follow up.


That would be great. So, the focus of the FOA for preventive interventions, and for understanding, the impact of policies is to understand we're looking at prevention of the initiation or escalation of use.
So, for escalation. Presumably, this would be among adolescents who are already experimenting with ENDS but do not have ENDS use dependence.  So, this would be focused on the prevention of that escalation from initial use to abuse or dependence.
Rachel do you want to add anything? 


[Rachel Grana speaking]
Yeah, sure. I think that this I agree with Belinda and I also think that yeah, prevention of escalation can also be measured as, you know, behaviorally as well as the psycho, social interpersonal construct as well.
But it can, it would be good to reach out and talk about your specific ideas with one of us to ensure that it's still responsive. But I, I think that's what's intended by escalation of kind of definition.


[Belinda Sims speaking]
Will the size of the study be judged negatively, for example, if the study is in one county, or could be replicated or does a statewide intervention study, carry more weight?
Well, that's not an issue specifically addressed in the FOA, but I think you want to consider what is the, the goal or purpose of your research.
And if you wanna talk more about your specific study idea, I would encourage you to schedule a time to meet with Rachel or with me, and we can discuss your concept paper or draft specific aims in more detail.
So, if I correctly understand, we can submit a proposal for a prevention program intervention? 
Yes, the focus of this FOA is on prevention of ENDS use.
And scanning again, while, other questions come in.
I do not see any hands raised.


Can you talk a bit more about what you were looking for from partnerships from community school groups?
So, the studies may or may not be situated in communities or schools.
It could be in other types of settings and systems and in terms of the collaboration of a stakeholder, the intent is to conduct research that will most likely be relevant to the setting or system that your targeting.
And so, the addition of the stakeholder as part of the research team is a way to better integrate that perspective into the work. And that's why we requested that it part of the project.
Rachel, do you want to add anything? 


[Rachel Grana speaking]
No, I think that covers it Belinda. That clarifies the intent and that it's you can think more broadly than just community school.
I guess while we have the time, I mean, I think, this is Rachel again, another thing to consider is how, you know, just to if you're choosing your partner and the stakeholder community that you're partnering with, you know, it's important to think of the feasibility and the established relationships and all those kinds of things.
So, I think that if, if that's what the questions about it, you know, should be in, it will be if it's a big part of your application needs to be very well developed and do best to be very well explained and integrated.


[Belinda Sims speaking]
Yes, very good advice. Okay. We'll just take a pause to see if other questions are coming in over the chat.
And I just like to ask Jorge if you can hear me, if it's possible to please try to capture the questions that we've had so far so that we can be sure to follow up on them if we can post this information to our website.


[Jorge Vizcaino-Rios speaking]
Sounds good. 


[Belinda Sims speaking]
Thank you.
Okay, I'm not seeing any other questions.
Give it a few more minutes.
And I would encourage you all if you do have questions about your particular projects to please reach out to Rachel or to me. And um that's what we're here for.
Okay, can we see your last slide? 


[Rachel Grana speaking]
Belinda, I think there was one more about how long the follow up is expected or recommended. Do you see that one in the chat? 


[Belinda Sims speaking]
Oh, yes. Yes.
That's a great question. Do you want to start or I can start and you follow up, either way. 


[Rachel Grana speaking]
So, go ahead. 


[Belinda Sims speaking]
Thanks. Okay. I will say something that probably sounds a little repetitive, but in terms of how long will follow up, how long of a follow up is expected, or recommended for our end outcomes.
I think it will determine be determined by the focus of your project, the age of your target population, the types of outcomes that you have selected.  But you want to propose something that will give you the opportunity to determine your primary outcome of focus.
So, we have not set a specific a requirement for any particular length of an outcome.  Applications can be up to five years, which provides some flexibility for developmentally appropriate follow up periods.


[Rachel Grana speaking]
I agree. Thanks Belinda. 


[Belinda Sims speaking]
And the last slide that I'm showing on the WebEx right now, those are all of the contacts for the FOA.
All right, we will give it two more minutes. If there are no other questions we'll end early. But we have time if there are more questions.
Okay, and I hope everybody's okay with the silence, which doesn't bother me while we're waiting for more questions.
Okay, if there are no other questions coming in.  Let's see.  From Rachel to everyone great, great questions. Everyone please reach out to one of us with further questions or to follow up.
Excellent. Thank you, Rachel.
So given that there are no other questions. I think we're going to conclude this Pre application webinar early and we encourage you to reach out if you have any other questions between now, and the application receipt date, which is October, nineteenth two thousand and twenty, which is a Monday. Alright, thank you, all, for participating.
Stop recording.  Thanks
everybody. Please do reach out. We're happy to hear from you.