Technical Assistance Webinar: Streamlining Mental Health Interventions for Youth Living with HIV in Low and Middle Income Countries

Transcript

TERI SENN: Thank you for attending this technical assistance webinar to discuss RFA-MH-25-140, Streamlining Mental Health Interventions for Youth Living With HIV in Low- and Middle-Income Countries.

Before we get started, I have a few reminders. This webinar is being recorded. The recording, including the questions and answers, will be posted online following the webinar. Feel free to type any questions you may have in the Q&A box during the presentation and we will read them aloud during the question session.

The purpose of this webinar today is to provide information about the Notice of Funding Opportunity, or NOFO, and to answer general questions. If you have additional specific questions about your application, please contact Dr. Allison or Dr. Senn to schedule a meeting.

So I'd like to introduce myself and other presenters today. I'm Teri Senn, a program officer in the NIMH Division of AIDS Research where I oversee a portfolio of research focused on mental health and HIV prevention and treatment. Also joining us today is Susannah Allison.

Susannah, do you want to introduce yourself?

SUSANNAH ALLISON: Hello, everyone, and happy Friday. I'm Susannah Allison. I'm a program officer here in the Division of AIDS Research at the National Institute of Mental Health, and great to have you all join.

TERI SENN: We have Elizabeth Barr today also. Can you introduce yourself?

ELIZABETH BARR: Hi, everyone. I'm Elizabeth Barr, the Associate Director For Interdisciplinary Research at the NIH office of Research on Women's Health, and it is my pleasure to be with you.

TERI SENN: I'm going to start with some very brief background.

This topic was important enough to merit a Request for Applications. There are numerous evidence-based mental health interventions. However, in many settings these interventions are not being delivered to people living with HIV, in part because lengthy, individually delivered mental health interventions are often challenging to implement in HIV care, particularly in resource-limited settings. So there is a real practical need to provide clinics and funders with streamlined versions of mental health interventions that will still lead to improvements in mental health in HIV outcomes.

Thus, the purpose of this initiative is to use novel methods to streamline evidence-based mental health interventions for youth living with HIV so that they require fewer resources to deliver while still leading to clinically meaningful improvements in mental health and HIV outcomes.

So we wanted to break this down a bit and talk about some specific phrases and words we use in here.

What does it mean to streamline? Well, when we say that word, we specifically mean to use fewer resources to deliver than the initial version. This could be using fewer personnel, taking less time, for example, by shortening the intervention, using fewer clinic resources, requiring less training and supervision. Those are just some examples of what -- the things that could be streamlined.

And streamlining is the real focus of this RFA, Request for Application, and we hope that investigators will be creative in their approaches to streamlining.

Now, you can streamline the intervention itself or you can focus on streamlining the delivery of the intervention. And, also, you might want to think about whether or not you want to compare the streamlined version to the original version of the intervention or delivery strategy.

We also talk about evidence-based mental health intervention. So what does that mean? So that's an intervention that has a strong body of evidence documenting that it improves mental health. Some examples might include cognitive behavioral therapy, problem-solving therapy or interpersonal psychotherapy, but there are many others as well. And the choice of evidence-based mental health intervention will be up to the person submitting the application, but you will have to justify that there is an evidence base, that the intervention chosen improves mental health.

The purpose also mentions youth living with HIV. And just to note, the focus of this Request for Application is specifically on youth ages 13 to 24 who are living with HIV. And then we also mention in the purpose improvements in mental health and HIV outcomes. So part of this NOFO wants you to assess both mental health and HIV outcomes. Not one or the other; you need to propose both of those.

So just a few administrative pieces. There are five key dates to keep in mind. The first is the Letter of Intent, due date July 12th. A Letter of Intent is not required, is not binding, and does not enter into the review of the application. However, the information provided in a Letter of Intent allows us to better plan for a review.

So the letter should include a title, name, address and phone numbers for the principal investigators, names of other key personnel, participating institutions, and number and title of the funding opportunity.

Probably the most important date that you want to know if you're considering applying for this is the due date. Applications must be submitted via ERA comments by 5:00 p.m. local time on August 12, 2024.

If you're new to ERA comments, I recommend that you reach out to your Office of Research Administration as soon as you can as an ERA account can take a while to obtain.

And then I just wanted to note that the scientific review meeting will be held in November 2024. The Advisory Council review will follow in January 2025 with an earliest possible grant start date of April 2025.

Who is eligible to apply to this Notice of Funding Opportunity? Any individual with the skills, knowledge and resources necessary to carry out the proposed research is eligible to apply. For this specific Request for Application, we do note that applications must include at least one PI from an institution in the country where the research will be conducted.

Please note that all PIs must have an ERA comments account, and it's noted that can take a little bit of time to obtain if you don't already have one, and also applicant organizations themselves must complete and maintain several registrations, including System for Award Management, SAM, EI Comments, and grants.gov registration.

I will also note that U.S. organizations and non-U.S. entities or institutions are eligible to apply, and foreign components are allowed for this particular Request for Application.

So this NOFO, Notice of Funding Opportunity, is solely for RO1 applications, and there are a few things to know related to that. In terms of the budget, application budgets are not limited, but they should reflect the actual needs of the proposed project. The maximum project period is five years, and, again, the proposed project should determine the project period. It doesn't need to be five years; that's just the maximum.

And I also want to note that the RO1 mechanism often involves applications with preliminary data and/or those including longitudinal analysis or proposing a larger clinical trial.

I also briefly wanted to go over some relevant research topics. Please note that this is not an exhaustive list; this is just to give you a sense of some of the things that we might be looking for in this call, but you're not in any way held to applying for what's in this list.

And I'm not going to read -- all of these are in the Request for Applications that's been published. I'm not going to read through all of them, but maybe I'll just note a few of them.

So a lot of these are focused on streamlining the intervention. You could look at the optimal points to intensify or lessen a mental health intervention. You can determine the critical components that are needed to achieve important improvements in mental health and HIV outcomes. You could compare different doses of an intervention to determine what is the minimal dose that's needed to be efficacious. You could also focus on streamlining the delivery of the intervention.

So some ways that you could look at that might be to test the use of technology to lessen provider burden, testing different implementation strategies, or determining rules for intensifying low-intensity interventions for those who are not initially responsive.

The Office of Research on Women's Health has some specific areas of interest, so I'm going to turn it over to ELIZABETH BARR to talk about those.

ELIZABETH BARR: Thank you, Teri.

The Office of Research on Women's Health does not directly fund applications as we do not have direct grant-making authority, but we work with our institute partners like the National Institute of Mental Health to support research aligned with our office's priorities.

For this Request for Applications, our areas of specific interest include incorporating gender equity frameworks into existing evidence-based mental health interventions, interventions that are specific to adolescent girls and young women and led by adolescent girls and young women, and developing strategies to integrate social and structural considerations into existing evidence-based interventions.

I encourage folks to reach out to me if you would like to discuss the potential alignment of your project with our office's priorities further.

Back to you, Teri.

SUSANNAH ALLISON: Actually, I think I'm going to take over for now.

ELIZABETH BARR: I'm sorry. Susannah, then.

SUSANNAH ALLISON: Thank you so much, Elizabeth.

Next we want to go, then, a little bit more into the specifics of the RFA.

I really want to reiterate the point that it is very important to make sure that you read through the RFA in its entirety. There are a lot of aspects that need to be included, and some of which, if are not included, will mean that your application is withdrawn prior to review, and we don't want that to happen for any of you.

So some of the important research considerations, as we've touched on, probably the most important one is that you are proposing methods to streamline an existing evidence-based mental health intervention.

Another is that you are focusing on youth who are living with HIV who are between the ages of 13 and 24. Your application does not have to include this full range, but you should provide the age range that you will be targeting and provide a justification for that age range.

You will need to include a youth advisory board to provide input throughout the study. The research needs to be in a low- or middle-income country, as defined by the World Bank, for this fiscal year, 2024. And although task-shifting to workers with less mental health training may be a component, this cannot be the sole method proposed for streamlining. And you also need to include at least one PI from an institution in the country where the research will be conducted.

Next slide, please.

As has already been mentioned, you do need to include both an HIV care continuum outcome and a mental health outcome. You need to describe the evidence that supports the mental health intervention that you are using, that you are adopting or streamlining. You need to describe the epidemiology of HIV in youth in the country where the work is being proposed. You need to talk about the cadre of workers who will be delivering the intervention, and provide plans for their training, supervision, and the monitoring of fidelity.

A plan also needs to be included for how the research will ensure that the intervention is culturally relevant.

Please specify and justify the gender of individuals who will receive the intervention, and we also are asking for a letter of support from key stakeholders who would be involved in scaling up the intervention in the future.

Next slide, please.

As I mentioned, there are a number of aspects which, if they are not included in your application, will mean that the application is nonresponsive, and the application will not be reviewed. These are listed here and have been discussed already, but I'll just run through them quickly.

An application will be withdrawn if it does not propose methods to streamline an existing evidence-based mental health intervention, if the application does not focus on youth living with HIV somewhere between the ages of 13 and 24 -- again, does not have to -- the youth do not have to be that full age range, but they do -- youth do have to be within that age range.

Applications that do not include a youth advisory board will be withdrawn. Applications that are -- do not take place within a low- and middle-income country, as defined by the World Bank, will be withdrawn. Applications that use task-shifting as the only method of streamlining will also not be considered. And the last two are applications that do not include at least one PI based at an institution in the country where the research will take place and applications that do not include an HIV care continuum outcome and a mental health outcome.

Next slide.

Here are some of the considerations that reviewers will be thinking about when they review your research strategy, so it is important that you include this information in your research strategy section:

How you will be streamlining the intervention. You need to provide the age range and the justification for the age range, describe the youth advisory board, describe the evidence base for the intervention, describe the epidemiology of HIV in youth in the countries, describe the cadre of workers who will be delivering the intervention and include those plans for training, supervision, and the monitoring of fidelity. Describe how the team will ensure the intervention is culturally relevant, and describe and justify the gender of the individuals who will receive the intervention. You do not have to include all genders. You can focus on one gender if that is scientifically appropriate, but you do need to provide that justification in your application.

Next slide, please.

One issue that we have seen over the last two years is that applications are submitted that are clinical trials, but the research team did not indicate that it was a clinical trial in the application, and this is also a reason to withdraw an application prior to review. So we really want to make sure that you look very closely at the decision tree or whether or not something is an NIH clinical trial.

For example, a clinical trial -- whether or not something is a clinical trial is not determined by the size of the study or whether or not there is randomization. If you are delivering an intervention to one person, following them over time and assessing a health outcome, that would be considered a clinical trial for NIH.

So, again, please be sure to go through those four questions very carefully, and if you have any questions about whether or not your study is a clinical trial, please reach out to one of us.

Next slide, please.

Another really important new policy at NIH and within NIMH is the data management and sharing policies. I want to draw your attention to two of these policies on this slide.

The first is the NIMH data management and sharing policy that is listed here. A few key components of this policy are that data must be shared via the NIMH data archive, or NDA. You do need to include a plan in your application for how you are going to share your data with the NDA. There are a lot of -- there are some useful examples on the NIMH website.

Some key components of that plan include how you will obtain informed consent to share data, how you will be collecting information from individuals to be able to create a global, unique identifier, and also please be sure to include costs associated with following the data management and sharing policy.

A related policy is our policy on common data elements. So I recommend you reviewing this notice, which does lay out a number of required measures. These include age, sex assigned at birth, current gender, HIV status, anti-retroviral or prep use, anxiety, and depression. And there are different measures there based on the age of the participants.

We have a number of recommended measures. So these are things that -- measures that are not required but would be great to see that you are collecting. These include social determinants of health, stigma and discrimination, post-traumatic stress disorder, and if individuals -- well, all of the individuals will be living with HIV, so measures on regiment adherence, persistence to anti-retrovirals and retention and care, HIV care.

Next slide.

I think the last point that we wanted to make sure you are aware of is that we will be holding annual meetings in years 1, 3 and 5 of the award. The year 1 meeting will be virtual, but years -- the meetings in years 3 and 5 will be in-person, so please be sure to set aside some funds within your budget for the PI or PIs and key collaborators to attend that in-person meeting.

Next slide.

And, lastly, if you have any questions at all about the Request for Applications, about any of the information that we have presented during this webinar, please do not hesitate to reach out to myself, Dr. Senn or Dr. Barr.

I am not seeing any questions, but I -- it does look like people are joining on the phone and not through Zoom.

I'm not sure if we can -- what to do.

TERI SENN: Maybe we can give folks another minute.

Maybe just a reminder that if you do have specific questions, please put them in the Q&A if you were able to join via Zoom. If not and you're not able to put your questions in right now, we're happy to answer questions by email. We did just have our email addresses up, and those will be, I believe, in the recording. But, also, we are easily findable online if you search our names and NIH, so we would be happy to answer questions by email or to set up a time to talk with people about any administrative questions, or if you have questions about your aims or your specific area of research that you're proposing, we would also be happy to set up an individual call with you to talk about your aims.

So maybe we can give people just one more minute.

Please, if you do have questions, enter them in the Q&A. And if we don't receive any questions, then we'll hope that we will just have done an amazing job of explaining the RFA to you.

PHONE PARTICIPANT: Hi. Can you hear me?

TERI SENN: Yes, we can.

PHONE PARTICIPANT: Lovely. Okay. I'm so sorry. For some reason I'm unable to log into the Gov Zoom.

This is -- my name is Julie Dennison. I'm from Hopkins.

Did I miss or did you mention how important is cost analyses to this opportunity?

TERI SENN: Thanks, Julie. Our apologies. I do think that people have had trouble logging in via Zoom and have called in by phone, so I'm glad that we're able to get folks unmuted so they can ask questions.

You know, I think -- cost analyses are not required. So they are perhaps a component of streamlining, but I think it would depend on the study. And so I think we would be happy to take a look at your aims and chat with you about how cost analyses might or might not fit in with that.

PHONE PARTICIPANT: Okay. Great, thank you.

TERI SENN: I think that we do have a few other people that may be able to unmute themselves and ask questions.

Is that right, Susan?

EVENT PRODUCER: Yes. If you have a question, please unmute and introduce yourself and ask your question. Thank you.

PHONE PARTICIPANT: Go ahead.

PHONE PARTICIPANT: Go ahead.

PHONE PARTICIPANT: Okay. I'm wondering -- Christina (inaudible) I'm wondering if we could hear a little bit more about the youth advisory board, which details are you looking for? Are you looking for specific types of individuals ages or is it more of a broad-based requirement that there is a youth advisory board? Thank you.

TERI SENN: Thanks for that great question. So we do not want you to put specific names in your grant application, but I think that we would need enough information to ensure that the youth advisory board is reflective of the population that they're representing and advising on.

Susannah, I don't know if you have anything to add to that.

SUSANNAH ALLISON: Yeah, the only thing I would add is that there's enough information included to ensure that youth are being meaningfully engaged in the study process. There are no sort of -- there isn't any more specific requirements beyond the involvement of a youth advisory board. And, yeah, that should reflect the population being targeted by the intervention.

PHONE PARTICIPANT: Thank you.

PHONE PARTICIPANT: Hi. This is Mary Brough. Can you all hear me? All righty. And I'm at NYU Langone.

I heard loud and clear that youth living with HIV are the focus, but I was wondering if it would be considered kind of out of bounds or not -- not fit with the RFA if we were looking at a status-neutral group of youth, so, you know, including youth living without HIV but, you know, at risk for it, as well as youth living with HIV.

TERI SENN: That's a great question. I think you would need to make sure that you were addressing all of the requirements of the RFA, so, you know, I think a status-neutral approach has many benefits.

The RFA does specifically require the focus on youth living with HIV. So I think, you know, that might be another question that maybe we could get a look at your aims and set up a separate time to talk about it. I think there might be ways that you can do that that might meet with the needs of the RFA, but it would have to be done really carefully to make sure that it was addressing all of the required elements of the RFA.

PHONE PARTICIPANT: Thank you.

PHONE PARTICIPANT: This is Lisa (inaudible) from the University of Colorado. Thanks for this. I'm sorry (inaudible) log in.

My question was, with the focus on streamlining the interventions, is the expectation that then that will be also fully evaluated in an RCP? So, for example, there are study designs that allow you to sort of look at the effectiveness of streamlining an intervention without then going into a full RCP of that intervention versus the standard of care. I'm not sure if that makes sense as a question.

TERI SENN: Yeah. Hi, Lisa.

Again, that's a really terrific question, and one where we would probably need to look at your aims. I think it does require -- the RFA does require that you're assessing both mental health and HIV outcomes, so there needs to be some assessment of the impact of the intervention on mental health and HIV outcomes. So I guess, again, I'd like to see your aims and perhaps chat with you more about that just to make sure that what you were proposing was still meeting the requirements of the RFA.

PHONE PARTICIPANT: Sounds great. Sounds great. Thank you. Thanks.

TERI SENN: I think we might have a few more folks who can unmute themselves and ask questions if you have those.

SUSANNAH ALLISON: Just to let you all know, because I know some joined after, we will be posting a recording of this webinar, and so that will include the slides. Apologies for those of you who have not been able to join via Zoom and see the slides, but we will be posting them.

Also, we are open to questions via email. So please -- those email addresses will be in the slides or you can always Google us at NIH and find our emails that way as well.

Or I think we're listed on the RFA, of course, as well in the points of contact at the very end.

TERI SENN: Maybe we'll just give it one more minute to see if anyone else would like to unmute and ask a question.

PHONE PARTICIPANT: I've never called in to a meeting. I don't know if you can hear me.

TERI SENN: We can hear you.

PHONE PARTICIPANT: This is Dorothy (inaudible). Sorry, I had trouble with the Zoom link, and it sounds like maybe I'm not alone in that, but happy to be in the room.

I just had a question on budget. Being that the plan is a total amount but spread across a few awards, do you have any advice on what our aim should be for our budget cap?

TERI SENN: Yeah, so there is no specific cap, but the proposed budget should reflect your aims and should be appropriate for the aims that you're proposing. So I think if you have more specific questions about your aims and budget, again, we would be more than happy to set up a time to talk with you about that.

PHONE PARTICIPANT: Great. Thanks.

TERI SENN: Thank you. And, again, our apologies that the Zoom link was not working correctly.

And, again, we'll just give maybe one more minute for anyone on the phone.

I think I do see a few folks who have -- who are up here on our screen by phone but haven't unmuted, so I wanted to make sure if anyone else has any questions, they do have the chance to ask.

Great. Well, I think maybe -- hearing no additional questions, I think that we can wrap up. And, again, just please feel free to reach out to us. We'd be more than happy to talk with you about any specific questions that you have about this and to provide some technical assistance on your aims or concept.

We appreciate you joining today and persisting with us despite the technical issues.

SUSANNAH ALLISON: Thanks, everyone.

EVENT PRODUCER: Thank you.

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