NAMHC Minutes of the 253rd Meeting

May 17, 2018

Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Mental Health Council

Introduction

The National Advisory Mental Health Council (NAMHC) held its 253rd meeting at 9:00 am, May 17, 2018 at the Neuroscience Center in Rockville Maryland. In accordance with Public Law 92-463, the session was open to the public until 12:30, and closed thereafter from 2:30 p.m. for consideration of grants applications. (See Appendix A: Review of Applications.) Joshua Gordon, M.D., Ph.D., Director of NIMH, presided as Chair.

Council Members Present

(Appendix B, Council Roster)

Chairperson

Joshua Gordon, M.D., Ph.D.

Executive Secretary

Jean Noronha, Ph.D.

Council Members

• Tami D. Benton, M.D.
• Randy D. Blakely, Ph.D.
• Benjamin G. Druss, M.D., M.P.H.
• Ian H. Gotlib, Ph.D.
• Alan E. Greenberg, M.D., M.P.H.
• David C. Henderson, M.D.
• Michael F. Hogan, Ph.D.
• Lisa H. Jaycox, Ph.D.
• John H. Krystal, M.D.
• Gregory A. Miller, Ph.D.
• Elyn R. Saks, J.D., Ph.D.
• Christopher A. Walsh, M.D., Ph.D.

Ad Hoc Members

• Cheryl King, Ph.D.
• Yael Niv, Ph.D.
• Neil Risch, Ph.D.
• Brandon Staglin

Ex Officio Members

Department of Veteran Affairs

• Amy Kilbourne, M.D., Ph.D.

Department of Defense

• Steven Pflanz, M.D.

Liaison Representative

• Paolo del Vecchio, MSW

Others Present at the Open Policy Session

• Cara Altimus, Milken Institute
• Erin Cadwalader, Lewis-Burke Associates
• Kurt De Soto, Association for Psychological Science
• Craig Fisher, American Psychological Association
• Karen Gibson-Serrette, Longevity Consulting
• Mel Gumina, Sign Language Interpreter
• Nathaniel Herr, Association for Behavioral & Cognitive Therapies
• Kelli Holmes, Sign Language Interpreter
• Michael Knopp, NIH Transcriber
• Eliseo Pérez-Stable, Presenter
• Elizabeth Scherer, Science Writer
• Anika Smith, Longevity Consulting
• Andrew Sperling, National Alliance on Mental Illness
• Paul Surgeonor, National Alliance on Mental Illness
• Fuller Torrey, Stanley Medical Research Institute
• A.J. Walker, National Assoc. of State Mental Health Program Directors
• Philip Wang, American Psychiatric Association

Open Policy Session Call to Order & Opening Remarks

Joshua Gordon, M.D., Ph.D.

NIMH Director, Dr. Joshua Gordon, opened the NAMHC meeting by welcoming Current and Ad Hoc Council Members, and the public. Following introductions, the Council unanimously passed a motion approving the final Summary Minutes of the January 25, 2018 meeting.

NIMH Director’s Report, Joshua Gordon, M.D., Ph.D.

Legislative Updates

Dr. Gordon briefly updated participants and attendees on recent NIMH interactions with the Congressional Neuroscience Caucus , noting that his joint briefing with NINDS Director Dr. Walter Koroshetz on The Brain Research through Advancing Innovative Neurotechnologies® (BRAIN ) Initiative was well received. Additionally, he reviewed the roundtables conducted with the Congressional Mental Health Caucus  (CHMC) on depression and suicide risk, youth suicide research, and prevention of suicide in older adults. Dr. Gordon said that the CMHC continues to express enthusiasm for supporting and increasing resources toward suicide prevention and research. This focus was further evidenced in NIMH staff meetings with various groups and representatives (including The Men’s Health Caucus , Rep. Tom Reed, the National Council for Behavioral Health  and the Medicare Access Coalition).

NIH/NIMH Budget

Noting that FY 2019 Appropriations Hearings for HHS and NIH were held on the same day as the Council meeting, Dr. Gordon stated that the Consolidated Appropriations Act of FY 2018 passed roughly six to eight weeks prior, with HHS receiving $78B and NIH, $37B. More specifically, $140M was added to the BRAIN Initiative, which brings total NIMH funding to $400M for FY 2018 and, as a result, allows the Institute to approach the funding target set by the BRAIN 2025 Advisory Committee to the Director. Dr. Gordon also pointed out that NIMH budget increases were proportionally aligned to other Institutes, culminating in a research project grants success rate of 23%. He added that with these additional funds, the Institute was pushing close to a $700M budget, correlating with anticipated funding for around 600 project grants.

NIMH Staff and Leadership News and Awards

Several NIMH staffers have received recognition in recent months, including: Megan Kinnane, Ph.D., (selected as Senior Advisor to the Director); Ann Wagner, Ph.D. (designated by the HHS secretary as Coordinator of the National Autism Committee); Karen Berman, M.D. (elected president of the Society of Biological Psychiatry); Jane Pearson, Ph.D. (recipient of the 2018 Society of Prevention Research Public Service Award); and Bill Potter, M.D., Ph.D. (Andrew Leon Distinguished Career Award). Dr. Gordon also highlighted the recent retirements of former NIMH Deputy Director Dr. Richard Nakamura, and former NIDCD Director Dr. James Batty. Dr. Noronha added that Nick Gaiano, Ph.D. has been selected as the new director of the Scientific Review Branch.

Workgroups

Dr. Gordon updated the Council members and meeting attendees on the Genomics Workgroup Report, emphasizing that communications disseminated via the website and social media are geared both toward informing investigators of principal recommendations, and ensuring that recommendations (e.g. appropriate, rigorous statistical methods, and unbiased genetic association trials/genes identification, etc.) are implemented and supported.

Additionally, he briefly reviewed Research Domain Criteria (RDoC) changes to the Matrix Workgroup, including standardizing revisions and evaluation of proposed changes and recommendations. He also noted that NIMH was interested in the proposed reorganization of positive valence domain by supporting studies to validate subconstructs through data.

NIH Large Cohort Studies, New Initiatives

Dr. Gordon stated that the 4th Annual BRAIN Initiative Investigators Meeting was especially notable for its dynamic interactions, and for helping reinforce NIMH need to disseminate new technologies to all investigators. He said that since the BRAIN Initiative is close to its halfway point, and the next step will be to determine strategic changes, given the technologies developed thus far. Changes will also be informed by public comments and suggestions. Additionally, the Adolescent Brain Cognitive Development (ABCD ) Study is underway, with more than 7,500 children recruited, and the first dataset with 4,500 participants released. Dr. Gordon said that ABCD is setting a new standard and paradigm for large future projects, with the goal to release data early and even prior to publication. Additionally, NIH’s All of Us  Research Program has launched, with the aim to consolidate data from various sources to enable dimensional constructs, thereby improving the predictive capacity of a variety of processes. Moving on to new initiatives, Dr. Gordon briefly discussed the Foundation for the NIH Biomarkers Consortium  which is focused on identifying and clinically validating biosignatures to improve diagnosis and targeted therapies, and the Helping to End Addiction Long-term (HEAL ) Initiative – a trans-agency effort to stem the opioid crisis and bolster cross-institutional prevention/treatment strategies for addiction and overdose.

HHS Updates

Dr. Gordon noted that during his first NIH visit, Health and Human Services Secretary Alex Azar met with NIH leadership, toured labs and held a Town Hall meeting. Dr. Gordon said that Azar is especially engaged on the subject of mental health. Secretary Azar also announced his strategic goals for FY 2018-FY 2022 , two of which are directly related to NIMH’s mission: 1) reducing the impact of illness and, 2) sustaining scientific advances.

Science Highlights

Dr. Gordon closed his update by briefly reviewing science highlights, ranging from the association between first psychotic disorder and mortality in adolescents and young adults, to neurobiological implications of central nervous system infections and community interventions in HIV. Other highlights included identification of genetic links to major depressive disorder, and basic neuroscience circuitry to extinguish fear.

Discussion

Dr. Gotlib inquired about the recruitment age for participants in the Alzheimer’s inflammation research, noting the benefit of data samples from younger individuals. Dr. Linda Brady, director NIMH Division of Neuroscience and Basic Behavioral Science, weighed in, noting that current samples had been previously collected from adults. Dr. Gotlib went on the record saying that he felt that it was “too late.”

Dr. Kilborne asked if the HEAL initiative was also exploring psychotherapies outside currently available pain therapies? Dr. Gordon answered that HEAL would encompass numerous multi-institute funding opportunities and strategies exploring alternative pain treatments.

Dr. Miller then inquired about future prospects for the NIMH budget, to which Dr. Gordon replied that there were no anticipated increases in FY 2018.

Dr. Hogan expressed interest in the interaction of opioid use/suicide. Dr. Gordon stated that although around 20,000 deaths are likely opioid-related, the association is unclear. He added that a multi-agency workgroup was exploring different strategies geared toward encouraging research at that specific intersection.

Brandon Staglin noted that alternative reality-style avatar therapy might be useful, prompting Dr. Gordon to add that it too, was under active investigation.

Finally, Dr. Kilborne (referring to the earlier question by Dr. Hogan) added that Veterans Administration research goals have prioritized suicide risk and opioids, and may be of some help to further initiatives in that regard.

NIMHD Updates, Eliseo Pérez-Stable

Dr. Pérez-Stable opened his discussion by providing a historical framework for the National Institute on Minority Health and Health Disparities (NIMHD), emphasizing that, as director, his focus has been to advance the science of minority health and health disparities while simultaneously maintaining the Institute’s legacy programs. Dr. Pérez-Stable acknowledged that federal categories and census definitions of racial/minority groups are limiting, but that the Institute continues to adhere to these definitions to explore health outcomes. Additionally, he stated that the integration of certain social determinants (e.g. income, physical environment, positive community interactions) and their long-term health influence inform current research efforts; this is especially important as socioeconomic factors affect health outcomes but have been largely ignored in clinical practice. These priorities are reflected in the reorganization of research areas that will now focus on clinical and health services, integrative biological/behavioral services, and community health/population sciences. He told the Council that among various research projects being funded, mental health outcomes among minority youth, and the association with peer support and health services, are important areas for potential collaboration. He closed with a review of future research directions, including developing data on the power of therapeutic relationships – namely primary care – to achieve health equity.

Discussion

Dr. Risch asked if NIMHD was exploring how to address multiracial, multiethnic identity. Dr. Pérez-Stable said that this is an increasingly important issue, given mixed race parenting and identity. However, he said that most people still identify with one group primarily (e.g. although the Census added the multi-race category in the year 2000, only 3% of the population checked that box), adding that he anticipates this to change and will play out in the next one or two decades.

Dr. Benton asked if there were any efforts underway to increase numbers of senior researchers conducting health disparities research. Dr. Pérez-Stable replied that he did not see this as being an issue since there were numerous established researchers funded by other Institutes doing similar work, as well as successful principal investigators in some NIMHD-funded centers. Dr. Benton then expressed the need for investigators interested in health disparities to find senior mentorship, to which, Dr. Pérez-Stable pointed out that it was a challenge across the NIH. He proposed the idea of distant mentoring.

Dr. Kilborne wondered if there were any opportunities to share best practices, not only in recruitment of people of color/other minority groups, but also, in terms of engaging underserved populations. Dr. Pérez-Stable replied that despite the lack of a universal standard and limited evidence supporting one approach over the other, it was essential for scientists and other researchers to go directly into communities and motivate community participation in research. He added that a consensus workshop could be held to possibly boost recruitment efforts.

Triennial Report on the Inclusion of Women and Minorities in NIMH Research, Andrea Beckel-Mitchener, Ph.D., Ashley Kennedy, Ph.D., MSCR

Dr. Beckel-Mitchener opened by acknowledging the role that Dr. Ashley Kennedy and team played in analyzing, evaluating, and presenting the data and slide summary. She stated that the Triennial Report is legislatively mandated to ensure that individuals are included in clinical research in a manner reflecting scientific questions being asked. Dr. Beckel-Mitchener emphasized several points, including: 1) data covered the breadth of NIMH-supported research, 2) compliance was ensured, and 3) recruitment was regularly evaluated to meet quality assurance standards, including ethnic/racial and gender categories. She noted that participant numbers, race, gender, and ethnicity across NIMH FY 2015, FY2016, and FY2017 were driven by the size of the Mental Health Research Network projects, and the ‘unknown category,’ largely by Detection of Spectrum Disorders study (there are large number of paper enrollees who historically do not report the demographic section). Nevertheless, she stated that phase 3 extramural research has relatively equal male/female breakouts with predominantly White, non-Hispanic participants. Dr. Beckel-Mitchener said that patterns across intramural studies are similarly consistent across all three fiscal years, with 85% to 90% of participants identifying as ‘non-Hispanic,’ with rates of ‘unknown’ and ‘Hispanic’ stable. She added that while Black and Native participants have slightly increased in number, the increase in not statistically significant.

Discussion

Dr. Miller asked if there was any way to improve representation in the studies? Dr. Beckel-Mitchener said that NIMH continues to examine best practices and noted that intramural programs were in place to improve minority outreach and participation. Dr. Miller countered with the point that most grants are noncompliant with regard to NIH representation standards and that it remains important to work on this issue. Dr. Gordon welcomed his comment, adding that reviews are conducted to ensure compliance at the program level, but that problem is pervasive across the NIH. Dr. Beckel-Mitchener also said that a bar will be placed on studies that slip past review until standards are satisfied.

Dr. Risch then asked if there was an explanation for lower Latino levels in studies compared to African-Americans, to which Dr. Beckel-Mitchener replied that there was none.

Dr. Niv inquired if there were data on inclusion of sex as a biological variable, and if the department had considered doing the same for race. Dr. Beckel-Mitchener pointed out that the slides were limited to the inclusion data but that the policy required studies to have sex as a biological variable. Additionally, while efforts were made to ensure this inclusion, delving deeper into gender-driven biological or racial distinctions are not currently required by policy.

Dr. King asked if there were any studies primarily recruiting racial and ethnic minority participants and if they were powered for scientific exploration? Dr. Beckel-Mitchener stated that there were studies targeting specific populations, and that she could provide that data at a later point.

Dr. Risch said that whether or not studies were sufficiently powered was a question consistently raised in grant reviews, and asked if findings from whites or other groups were extrapolated? Dr. Gordon interjected that there was a need to ensure that clinical studies were performed with samples that reflected the general U.S. population so that findings could be generalized, adding that there was a need across NIH to pay better attention to explicit disparities between ethnic groups and racial categories, as well as to underserved populations. With regard to specific initiatives that make up gaps (an issue also raised by Dr. Risch), Dr. Gordon referenced NIMH participation in the H3Africa Project , as well as projects targeting Native Americans. Dr. Risch added one additional thought, commenting that oversampling could likely be considered a political versus a scientific question.

Dr. Gordon thanked the Council for its questions, and Dr. Beckel-Michener for the report. A motion to approve was passed.

RDoC CMAT (Changes to the Matrix) Workgroup Update, Bruce Cuthbert, Ph.D.

Dr. Cuthbert opened his presentation by reviewing the genesis of the Research Domain Criteria project and the RDoC Framework. He explained that the goal is to study major domains of functioning as measured across multiple units of analysis (for example, brain circuit activity, behavioral task performance, self-reports of behavior or internal states), and that multiple dimensional constructs representing a normal-to-abnormal range of functionality resided in each domain. Using blood pressure and diabetes as analogies, he stated that shifts from normal range toward the tail of distribution (which represents various pathologies) provided interventional and even clinically preventive opportunities. Within this framework, the CMAT Workgroup was charged to develop a standardized process for submitting proposed changes, and then evaluate said changes so that final recommendations could be made to the Council. Noting the participation of several NIMH Advisory Council members on the CMAT Workgroup, he explained the evaluation process as well as criteria used to add or revise a construct. Regarding the rationale underlying revised positive valence constructs (PVS), he explained that the changes were made to more closely align with computational perspectives (a high priority for NIMH), as well as animal studies and neuroimaging. He added that they also added clarity and removed redundancy. Dr. Cuthbert emphasized that they were exemplars (rather than prescriptive) and represented a broad spectrum of research approaches that NIMH currently funds. He then provided an example of a proposed PVS reorganization alongside current organization, which outlines responses to positive motivational reward situations or contexts with proposed reward reinforcement subconstructs.

Dr. Cuthbert summarized by noting that the Committee is making progress and moving forward on newly defined domain – motor functioning – that he expects will be presented at the September Council Meeting. The Committee has also started examining negative valence. It will additionally be considering potential refinements to both the matrix and the criteria used to evaluate matrix changes.

Discussion

Dr. Krystal asked if there was any consideration of reversal learning or the flexibility of reversal learning when revising the PVS for motivational reward situations? Dr. Cuthbert commented that while this might fall under probabilistic and reinforcement learning, avoiding the so-called ‘grain size’ (grain factor) prevents the framework from becoming too unwieldy. He added that if someone were to present a reversal learning study that was orthogonal to DSM categories (thereby making it useful in a translational way), then the Council might consider it. However, he emphasized that there were no resources to create a ‘thorough encyclopedic compendium of all of these systems.’

NIMH staff member Dr. Janine Simmons commented that the example was a negative valence domain but that there were other domains in which constructs around learning, memory might overlap with the RDoC organization. Dr. Cuthbert responded that the classification system was artificial and agreed that many systems interacted to produce adaptive behavior.

Dr. Gotlib asked if there was any plan to move past constructs and subdomains and actually measure them (i.e., integrate across units within a sample to determine if the units should be included or if there were units that should be added)? While acknowledging the point, Dr. Cuthbert said that the goal had been to be heuristic and open so that people could use it in ways that were most useful and constructive.

He added that the working group would happily entertain suggestions and emphasized that decisions fall within the purview of the CMAT group.

Dr. Niv expressed confusion over the distinction between reward prediction error and reinforcement learning, and habits from reinforcement learning, etc. Dr. Cuthbert agreed, noting that some of it goes toward computational processes but that there were subtle differences as well. He then reiterated that the framework was created with basic research in mind so that it was accessible to the clinical community.

Dr. Gordon then interjected that one of the concept clearances approved previously by the Council that Dr. Ferrante and others are working to finalize, will address questions raised in the last few comments. He said that an initiative would be published asking investigators to test within constructs behaviorally and across multiple levels at their discretion.

Dr. Niv followed up on her previous question to ensure that investigators were not being asked to choose one RDoC version over another (i.e. 2.1 vs 2.2). Dr. Cuthbert confirmed, adding that it is impossible to code the RDoC grants, and that investigators could do both.

Mr. Staglin asked whether or not enough evidence had accumulated on the constructs to allow the development of treatment interventions based on them? Dr. Cuthbert stated that several proof-of- concept trials (including NIMH-funded studies) were starting but that practical considerations (e.g., how to measure precision medicine outcomes) needed to be worked out. Dr. Gordon then asked Dr. Cuthbert to comment on one or two current studies that might demonstrate the utility of the RDoC construct. Briefly, Dr. Cuthbert mentioned that there was a UT-Dallas study examining patients with psychotic spectrum disorders and that investigators had discovered three clusters (biotypes) that appear to better relate to aspects of neurobiology than to DSM diagnosis. He said that another group in Florida was evaluating anxiety disorders and their relationship between under-reactive (blunted) response and clinical impairment. He noted that utilization of the RDoC approaches would allow them to examine the developmental trajectory.

As RDoC group Co-Chair, Dr. Miller referred Council Members to the report in their handout that refers to specific definitions. Additionally, he reiterated the data-, field-driven intent of the RDoC, stating that the group was ‘following the field as much as leading it.’

Dr. Gordon thanked Drs. Miller and Cuthbert and asked for a motion to approve the reports. A motion to approve was passed.

Confirming approval, Dr. Gordon said that changes would be made to the Matrix as soon as websites updates were completed.

Concept Clearances, Lois Winsky, Ph.D., Michele Ferrante, Ph.D., Dianne Rausch Ph.D.

Dr. Gordon remarked that the public concept clearance announcements were geared toward shaping future funding initiatives and determining whether or not they should remain priorities for the Institute. Noting that time was limited for the concept clearance presentations, he encouraged Council members to send along additional questions or comments after the meeting.

Building in vivo Preclinical Measures of Circuit Engagement for Therapeutic Development, Lois Winsky, Ph.D.

Dr. Winsky introduced the first concept, noting that while NIMH RDoC project is aimed at providing a context and basis for heterogeneity in clinical presentation/treatment response of patients within categorical diagnoses, a parallel process in the preclinical space has been lacking. In an effort to improve the predictive value of preclinical assays in therapeutic development, there are two proof-of-concept studies geared toward identifying non-invasive neurophysiological measures that might potentially serve as predictive assays across preclinical species to humans. Consequently, this would limit speculative extrapolations of preclinical animal findings to humans. Using the example of prefrontal gamma power effects on reward-driven executive function, Dr. Winsky explained that the validation component might involve stimulating or inhibiting the dopamine circuits out to the prefrontal cortex to ascertain if physiology and underlying circuitry effects are similar (i.e. in vivo manipulation and direct measurement of underlying brain circuits). These responses would then be tested and compared to evaluate assay sensitivity, selectivity, and re-test stability.

Discussion

There were no questions from the Council, so Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Applying Computationally-Driven Behaviors for Back-Translation in Psychiatry, Michele Ferrante, Ph.D., Janine Simmons, M.D., Ph.D.

Dr. Simmons explained that the second concept related directly to the work of the RDoC project and Dr. Winsky’s team, reiterating that translational research requires the ability to investigate mental health questions and neural circuitry in both animals and humans. The Concept goal is three-fold: 1) studying mental health behaviors by defining sub-components (parameters); 2) specifying the relationship that exists between them, and then, 3) applying sensitive quantitative measurement techniques that can mathematically capture/parameterize their relationships across functional domains. Dr. Ferrante then explained that a computational model of behavior might be achieved by breaking down behavior into mathematically-described fine-grained parameters; this would result in a new behavioral theory that could then be experimentally validated and optimized. Dr. Ferrante stated that future responsive projects would identify well-defined, psychiatric-centric questions in behavioral science that reflect a dimensional process that links to a specific functional domain. Additionally, project goals would focus on behaviors that have not been extensively mathematically modeled (e.g. learning theory), have the potential for back-translation from humans to animals, and that readily lend themselves to computational, predictive analysis.

Discussion

Dr. Gotlib asked if Dr. Ferrante might explain why back translation to animals is a goal? Dr. Ferrante said that while preclinical animal studies might demonstrate why a drug stays in the system, they cannot extrapolate how cognitive function or other factors relevant to mental health are affected. Dr. Simmons interjected that back-translation is an eventual goal and that the concept is also an attempt to stimulate untested theories or ideas with the community. Dr. Gordon acknowledged that while this is a historical departure for NIMH, the ultimate goal is to move away from purely behavioral studies and explore neurobiological concepts and components that can be translatable by computational theory. Dr. Miller reinforced these statements, further explaining that these models are actually animal neuroscience models.

Dr. Niv then commented that the focus on discovering computational constraints, behaviors, or models that can differentiate large, unselected human populations might ultimate provide diagnostic value, noting that computational models are invaluable for tracking dynamics and change.

Dr. Gordon thanked the speakers and Council members and called for a motion to approve the concept. A motion to approve was passed.

Novel Imaging Approaches for the Detection of Persistent HIV in the CNS, HIV-associated Inflammation, and Molecular Pathology, Dianne Rausch, Ph.D.

Shifting gears, Dr. Rausch introduced the first of three concepts centered on HIV. She said that the goal was to encourage adoption of current and new imaging technologies for detection of persistent or latent and reactivated HIV, and HIV-induced pathology/pathophysiology and inflammation in the central nervous system (CNS) in people living with virally-suppressed HIV. She highlighted the need to detect HIV and its actions on supportive brain cells, microphages, microglia, etc. by harnessing novel imaging approaches combined with biomarkers.

As there were no questions from the Council Members, Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Addressing the Role of Violence in HIV Care and Viral Suppression, Dianne Rausch, Ph.D.

Dr. Rausch shared that the second HIV concept focused on the need to advance understanding of the role of past or ongoing violence on HIV care engagement, retention, medication adherence, and viral suppression, with the goal to develop and test novel interventions to improve outcomes. Noting that data demonstrate a clear association between women experiencing partner violence and antiretroviral therapy (ART) adherence and viral suppression, Dr. Rausch emphasized the importance of addressing this particular barrier. She added without addressing psychosocial conditions associated with poor HIV outcomes (such as partner violence), that achieving the World Health Organization’s 90-90-90 goals (i.e., diagnosing 90% of people living with HIV, linking 90% of diagnosed to ART, and achieving 90% viral suppression) was unlikely. Toward that end, Dr. Rausch briefly reviewed the need to stimulate studies to better understand the mechanisms through which violence affects outcomes in HIV, as well as understand the resilience among people who have experienced it. Interventions would be developed and tested that address these sequelae, multilevel factors (e.g., gender, violence norms), and determine the optimal combination of interventions to improve overall outcomes. She added that once identified and tested, scientific approaches to implementation might include HIV provider- and clinic-level screening and preventive services, incorporation of violence-focused interventions into existing HIV services, and optimization of HIV care delivery in conflict settings.

Discussion

Dr. Krystal noted that data suggest drug abuse affects HIV outcomes through its effect on CD4 cells transcriptomes, adding that it is possible that post-traumatic stress disorder (PTSD) increases ART resistance by direct transcriptional effects on various white cells. Hence, he wondered if there were any plans to include a medical biomedical piece to compliment service interventions? Dr. Rausch acknowledged the role that PTSD may have but noted that first the goal was to focus on the psychosocial area first in order to narrow the focus and improve the ability to target mechanisms for intervention.

Mr. del Vecchio suggested that Dr. Rausch consider the inclusion of people with serious mental illnesses (who are especially vulnerable to HIV, score lower on 90-90-90 goals, and are often victims of violence) in the concept development. Dr. Rausch agreed that it was vitally important, noting that a similar domestic effort had been conducted, and that it was a high-priority for global development.

Dr. Jaycox asked if international proposals were being encouraged. Dr. Rausch stated that the effort was both domestic and international.

Dr. Gordon then called for a motion to approve the concept. A motion to approve was passed.

Promoting Reductions in Intersectional StigMA (PRISM) to Improve the HIV Prevention Continuum, Diane Rausch, Ph.D.

Dr. Rausch introduced the last concept. Noting that stigma was a consistent and pernicious challenge to evidenced-based HIV prevention, she explained that the concept goal was threefold: 1) advance measures of interventional stigma, 2) examine the mechanisms or pathways by which testing, and care linkage are impeded, and, 3) develop and test interventions to overcome this barrier and improve HIV prevention services among key at-risk populations. She added that few studies have applied the concept of intersectional stigma (defined as multiple stigmatized identities, such as HIV, mental illness, gender, race, sexual orientation) to these issues. Referring to a framework developed by UNAID, Dr. Rausch briefly reviewed the following: 1) drivers of stigma (e.g., lack of awareness, fear, or infection, social judgement), 2) facilitators (e.g., institutional, cultural, or individual), and 3) how they intersect to ‘mark’ stigma. With regard to the last factor, Dr. Rausch explained that this referred to individuals who anticipate or internalize stigma or embrace the fact that they are ‘suboptimal.’ She said that because current interventions aimed at improving the HIV prevention continuum do not target factors (individual, culture, institutional) that maintain poor outcomes, that this research aimed to apply intersectionality theory to measurement and analytical approaches of intersectional stigma. She concluded by noting these efforts would ultimately culminate in interventions to overcome factors keeping the “AIDS-free generation” out of reach.

Discussion

Dr. Risch asked Dr. Rausch to explain what a ‘suboptimal person’ was? Dr. Rausch replied that the term referred to people (e.g., men who have sex with men or LGBT) who embrace that they have HIV and anticipate stigma in ways that make them feel less or suboptimal. Dr. Risch interrupted, asking it was a paraphrase for being discriminated against? Dr. Rausch concurred, adding that these people already feel less than optimal since that they have already experienced discrimination.

Dr. King stated that the concept of intersectional stigma raises minority health and health disparities issues and wondered how it might crossover to Dr. Pérez-Stable’s earlier presentation? Dr. Rausch said that it crosses over very closely and that a lot of the targets for these studies are minorities, sexual minorities, Black/Hispanic minorities, poverty, etc.

Dr. Gordon interjected, thanking Dr. Rausch and the Council and asked for a motion to approve the concept. A motion to approve was passed.

Dr. Gordon then asked the Council to forward along any further comments to Dr. Noronha or to the presenter.

Public Comment Period

Andy DeSoto, Assistant Director for Policy at the Association for Psychological Science (APS) extended his appreciation to NIMH and the Council for its continued support for behavioral research. He then advocated on behalf of APS, stating that the organization, while supportive of increased transparency and public reporting, has come out opposing NIH’s expanded definition of clinical trials. He encouraged NIH and the Council to continue consulting with members of the basic behavioral research community, and developing new policies related to this issue. Additionally, he introduced the Council members and public to APS’ new journal ‘Advances in Methods and Practices in Psychological Science’ and invited consideration as an outlet for practice or methods in the area.

Adjournment

The open session of the NIMHAC meeting adjourned at 12:30 p.m.

Joshua A. Gordon, M.D., Ph.D.

Closed Session

The grant application review portion of the meeting was closed to the public in accordance with provisions as set forth in Section 552b(c)(4) and 552b(c)(6). Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended. The closed session was set to resume at 2:30 p.m.

Appendix A

IRG Recommendation
Category	Scored #	Scored Direct Cost $	Not Scored (NRFC) #	Not Scored (NRFC) Direct Cost $	Other #	Other Direct Cost $	Total #	Total Direct Cost $
Research	668	$938,706,924	541	$651,057,025	0	0	1209	$1,589,763,949
Research Training	0	0	0	0	0	0	0	0
Career	80	$61,920,358	48	$37,787,219	0	0	128	$99,707,577
Other	0	0	0	0	0	0	0	0
Totals	748	$1,000,627,282	589	$688,844,244	0	$0	1337	$1,689,471,526

Appendix B

Department of Health and Human Services
National Institutes of Health
National Institutes of Health
National Advisory Mental Health Council
(Terms end 9/30 of designated year)

• Joshua A. Gordon, M.D., Ph.D.
  Director
  National Institute of Mental Health
  Bethesda, MD

Executive Secretary

• Jean Noronha, Ph.D.
  Director
  Division of Extramural Activities
  National Institute of Mental Health
  Bethesda, MD

Members

• Tami D. Benton, M.D. (19)
  Psychiatrist-in-Chief
  Department of Child and Adolescent Psychiatry And Behavioral Sciences
  Children’s Hospital of Philadelphia
  Philadelphia, PA
• Randy D. Blakely, Ph.D. (20)
  Professor
  Department of Biomedical Sciences
  Charles E. Schmidt College of Medicine
  Florida Atlantic University
  Jupiter, FL
• Benjamin G. Druss, M.D., M.P.H. (18)
  Rosalynn Carter Chair in Mental Health and Professor
  Department of Health Policy and Management
  Rollins School of Public Health
  Emory University
  Atlanta, GA
• Ian H. Gotlib, Ph.D. (20)
  David Starr Jordan Professor and Chair
  Department of Psychology
  Stanford University
  Stanford, CA
• Alan E. Greenberg, M.D., M.P.H. (20)
  Professor and Chair
  Department of Epidemiology and Biostatistics
  School of Public Health
  George Washington University
  Washington, DC
• David C. Henderson, M.D. (20)
  Chair
  Department of Psychiatry
  Boston University School of Medicine
  Boston, MA
• Michael F. Hogan, Ph.D. (18)
  Consultant and Advisor
  Hogan Health Solutions LLC
  Delmar, NY
• Lisa H. Jaycox, Ph.D. (20)
  Senior Behavioral Scientist
  Health Program
  Rand Corporation
  Arlington, VA
• Cheryl A. King, Ph.D. (21)
  Director
  Mary A. Rackham Institute
  Professor, Department of Psychiatry and Psychology
  University of Michigan
  Ann Arbor, MI
• John H. Krystal, M.D. (19)
  Robert L. McNeil, Jr. Professor of Translational Research
  Chair, Professor of Neurobiology
  Chief of Psychiatry, Yale-New Haven Hospital
  Department of Psychiatry
  Yale University School of Medicine
  New Haven, CT
• Gregory A. Miller, Ph.D. (20)
  Professor and Chair
  Department of Psychology
  University of California, Los Angeles
  Los Angeles, CA
• Yael Niv, Ph.D. (21)
  Associate Professor
  Princeton Neuroscience Institute
  Department of Psychology
  Princeton University
  Princeton, NJ
• Neil J. Risch, Ph.D. (21)
  Director
  Institute of Human Genetics
  Lamond Family Foundation Distinguished Professor In Human Genetics
  University of California, San Francisco
  513 Parnassus Avenue
  San Francisco, CA
• Rhonda Robinson Beale, M.D. (19)
  Senior Vice President and Chief Medical Officer
  Blue Cross of Idaho
  Meridian, ID
• Elyn R. Saks, J.D., Ph.D. Ad Hoc (20)
  Orrin B. Evans Professor of Law
  Gould School of Law
  University of Southern California
  Los Angeles, CA
• Brandon Staglin (21)
  Director of Marketing and Communications
  One Mind Institute
  Rutherford, CA
• Hyong Un, M.D. (17)
  Head of EAP & Chief Psychiatric Officer
  AETNA
  Blue Bell, PA
• Christopher A. Walsh, M.D. (19)
  Chief, Division of Genetics and Genomics
  Boston Children’s Hospital
  Bullard Professor of Pediatrics and Neurology
  Harvard Medical School
  Boston, MA

Ex Officio Members

Office of the Secretary, DHHS

Alex Azar
Secretary
Department of Health and Human Services
Washington, DC

National Institutes of Health

Francis Collins, M.D., Ph.D.
Director
National Institutes of Health
Bethesda, MD

Department of Veterans Affairs

Amy M. Kilbourne, Ph.D., M.P.H..
Director
Quality Enhancement Research Initiative
Health Services Research & Development
Department of Veterans Affairs, Ann Arbor
Ann Arbor, MI

Department of Defense

Steven E. Pflanz, M.D.
Air Force Director of Psychological Health
Mental Health Branch Chief
Air Force Medical Support Agency
Fall Church, VA

Liaison Representative

Paolo del Vecchio, M.S.W.
Director
Center for Mental Health Services
Rockville, MD