The National Institute of Mental Health is issuing this Notice to highlight interest in receiving grant applications focused on understanding and addressing the impact of mental health comorbidities, including mental health disorders as well as violence and trauma, on the HIV prevention and treatment continua.

In the U.S. and globally, mental disorders are prevalent among populations at risk for HIV acquisition and transmission, as well as people living with HIV (PLHIV). Exposure to violent or traumatic events is frequently comorbid with mental health disorders, and also impacts the HIV prevention and treatment continua. Mental disorders and violence/trauma are associated with increased HIV acquisition and transmission risk behaviors, and they may be a barrier to the uptake of HIV prevention tools such as HIV testing and Pre-Exposure Prophylaxis (PrEP), as well as HIV care and treatment.

There are numerous evidence-based interventions to improve mental health; however, there are gaps in our understanding of how to best address mental health comorbidities in the context of HIV prevention and treatment. The effect of efficacious mental health interventions on HIV prevention and treatment outcomes is mixed, and efficacious mental health treatment may need to be combined with effective HIV prevention and care interventions to maximally improve mental health and HIV outcomes. Some populations, such as perinatal women, have unique biopsychosocial factors that impact their mental health, but are understudied in terms of addressing mental health comorbidities to improve HIV prevention and treatment outcomes. Mental health comorbidities besides depression have rarely been addressed in HIV research, despite the high prevalence of disorders such as anxiety and post traumatic stress in people at risk for or living with HIV. Despite the high prevalence of violence exposures among people at risk for or living with HIV, there are gaps in our knowledge of the mechanisms through which violence impacts the HIV prevention and treatment continua; further, there are few empirically based interventions to address violence that have been shown to improve HIV prevention and treatment outcomes.

There is a need to deliver efficacious mental health and violence/trauma-related treatments in scalable and cost-efficient ways. Deployment of effective interventions depends upon a number of factors, including routine screening to identify individuals with mental disorders. Staffing and systemic changes in busy clinical settings may be needed for effective implementation of mental health interventions. Targeted implementation science can help to answer these key questions and produce generalizable knowledge regarding feasible and scalable approaches.

Areas of Research Interest

Areas of programmatic interest include, but are not limited to:

• Studies to adapt and test interventions designed to improve mental health and HIV prevention or treatment outcomes, along with examination of potential mechanisms of change.
• Studies to adapt and test interventions designed to address violence or trauma exposure to improve HIV prevention or treatment outcomes, along with examination of potential mechanisms of change.
• Studies designed to address mental health and/or trauma-related factors that adversely impact mobile populations, such as migrants, displaced people, and individuals who are homeless or marginally housed, in accessing and benefitting from HIV care and prevention services.
• Studies to evaluate differentiated models of mental health or trauma-related care for those at high risk for HIV transmission or acquisition or living with HIV who experience more mild mental disorder or trauma symptoms versus those with more severe symptoms or diagnoses.
• Studies to test approaches to integrating screening for mental health symptoms or trauma/violence into HIV prevention or care, and link to or provide appropriate levels of mental health/trauma-related care and HIV prevention or treatment.
• Studies to develop innovative models of integrated services to improve HIV- and mental health or trauma-related outcomes, along with examination of change mechanisms.
• Studies to test decision support tools to help individuals, couples, or providers make informed choices and utilize evidenced-based mental health/trauma and HIV prevention or treatment services.
• Studies to examine the impact of changes in policy/legislation that affect delivery of mental health or trauma-related care and HIV integration.
• Comparative effectiveness research to determine the relative effects of interventions for mental disorders or violence/trauma on HIV-related prevention and treatment outcomes.
• Cost-effectiveness studies to assess economic benefits of interventions addressing mental health or trauma/violence to improve HIV prevention and care outcomes.
• Studies designed to enhance understanding and identify modifiable targets of provider, clinic and systems-level factors that may impact capacity to implement evidence-based screening for mental disorders or trauma and provision of appropriate mental health/trauma services among persons at highest risk for HIV acquisition or people living with HIV.

It is strongly recommended that applicants review the NIMH Division of AIDS Research current Funding Opportunity Announcements (available on our website at https://www.nimh.nih.gov/about/organization/dar/aids-related-funding-opportunity-announcements-foas.shtml), and consult with a Program Officer before application submission.

The NIMH has published updated policies and guidance for investigators regarding human research protection and clinical research data and safety monitoring (NOT-MH-15-025). The application’s Protection of Human Subjects section and data and safety monitoring plans should reflect the policies and guidance in this notice. Plans for the protection of research subjects and data and safety monitoring will be reviewed by the NIMH for consistency with NIMH and NIH policies and federal regulations.

Application and Submission Information

This notice applies to due dates on or after May 7, 2020 and subsequent receipt dates through May 8, 2023.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-20-144, Innovations in HIV Prevention, Testing, Adherence and Retention to Optimize HIV Prevention and Care Continuum Outcomes (R01 Clinical Trial Optional
• PA-20-145, Innovations in HIV Prevention, Testing, Adherence and Retention to Optimize HIV Prevention and Care Continuum Outcomes (R21 Clinical Trial Optional
• PA-20-141, Formative and Pilot Intervention Research for Prevention and Treatment of HIV/AIDS (R34 Clinical Trial Optional)

• PA-19-126, Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Not Allowed)
• PA-19-127, Mentored Research Scientist Development Award (Parent K01 - Independent Clinical Trial Required)
• PA-19-116, Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Required)
• PA-19-117, Mentored Clinical Scientist Research Career Development Award (Parent K08 Independent Clinical Trial Not Allowed)
• PA-19-118, Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Required)
• PA-19-119, Mentored Patient-Oriented Research Career Development Award (Parent K23 Independent Clinical Trial Not Allowed)
• PA-19-052, NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)
• PA-19-129, NIH Pathway to Independence Award (Parent K99/R00 Independent Clinical Trial Required)
• PA-19-130, NIH Pathway to Independence Award (Parent K99/R00 - Independent Clinical Trial Not Allowed)
• PA-19-121, Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
• PA-19-122, Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Not Allowed)
• PA-19-272, PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PA-19-273, PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
• PA-19-270, PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-19-271, PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required)
• PAR-19-051, Emerging Global Leader Award (K43 Independent Clinical Trial Required)
• PAR-19-098, Emerging Global Leader Award (K43 Independent Clinical Trial Not Allowed)
• PAR-17-485, NIMH Research Education Mentoring Program for HIV/AIDS Researchers (R25)
• PAR-18-714, Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 - Clinical Trial Not Allowed)
• PAR-19-133, Academic Research Enhancement Award for Undergraduate-Focused Institutions (R15 Clinical Trial Required)
• PAR-19-134, Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Not Allowed)
• PAR-19-135, Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools (R15 Clinical Trial Required)
• PAR-19-283, Fogarty HIV Research Training Program for Low-and Middle-Income Country Institutions (D43 Clinical Trial Optional)
• PA-19-192, Ruth L. Kirschstein National Research Service Award (NRSA) Individual Fellowship for Students at Institutions Without NIH-Funded Institutional Predoctoral Dual-Degree Training Programs (Parent F30)
• PA-19-195, Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship (Parent F31)
• PA-19-196, Ruth L. Kirschstein National Research Service Award (NRSA) Individual Predoctoral Fellowship to Promote Diversity in Health-Related Research (Parent F31 -Diversity)
• PA-19-188, Ruth L. Kirschstein National Research Service Award (NRSA) Individual Postdoctoral Fellowship (Parent F32)
• PA-18-403, Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Grant (Parent T32)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

For funding consideration, applicants must include NOT-MH-20-013 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Scientific/Research Contact(s)

Teri Senn, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-761-7852
Email: [email protected]

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]