The National Institute of Mental Health is issuing this Notice to highlight interest in receiving implementation research grant applications designed in partnership with domestic and global service providers. These applications should target the unique needs in jurisdictions, both in cities and rural areas, that have been disproportionally affected by the HIV/AIDS epidemic in the US, and globally.

Background

There is consensus among HIV/AIDS leaders in government, service, research, and the HIV/AIDS community that the goals set by domestic and global HIV/AIDS policy-makers to reduce incident HIV-infections are achievable for HIV testing, Pre-exposure prophylaxis (PrEP) initiation, treatment initiation, and viral suppression. There are now numerous examples where the combination of political will, adequate financing and human resources, access to prevention and treatment tools, targeted deployment of evidence-based intervention, and community mobilization and partnerships has resulted in 80-90% rates of population-level viral suppression. Notably, these successes have been achieved at country, province/state, city, and local levels. To continue to effectively implement evidence-based HIV prevention and treatment tools at scale, implementation science studies are needed to better understand the process at multiple levels; for example, context, culture, systems, organizations, providers, support staff, consumers and family members, and policy makers. Each of these factors and stakeholders can influence the adoption, adaptation, integration, scale-up and sustainability of effective tools and interventions.

However, to maintain these rates and to replicate these successes domestically and globally, the correct combination of efficacious behavioral, social, and biomedical interventions for HIV prevention and treatment must be taken to scale in places where critical components and supports are not optimal. Moreover, in some communities, there are oppositional forces and barriers that make achievement of HIV prevention and treatment goals even more challenging.

The US strategy for HIV prevention and treatment focuses on maximizing HIV diagnoses, initiation and sustainment of effective HIV treatment as early as possible, deploying PrEP and other effective prevention tools to those at highest risk for HIV, and responding and containing outbreaks of HIV infection when/where they occur. Success of these strategies depends on partnerships among local and state health departments, communities, service providers, and research institutions. This Notice seeks to strengthen the collaboration between NIH research grantees and the service delivery efforts of the federal agencies collaborating on this effort. This Notice encourages implementation research to advance the science and enhance the service delivery of the Centers for Disease Control and Prevention (CDC), the HIV/AIDS Bureau of the Health Resources Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA), the Indian Health Service (IHS), the U.S. Department of Veterans Affairs (VA), and state, city, and local public health departments.

Globally, HIV/AIDS prevention and treatment intervention targets are outlined in the PEPFAR 3.0 Strategy (https://www.pepfar.gov/documents/organization/234744.pdf) which underscores the importance of doing the “Right things, in the Right Places” to curb the epidemic. NIH-funded HIV/AIDS implementation science should correspond to the most urgent needs in the HIV/AIDS service community. As described above, implementation science to address these needs should address multiple levels of influence for adaptation, integration, scale-up and sustainability, and research must be coordinated with public health leadership and providers. Research is especially encouraged in collaboration with the entities and service platforms that provide the HIV/AIDS prevention and treatment that will achieve the 90/90/90 goals: i.e., PEPFAR, CDC, HRSA, WHO, USAID, UNAIDS, and other relevant Ministry of Health (MOH) - supported public health providers.

A guiding principle for targeted implementation science is that research teams are required to have academic and public health collaboration with service providers for the proposed research, in order to optimize the match of the research directions with local needs, and to optimize the public health impact of the research implementation and findings.

Areas of Research Interest:

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

• Studies designed to enhance HIV prevention providers’ (systems, providers, operational tools) capacity to target evidence-based interventions (EBIs) to the persons at highest risk for HIV in their communities.
• Studies to optimize the implementation (uptake, effectiveness, efficiency) of individual and/or combination prevention EBIs (e.g., behavioral/social risk-reduction, male circumcision, PrEP, condom provision), designed to maximize the optimal targeting, uptake, coverage, effectiveness, and efficiency of service provision.
• Studies to optimize the implementation (uptake, effectiveness, efficiency) of individual and/or combination EBIs designed to maximize HIV testing, linkage to HIV care, earlier treatment initiation, adherence and engagement HIV testing - that could include advancements in approaches and technologies.
• Studies to understand and address provider, clinic, and systems-level factors that may impact antiretroviral initiation, antiretroviral adherence, or patient retention, for the purpose of informing provider training, clinic practice, and healthcare policy.
• Studies of the impact of varying models of differentiated HIV care on HIV care continuum outcomes, which could include studies to evaluate optimal approaches to integrate community care delivery to include HIV prevention, care, and treatment with related services (mental and substance use disorders, sexually transmitted infections, family planning, prenatal care, malaria, tuberculosis).
• Studies to optimize the implementation of targeted interventions designed to reduce documented racial/ethnic, gender, and age-related disparities in HIV prevention and treatment outcomes.
• Studies designed to enhance understanding of the epidemiologic contexts for targeted interventions (e.g., accurate rates of testing, linkage, initiation and viral suppression that indicates gaps and targets for intervention).
• Studies of systemic interventions to influence organizational structure, climate, and culture, in order to promote organizational readiness and capacity for intervention adoption, and implementation with fidelity and effectiveness.
• Studies to understand, implement, and evaluate technological innovations (including media) in order to enhance the scalability of interventions.
• Studies of cost and cost-effectiveness of intervention delivery in real-world settings.
• Studies to understand the benefit of varying training methodologies (e.g., didactic training, clerkship, on-site mentoring, on-going consultation, internet-based courses) to prepare providers to offer HIV prevention and treatment services.
• Studies to examine the impact of changes in policy/legislation that affect delivery of HIV/AIDS-related prevention services and treatment.
• Studies to determine the impact of new payment mechanisms, including the cost-effectiveness of alternative treatments, services or structures for provision of services.
• Studies to identify, describe, or track individual, family, provider, organizational or systems-level outcomes resulting from changes in services or benefits.
• Studies to inform how best to replace or discontinue interventions, especially those that are less effective or ineffective as compared to best evidence-based practices. The study of this process, and the resulting outcomes, has been referred to as de-implementation.

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-20-024” (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)

Christopher Gordon, PhD
Telephone: 240-627-3867
Email: cgordon1@mail.nih.gov

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: siscor@mail.nih.gov