Key Dates

Related Announcements

• May 12, 2023 - HIV Prevention and Alcohol (R34 Clinical Trials Optional). See NOFO PAS-23-172
• May 12, 2023 - HIV Prevention and Alcohol (R01 Clinical Trials Optional). See NOFO PAS-23-173
• January 11, 2023 - Formative and Pilot Intervention Research to Optimize HIV Prevention and Care Continuum Outcomes (R34 Clinical Trial Optional). See NOFO PAR-23-060
• January 11, 2023 - Innovations to Optimize HIV Prevention and Care Continuum Outcomes (R21 Clinical Trial Optional). See NOFO PAR-23-061
• January 11, 2023 - Innovations to Optimize HIV Prevention and Care Continuum Outcomes (R01 Clinical Trial Optional). See NOFO PAR-23-062
• May 10, 2020 - Dissemination and Implementation Research in Health (R01 Clinical Trial Optional). See NOFO PAR-22-105
• May 10, 2020 - Dissemination and Implementation Research in Health (R21 Clinical Trial Optional). See NOFO PAR-22-109
• May 07, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed) See NOFO PA-20-195
• May 07, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required). See NOFO PA-20-194
• May 05, 2020 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed). See NOFO PA-20-185
• May 05, 2020 - Research Project Grant (Parent R01 Clinical Trial Required). See NOFO PA-20-183

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Office of AIDS Research (OAR)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute on Aging (NIA)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

National Institute of Nursing Research (NINR)

National Institute on Minority Health and Health Disparities (NIMHD)

Purpose

The objective of this Notice of Special Interest (NOSI) is to solicit applications proposing research that is grounded in implementation science and can address the goals of the Ending the HIV Epidemic in the U.S. (EHE) initiative. The overall objective of the EHE initiative is to address the ongoing public health crisis by reducing the number of incident HIV infections in the United States by 75 percent by 2025 and by at least 90 percent by 2030, compared to the baseline infection rate in 2017. Projects will leverage research-community collaborations and scientific advances in HIV prevention, diagnosis, treatment, and cluster and outbreak response to advance the EHE goals, using innovations to tailor strategies to facilitate implementation and sustainability of evidence-based interventions in communities disproportionately impacted by HIV.

Background

The EHE initiative, coordinated by the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary of Health, focuses on four strategies:

• Diagnose all people with HIV as early as possible.
• Treat people with HIV rapidly and effectively to reach sustained viral suppression.
• Prevent new HIV transmissions by using proven interventions, including pre-exposure prophylaxis (PrEP) and syringe services programs.
• Respond quickly to potential HIV outbreaks to get needed prevention and treatment services to people who need them.

For this federal response, the National Institutes of Health (NIH) is collaborating with the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS), and the Substance Abuse and Mental Health Services Administration (SAMHSA) to support implementation research to address the four key strategies of the EHE initiative. Success of the EHE initiative depends on trusted partnerships among local and state health departments, communities, service providers, people with HIV or who have certain risk factors for HIV, and research institutions.

While efficacious HIV prevention and treatment tools, including new long-acting formulations, exist, uptake within community-based and clinical care settings remains suboptimal, limiting the number of individuals engaged in prevention, care, and treatment. More than half of people with HIV in the United States do not receive regular HIV medical care. People with HIV also frequently face comorbidities and coinfections that impact treatment and prevention efforts. Innovative delivery strategies implemented by multidisciplinary and/or multisectoral teams across diverse community settings are needed to improve the reach of testing, treatment, and prevention interventions. Implementation research is a key approach to identifying and understanding such strategies and to assessing their effectiveness in specific populations and geographic contexts.

Moreover, social and structural determinants of health—including poverty, homelessness, stigma, and discrimination, combined with factors such as mental health conditions and substance use disorders (e.g., alcohol, drug, and polysubstance)—underlie and contribute to inequities in HIV prevention, linkage to care, and optimal uptake of antiretroviral therapy (ART). Limitations inherent in some health care systems hinder the ability to serve communities highly affected by HIV and other structural and social challenges. Syndemic approaches integrate a variety of health care, social, and community services to address intersecting diseases and health conditions, as well as the social and economic barriers at the root cause of health disparities. Such approaches are increasingly recognized as essential in efforts to end HIV.

Implementation research is defined as the scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings to improve individual outcomes and benefit population health. Implementation research, therefore, seeks to understand and change the behavior of practitioners and support staff, organizations, consumers and family members, and policymakers to improve the adoption, implementation, and sustainability of evidence-based health interventions and guidelines. In addition to changing behaviors, implementation research also can understand and evaluate how to modify internal/external policies or procedures, norms, or other social and structural factors that are impeding implementation and sustainability of intervention delivery.

Implementation strategies are the actions taken to enhance adoption, implementation, and sustainability of evidence-based interventions.

Research Objectives

This NOSI invites research applications to advance the goals of the EHE initiative through implementation research in geographic areas with high HIV incidence. Studies of implementation strategies should build knowledge both on implementation outcomes, or overall effectiveness of the strategies, and on implementation mechanisms, or “how and why” the strategies are effective. Data on mechanisms of action, moderators and mediators, sustainability, and costs/cost-effectiveness of implementation strategies will greatly aid decision-making on which strategies work for which interventions, in which settings, and for what populations.

The proposed research must address one or more of the four EHE strategies (Diagnose, Treat, Prevent and Respond). Studies focused on syndemic approaches integrating HIV services with efforts to address intersecting health conditions and/or social determinants of health are strongly encouraged. Applications should include innovative approaches and study designs to enhance engagement efforts across diverse community settings interacting with people disproportionately affected by HIV, including public health agencies, health care organizations, health departments, behavioral health settings providing treatment for mental health conditions and substance use disorders, the criminal legal/justice system, faith-based communities, social service agencies, and implementing partners. It is expected that community-based and outreach approaches will be incorporated to remove or alleviate barriers to conventional prevention and treatment access. Communities and/or people with lived experience must be meaningfully engaged through shared partnership. 

NIH encourages applications led by or that include collaborations with a variety of institutions, including, for example, Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions (HSIs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Areas of programmatic interest include but are not limited to:

• Developing and testing strategies to expand engagement and re-engagement in HIV prevention, testing, treatment, care, and response services with a focus on populations that are disproportionately impacted by HIV and/or that are largely unreached by current programs, including but not limited to populations experiencing unstable housing or homelessness, or people who are currently or formerly incarcerated.
• Utilizing a syndemics approach to develop and test holistic, multicomponent interventions to sustainably address structural and other social barriers to care and retention (e.g., mental health conditions, substance use, medication adherence, management of chronic health conditions and comorbidities, housing instability, food insecurity, racism, poverty, transportation, stigma, etc.).
• Designing and testing integrated disease care models to address barriers to HIV prevention or treatment outcomes posed by chronic health comorbidities, including those associated with HIV and aging, and coinfections, including detection, prevention, and treatment of sexually transmitted infections (STIs).
• Assessing innovative community-based prevention and treatment strategies (e.g., peer community outreach, navigation for transitional housing programs, mobile health (mHealth), HIV self-testing).
• Developing and/or evaluating programs to reduce stigma and bias related to HIV, sexual orientation, patterns of alcohol use, drug use status, mental health conditions, and/or race and ethnicity.
• Leveraging information and communication technologies to improve engagement and retention in HIV prevention, treatment, and services, including integrated services addressing related health conditions.
• Developing and testing rapid implementation strategies to improve HIV testing, care, and prevention services among people in sexual and needle-sharing networks affected by rapid HIV transmission (e.g., clusters and outbreaks).
• Using nurse-driven approaches to enhance the implementation of community and population-based prevention approaches.
• Developing and testing interventions to address structural-level factors, including stigma, discrimination, social norms, and policies/laws that impact HIV outcomes.
• Developing effective dissemination approaches for communicating and integrating implementation knowledge to specific audiences, with the goal of scaling-up, replicating, and/or sustaining evidence-based strategies to improve HIV prevention, treatment, and response.
• Understanding and addressing provider, clinic, and systems-level factors that may impact the delivery of HIV prevention and treatment, including ART initiation and adherence, PrEP delivery, patient retention, and HIV nonoccupational post exposure prophylaxis (nPEP) delivery.
• Implementation strategies to adopt and integrate evidence-based health interventions to address stigma and bias related to HIV and HIV-related gender-based violence, focusing on interpersonal relationships across diverse contexts, including intimate partner and familial relationships as well as clinician-patient interactions, particularly experienced by older adults and individuals from minoritized populations such as sexual and gender minorities.
• Research to examine the potential impact of certain interventions such as HIV pre-exposure prophylaxis (PrEP) on health and on effectiveness of current measures to prevent the transmission of HIV through blood products and other therapeutic products of human origin.

Additional application requirements and information

• Applications must incorporate implementation science theories, models, and/or frameworks. In addition, if appropriate, applicants may consider using the implementation research logic model (IRLM) as a tool to describe and link the determinants, strategies, mechanisms of action, and implementation outcomes being studied.
• While not required, applicants may find the EHE Grant Resources, developed by the NIH-funded Coordination, Consultation, and Data Management Center (CCDMC), to be a helpful resource in developing their research proposals.
• Research must involve one or more collaborations with local implementing partners supported by CDC, HRSA, IHS, or SAMHSA. Community partners may include community-based organizations, public health agencies, health care organizations, health departments, behavioral health settings providing treatment for mental health conditions and substance use disorders, the justice system, faith-based communities, social service agencies, and other relevant parties.
• Applicants are encouraged to involve implementation/community partners early as they develop their research proposals to ensure data resulting from these projects will support local efforts to guide decision-making on prevention, care, and treatment needs at the local level.
• Research strategy should include attention to issues of resources expended, program costs, cost-effectiveness, or other economic outcomes related to dissemination and/or implementation.
• Applicants must include and describe a communication plan with implementing and community partners during the project period, including dissemination of outcomes agreed to by all parties.
• Research must focus on one of the geographically defined EHE priority areas: 48 counties, Washington, DC, and Puerto Rico, where the majority of the new HIV diagnoses are reported, as well as in 7 states with a disproportionate occurrence of new HIV diagnoses in rural areas.

Expectations around communication and reporting

• Recipients funded through this NOSI will have additional expectations around communication and reporting in support of the broader EHE initiative.
• Recipients are expected to work with the NIH-funded CCDMC to report project plans, progress, and outcomes on a quarterly basis. Recipients will work with the CCDMC to coordinate and harmonize outcome measurements.
• Recipients are encouraged to leverage implementation science resources available through the NIH-funded Regional Implementation Science Hubs, which include training, consultation, and technical assistance.  
• Recipients will be expected to participate in an annual meeting that will include other NIH-funded researchers working on implementation science to support ending the HIV epidemic, as well as federal staff and community partners.

The research areas below will NOT be supported through this NOSI:

• Research focused only on surveillance to identify people with HIV who are suboptimally engaged in existing HIV treatment programs.
• Interventions that are not substantially different from conventional service delivery that failed to engage patients with extensive adherence challenges.
• Drug or device safety trials with registration requirements.
• Studies that do not include a multidisciplinary team approach, including a community partner.
• Projects to develop de novo health interventions with a primary aim of testing efficacy.
• Research focused on identifying social determinants as risk factors, without implementing interventions.

Application and Submission Information

This notice applies to due dates on or after September 7, 2024, and subsequent receipt dates through January 9, 2026.

NIH ICs have other published NOFOs relevant to EHE that are not included in this NOSI. These NOFOs might be specific to each IC mission area.

Applicants are advised to consider the missions of the participating ICs and are encouraged to contact the appropriate Scientific/Research Contact(s) listed at the bottom of this NOSI prior to application submission.

Applicants must select the IC and associated NOFO to use for submission of an application in response to the NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that NOFO. Non-responsive applications will be withdrawn from consideration for this initiative.

Submit applications for this initiative using one of the following NOFOs or any reissues of these announcements through the expiration date of this notice.

In addition, applicants using NIH Parent announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those NOFOs are acceptable and based on usual application-IC assignment practices.

*NOTE : NHLBI will only accept mechanistic clinical trials in response to  PA-20-183 , in accordance with  NOT-HL-19-690 . Applicants wishing to propose non-mechanistic clinical trials may consider applying to one of the NHLBI clinical trial mechanisms described at  https://www.nhlbi.nih.gov/grants-and-training/clinical-trial-development-continuum . Non-mechanistic clinical trials submitted in response to this NOSI via  PA-20-183  will be withdrawn.

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

• For funding consideration, applicants must include “NOT-AI-24-059” (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 not be considered for the NOSI initiative.

Inquiries

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

Scientific/Research Contact(s)

Eric Refsland, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7193
Email: [email protected]

Rebecca Mandt, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-7695
Email: [email protected]

Shimian Zou, PhD
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-435-0074
Email: [email protected]

Ann Namkung Lee, MPH
National Institute of Aging (NIA)
Telephone: 301-496-6838
Email: [email protected]

Kendall J. Bryant, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-0332
Email: [email protected]

Sonia Lee, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-4783
Email: [email protected]

Vasundhara Varthakavi, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-2146
Email: [email protected]

Christopher Gordon, PhD
National Institute of Mental Health (NIMH)
Telephone: 240-627-3867
Email: [email protected]

Yewande Oladeinde, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-402-1366
Email: [email protected]

Leigh A. Willis, PhD, MPH
National Institute for Nursing Research (NINR)
Telephone: 240-687-1634
Email: [email protected] 

Amber Wilson, MPH
NIH Office of AIDS Research (OAR)
Telephone: 301-761-6314
Email: [email protected]

Financial/Grants Management Contact(s)

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2988
Email: [email protected]

Fatima Kamara
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-7916
Email: [email protected]

Laura Pone
National Institute on Aging (NIA)
Telephone: 301-451-9956
Email: [email protected]

Judy S. Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Phone: 301-443-4704
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Pamela Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email: [email protected]

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

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Susan A. Toy
National Institute of Nursing Research (NINR)
Telephone: 202-725-8503
Email: [email protected]