Key Dates

Related Announcements

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-20-195 - NIH Exploratory/Developmental Research Project Grant (Parent R21 Clinical Trial Not Allowed)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute on Drug Abuse (NIDA)

National Institute of Mental Health (NIMH)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to communicate special interest in epidemiology investigations to quantify the impact of the coronavirus disease 2019 (COVID-19) pandemic on Human Immunodeficiency Virus (HIV) prevention, incidence, transmission, and outcomes. This NOSI encourages research on the impact and strategies needed to adapt the HIV/AIDS response through agile and innovative support of prevention and care and the maintenance of sustained HIV viral suppression during the coronavirus disease 2019 (COVID-19) pandemic.

Background

HIV infections in the United States continue to be a major public health concern. There are an estimated 1.2 million American people living with HIV (PLWH), and 1 out of 8 people with HIV do not know they have it. HIV also remains one of the world’s most serious health and development challenges. The UNAIDS 2019 Report stated that there were 37.9 million PLWH globally with 1.7 million new HIV diagnoses and 770,000 deaths associated with AIDS-related illness during that year. Major global efforts have been mounted to address the HIV epidemic in the last 20 years and significant progress has been made. The number of people newly infected with HIV, and the number of deaths associated with AIDS-related illness have declined over the years, and the number of PLWH receiving treatment increased to 25.4 million in 2019.

Challenges continue to complicate HIV control efforts. Many PLWH or at risk for HIV infection do not have access to prevention, treatment, and care, and there is still no cure. At best, HIV is a chronic disease requiring vigilance for ongoing effective prevention of infection and therapy to allay disease progression and deter the risk of ongoing HIV transmission. Adherence to HIV medications is critical to maintain viral suppression while retention in care allows monitoring of resistance to therapies and changes in viral load and CD4 cell count. Furthermore, HIV testing and access to preventive PrEP therapies are critical to efforts aimed at controlling the HIV epidemic.

There is concern that the global COVID-19 pandemic has disrupted HIV treatment and prevention programs in ways that will lead to a rise in HIV transmission and in turn produce new HIV outbreaks. While the full impact of COVID-19 on HIV remains to be seen, it is estimated that such interruptions could result in many deaths related to HIV.

Recommendations to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) exposure may interfere with ongoing and consistent care for persons with chronic HIV or exacerbate behavioral risks such as substance use. The economic impact, food and housing insecurity, fear of contracting a second potentially serious disease, misinformation and stigma may also prevent persons from seeking needed medical care. As global travel and transport are disrupted, drug supply chains may be jeopardized. Medication shortages and delays for antiretroviral (ARV) deliveries can have critical consequences for maintaining individual viral suppression in PLWH and for prevention of ongoing HIV transmission.

The current COVID-19 pandemic has created a natural opportunity to explore, document, and quantify expected and unexpected consequences of a major world-wide disruption in HIV research, HIV prevention and treatment programs, and in the HIV continuum of care, clinical outcomes for PLWH, and world-wide risk of new outbreaks of HIV infection.

Research Objectives

This NOSI encourages research that can quantify and describe the impact of COVID-19 acute and post-acute disease on the HIV/AIDS epidemic in the United States and worldwide. PLWH may have systemic health disparities, co-morbidities, and socio-economic inequities that place them equally vulnerable to COVID-19. Public health mitigation efforts to control COVID-19 may create barriers to care for PLWH resulting in more severe disease and hospitalizations. This NOSI encourages research that can address and quantify the complicated cascade of events resulting from an acute respiratory pandemic on the existing HIV/AIDS pandemic, and the need for vigilant care to treat and prevent HIV transmission and outbreaks of new infections. Research into the interplay of protective effects, immunologic responses, and emergence of COVID-19 variants in PLWH is also needed.

Use of data science and epidemic modeling approaches such as forecasting with machine learning, analysis of electronic health records and other data sources, and modeling the complications of interruptions and disruptions in prevention and care are encouraged, as are investigations into local complications of health care burdens and barriers to HIV control.

Areas of Interest

NIAID Areas of Interest:

This NOSI seeks to promote research in epidemiology; social and behavioral sciences; and HIV prevention and clinical care. Areas of interest include but are not limited to:

• Improve our understanding of HIV risk, health seeking behaviors, and the complex contextual environment during an acute respiratory pandemic.
• Document and evaluate the impact of COVID-19 infection risk and disruption of HIV treatment on HIV transmission and HIV outbreaks.
• Evaluate how long-term systematic disparities and determinants of health associated with poor HIV health outcomes are exacerbated during the COVID-19 pandemic.
• Determine the contribution of HIV immunosuppression on COVID-19 co-morbidities and response to preventive vaccines.
• Investigate the emergence of SARS-CoV-2 variants in immunocompromised persons with HIV who may or may not have received COVID-19 vaccinations.
• Employ novel modeling and prediction methods to evaluate the intersection of HIV and COVID-19 pandemics.
• Assemble social, structural, behavioral data to model social and epidemic transmission networks for intersection and overlap of the two pandemics.
• Determine the impact of COVID-19 on HIV prevention and care during public health mitigation and isolation strategies.
• Capture, model, and create visualizations of geospatial disruptions in HIV care, treatment, and access to antiretroviral medications in the context of COVID-19 infection.
• Determine rates of changes in HIV viral suppression and hospitalizations due to COVID-19.

NIDA Areas of Interest:

The National Institute on Drug Abuse (NIDA) is interested in research at the intersection of substance use and HIV/AIDS in the Era of COVID-19, particularly the impact of the evolving COVID-19 pandemic and the public health response. Research may include, but is not limited to, the following:

• The impact of COVID-19 and pandemic-related policies as they may affect substance use patterns (e.g., changes in substances of common use, overdose, drug markets) and the consequences of these changes for HIV prevention and care.
• The impact of COVID-19 on services for HIV care, harm reduction, substance use treatment, and co-morbid conditions (e.g., HCV), including changes to service delivery methods and the ability of these services to provide adequate coverage.
• Assess COVID-19 vaccination coverage among people who use drugs, with attention to pattens of substance use, HIV status and HIV/substance use-related comorbidities, with consideration of individual and social factors that may mediate moderate coverage.
• Population-based research that considers impacts of COVID-19 on HIV acquisition and across the continua of HIV prevention and care among different populations of people who use drugs, with particular attention to considerations such as changes in insurance status, housing, income, and material insecurities.

NIMH Areas of Interest:

• Use of data science and epidemic modeling approaches such as forecasting with machine learning, analysis of electronic health records and other data sources, and modeling the complications of interruptions and disruptions in prevention and care.
• Use of data science approaches to examine the impact of mental health and mental health comorbidities, stigma, and other social behavioral determinants of health on HIV-related outcomes in the context of the COVID-19 pandemic.

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

• Clinical trials requiring an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application or assessing the safety of the intervention.
• Clinical trial planning activities for protocol development.
• Studies of mental health and mental health comorbidities, stigma, and other social behavioral determinants of health not linked to HIV-related outcomes (e.g., viral suppression, PrEP retention)

Application and Submission Information

Applicants must select the IC and associated FOA to use for submission of an application in response to this NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative. In addition, applicants using NIH Parent Announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those FOAs are acceptable and based on usual application-IC assignment practices.

This notice applies to due dates on or after September 7, 2021 and subsequent receipt dates through May 7, 2024.

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.

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-AI-21-057 (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

Scientific/Research Contact(s)

Rosemary McKaig, M.P.H, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3214
Email: rm434n@nih.gov

Richard A. Jenkins Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-1923
Email:jenkinsri@mail.nih.gov

Lori A.J. Scott-Sheldon, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-792-2309
Email: lori.scott-sheldon@nih.gov

Financial/Grants Management Contact(s)

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2899
Email: adevine@niaid.nih.gov

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
Email:pfleming@nida.nih.gov

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: siscor@mail.nih.gov