Key Dates

Related Announcements

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

PAR-19-368 - Accelerating the Pace of Drug Abuse Research Using Existing Data (R01 Clinical Trial Optional)

PA-20-183 - Research Project Grant (Parent R01 Clinical Trial Required)

Issued by

National Institute on Drug Abuse (NIDA)

Purpose

The purpose of this Notice is to encourage grant applications proposing research that makes use of available, large data sets with the objective of improving HIV epidemic modeling and service planning, with greater attention to the role of substance use. Data may be from NIDA-funded or co-funded projects as well as from other sources. This Notice is expected to increase the utilization of existing data including epidemiologic and clinic cohorts, longitudinal follow-up studies of interventions, as well as other publicly available data including those provided by government bodies, data warehouses and commercial data sources. Existing data may include data from completed projects as well as those that are ongoing.

Results from studies supported by this NOSI are expected to generate knowledge that can be used to answer significant questions about HIV epidemics, promote efficient provision of services, and address limitations of existing models that have guided public policy. NIDA is particularly interested in research that integrates substance use considerations into program planning and policy to increase the quality of HIV services and their responsiveness to substance using populations.

Background

The past limitations of HIV surveillance systems led to generation of a large, often influential literature that has modeled epidemic projections including the potential impacts of novel approaches to HIV prevention and care. This literature usually has neglected the impact of substance use even though epidemiologic research has indicated the importance of substance use as an attributable risk for HIV acquisition. Cross-validation of models rarely occurs although the small number of such studies have raised important questions about influential prior work, including that among substance use-related HIV epidemics. There also has been inattention to variations in epidemics within the US and other countries and how substance use may have influenced these variations, as well as change in epidemics over time.

Population-based data have evolved dramatically over the past two decades, including data that are useful for modeling HIV and substance use epidemiology and related services. HIV planning processes for Ryan White and Centers for Disease Control and Prevention (CDC) prevention funds no longer rely primarily on AIDS cases or testing data; HIV diagnoses are now routinely tracked longitudinally by public health authorities. Data warehouses such as those fostered by health departments and non-profit funders such as the Urban Institute at the regional and state level often enable aggregation of demographics, vital statistics and public health data that can help explain substance use and HIV outcomes. Insurance claims data have become more available to academic researchers along with electronic health records and commercially available prescribing data. New cohorts such as NIDA’s C3PNO collaborative, the expansion of the Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) collaborative within the (CFAR) and aggregations of existing cohorts such as the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) and the International epidemiology Databases to Evaluate AIDS (IeDEA) all provide opportunities to better understand HIV epidemiology and its clinical course. NIDA and other NIH Institutes support data archives such as the National Addiction & HIV Data Archive Program (NAHDAP) which include public use datasets from observational and clinical trial research.

The expansion of data sources has been paralleled by the development of new longitudinal data analysis techniques as well as new approaches to geographic analysis of data. This NOSI seeks to further methodologic advances and support the development and testing of new statistical methods to carryout modeling of epidemics and service provision. Substance use should be integrated into study aims and hypotheses in ways that reflect its roles in HIV risk and the ways it may impede consistent participation in prevention and care.

The full range of substance use will be considered including problematic, episodic use and substance use disorders, as well as a complete range of relevant substances (including alcohol and tobacco) and modes of substance administration, including injection and non-injection use. Substance use may affect transmission directly as in the case of injection or may affect HIV acquisition/transmission through sexual risk behavior or treatment adherence. Applications should provide an epidemiologic justification for the substance use scope that is addressed. Domestic and overseas intervention studies will be considered with particular attention to populations who have disproportionate burden of HIV infection.

Research Objectives

NIDA is interested in applications that make use of existing data, such as epidemiologic cohorts, clinic cohorts and longitudinal follow-up studies of interventions, as well as other publicly available sources of data including data warehouses and commercial data sources. Substance use should be a key component of any research supported by this NOSI.

This NOSI encourages, but is not limited to, research applications in the following areas:

• Broad population-based research questions applicable to HIV epidemiology and intervention.
  • Explaining decline in new HIV cases among People Who Inject Drugs (PWID) in the US prior to 2015.
  • Investigating the role of substance use in the HIV epidemic among women, including the decline of new diagnoses among women in the US since 2000.
  • Investigating the continuing role of methamphetamine and new HIV diagnoses among gay men in the US.
• Validation and recalibration, applying real world data related to substance use to models that have been influential to HIV policy, research, and program practice.
  • Evaluating the performance of models that informed the 2015-2020 National HIV/AIDS Strategy, with attention to factors such as the contributions of substance use to attributable risk and treatment adherence.
  • Evaluating the contributions of harm reduction and HIV treatment as prevention to the evaluation of PWID epidemics.
• Projects working in collaboration with national, state/provincial, and/or local HIV planning processes (e.g., Ryan White and CDC funding in the US; national AIDS programs, PEPFAR, etc. in international settings) to develop data-driven models to better estimate potential epidemic trajectories and optimize implementation of evidence-based interventions including those addressing an applicable range of substance use. Engagement of public health staff as co-investigators is preferred where this is possible. Projects should address novel, explanatory research questions that can move the field forward.
  • Evaluate the effect of increasing the range of available data, particularly data related to substance use, on epidemic forecasts and HIV prevention and care planning for states.
  • Evaluate how different types of data and different analytic techniques effect the prediction of HIV hotspots and outbreaks.
  • Evaluate how state and local health departments can increase their capacity for utilizing multiple data sources for routine planning and evaluation of HIV and related services.
• Models that combine multiple existing datasets that incorporate substance use in novel ways to generate new insights into key dynamics of HIV acquisition/transmission or HIV care and viral suppression, such as:
• • What accounts for the absence of HIV epidemics (or relatively low rates of new HIV diagnosis) in locales where factors related to HIV acquisition are present (e.g., relatively high STI rates, concentrated poverty, drug use epidemics)?
  • How do different drug markets affect rates of HIV acquisition?
• Development and testing of new statistical techniques for epidemiologic forecasting and service provision that can help guide program planning.
  • How can models better predict rare events such as HIV cases within large, heterogenous populations or potential for outbreaks among difficult to reach populations such as PWID?
  • What is the utility of machine learning and other contemporary techniques over simpler approaches to combining data?

Application and Submission Information

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

• PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PAR-19-368 - Accelerating the Pace of Drug Abuse Research Using Existing Data (R01 Clinical Trial Optional)
• PA-20-195 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

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-DA-21-007 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)

Richard A. Jenkins PhD
National Institute on Drug Abuse/Division of Epidemiology, Services and Prevention Research
Telephone:301-443-1923
Email: jenkinsri@mail.nih.gov