Notice of NIDDK Participation in PA-14-136 "Prevention and Treatment of Substance Using Populations with or at Risk for HCV (R21)"

Notice Number: NOT-DK-14-013

Key Dates
Release Date: April 7, 2014

Related Announcements
PA-14-136

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

The purpose of this Notice is to announce that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will participate, effective immediately, in PA-14-136, "Prevention and Treatment of Substance Using Populations with or at Risk for HCV (R21)".  The following sections of PA-14-136 have been updated to reflect NIDDK's participation in this FOA.

Part 1. Overview Information

Components of Participating Organizations
National Institute on Drug Abuse (NIDA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.279: 93.847

Part II. Section I. Funding Opportunity Description 

Research Objectives
This FOA offers the opportunity to conduct exploratory clinical and basic research focused on prevention and treatment of HCV for at-risk substance using populations, including those infected with or at risk for HIV. The R21 mechanism supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. This FOA would support, but is not limited to, research on the following issues:

  • Refining HCV screening technologies and testing algorithms to better characterize those populations at risk for HCV (e.g., rural and suburban young adult IDUs; HIV+ MSM with drug use);
  • Identifying individual, environmental, and relational network factors which place IDU at high risk for HCV and HIV acquisition and transmission;
  • Assessing the effectiveness of various strategies to improve HCV testing rates for asymptomatic and/or at-risk individuals in primary care, drug treatment, and/or other health care settings;
  • Evaluating strategies to facilitate access to RNA testing to confirm virologic status in those individuals who initially test positive on rapid HCV point-of-care antibody testing in non-medical settings.
  • Testing HCV/HIV preventive and risk reduction strategies among at risk populations;
  • Assessing current prevention efforts or developing prevention modalities for individuals injecting opiates formulated for oral use;
  • Developing strategies to maximize access to and engagement of at-risk populations in HCV/HIV treatment, including strategies to optimize HCV treatment adherence, particularly with DAA regimens;
  • Measuring the impact of engagement in HCV treatment and care on injection and non-injection drug users risk behavior and/or HCV/HIV transmission; 
  • Examining models of care to coordinate rapid point of care HCV testing and HCV/HIV prevention and treatment in various systems of care for at-risk populations (e.g., Federally Qualified Health Centers, emergency departments, drug abuse and opiate treatment programs, infectious disease clinics, criminal justice settings);
  • Assessing access to, use of, and effectiveness of newer HCV treatment regimens for at-risk substance using populations;
  • Assessing provider attitudes, issues, barriers regarding HCV screening and treatment for injection and non-injection drug users;
  • Measuring the capacity of treatment providers and related service delivery organizations to adopt and integrate HCV testing and preventive and treatment interventions
  • Testing community-based structural approaches to enhance HCV prevention and treatment strategies;
  • Investigating HCV treatment outcomes that take into account: HCV genotype; completion of treatment with or without sustained virologic response; race/ethnicity; age; coinfection (HIV) status; and comorbid conditions, e.g., neurocognitive status;
  • Exploring the role of genetic variability, epigenetic processes, and non-coding RNAs in HCV progression and treatment response in drug using populations;
  • Studying the drug-drug interactions between antiviral and DAA agents, drug of abuse, and medications used to treat substance dependence, and the best practices for managing them;
  • Employ in vitro and animal models to investigate drug-drug interactions between HCV protease inhibitors (telaprevir and boceprevir), drugs of abuse, and antiretroviral agents for developing strategies for safe and effective hepatitis C treatment;
  • Studying the impact of substance abuse and HIV infection on: 1) HCV disease progression in dually diagnosed HCV/HIV infected populations; and 2) in HCV 'superclearers' and in those who get re-infected.
  • Studying the frequency, risk factors and nature of HCV relapse after successful antiviral therapy focusing upon virologic, immunologic and host factors that might account for lack of solid immunity after recovery.

Part 2. Section VII. Agency Contacts

Scientific/Research Contacts
Edward Doo, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-4524
Email: Dooe@niddk.nih.gov  

Averell Sherker, M.D., FRCP (C) 
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-6207
Email:  averell.sherker@nih.gov

Financial/Grants Management Contacts
Florence Danshes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8861
Email: danshesf@niddk.nih.gov

Karin J. Mastrangelo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-443-3603
Email: Karin.mastrangelo@nih.gov

Inquiries

Please direct all inquiries to:

Edward Doo, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-4524
Email: dooe@niddk.nih.gov

 

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