VIRAL HEPATITIS AND HIV IN DRUG AND ALCOHOL USERS Release Date: January 11, 2000 RFA: DA-00-006 National Institute on Drug Abuse National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: February 28, 2000 Application Receipt Date: March 28, 2000 THIS REQUEST FOR APPLICATIONS (RFA) USES THE MODULAR GRANT AND JUST- IN-TIME CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism invite applications for cross- disciplinary research on viral hepatitis and HIV/AIDS in drug and/or alcohol users. This RFA is intended to address gaps in prevention, natural history, pathogenesis, and treatment research related to viral hepatitis infection in drug and/or alcohol users, both with and without concomitant HIV infection, with an emphasis on research related to co- infections. Epidemiologic studies demonstrate that hepatitis C (HCV) and hepatitis B (HBV) are endemic among injection drug users (IDUs), as well as those that abuse alcohol. Common risk factors in drug users,, such as multi-person use of syringes, have resulted in high prevalence rates for HCV, HBV, and the human immunodeficiency virus (HIV) infection. Improved approaches to prevent acquisition and ongoing transmission of infection are urgently needed, as are strategies to improve access to diagnostic screening and care. Factors determining progression and outcome in drug users infected with HCV are not well understood, nor are the consequences of concomitant infections and ongoing drug use. Few data are available regarding the effectiveness of behavioral and biomedical interventions in drug users. In HIV-HCV co-infected individuals, there is increasing evidence that HIV seropositivity accelerates HCV-related liver fibrosis progression. Alcohol consumption in this population increases the risk of progression to end-stage liver disease. This RFA will support epidemiologic, prevention, clinical and basic research on the acquisition and transmission of infection, on the clinical course and consequences of infection, and on the design and effectiveness of behavioral and medical interventions for reducing risk behaviors, disease transmission, morbidity and mortality. Researchers are encouraged to utilize and integrate complementary methodological approaches in their study designs, including epidemiology, ethnography, prevention science, virology, and clinical medicine. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This RFA, Viral Hepatitis and HIV in Drug and Alcohol Users, is related to the priority areas of alcohol and other drugs, HIV infection, and sexually transmitted diseases. Potential applicants may obtain a copy of Healthy People 2000 at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanism of support for this RFA will be the investigator-initiated research project grant (R01). Applicants are advised to contact NIDA or NIAAA program staff listed under INQUIRIES for additional information. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Specific information on individual research mechanisms can be obtained from the NIDA home page at http://www.nida.nih.gov/Funding.html. Support may be requested for a period of up to 5 years for R01 grants. Modular budgeting procedures apply for grants up to $250,000. See http://grants.nih.gov/grants/funding/modular/modular.htm for further information about modular budgets. FUNDS AVAILABLE NIDA intends to commit approximately $1,500,000 in FY 2000 to fund approximately four to five new grants in response to this RFA. NIAAA intends to commit approximately $1,000,000 to fund approximately three to four new grants. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of NIDA and NIAAA provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Background Research in both domestic and international populations of IDUs has demonstrated consistently high rates of HCV infection, and IDUs account for the majority of incident HCV cases acquired annually in the United States. Studies also demonstrate high incidence and prevalence rates for HBV infection in IDUs. Research has shown that acquisition of HBV and HCV can occur rapidly following initiation of injection drug use, with very high rates of new HBV and HCV infection occurring among new injectors within the first year of injection. Co-infection rates for HBV, HCV, and HIV tend to cluster among IDUs and are characteristically endemic among experienced IDUs. Research has also revealed a higher risk of HIV and HCV maternal-to-infant transmission from mothers who are co- infected with both viruses. While studies have established that the major mode of acquisition of hepatitis in drug users is through parenteral drug use, the roles of non-parenteral drug use and high-risk sexual behavior in the acquisition and transmission of HCV are poorly understood. Epidemiologic data highlight a need for prevention research that targets at-risk groups of adolescents and young adults, non-injecting drug users, non-injectors transitioning to injecting drug use, persons who have initiated drug injection, and experienced injectors. Comprehensive intervention approaches to improve access to infection screening and HBV immunization to prevent ongoing transmission from already infected drug users and to reduce morbidity associated with continued drug and alcohol use are critical. Research gaps remain in understanding the pathogenesis of multiple viral infections, the impact of drug or alcohol use and other factors on disease progression, and the clinical consequences of infection in drug and/or alcohol users with multiple acute and chronic health conditions. Given the large population of drug and/or alcohol users infected with both hepatitis and HIV, there is a need for initiating studies to address treatment issues for drug and/or alcohol users with both single and concomitant infections. Few data are available regarding therapeutic effectiveness, hepatotoxicity, drug interactions, and clinical outcomes. Areas of Research Focus This initiative will support research in the following areas: (1) the epidemiology of acquisition and transmission of single and co-occurring blood-borne infections, 2) the behavioral dynamics and drug use-related processes associated with the acquisition and transmission of viral hepatitis and HIV infections, including factors which influence transitions from non-injection to injection drug use and their implications for the development of prevention interventions, (3) the adaptation, replication, and testing of community-based outreach prevention interventions to extend the lessons learned from HIV intervention research in preventing the spread and co-occurrence of HIV, HBV, HCV, (4) the impact of syringe access and needle exchange programs on the incidence, prevalence, and transmission of viral hepatitis and HIV infections, and as points of access to facilitate entry to drug treatment and ancillary social, health, and medical services, (5) the natural history of single and co-occurring blood-borne infections, in both acute and chronic infection, (6) the viral, immunologic, genetic, and drug/alcohol use factors which may influence susceptibility, recovery and persistence, and progression of one or more viral diseases, (7) the association of viral loads and viral load fluctuations relative to demographic characteristics, sexual and drug/alcohol using behaviors, and HIV virologic and immunologic status, (8) the social, behavioral, and medical consequences of viral hepatitis and HIV for drug and/or alcohol users, (9) the strategies for improving access to and delivery of biomedical interventions to drug users, such as HBV vaccines, available therapeutic agents, and screening/testing and counseling services, (10) the effectiveness of biomedical interventions, the consequences (e.g., drug interactions, hepatotoxicity) of multiple therapeutic interventions, and the development of improved clinical management approaches, (11) the bioethical considerations involving availability of care to drug users and provider attitudes regarding the inclusion of drug users in research and in clinical management approaches, and (12) the role of alcohol use in the progression of liver fibrosis to end-stage liver disease in individuals with HCV-HIV co-infection. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale or justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, published in the Federal Register on March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning these policies. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA’s home page at http://www.nida.nih.gov/ or may be obtained by calling (301) 443-2755. LETTER OF INTENT Prospective applicants are asked to submit by February 28, 2000, a letter of intent that includes a descriptive title of the proposed research, the name, address, telephone number, and institution of the Principal Investigator, the names of other key investigators and their respective institutions (if applicable), and the title and number of this RFA in response to which the application will be submitted. Although a letter of intent is not required, is not binding and is not a factor in the peer review of the application, the information it contains is helpful in planning for the review of applications. The letter of intent is to be sent to: Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, E-mail: GrantsInfo@nih.gov. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested, as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers, and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page (see http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages). At the top of the page, enter the total Direct Costs requested for each year. This is not a Form page. Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (Direct plus F&A) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested Modular Direct Cost amount. Include the letter of intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the Form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, and - List selected peer-reviewed publications, with full citations. CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the title and number of this RFA must be typed in Item 2 on the face page of the application form, and the YES box must be marked. The RFA number must be typed on the label as well. The sample RFA label is available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf and has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Director, Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) Applications must be received by March 28, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Research (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by NIDA. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council on Drug Abuse or the National Advisory Council on Alcohol Abuse and Alcoholism. REVIEW CRITERIA The goals of NIH-supported research are to advance the understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. (1) Significance: Are the goals and objectives of this application relevant to this RFA? Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: The adequacy of plans to include both genders, minorities, and their subgroups, as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The adequacy of plans to make data available to other investigators in a timely fashion. The reasonableness of the proposed budget and duration in relation to the proposed research. The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. The adequacy of plans for including children as appropriate for the scientific goals of the research. Schedule: Letter of Intent: February 28, 2000 Application Receipt Date: March 28, 2000 Council Review: September 2000 Earliest Start Date: September 29, 2000 AWARD CRITERIA Award criteria that will be used to make award decisions include: scientific merit as determined by peer review, availability of funds, and programmatic priorities. INQUIRIES Inquiries concerning this RFA are strongly encouraged. The opportunity to clarify issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Elizabeth Lambert, M.S. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse 6001 Executive Boulevard, Room 5198, MSC 9593 Bethesda, MD 20892-9593 Telephone : (301) 402-1933 FAX : (301) 443-4100 E-mail: el46i@nih.gov Thomas F. Kresina, Ph.D. National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Room 402, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-6537 FAX (301) 594-0673 E-mail: tk13v@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX : (301) 594-6847 E-mail: gf6s@nih.gov Nancy Brennan Budget Officer National Institute on Alcohol Abuse and Alcoholism PFMB Willco Bldg, Suite 412 6000 Executive Boulevard Bethesda, MD 20892-7003 Telephone: (301) 443-9735 FAX: (301) 443-8634 E-mail: nbrennan@wilco.niaaa.nih.gov Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone : (301) 443-2755 FAX: (301) 443-0538 E-mail: tl25u@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and are administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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