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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