Full Text NR-96-001
 
 
SYMPTOM MANAGEMENT OF PERSONS INFECTED WITH HIV
 
NIH GUIDE, Volume 25, Number 4, February 16, 1996
 
RFA:  NR-96-001
 
P.T. 34

Keywords: 
  AIDS 
  Nursing 

 
National Institute of Nursing Research
 
Letter of Intent Receipt Date:  April 26, 1996
Application Receipt Date:  May 15, 1996
 
PURPOSE
 
The National Institute Of Nursing Research (NINR) invites
applications for research related to interventions to improve the
care of individuals infected with HIV.  The purpose of this
initiative is to increase the quality of life of persons infected
with HIV by decreasing the negative impact of physical and
psychological symptoms associated with the disease, its complications
or treatment.
 
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 Request
for Applications (RFA), Symptom Management of Persons Infected with
HIV, is related to the priority areas of HIV infection and chronic
disabling conditions.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or
Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington,
DC 20402-9325 (telephone 202-512-1800).
 
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
 
This RFA will use the National Institutes of Health (NIH) research
project grant (R01).  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the
applicant.  The total project period for an application submitted in
response to this RFA may not exceed three years.  The anticipated
award date is September 30, 1996. Because the nature and scope of the
research proposed in response to this RFA may vary, it is anticipated
that the size of an award will vary also. This RFA is a one-time
solicitation.  Future unsolicited competing continuation applications
will compete with all investigator-initiated applications and be
reviewed according to the customary peer review procedures.
 
FUNDS AVAILABLE
 
Approximately $1 million in total costs for the first year will be
committed to fund applications submitted in response to this RFA.  It
is anticipated that three or four applications will be funded.  This
level of support is dependent upon the receipt of a sufficient number
of applications of high scientific merit.  Although this program is
provided for in the financial plans of the NINR, awards pursuant to
this RFA are contingent upon the availability of funds for this
purpose.
 
RESEARCH OBJECTIVES
 
Nearly one million Americans are estimated to be living with HIV
infection. These people face a current or anticipated loss of immune
function and the consequent development of opportunistic infections
and/or malignancies, which may eventually affect nearly all organ
systems.  Care of persons with HIV infection requires efforts to
forestall the immune system breakdown and to cope with the
multi-system, and often synergistic, clinical problems that result
from the disease and its treatment. Important goals include relief of
distressing symptoms resulting from the disease process, management
of side-effects of therapeutic regimens, prolongation of disease-free
intervals, and improvement of quality of life.  Of particular concern
are such problems associated with HIV infection as cachexia,
diarrhea, fatigue, cognitive impairment, peripheral neuropathies,
anxiety, and depression.
 
The management of some symptoms experienced by HIV-infected
individuals is largely based on clinical studies conducted on other
populations.  For example, care of HIV patients is based on
interventions to manage cachexia and cope with mouth ulcers tested
with cancer patients, strategies to cope with dementia developed for
Alzheimer's disease patients, methods to provide oral rehydration
developed for pediatric patients with diarrhea, and interventions to
reduce the impact of dyspnea developed for patients with other
respiratory problems.  The effectiveness of these interventions for
HIV patients is not documented nor is information available to assist
the clinician to appropriately adjust intervention strategies to meet
the specific demands of HIV infection and its sequelae.
Additionally, some symptoms that are particularly troublesome to AIDS
patients have not yet received adequate study in any population.  For
example, fatigue is especially debilitating for persons with AIDS,
yet further instrumentation and methodological refinement is needed
before interventions to manage fatigue can be adequately tested.
 
Of particular concern with HIV is the complexity of the symptom
experience.  Symptoms such as cachexia, fatigue, and depression tend
to co-occur, requiring complex intervention strategies to adequately
impact on patient outcomes.  Further descriptive data about the
patterns of such interacting symptoms and their exacerbation or
resolution over time would aid the design of appropriate
interventions.  Further testing of current interventions with large
enough samples to adequately analyze complex data sets would provide
better insight into the success or failure of these treatment
strategies.
 
This initiative invites applications that address the specific
physical and psychosocial problems faced by individuals infected with
HIV over the course of the disease and its treatment.  Research
projects should focus on developing, implementing, and evaluating
interventions directed at decreasing the negative impact of such
symptoms.  Examples of problems targeted by this initiative include
HIV wasting, diarrhea, taste disturbances, fatigue, dyspnea, skin
breakdown, pain, peripheral neuropathies, cognitive impairment,
depression, anxiety, sleep disorders, and social isolation.
 
Projects may be descriptive or experimental.  With adequate
justification of knowledge gaps,  baseline data may be collected and
analyzed that will enhance the development of clinical interventions.
However, where possible, interventions designed to ameliorate
designated symptoms should be evaluated for efficacy under conditions
that will permit comprehensive analysis of appropriate outcome
measures.  Such interventions must have the potential for
implementation into routine clinical practice.
 
Because of the complexities of the problems faced by persons with HIV
infection, a multi disciplinary research approach is recommended.
Expertise from immunology, nutrition, molecular biology, exercise
physiology, endocrinology, psychology and psychiatry, and other
health-related disciplines should be included as appropriate for the
target symptom and population.
 
Applicants are encouraged to make use of ongoing HIV or other medical
research efforts.  Applications from institutions that have an AIDS
Clinical Trials Unit (ACTU) or a General Clinical Research Center
(GCRC) may wish to identify these programs as a resource for
conducting the proposed research.  If so, a letter of agreement from
the program director or Principal Investigator should be included
with the application.  Applications are invited for support of
projects to address issues including, but not limited to:
 
o  the development of nonpharmacologic or multi-modal management
strategies to alleviate physical or psychosocial symptoms associated
with HIV infection, its complications, and its treatment.
 
o  the identification of underlying factors that explain differential
responses to clinical conditions and treatment regimens and methods
to address these factors.
 
o  the development or refinement of instruments to assess symptoms
and monitor changes resulting from interventions to alleviate these
symptoms, if such instruments are not currently available.
 
o  careful scientific observations of the natural history or clinical
course of symptoms occurring during the progression of HIV infection
and its treatment if such observation is needed to adequately
identify variables that can be clinically manipulated to reduce the
severity or impact of those symptoms.
 
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 and 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) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990. The new policy contains some
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted
in the NIH Guide for Grants and Contracts, Volume 23, Number 11,
March 18, 1994.
 
Investigators also may obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning the policy.
 
LETTER OF INTENT
 
Prospective applicants are asked to submit, by April 26, 1996, a
letter of intent that includes a descriptive title of the proposed
research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the RFA in response to
which the application may be submitted.  Although a letter of intent
is not required, is not binding, and does not enter into the review
of a subsequent application, the information that it contains allows
NINR staff to estimate the potential review workload and avoid
conflict of interest in the review.
 
The letter of intent is to be sent to:
 
Dr. Ernest Marquez
Office of Review
National Institute of Nursing Research
Building 45, Room Number 3AN-24
Bethesda, MD  20892-6300
Telephone:  (301) 594-2736
FAX:  (301) 480-8256
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev. 5/95) is to be used
in applying for these grants.  Applications kits are available at
most institutional offices of sponsored research and may be obtained
from the Grants Information Office, Office of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267,
email:  girg@drgpo.drg.nih.gov.
 
The RFA label available in the PHS 398 (rev. 5/95) 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 RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed, photocopies, in one package to:
 
DIVISION OF RESEARCH GRANTS
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:
 
Dr. Ernest Marquez
Office of Review
National Institute of Nursing Research
Building 45, Room 3AN-24
Bethesda, MD  20892-6300
 
Applications must be received by May 15, 1996.  If an application is
received after that date, it will be returned to the applicant
without review.  The Division of Research Grants (DRG) 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 DRG 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 DRG
and responsiveness by the National Institute of Nursing Research.
Incomplete applications will be returned to the applicant without
further consideration.  If the application is not responsive to the
RFA, DRG staff may contact the applicant to determine whether to
return the application to the applicant or submit it for review in
competition with unsolicited applications at the next review cycle.
 
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 the National Institute of Nursing Research
in accordance with the NIH peer review procedures.  As part of the
initial merit review, all applications will 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 applications under review, will be discussed, assigned a priority
score, and receive a second level review by the appropriate national
advisory council or board.
 
Review criteria for this RFA are generally the same as those for
unsolicited research grant applications:
 
o  scientific, technical, or medical significance and originality of
proposed research
 
o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research
 
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research
 
o  availability of the resources necessary to perform the research
 
o  appropriateness of the proposed budget and duration in relation to
the proposed research
 
The initial review group will also examine the provisions for the
protection of human and animal subjects and the safety of the
research environment.
 
AWARD CRITERIA
 
The anticipated date of award is September 30, 1996.  The following
will be considered in making funding decisions:
 
o  quality of the proposed project as determined by peer review
o  availability of funds
o  program balance among research areas of the RFA.
 
INQUIRIES
 
Inquiries concerning this RFA are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
June R. Lunney, PhD RN
Division of Extramural Programs
National Institute of Nursing Research
Building 45, Room Number 3AN-12
Bethesda, MD  20892-6300
Telephone:  (301) 594-6908
FAX:  (301) 480-8260
Email:  JLunney@EP.NINR.NIH.GOV
 
Direct inquiries regarding fiscal matters to:
 
Mr. Jeff Carow
Grants Management Office
National Institute of Nursing Research
Building 45, Room Number 3AN-32
Bethesda, MD  20892-6301
Telephone:  (301) 594-5974
FAX:  (301) 480-8256
Email:  JCarow@EP.NINR.NIH.GOV
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.361, Nursing Research.  Awards are made under
authorization of the Public Health Service Act, Title IV, Part A
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and
285) and 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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