Full Text NR-94-004

SYMPTOM MANAGEMENT OF PERSONS INFECTED WITH HIV

NIH GUIDE, Volume 23, Number 5, February 4, 1994

RFA:  NR-94-004

P.T. 34

Keywords: 
  AIDS 
  Health Services Delivery 
  Nursing 


National Institute of Nursing Research

Letter of Intent Receipt Date:  April 5, 1994
Application Receipt Date:  May 6, 1994

PURPOSE

The National Institute of Nursing Research (NINR) invites
applications for preliminary investigations that will lead to
large-scale clinical studies of interventions to improve the care of
individuals infected with the HIV virus.  The purpose of this
research initiative is to lay the foundation from which intervention
strategies can be tested to alleviate the physical symptoms
associated with HIV infection and its treatment, prolong the
symptom-free period of HIV infection, and improve the quality of life
of persons living with AIDS.

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
"Healthy People 2000" (Summary Report:  Stock No. 017-001-00473-1)
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325 (telephone 202-783-3238).

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.
Applications from minority individuals and women are encouraged.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) individual
research project grant (R01).  Responsibility for the planning,
direction, and execution of the proposed project will be solely that
of the applicant.  Awards will be administered under PHS grants
policy as stated in the Public Health Service Grants Policy Statement
(Oct 1, 1990).  The total project period for applications submitted
in response to the present RFA may not exceed three years.  The
anticipated award date is September 30, 1994.  Awards will be limited
to $100,000 in total costs (combined direct and indirect costs) for
each funding year.  This RFA is a one-time solicitation for
applications for new awards.  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 $600,000 in total costs for the first year will be
committed to fund applications submitted in response to this RFA.  It
is anticipated that six applications will be funded.  This level of
support is dependent on 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 living with HIV infection.  These
individuals 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 HIV-infected persons requires efforts to forestall the immune
system breakdown and to cope with the multisystem, and often
synergistic, clinical problems that result from the HIV-infection and
its treatment.  Important goals include relief of distressing
symptoms resulting from the disease process, management of
side-effects from therapeutic regimens, prolongation of distress-free
intervals, and improvement of quality of life.  Of particular concern
are the physical problems frequently associated with HIV infection,
including problems of ventilation, nutrition, elimination, energy
maintenance, neurological function, mobility, host defenses, skin
integrity, and comfort.

The management of some physical 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 chronic
obstructive pulmonary disease.  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
with 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.

In response to the priorities selected by the first Conference on
Nursing Research Priorities (CORP) in 1988, a Priority Expert Panel
(PEP) was convened by the NINR to examine issues related to the
nursing care and prevention issues related to HIV infection.  The
following recommendations were among those made by that panel
concerning the physiological aspects of care that have yet to be
adequately addressed:

o  Investigate strategies to effectively manage physical symptoms
associated with HIV infection, including: dyspnea, inadequate
nutrition, diarrhea, neurocognitive dysfunction, nosocomial
infections associated with compromised host defenses, fatigue, and
pain.

o  Assess short- and long-term effects of behavioral and other
nonmedical therapies on disease progression and quality of life in
HIV-infected persons.

Issues related to the effectiveness of interventions in HIV/AIDS were
identified again as a priority by the second NINR CORP in November
1992.  A priority expert panel will be convened in FY 1996 to further
develop research recommendations.  This initiative seeks to stimulate
preliminary studies in anticipation of that future research agenda.

The purpose of this research initiative is to lay the foundation from
which intervention strategies can be tested to alleviate the physical
symptoms associated with HIV infection and its treatment, prolong the
symptom-free period of HIV infection, and improve the quality of life
of persons living with AIDS.  Research should focus on problems
refractory to, or incompletely relieved by, medical intervention, as
well as development of strategies to ameliorate the physical symptoms
that are secondary to the medical management of HIV infection.  To be
responsive to this initiative, research concerning quality of life
issues with persons infected with HIV should focus on the role of
physical symptoms.  Behavioral intervention strategies may be tested
to alleviate physical symptoms, prolong symptom-free intervals of HIV
infection, or improve quality of life; however, outcome measures must
include physiological responses to these interventions. Although the
primary focus is on nonpharmacologic interventions, research is also
needed that addresses the multimodal treatment approaches including,
but not limited to, pharmacological interventions for managing
symptoms.  Studies addressing only pharmacological interventions will
not be considered as responsive to this RFA.

These preliminary studies may address scientific assessment, design,
methodological, and feasibility issues that need to be resolved
before large-scale clinical trials can be undertaken.  Studies may
appropriately seek information about the acceptability, safety, and
rationale for the effectiveness of interventions.  If descriptive
research is needed to examine the onset, pattern, and progression of
particular physical symptoms that occur during the clinical course of
HIV infection and its treatment, such research must focus on the
identification of variables that can be manipulated to reduce the
severity or impact of these symptoms.  The theoretical basis for the
planned study must be clearly explicated and linked to the
intervention plans.  Interventions must be carefully and clearly
defined in terms of purpose, composition, means of implementation,
and anticipated effect.  Particular attention should be paid to
ensuring that the anticipated effects have clearly defined outcome
measures.

Health care providers such as nurses have a key role in the
assessment, management, and prevention of physical symptoms
associated with HIV infection and its treatment.  Because of the
complexity of these symptoms, however, a multimodal approach to
treatment is often most appropriate.  Interdisciplinary research
teams would make a significant contribution to the scientific
knowledge generated by studies responsive to this initiative.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research
Resources may wish to identify the GCRC as a resource for conducting
the proposed research.  If so, a letter of agreement from either the
GCRC 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 multimodal management
strategies to alleviate the physical 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 physical
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 physical 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.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH policy is that applicants for NIH clinical research grants and
cooperative agreements are required to include minorities and women
in study populations so that research findings can be of benefit to
all persons at risk of the disease, disorder or condition under
study; special emphasis must be placed on the need for inclusion of
minorities and women in studies of diseases, disorders and conditions
which disproportionately affect them.  This policy is intended to
apply to males and females of all ages.  If women or minorities are
excluded or inadequately represented in clinical research,
particularly in proposed population-based studies, a clear compelling
rationale must be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues must be addressed in developing a research
design and sample size appropriate for the scientific objectives of
the study.  This information must be included in the form PHS 398
(rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in
Section 5, Human Subjects.  Applicants are urged to assess carefully
the feasibility of including the broadest possible representation of
minority groups.  However, NIH recognizes that it may not be feasible
or appropriate in all research projects to include representation of
the full array of United States racial/ethnic minority populations
(i.e., Native Americans [including American Indians or Alaskan
Natives], Asian/Pacific Islanders, Blacks, Hispanics).

The rationale for studies on single minority population groups should
be provided.

For the purpose of this policy, clinical research is defined as human
biomedical and behavioral studies of etiology, epidemiology,
prevention (and preventive strategies), diagnosis, or treatment of
diseases, disorders or conditions, including, but not limited to,
clinical trials.

The usual NIH policies concerning research on human subjects also
apply.  Basic research or clinical studies in which human tissues
cannot be identified or linked to individuals are excluded.  However,
every effort should be made to include human tissues from women and
racial/ethnic minorities when it is important to apply the results of
the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application,
the application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the
selected study population is inadequate, it will be considered a
scientific weakness or deficiency in the study design and reflected
in assigning the priority score to the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants or cooperative agreements that do not comply with these
policies.

LETTER OF INTENT

Prospective applicants are asked to submit, by April 5, 1994, 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 subsequent applications, the information that it contains allows
NINR staff to estimate the potential review workload and to 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
Westwood Building, Room 740
Bethesda, MD  20892
Telephone:  (301) 594-7865
FAX:  (301) 594-7894

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301/710-0267.

The RFA label available in the PHS 398 (rev. 9/91) 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
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Dr. Ernest Marquez
Office of Review
National Institute of Nursing Research
Westwood Building, Room 740
Bethesda, MD  20892

Applications must be received by May 6, 1994.  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 NINR.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NINR staff will 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 may be triaged by an NINR peer review group on the basis
of relative competitiveness.  The NIH will withdraw from further
competition those applications judged to be non-competitive for award
and notify the applicant Principal Investigator and institutional
official.  Those applications judged to be competitive will undergo
further scientific merit review.  Those applications that are
complete and responsive will be evaluated in accordance with the
criteria stated below for scientific/technical merit by an
appropriate peer review group convened by the NINR.  The second level
of review will be provided by the National Advisory Council for
Nursing Research.

Review criteria for this RFA are generally the same as those for
unsolicited research grant applications:

o  significance and originality of the research and methodological
approaches;

o  feasibility of the research and adequacy of the research design;

o  for clinical studies, the appropriateness of the proposed gender
and minority composition of the study population to the scientific
objectives of the study;

o  training, experience, research competence, and commitment of the
investigator(s);

o  adequacy of the facilities and resources;

o  appropriateness of the requested budget for the work proposed; and

o  provisions for the protection of human subjects, the humane care
of animals, and biosafety conditions.

AWARD CRITERIA

The anticipated date of award is September 30, 1994.  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

Written and telephone inquiries concerning this RFA are encouraged.
Direct inquiries regarding programmatic issues to:

June R. Lunney, Ph.D., R.N.
Acute and Chronic Illness Branch
National Institute of Nursing Research
Westwood Building, Room 754
Bethesda, MD  20892
Telephone:  (301) 594-7397

Direct inquiries regarding fiscal matters to:

Sally A. Nichols
Grants Management Officer
National Institute of Nursing Research
Westwood Building, Room 748
Bethesda, MD  20892
Telephone:  (301) 594-7498

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 Part 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.

.

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