Subject: RFA: Symptom Management of Persons Infected with HIV
From: phil (J. Philip Miller)
Date: Sat, 5 Feb 1994 09:25:42 GMT

[slightly abridged - jpm]

SYMPTOM MANAGEMENT OF PERSONS INFECTED WITH HIV

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

RFA:  NR-94-004

P.T. 34; K.W. 0715008, 0730050, 0785130

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.

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.

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

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

-- 
     J. Philip Miller, Professor, Division of Biostatistics, Box 8067
	 Washington University Medical School, St. Louis MO 63110
	  [email-masked] - (314) 362-3617 [362-2693(FAX)]