From: phil (J. Philip Miller) Subject: RFA: Symptom Management of Persons Infected with HIV 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 phil@wubios.WUstl.edu - (314) 362-3617 [362-2693(FAX)]