COPING WITH AIDS AS A CHRONIC LONG-TERM ILLNESS Release Date: December 15, 1998 PA NUMBER: PA-99-026 P.T. National Institute of Mental Health National Institute on Drug Abuse National Institute of Nursing Research PURPOSE The efficacy of potent regimens combining protease inhibitors and antiretroviral drugs is a remarkable achievement in HIV medicine. As a result of these new treatments, people with HIV or AIDS, having come to terms with the prospect of imminent death, now have the potential of many more years of life. Managing the mental, emotional, and medical challenges of living with HIV/AIDS as a chronic illness is a new area for research study and intervention. 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 PA, Coping with AIDS as a Chronic Long-Term Illness, is related to the priority areas of mental health, drug abuse, and mental disorders, and HIV Infection. 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 foreign and domestic, 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. Foreign institutions are not eligible for small grants (R03) or program project grants (P01s). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Applications may submitted in response to this program announcement using individual research project grant (R01) mechanism. RESEARCH OBJECTIVES Summary The new and potent HIV treatments have created experiences in which, after having come to terms with imminent death, Persons Living with HIV or AIDS (PLHIV/AIDS) have the potential of many more years of life. Confusion and trauma may result from this situation, which stems from the difficulty of reconciling two contradictory life orientations: an acceptance of a premature death and reenergizing life with new possibilities. Living with HIV/AIDS as a chronic illness (like diabetes), which like other serious illnesses intrudes on and reshapes a person"s life and priorities, is a new and once unthinkable area for research. The following four sections suggest areas of research to meet the health promotion and disease prevention of PLHIV/AIDS. The four broad areas of research include: (1) medical decision making and adherence, (2) practicing safer HIV-related sexual behaviors, (3) stress, and coping, and (4) quality of life. Researchers need not limit themselves to these topics. Medical Decision Making and Adherence Background Issues Patients and their treating physicians need to make critical medical decisions about when to begin anti-retroviral therapy and which combination of HIV phamacotherapies will be most effective. Combination therapies can inhibit viral replication and reduce virus load to barely detectable levels in the blood of seropositive persons. However, the benefits from combination medication regimens can be maintained only if taken properly, and the directions for taking antiretroviral therapy are extremely complex. Research is needed to develop effective methodologies for measuring direct and indirect adherence to treatment regimens. Studies might identify the effect of collaborative decision making, appropriate informed consent, and cognitive functioning on adherence to medications. The role of families and other social support systems in ensuring treatment adherence might be assessed. Predictors of safer sex and drug use practices, as well as adherence to medication might be identified, as might beliefs about viral load reduction and infectivity. Potential Research Areas o Develop effective methodologies for measuring direct and indirect adherence to treatment regimens o Support research on adherence to treatment regimens, including communication techniques to improve shared decision making between health care providers and HIV-infected individuals, and behavioral strategies to manage symptoms secondary to treatment protocols and disease progression o Study role of cognitive functioning in medical decision making and adherence o Identify critical components in process of understanding informed consent and its effects on adherence to medication regimens o Assess the role of patients in medical decision making and adherence and their satisfaction with treatment o Study the effect of patient education and different modes of instruction in dosing regimens on adherence to treatment therapies o Identify the role of families and other social support systems in ensuring that well thought out medical decision making and treatment adherence occur o Assess the predictors of both practicing safer sexual and drug using behaviors and adherence to medication regimens and beliefs about reduction in viral load o Identify the relative contribution of inadvertent non-adherence (e.g., forgetting, sleeping through doses) versus deliberate modification of the regimen by the patient (e.g., extending the duration between doses or omitting doses for scheduling reasons, or reducing dosages because of concerns about symptoms) o Identify and treat mental disorders, neurocognitive deficits, and other psychopathology that negatively impact on the level of functioning and feeling of well being of people with AIDS. Examples of such conditions include: depression, anxiety, concentration and memory deficits, and chronic pain o Identify drug-drug interactions that are potentially clinically significant for patients with AIDS receiving multiple medications, and in particular of the interactions between antiretroviral agents and psychotropic medications (e.g., antidepressants, anxiolytics). Development and testing of strategies to avoid or minimize the clinical impact of these interactions o Study the role of "Stages of Change" and other models as predictors of adherence to HIV treatment regimens o Develop interventions that target medical decision making in PLHIV with co- occurring mental disorders and/or drug abuse. Practicing Safer HIV-Related Sexual Behaviors Background Issues Lack of complete adherence to combination therapies can result in the development of resistant strains of HIV, which can have devastating implications for the ability to stem transmission and treat HIV-infected individuals. In addition, as new combination therapies bring HIV-infected individuals improved health and a decline in detectable virus, they may believe they are less infectious and may lapse into unsafe sexual and drug-using behaviors. This could have the effect of increasing HIV transmission, if the virus is still viable at undetectable levels or mutates into a newly resistant virus. Most of the HIV/STD prevention programs are aimed at encouraging seronegative people to engage in safer sexual and drug-using behaviors so they will not become infected. Many of these programs could be used with seropositive individuals, as well. However, to ensure that the programs will be effective with people who have HIV/AIDS, preventive interventions could be tailored to their altruism and self-interest. Predictors of high-risk sexual behavior of individuals on combination therapies including beliefs about the role of protease inhibitors and viral load levels on infectivity and risky behaviors might be identified. Determinants of unsafe sexual behaviors in serodiscordant couples might be identified and prevention programs developed. Unsafe sexual behaviors related to drug abuse, e.g., trading sex for drugs or money to buy drugs, engaging in unsafe sex while intoxicated or during withdrawal, might be targeted. Potential Research Areas o Develop effective AIDS prevention programs to change high risk sexual and drug using risk behaviors in seropositive persons o Develop programs to enhance quality of life as a motivation to practice safer sexual behavior o Develop interventions to promote safer sex among PLHIV with co-occurring mental disorders o Determine predictors of high-risk sexual behavior of persons on combination therapies, including examining the role of protease inhibitors and viral load levels on beliefs about infectivity and risky behaviors o Identify determinants of unsafe sexual behaviors in serodiscordant couples o Assess the effects of early identification of HIV serotesting and counseling on HIV risk behaviors o Identify the effect of behavioral interventions and HIV treatment on HIV- related risk behaviors, the utilization of HIV prevention services and the transmission of HIV o Develop programs to promote and maintain safer sexual behaviors in the context of untreated or relapsed drug abuse. Stress and Coping Background Issues In the past two decades, a large literature has grown up around the subject of coping with life"s stresses and crises, including chronic illness. Good coping skills can improve the quality of life, can be taught, and may bolster the immune system. Research is needed to examine successful coping styles and coping repertoires among people with HIV/AIDS. Studies might identify predictors of failure to cope ("living in the empty present") or maladaptive coping and might develop interventions to teach the identification of problems and effective coping to seropositive persons, their family members, and caregivers. Potential Research Areas o Examine successful coping styles and coping repertoires among PLHIV/AIDS o Identify predictors of failure to cope ("living in the empty present") or maladaptive coping and develop interventions to teach the identification of problems and effective coping o Investigate the role of hope and its components in effective coping o Identify positive changes and strengths in PLHIV/AIDS o Develop and test strategies for teaching more effective coping styles to PLHIV/AIDS o Develop and test interventions for teaching more effective coping styles to family members and caregivers (e.g., families of pediatric AIDS survivors) o Identify biopsychosocial factors that predict which PLHIV/AIDS will survive over long-term treatment with protease inhibitors and other new treatments o Examine whether survivors who respond well to protease inhibitors and cope well with AIDS as an illness with chronic symptoms share certain personality traits or have a particular type of "survivor personality" o Identify major organizing themes for issues important in the lives of PLHIV/AIDS o Develop and test interventions at various levels targeting issues/problems in the ongoing stages of handling the chronicity of HIV/AIDS. Quality of Life Background Issues Quality of life (QOL) has become an important area of outcome research among long-term survivors of life-threatening illnesses. The measurement of QOL must take into account multiple variables in several dimensions. Although extensive research has yet to be undertaken for the population of interest in this Program Announcement, several areas of quality of life are likely to be important: (1) the side effects and intrusiveness of medication regimens, (2) return to work and financial concerns, (3) role resumption and role retention (the ability to maintain valued social roles), (4) social support and independence, and (5) sexuality and self-concept. Numerous QOL studies have found that the extent and richness of one"s social network is strongly related to good self-reported quality of life. Families, however, are sometimes broken up by long-term illness, because of divorce or the necessity of finding others to care for young children. Many women who are PLHIV/AIDS have had to give their children to others to raise. Those who respond to protease inhibitors may wish to resume the role of mother, and may require special support. In addition, PLHIV/AIDS may have had their social networks decimated by AIDS. Poverty and substance abuse among the survivor"s family and friends may make them undependable in terms of support. It is relatively recently that evidence has been found for the role of psychosocial factors, such as emotional support from others, in increasing the likelihood of survival. The stigma that is associated with AIDS may result in social isolation (both community- and self-imposed), as has been found for cancer survivors and their families, and can have a negative effect on treatment adherence and health status. Potential Research Areas o Identify QOL measures specific to the needs and lives of PLHIV/AIDS receiving long-term medical treatments o Examine expectations of PLHIV/AIDS in regard to maintaining past quality of life and adapting to current quality of life and its impact on health status o Examine predictors of return to work and the role of returning to work in the quality of life of PLHIV/AIDS on multiple treatment regimens o Identify workplace issues/problems related to the long-term illness and solutions (e.g., the intrusion of medication schedules and/or side effects on work performance) o Examine workplace discrimination in this population, especially for blue- collar workers, and identify avenues for change o Identify social support needs specific to this population and examine issues/problems regarding social support, role retention and resumption, family burden, etc. o Develop and test interventions for improving stress and coping for PLHIV/AIDS and its impact on QOL and disease progression o Develop and test interventions to enhance the development of social support from families and friends o Develop and test interventions (job counseling, retraining, etc.) to enable return to work by PLHIV/AIDS who are being successfully treated o Develop and test interventions for supporting the families of PLHIV/AIDS in adapting to HIV/AIDS as a chronic condition o Identify the psychosocial variables that are predictors of adapting to HIV and mediators of change associated with effective secondary prevention programs o Test the effectiveness of preventive interventions in improving quality of life and promoting health-enhancing behavior of PLHIV/AIDS o Develop and test interventions to minimize the impact of stigmatization of HIV-infected persons, including decisions regarding treatment and QOL o Support health services research and evaluation to assess the impact of changes in the health care delivery system on care, disease progression, and QOL o Conduct research to identify and remove barriers to effective health care utilization, including access, continuum of care, and health and social services to improve treatment adherence and QOL. 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 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," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at the following URL address: http://www.nih.gov/grants/guide/notice-files/not94-105.html 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://www.nih.gov/grants/guide/notice-files/not98-024.html APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard AIDS-related application deadlines as indicated in the application kit. 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, fax: (301) 480-0525 Email: GrantsInfo@NIH.GOV. The title and number of the program announcement must be typed in Section 2 on the face page of the application. An applicant planning to submit a new (Type 1) investigator-initiated grant application requesting $500,000 or more in direct costs for any year is advised that he or she must contact Institute program staff (see INQUIRIES, below) before submitting the application, i.e, as plans for the study are being developed. Furthermore, the applicant must obtain agreement from Institute staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in the cover letter that is sent with the application, the staff member and Institute who agreed to accept assignment of the application. The completed original application and five legible copies must be sent or delivered 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard 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, when applicable. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written review, comments on the following aspects of the application will be made 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 the assignment of 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. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: 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 method? 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? (6) Appropriateness of the proposed budget and duration in relation to the proposed research, (7) Adequacy of plans to include both genders, children and adolescents, and minorities and their subgroups as appropriate for the scientific goals of the research, or justification for their exclusion. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women, Children and Adolescents and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer and national advisory council review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Willo Pequegnat, Ph.D. Office of AIDS Research National Institute of Mental Health 5600 Fishers Lane, Room 18-101 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: wpequegn@nih.gov Sander Genser, M.D. Clinical Medicine Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-08 Rockville, MD 20857 Telephone: (301) 443-1801 FAX: (301) 443-6566 Email: sq73f@nih.gov June R. Lunney, Ph.D., R.N. Division of Extramural Activities National Institute of Nursing Research 45 Center Drive, Room 3AN-12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6908 FAX: (301) 480-8260 Email: June_Lunney@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Bethesda, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov Jeff Carow Grants Management Office National Institute of Nursing Research 45 Center Drive, Room 3AN-12, MSC 6301 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 FAX: (301) 480-8260 Email: Jeff_Carow@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH), 93.279 (NIDA), and 93.361 (NINR). 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. Awards will be administered under PHS grants policy as stated in the NIH Grants Policy Statement (October 1, 1998). PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse 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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