SUPPLEMENTS FOR THE STUDY OF DRUG ABUSE AND HIV/AIDS Release Date: July 8, 1999 NIH GUIDE P.T. Keywords: AIDS Drugs/Drug Abuse Epidemiology Behavioral/Social Studies/Service National Institute on Drug Abuse PURPOSE The National Institute on Drug Abuse (NIDA) announces the availability of funds to supplement existing federal research project grants for the study of issues related to drug abuse and HIV/AIDS. Funding will be available through administrative supplements. RESEARCH OBJECTIVES Background The HIV/AIDS epidemic has demonstrated an increasing association with drug abuse, through transmission of HIV by contaminated drug injection equipment, high-risk sexual behavior with an infected drug user, and perinatal exposure of newborns from infected drug-abusing mothers. With this Supplement Announcement, NIDA plans to continue to develop a strong multidisciplinary basic, clinical, epidemiologic, behavioral, and ethics research program in response to the challenge of the interactions of drug abuse with the HIV/AIDS epidemic. The Supplement Program is designed to encourage and enhance interactive, multidisciplinary collaborative projects involving researchers with primary foci both within and outside the area of drug abuse. Areas of Interest In an effort to improve and expand its research on drug abuse-related aspects of HIV/AIDS, NIDA will consider requests from current NIDA/NIH grantees and those supported by other federal agencies (e.g., the National Science Foundation (NSF), the Health Resources and Services Administration (HRSA), the Department of Defense (DOD), the National Institute of Justice (NIJ), the Department of Education (DOE) to expand and/or enhance ongoing research to include drug use related HIV/AIDS issues. The primary intent of this Program is to encourage grantees who have not focused on drug use related AIDS issues to do so, thus recognizing that drug abuse and HIV/AIDS are two diseases that must be prevented and treated in parallel. Thus, projects which currently focus solely on either AIDS-related or drug abuse issues are encouraged to strengthen efforts in this complementary area. Grantees are especially encouraged to examine ongoing projects which may not have been designed to examine AIDS-related issues for HIV/AIDS relevance. For example, those doing basic AIDS research, but who have not investigated how drugs of abuse may act within their area of investigation, are encouraged to apply. Current areas of NIDA-supported drug use research that are considered HIV/AIDS-related include those listed below as well as crosscutting areas of relevance; e.g., issues related to race/ethnicity, minority status, socioeconomic status, gender differences, and issues that are unique to women or to men. For example, gender-related research has shown that women's HIV viral loads are not the same as men's, raising the issue of whether women may need earlier interventions with anti-viral therapies. Another example may be a field such as genetics in which the rapid development of knowledge as well as technology (e.g., gene chip arrays, quantitative trait locus analysis) may be broadly applicable to a number of research areas. As relevant data emerge from laboratory, field, and clinical HIV/AIDS research, investigators are urged to include these crosscutting perspectives in their research design and analyses, where appropriate. Natural History and Epidemiology o International or national studies of the epidemiology and natural history of infectious diseases commonly transmitted by drug injection and/or sexual behavior and/or other behaviors associated with drug use (e.g., Hepatitis A, B and C; STDs; Tuberculosis; and HIV). o Studies of interactions among chronic drug use and the treatment of HIV and comorbid mental disorders and other infectious diseases, including studies of health seeking behaviors. o Studies to determine the incidence and prevalence of HIV infection and AIDS among drug abusers, their sexual partners, and their newborns, including monitoring the trends in HIV infection and AIDS-related diseases and addressing specific subpopulations such as adolescents, women, and minorities. o Research on the natural history of HIV/AIDS in the above populations, including the natural history of the dynamics of HIV and other blood borne infectious disease transmission in sexual and drug-using networks. o Research on the nature and extent of HIV risk behaviors and factors that affect risk in the above populations. o Research to develop improved survey designs, including interview protocols and measurement instruments, and new biostatistical techniques to detect, measure, and characterize drug use in adolescent and adult populations at risk for HIV. o Studies of the nature, extent, and progression of drug use and abuse, which include assessment of knowledge and attitudes regarding HIV/AIDS, and/or the incidence, prevalence, and nature of drug-related HIV risk behaviors. Etiology and Pathogenesis o Studies to define interactions between drugs of abuse and the operation of secondary messenger pathways affecting lymphocyte or monocyte function. o Studies to define the role of drugs of abuse and related compounds or drug abuse treatment medications on susceptibility, onset, and progression of HIV disease. o Studies to further develop and utilize experimental models to study the effects of drugs of abuse on the pathogenesis of central nervous system lentivirus infections. o Studies to investigate the role of drugs of abuse and related endogenous substances and other biological and environmental factors in modulating HIV- induced neuroAIDS. o Studies to identify and elucidate the role of drug abuse on immune susceptibility and development and progression of AIDS-related opportunistic infections; e.g., "smoking" drugs of abuse and bacterial pneumonias. o Studies of the nutritional, metabolic, endocrine, and gastrointestinal disorders and their underlying pathophysiology in HIV-infected drug abusers. o Research on adulterants/contaminants of drugs of abuse and their roles in the etiology, pathogenesis, and natural history of HIV/AIDS and associated illness in drug abusers. o Studies of the role of patterns of drug abuse in HIV/AIDS progression among women; e.g., in perinatal transmission of HIV and the effects on the fetal and neonate nervous system, immune system, and placenta. o Studies of the effects of drugs of abuse and drug treatment medications on immune function, which may increase our knowledge of the immune dysfunction characteristic of HIV infection. o Studies of how drugs of abuse may modulate the immune system through the hypothalamic-pituitary axis and other parts of the central nervous system. o Basic and clinical research on neurobiologic, neurologic, neuropsychological, and psychiatric consequences of drug abuse that have relevance for understanding the natural history of HIV/AIDS-related dementia in drug users. o Studies of dual function receptor systems; e.g., opioid, with activation receptors of immune cells and subsequent induction of immune cell responses, including cytokine responses and other host factors. Therapeutics o Research to improve access to health services provided to and long-term therapeutic strategies designed for HIV-infected drug users, their sexual partners, and their children, including studies of: a. Strategies to improve adherence with HIV medications (e.g., simultaneous or co-located drug abuse and HIV treatment); b. Recruitment and retention of HIV-infected drug users into HIV/AIDS treatment; c. Delivery of linked medical and drug abuse treatment services through drug abuse treatment programs and/or other health services delivery programs (e.g., mobile van services); d. Strategies to improve adherence with tuberculosis detection and treatment; and e. Methods to improve STD and Hepatitis C prevention, detection, and treatment. o Evaluation of the safety, efficacy, and acceptability of new agents and approaches, including alternative and complementary therapies (e.g., chemopreventive treatment with micro- and macronutrients such as vitamins and trace elements), in the treatment of wasting syndrome, growth failure, and other complications of HIV infection in drug users. o Research that investigates interactions between approved and investigational medications for drug addiction and HIV pharmacotherapies. o Research to test the feasibility of enhancing recruitment of HIV- infected drug users, their sexual partners, and infants into HIV/AIDS-therapeutics clinical trials, including specific racial/ethnic and hidden subpopulations. Vaccines o Research on improving behavioral and/or biomedical methods to deliver HIV and other infectious disease vaccines to adolescent and adult drug-using populations. o Research to recruit injection and non-injection drug users at high risk of HIV infection into clinical trials of vaccines, including developing specific strategies to study children, adolescents, and adults. o Investigation of how drugs of abuse may affect or modulate cofactors for HIV transmission. Those cofactors include, for example, vaginal/cervical epithelium changes during puberty; hormonal changes during pregnancy; and use of contraceptives, hormonal replacement therapy, or steroid use. o Studies of the genital tract immune system and inflammatory activity that might compromise integrity of the genital tract or inductive ability of vaccines. Studies of drugs of abuse and genital mucosal inflammation induced by drug use behavior which facilitate HIV transmission in injection and non- injection drug users. o In collaboration with institutions and communities being targeted, explore behavioral and social issues and prevention activities that might have a substantial impact on the design or conduct of a trial, including: a. Evaluation of other biomedical and behavioral interventions that could prove of benefit in decreasing the incidence of HIV infection in the populations identified for future vaccine efficacy trials and assessment of their potential impact on the evaluation of vaccine efficacy; b. Conduct of behavioral research in populations at high risk for HIV infection to determine, for example, appropriate risk-reduction interventions and to estimate risk behavior and recruitment, adherence, and retention strategies pertinent to the design and execution of a successful efficacy trial, especially for populations that have been historically underrepresented in clinical trials; c. Determination of possible adverse social, economic, behavioral, or legal consequences of participation in clinical trials and development of broadly applicable strategies for mitigating potential harm; d. Determination of optimal methods of achieving informed consent for vaccine efficacy trials; and e. Research on the ethical conduct of health care workers in performing drug use and HIV-related studies. Behavioral and Social Science Research o Research to develop, evaluate, and disseminate prevention strategies to reduce the incidence of drug use related HIV infection, including high risk drug use associated sexual behavior (e.g., in adolescents and perinatal transmission in drug-abusing mothers). These include: a. Community-based behavioral and social intervention strategies to reduce needle-sharing and high risk sexual behavior among injection drug users, crack cocaine users, and methamphetamine users and their sexual partners; b. Behavioral aspects of other prevention and intervention strategies, such as compliance with barrier methods, vaccine, and HIV therapeutics regimens; c. Prevention strategies targeting adolescents or other groups at high risk for initiating injecting drug use and/or initiating sexual risk behaviors in association with drug use; and d. Development of new or improved HIV-risk and drug use risk screening questionnaires that are developmentally appropriate for use with specific target populations (e.g., early adolescents, older women, young minority men) and are adequately predictive of immediate and future exposure to HIV infection if preventive intervention does not occur. o Studies of the determinants of risk behaviors known to transmit HIV and of the principles of behavioral change necessary to reduce the risk of HIV transmission among adolescent injecting drug users and their sexual partners, and adolescent non-injecting drug users who engage in high risk sexual behaviors associated with their drug use. o Studies of simultaneous treatment interventions for drug dependence and comorbid conditions that meet all of the following criteria: a. Designed to determine the efficacy or effectiveness of psychosocial and/or pharmacological treatment interventions for drug dependence that have a high probability of leading to reductions in transmission of infectious diseases associated with drug use; e.g., HIV, hepatitis, or other medical consequences of drug use (e.g., hypertension, diabetes mellitus); and b. The target population must be in-treatment or out-of-treatment individuals at high risk for HIV infection as a result of either drug injecting or sexual behavior associated with their drug use, or be HIV seropositive drug users where the intervention is intended to prevent further spread of disease; and c. Drug use injection and non-injection practices and/or sexual AIDS risk behaviors must be assessed as part of the research design; and d. HIV risk reduction counseling is either (1) provided to research subjects during the course of the study or (2) included as part of the intervention under study and evaluated as part of the research design. o Studies of the impact of HIV/AIDS on the drug abuse treatment delivery system and on provision of HIV/AIDS services within drug treatment programs, including those provided under managed care. o Studies of the cost, cost-benefit, and cost-effectiveness of interventions to reduce HIV risk behaviors and prevent the transmission of HIV. o Studies of the organization and management of services for HIV-positive drug abusers, including studies of the barriers to service access and utilization and strategies for overcoming them. o Studies of the organization and management of drug use and medical services provided by mobile care systems (e.g., vans) as a method for improving care access. o Research to enhance the effectiveness of other HIV prevention interventions, such as studies of the recruitment of injecting drug users and high-risk non-injecting drug users into drug abuse treatment. o Research to improve the understanding of basic principles of behavior change, maintenance of behavior change, and relapse that have implications for the prevention of HIV transmission that is drug-related. Information Dissemination o Research on mass media and other education strategies focused on AIDS and drug abuse in children (ages 8-12), adolescents, adults, racial/ethnic groups, and gender specific groups. o Studies of HIV and drug use prevention strategies for clinical and education professionals involved in HIV risk reduction and/or drug abuse and HIV/AIDS treatment with stigmatized populations. Research Mentoring and Career Development o Support for mentoring and career development opportunities designed to (1) attract and support scientists and clinicians entering the HIV/AIDS field from every level of the career path and (2) expand NIDA's research workforce to better represent the cultural, genetic and age diversity of drug-abusing populations and others at risk for HIV/AIDS. Research Ethics o Studies of the ethical, legal, and social interactions and resulting issues related to AIDS and drug abuse. Investigators are referred for general topic areas and more background information to three current program announcements: Mentored Scientist Development Award in Research Ethics (PAR- 98-006), Short-Term Courses in Research Ethics (PA-99-051), and Research on Ethical Issues in Human Studies (PA-99-074). International Research Collaboration o Research support for collaborative national and international research with a focus on drug abuse-related links to HIV/AIDS. International collaborative research may involve, for example, any of the above areas (e.g, etiology and pathogenesis, natural history/epidemiology, vaccines, social and behavioral sciences, information dissemination, research ethics). SPECIAL REQUIREMENTS Budget/Administrative Issues For FY 1999, approximately $1,700,000 will be available for the funding of administrative research supplements to existing federal grant projects. Subject to the availability of funds, similar amounts, as well as funding for competing supplements, will be made available in future years. Administrative supplements are provided to cover unanticipated cost increases that are associated with achieving the objectives within the original scope of a project. These supplements can include cost increases that result from making modifications in the scope of a project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes. For NIDA grantees, administrative supplemental funding in excess of 25 percent of the Council- approved direct costs of the parent project or $100,000, whichever is less, requires NIDA Council approval. This requirement does not apply to grants supported by other NIH Institutes or grantee applications from federal agencies other than NIH. These applications undergo program, grants management, and budget review within NIDA and may be submitted for the remainder of FY 1999, but no later than July 26, 1999. An original and two copies of the application must be received in the Grants Management Branch (see address below) by this date. Supplements may not exceed the stated life of the parent project. Parent grants that would require no-additional-cost extension during the supplement period will not be eligible for supplementation. Supplement may not represent changes in the basic goals or intent of the project nor alter the scope of the parent grant. AIDS-related supplement requests to either non- AIDS or AIDS-related grants will receive expedited review, according to Section 301 of the Public Health Service Act (42 USC241). Applicants from outside NIDA must inform their Program Officer at their Granting Federal Agency with respect to their intention to submit an application for these supplements and must submit with the application a letter from the granting agency stating that (1) the proposed supplement is judged to fit within the scope of the funded grant and (2) the granting agency is willing to accept the supplement if funding by NIDA is offered. The letter must include the name and contact information for the Program Officer at the granting agency. A copy of the letter must be sent to the NIDA Center on AIDS and Other Medical Consequences of Drug Abuse at the address listed below. INQUIRIES Inquiries concerning this notice are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sander G. Genser, M.D., M.P.H. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse 6001 Executive Boulevard, Rm. 5198, MSC 9593 Bethesda, MD 20892-9593 Telephone: (301)443-1801 Email: sg73f@nih.gov Direct fiscal inquiries to: Gary Fleming, J.D. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Rm. 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 Email: gf6s@nih.gov Direct inquiries regarding review issues to: Teresa Levitin, Ph.D. Director, Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES Supplement applications are to be submitted in the grant application form PHS 398 (rev. 4/98). 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, E-mail: GrantsInfo@nih.gov. Submit a signed typewritten original of the supplement application, including the Checklist, and five signed photocopies to: Chief, Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Rm. 3131, MSC 9541 Bethesda, MD 20892-9541 To be eligible for consideration for these FY 1999 funds, supplement applications must be received by July 26, 1999. If an application is received after that date, it will be returned to the applicant without review.
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