SUPPLEMENTS FOR THE STUDY OF DRUG ABUSE AND HIV/AIDS NIH GUIDE, Volume 26, Number 3, January 31, 1997 P.T. 34 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 NIH research project grants for the study of issues related to drug abuse and HIV/AIDS. Funding will be available through administrative and competing supplements. RESEARCH OBJECTIVES Background The HIV/AIDS epidemic has demonstrated an increasing association with drug abuse, through transmission of the 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. The proportion of cases attributed to injection drug use alone has steadily increased from 12 percent in 1981 to 32 percent in 1995. Clearly, the drug abuse links to the AIDS epidemic warrant a strong Federal research effort. The NIDA has responded to that challenge by building a multi-disciplinary program of research including, but not limited to: improved strategies to reduce drug-abuse related behaviors that are linked to the transmission of HIV, research on the epidemiology of drug-abuse related HIV disease, as well as studies of the biological and behavioral factors that influence HIV infection and disease progression. 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 grantees to expand and/or enhance ongoing research to include HIV/AIDS issues. The primary intent of this program is to encourage grantees who have not focused on AIDS-related issues to do so; however projects which do will also be eligible. Grantees are especially encouraged to examine ongoing projects which may not have been designed to examine AIDS-related issues for HIV/AIDS relevance. Current areas of research supported by NIDA that are considered HIV/AIDS-related include the following: Natural History and Epidemiology 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. o Research on the natural history of HIV/AIDS in the above populations, including the dynamics of HIV 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 better measure and characterize HIV risk behaviors and transmission. Also of interest are studies to develop improved methods to measure reliability, validity, and estimation error. o Studies of the epidemiology and natural history of infectious diseases commonly transmitted by drug injection and/or sexual behavior associated with drug use, e.g. hepatitis, endocarditis, syphilis, or gonorrhea, which may serve to elucidate HIV infection. 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 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 lentivirus infections. o Studies of drugs of abuse and other factors contributing to HIV-related malignancies and other diseases, e.g., the role of nitrite inhalants and Kaposi's sarcoma. 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 role of patterns of drug abuse in HIV/AIDS progression among women, 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 the interactions between drugs of abuse, the immune system, the hypothalamic-pituitary axis, and 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 unique receptor systems, e.g. opioid and cannabanoid, of immune cells and subsequent induction of immune cell responses including cytokine responses and other host factors. o Studies of structure-activity relationships of receptor ligands that modulate immune function. Therapeutics 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. o Research to improve health services provided to and long-term therapeutic strategies designed for HIV-infected drug users, their sexual partners, and children, including studies of: a. strategies to improve adherence with HIV medications; 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; d. strategies to improve adherence with tuberculosis detection and treatment. o Research that investigates interactions between approved and investigational medications for drug addiction and HIV pharmacotherapies. Vaccines o Research on behavioral and/or biomedical aspects of delivery of HIV vaccine candidates to drug users. o Research to determine how drugs of abuse modulate immune responses against HIV. o Research to recruit injection drug users and other drug users at high risk of HIV infection into clinical trials of vaccines. Behavioral and Social Science Research o Research to develop, evaluate, and disseminate prevention strategies to reduce the incidence of HIV infection related to drugs of abuse, i.e. sharing of contaminated needles/syringes, high risk sexual behavior associated with drug use, perinatal transmission in drug-abusing mothers. These include: a. the study of community-based behavioral and social intervention strategies to reduce needle-sharing and high risk sexual behavior among injection drug users, crack cocaine users, and their sexual partners. b. the study of behavioral aspects of other prevention and intervention strategies, such as compliance with barrier methods, vaccine, and HIV therapeutics regimens. c. prevention strategies targeting youth or other groups at high risk for initiating injecting drug use and/or initiating sexual risk behaviors in association with drug use. 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 injecting drug users and their sexual partners, and non-injecting drug users who engage in high risk sexual behaviors associated with their drug use. o Studies of treatment interventions for drug dependence 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 HIV transmission; and b. the target population must be 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; and c. drug 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 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, 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. o Studies of education strategies for clinical professionals involved in HIV risk reduction and/or drug abuse and HIV/AIDS treatment. Research Mentoring and Career Development o Support for mentoring and career development opportunities designed to attract and support scientists and clinicians entering the HIV/AIDS field from every level of the career path, and to 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. International Research Collaboration o Research support for collaborative national and international research with a focus on drug abuse-related links to HIV/AIDS. SPECIAL REQUIREMENTS Budget/Administrative Issues For FY 1997, approximately $2,500,000 will be available for the funding of both administrative and competing supplements to existing NIH research projects. Subject to the availability of funds, similar amounts will be made available in future years. Competing supplements are provided for expansion of a project's scope or the research protocol. These are treated as new applications for purposes of the review requirements and competition for funds, and are reviewed in accordance with NIH standard procedures, i.e., peer review/council review. Competing renewal supplement requests must be submitted in accordance with standard receipt dates; AIDS-related project dates are January 1, May 1, and September 1. Administrative supplements are provided to cover unanticipated cost increases that are associated with achieving the objectives within the original scope of a project, and 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. Administrative supplemental funding is generally limited to 25 percent of the Council-approved direct costs of the project or $100,000, whichever is less. These applications undergo program, grants management, and budget review within NIDA and may be submitted for the remainder of FY 1997, but no later than August 1, 1997. Neither administrative or competing supplements may exceed the stated life of the parent project. Neither supplement may represent changes in the basic goals or intent of the project or may 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 USC 241). INQUIRIES Inquires concerning this notice are encouraged. The opportunity to clarify any issue or questions from potential applicants are welcome. Direct inquiries regarding programmatic issues to: Steven W. Gust, Ph.D. Office on AIDS National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301)443-6480 Email: sg84q@nih.gov Direct fiscal inquiries to: Gary Fleming, J.D. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6710 Email: gf6s@nih.gov .
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