Full Text PA-95-057 HIV RISK BEHAVIORS, DETERMINANTS AND CONSEQUENCES NIH GUIDE, Volume 24, Number 16, May 5, 1995 PA NUMBER: PA-95-057 P.T. Keywords: National Institute on Drug Abuse PURPOSE The purpose of this program announcement is to stimulate research on the social and other environmental factors that influence the drug injecting and sexual HIV risk behaviors of drug users and their sexual partners. Behaviors do not occur independent of, but are shaped by, the social and physical environment, as well as the individual's psychological and physiological status. By understanding how characteristics of the environment act and interact with each other, and with other characteristics of the individual, more effective HIV prevention strategies can be developed. Important aspects of this concept involve improving knowledge of factors that determine the temporal variability in risk behaviors, i.e., why risk behaviors occur at some times and not at others, and of factors underlying behaviors that protect against HIV transmission. Populations of interest include injecting drug users (IDUs), sexual partners of IDUs, and non-injecting drug users whose HIV risk behaviors may be related to their drug use. 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 program announcement, HIV Risk Behaviors, Determinants, and Consequences, is related to the priority area of reducing HIV transmission. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202 783-3238). 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. MECHANISM OF SUPPORT Research support mechanisms include traditional research project grants (R01), small grants (R03), and FIRST (R29) awards. Submissions as Investigator-Initiated Interactive Research Project Grants (IRPG) may be made. For information on the IRPG mechanism, see NIH Guide for Grants and Contracts, Vol. 23, No. 28, July 29, 1994. Because the nature and scope of the research proposed in response to this program announcement may vary, it is anticipated that the size of an award will also vary. Traditional research project grants (R01) provide support for up to five years. Small grants (R03) provide research support of up to $50,000 per year in direct costs plus appropriate indirect costs for up to two years. FIRST (R29) awards provide support for five years and up to $350,000 in direct costs over the entire project period. RESEARCH OBJECTIVES Background and Significance Injection drug use and sexual activity with injecting drug users are increasingly important modes of HIV transmission in the United States. Of 396,015 adult cases of AIDS reported to the CDC through June 1994, 31 percent were injecting drug users and 3.5 percent were sexual contacts of IDUs. Of reported cases of AIDS among women in the U.S., 48 percent were attributable to injection drug use and 20 percent were attributable to heterosexual contact with a male IDU, making these the first and second highest exposure categories, respectively, in women. Thirty eight percent of the 5,734 pediatric AIDS cases were in children of mothers who injected drugs; 17 percent were in children of mothers who were sex partners of IDUs. Non-injecting drug use has also been associated with increased HIV risk, (e.g., in homosexual and bisexual men, in sexual exchanges for "crack" cocaine). Of particular concern is that the proportion of cases related to drug abuse has steadily increased over the last decade. Among drug users and their sexual partners, considerable variability exists in the extent of HIV risk behaviors, not only among different individuals, but also for each person over time and from one situation to another. Factors that influence involvement in risky behaviors are not well understood. Research has focused primarily on specific risk behaviors and on the individual "at risk." Relatively little attention has been given to the contextual, situational, or temporal variability in these behaviors. Of special interest is the episodic nature of HIV risk-taking behaviors and the factors that account for change and/or stability of such behaviors. Research on situational and other environmental factors that influence decisions to engage in behaviors known to transmit HIV are needed to enhance the development of effective strategies to prevent infection with HIV. Program Objectives The primary goal of this program announcement is to improve the knowledge base on social and other environmental factors influencing drug-related HIV risk behaviors. Studies should be focused on hypothesis generation and testing in order to discover and clarify determinants of HIV-related risk behaviors. Study designs should result in data on antecedents and consequences of behavior that initiate, increase, maintain, or diminish risk behaviors. Variables may be selected from one or several domains of social, cultural, economic, psychological, environmental, or physiological factors. Applications using the dyad or social network within which risk behaviors occur as the unit of study are encouraged. Studies are also encouraged that will enhance understanding of why some individuals engage in certain types of risk behaviors that others encountering many of the same influences do not. While intervention studies are not the focus of this program announcement, it is intended that the knowledge gained from studies supported will identify factors amenable to intervention. Thus, research under this program announcement should be applicable to public health interventions and intervention research. The developmental phases of risk behaviors also need to be studied to determine when transitions occur and when would be the best opportunities for intervention and change. For example, we need to improve understanding of the impact of social and cultural factors on the development of drug injection and drug-use related sexual behaviors, identification of competing needs and choices that are involved in situations in which risky behaviors occur, assessment of the impact of factors such as perceptions of HIV prevalence and community (social network) drug use patterns, and delineation of relationships between developmental processes and risk, (e.g., adolescent's establishment of independence from family). Other examples of areas of interest include, but are not limited to: a. Initiation of drug injection, including factors influencing the transition from non-injecting to injecting use, e.g., assessment of the roles of social networks, peer influence, and community influences. b. Continuation of injecting drug use with particular examination of injection patterns associated with use of specific drugs or drug combinations, sharing of needles and other paraphernalia, sexual risk, gender roles, and choice of location for drug use. c. Physiologic effects of drugs (e.g., withdrawal, impaired learning or reasoning while abusing drugs) and their interaction with psychological, social, and environmental factors in determining the natural history of drug use and HIV risk behaviors. d. Factors affecting decisions to use risk reduction strategies, such as bleach disinfection, refraining from sharing, discontinuing injection, or participation in needle exchange programs; factors related to relapse from these risk reduction strategies to behavior with increased risk levels. e. Sexual risk behaviors associated with drug use, such as the mechanisms by which "crack" cocaine use, methamphetamine use, or specific aspects of drug use among homosexual or bisexual men, adolescents, women, and other under-studied groups contribute to risk. f. Aspects of the social dyad, social networks, peer influences, peer group composition, and beliefs about gender roles that may contribute to sexual risk taking in conjunction with or separate from drug use. g. Environmental and community-level structural factors that may be associated with level of HIV risk, including factors such as the prevalence of drug use in a region or community, population trends, economic resources available to a community, access to sterile syringes, the presence of institutions that support family cohesion, etc. Regional or community-level interpersonal factors could also be studied, e.g., neighborhood cohesion, overlap of various social networks, communication styles, police-resident interactions, attitudes towards drug and alcohol users in the community, etc. h. Specification of factors that influence drug using and sexual behaviors in HIV seropositive drug abusers. i. Studies that specifically focus on understanding individuals who have avoided or reduced risk, despite the influence of factors normally associated with high levels of risk. Such studies should clarify protective factors, whether they be interpersonal, environmental, or intrapersonal. j. Studies of the relationship between the natural history of HIV infection and transmission risk and behaviors. k. Studies of the impact of cognitive and/or neurologic impairment that results from drug use as well as HIV infection on the decision-making processes involved in avoiding or engaging in risk behaviors. l. Studies on the time course of the multilevel processes (physiological, psychological, social, and environmental) that determine particular risk behaviors on the part of individuals. Such studies may involve naturalistic methodologies such as case histories, diary keeping, and the like. m. Studies to develop new or adapt existing methodologies to improve validity and reliability of measures, and to strengthen research designs and data analytic capabilities. 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 new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. 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 reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard AIDS receipt dates indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grant Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, telephone 301/710-0267. The title and number of this program announcement must be typed in Item 2a on the face page of the application. FIRST award applicants must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants 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 that are complete and responsive to the program announcement 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. Small grants do not receive a second-level review. Review Criteria o Scientific, technical, or medical significance and originality of the proposed research; o Appropriateness and adequacy of the research approach and methodology proposed to carry our the research; o Qualifications and research experience of the principal investigators; o Availability of resources necessary to the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; and o Adequacy of the plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. The initial review group will also examine the provisions for the protection of human and animal subjects, and safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the Institute. The following will be considered in making funding decisions: quality of the proposed project as determined by the peer review, availability of funds, and program priority. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Richard H. Needle, Ph.D., M.P.H. Community Research Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-30 Rockville, MD 20857 Telephone: (301) 443-6720 Email: rn28e@nih.gov Direct inquiries regarding fiscal matters to: Dr. Gary Fleming Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gfleming@aoada2.ssw.dhhs.gov AUTHORITIES AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279 and 93.242. Awards are made under authorization of the Public Health Service Act, Section 301, and administered under PHS policies and Federal Regulations at 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. Grants must be administered in accordance with the Public Health Service Grants Policy Statement (DHHS Publication No. (OASH) 82-50-000 GPO 0017-020-0090-1 (rev. 4/94). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use 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 routing 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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