Full Text PA-95-030 PREVENTION OF RELAPSE TO HIGH-RISK BEHAVIORS NIH GUIDE, Volume 24, Number 5, February 10, 1995 PA NUMBER: PA-95-030 P.T. 34 Keywords: Behavioral/Experimental Psychology Mental Disorders Disease Prevention+ National Institute of Mental Health National Institute on Drug Abuse PURPOSE The National Institute of Mental Health (NIMH) and National Institute on Drug Abuse (NIDA) are encouraging research applications that address the issue of relapse to high-risk behaviors after behavior change. This program announcement (PA) is critical because prevention efforts must be developed to sustain the changed behaviors over time and prevent relapse. The urgency of the AIDS crisis demands that top priority be given to research with implications for preventive interventions that reduce the incidence of relapse to high-risk behaviors. Research is needed to develop methods and techniques to understand, prevent, and/or change high-risk sexual and drug-abusing behaviors and to maintain long-term behavior change. In addition, research is encouraged to identify psychological, social, and cultural factors that contribute to relapse. Research is needed to determine the role of alcohol consumption in the initiation and maintenance of high-risk behaviors. Even if an AIDS vaccine were to be identified in the next few years, prevention efforts would continue to be the primary way to stop the further spread of HIV infection. Because long-term maintenance of low-risk, HIV-related behaviors is a critical issue in the primary prevention of the spread of HIV, this program announcement solicits theoretically grounded research applications focusing on behavioral strategies for relapse prevention. 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, Prevention of Relapse to High-Risk Behaviors, is related to the priority areas of mental health and mental disorders and HIV infection. 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) through the 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 organizations and institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards or program project grants (P01). MECHANISMS OF SUPPORT Support for applications submitted in response to this program announcement will be through individual research projects (R01s), FIRST awards (R29), and program project grants (P01). RESEARCH OBJECTIVES Background The major objective of research supported under this PA is to identify effective ways to prevent relapse to behaviors that place persons at high risk for infection by the AIDS virus. The behaviors involved in such risk are sexual behaviors (e.g., having unprotected sexual contact with an infected individual) and contamination of drug injection equipment. Current research indicates that the acquisition of knowledge through educational materials is not sufficient to produce sustained behavior change in many individuals who participate in high-risk behaviors. Relevant research is encouraged to improve knowledge and understanding of relapse behaviors. Study Populations/Target Groups Study populations or target groups should include those most likely to relapse to high-risk behaviors. These would include predefined groups such as gay and bisexual men, particularly young men, and drug users who inject. Areas of Interest The following section suggests areas of research to meet the health promotion and disease prevention objectives outlined above. Researchers responding to this PA, however, need not limit themselves to these topics. o Studies identifying factors that differentiate persons who relapse from those who maintain low-risk behaviors o Research on the psychological, physiological, social, and cultural determinants of relapse to high-risk behaviors o Research on the relationship of knowledge and attitudes associated with maintenance of low-risk behaviors o Research on the effect of alcohol and drug use on judgment, decision making, and perception of risk associated with relapse to high-risk behaviors o Studies on how low self-efficacy and a sense of helplessness may contribute to relapse o Studies on the effects of affective states on the maintenance of low-risk behaviors o Studies on the social pressures associated with relapse, and changing social norms that can ensure maintenance of safer sexual behaviors o Studies on coping with relapse episodes to stimulate recovery to low-risk behaviors o Studies testing relapse models from other health areas (e.g., smoking cessation, weight control) to HIV/AIDS o Research testing relapse preventive interventions targeted to specific at-risk populations 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 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, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff 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 under the receipt deadlines for AIDS applications. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267. The title, Prevention of Relapse to High-Risk HIV Behaviors, and number of the program announcement must be typed in Section 2a on the face page of the application. Applications for the FIRST Award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST Award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. 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 resources for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. 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 Bethesda, MD 20892 Bethesda, MD 20817 (express mail) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate initial review group in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. 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. Review Criteria Criteria for scientific/technical merit review of applications are: o Significance and originality from a scientific or technical standpoint of the goals of the proposed research o Qualifications and experience of the principal investigator and demonstrated staff expertise in family processes, prevention research, statistics, cultural competence, AIDS, and other areas specific to the questions under investigation o Adequacy of the conceptual and theoretical framework for the research, including cultural relevance to the target populations and evidence of familiarity with relevant research literature o Scientific merit of the research design, approaches, intervention, and methodology o Access to target population(s) o Sample selection and retention methods and efforts to determine factors that influence refusal rate o Adequacy of the data analysis plan o Adequacy of the existing and proposed facilities and resources o Appropriateness of the budget, staffing plan, and time frame to complete the project o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. 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 subjects and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that Institute. The following will be considered in making funding decision: o Scientific merit as determined during the peer review process o Availability of funds o Balance among target populations with priority given to understudied populations For applications assigned to the NIMH or NIDA, additional criteria concern: o Balance among theoretical and multicultural approaches, and o Balance among geographic areas 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 on AIDS National Institute of Mental Health Parklawn Building, Room 10-75 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: WPEQUEGN@AOAMH2.SSW.DHHS.GOV Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 Email: DT21a@NIH.GOV Direct inquiries regarding projects with a focus on drug abuse aspects of HIV/AIDS to: Steven W. Gust, Ph.D. Deputy Director, Office on AIDS National Institute on Drug Abuse 5600 Fishers Lane, Room 10-05 Rockville, MD 20857 Telephone: (301) 443-6697 FAX: (301) 443-2317 Email: SGUST@AOADA2.SSW.DHHS.GOV Direct inquiries regarding projects with a focus on issues relevant to nursing practice to: June R. Lunney, Ph.D., R.N. Health Promotion/Disease Prevention Branch National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6908 FAX: (301) 480-8260 Email: JLUNNEY@EP.NINR.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242, Mental Health Research Grants, and 93.279, Drug Abuse Research Grants. 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. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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