Full Text PA-95-070 BRIEF INTERVENTIONS TO PREVENT THE SPREAD OF AIDS NIH GUIDE, Volume 24, Number 2, June 16, 1995 PA NUMBER: PA-95-070 P.T. 34 Keywords: AIDS Disease Prevention+ Behavioral/Social Studies/Service National Institute of Mental Health PURPOSE The National Institute of Mental Health (NIMH) is encouraging applications for the suppor tof research on brief preventive interventions that can be implemented in public health clinics and community-based organizations to prevent the further spread of HIV. This program announcement (PA) is critical because prevention efforts must be developed to reach individuals who may not proactively seek HIV prevention programs to change high-risk behavior. The urgency of the AIDS crisis demands that top priority be given to research with implications for preventive interventions that access hard-to-reach populations who are at high risk for HIV infection. 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 further spread of HIV infection. Research is needed to develop methods and techniques to motivate people to assess their risk for HIV and to seek help in changing high-risk, HIV-related behaviors, and to seek additional behavior-change help. Some people may not actively seek long-term HIV prevention programs, but might be reached at clinics where they are being treated for other medical problems. Therefore, brief interventions that could be used in Sexually Transmitted Disease (STD) clinics, health care facilities, and alternative (non-health care) sites are urgently needed. This program announcement solicits theoretically grounded research applications focusing on developing models of brief HIV prevention programs. No definition is provided for "brief intervention" so that investigators can develop and test a range of single and short-term interventions. 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, Brief Interventions to Prevent the Spread of AIDS, 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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29s) awards or program project grants (PO1s). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for applications submitted in response to this program announcement will be through individual research projects (R01s), FIRST awards (R29s), and program project grants (P01s). RESEARCH OBJECTIVES Background The major objective of research supported under this PA is to identify effective brief interventions that can be implemented in clinics and other primary health care facilities. Current research indicates that HIV education campaigns that primarily provide information about the HIV virus, modes of infection, and methods of prevention do not produce sustained behavior change. In addition, models of brief interventions that access hard-to-reach populations who may not otherwise be exposed to HIV prevention programs are urgently needed. Areas of Interest The following section suggests areas of research to meet the health promotion and disease prevention objectives of this PA. However, researchers responding to this PA need not limit themselves to these topics. o Which modality of intervention (e.g., counseling, psychotherapy, health information, health education, community-level intervention) and modality of delivery (e.g., individual, group, written, interactive video, etc.), provide the most effective, parsimonious intervention in different settings? o What are the best settings for implementing brief HIV prevention interventions, and who is the best intervenor (e.g., physician, nurse, counselor, peer)? o What are the critical components in a brief intervention that will motivate individuals to assess HIV risk and seek help? o Are there brief counseling models that are generalizable and effective with different populations? o Which brief interventions are most effective in producing sustained behavior change? o What are possible barriers to conducting brief interventions in various settings (e.g., barriers to having health-care providers discuss specific sexual behaviors, lack of referrals for seropositives and for seronegatives, barriers to adopting preventive health behaviors for individuals who have been serotested and learn that they are seronegative) and how can they be overcome? o What is the appropriate means of defining, operationalizing, and measuring the effectiveness of a given brief intervention? o What types of outcomes might be expected from brief interventions (e.g., changes in sexual behavior, help-seeking behavior, increased readiness to change, changed attitudes and beliefs, etc.)? o What are realistic behavioral outcome goals for different individuals and groups as a result of brief interventions? o What factors mediate test-seeking behavior (e.g., demographic and motivating factors)? What is the emotional/ behavioral impact of deciding to be tested or planning to be tested? What factors predict which individuals will return for test results? What factors predict an individual's ability to cope with test results? o Is it possible to set standards for the content and process of prevention interventions delivered in various settings? How can the content of counseling sessions be evaluated? How can quality assurance be conducted? 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 20, 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 Aplications 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, 6701 Rockledge Drive, Room 1040, Bethesda, MD 20892; telephone 301/710-0267. The title, "Brief Interventions to Prevent the Spread of HIV," 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. 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 courier/overnight mail 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 an appropriate National Advisory Council. Several other Institutes have an interest in research in this research area. Most notably, the National Institute of Nursing Research, the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Aging, and the National Institute on Child Health and Human Development. Applications submitted in response to this Program Announcement will be referred to initial review groups in accordance with PHS referral guidelines. Review Criteria 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 prevention research, AIDS, multicultural assessment of diverse populations, statistics, AIDS, and other areas specific to the questions under investigation o adequacy of the conceptual and theoretical framework for the research 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. For those applications assigned to the NIMH, 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 o balance among theoretical and multicultural approaches 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@A0AMH2.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 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental Health 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. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). 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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