Full Text AA-97-003 DEVELOPING ALCOHOL-RELATED HIV PREVENTIVE INTERVENTIONS NIH GUIDE, Volume 25, Number 41, November 29, 1996 RFA: AA-97-003 P.T. 34 Keywords: Alcohol/Alcoholism AIDS Disease Prevention+ National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: March 21, 1997 Application Receipt Date: April 24, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks to stimulate the design, development, and testing of alcohol-related HIV preventive interventions that have the potential for reducing the risk of transmission of HIV in alcohol using, abusing, and dependent populations. Alcohol consumption has been identified as an important behavioral cofactor for HIV infection and has been consistently associated with HIV-risk behaviors over time. Alcohol use has been shown to predict time to seroconversion among gay men. Significantly higher rates of HIV infection are found among clinical samples of alcoholics and nonclinical samples of individuals who meet criteria for alcohol dependence than in the general public. In addition, reduction in alcohol use is associated with reduced sexual risk taking. Alcohol-related HIV interventions are currently being tested among gay and bisexual men, Native American youth, and persons in alcoholism treatment. Initial results suggest that a wide range of HIV-risk behaviors can be reduced after intervention and at follow-up, particularly among gay men. This research suggests that substance abuse prevention and treatment programs that include HIV components are more effective in reducing alcohol consumption and risky sexual practice than programs those that do not contain these components. Similarly, it appears that HIV prevention programs that include an alcohol risk reduction component may be more effective in reducing HIV risk behaviors than those that do not. This Request for Applications (RFA) reflects "Findings and Recommendations" suggested by the "NIH AIDS Research Program Evaluation; Behavioral, Social Science, and Prevention Research Area Review Panel." The review panel recommended a substantial increase in support for preventive intervention research in a diverse range of alcohol-related settings, drinking populations, and HIV-risk populations. Investigators are encouraged to move beyond basic behavioral studies to measure the efficacy and effectiveness of substance use risk-reduction interventions in populations at risk for both alcohol problems and HIV infection. The emphasis of this RFA on prevention research in the alcohol/AIDS area continues the previous focus of the NIAAA Prevention Research Branch on primary prevention of HIV and alcohol abuse among alcohol users. In addition, this RFA addresses secondary prevention among HIV infected alcoholics who may be more likely than other HIV infected individuals to engage in high-risk sexual behavior, to use unclean needles, and to have problems adhering to therapeutic treatments for HIV and AIDS. 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 RFA is related to the priority area of AIDS prevention. 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 202-512-1800). ELIGIBILITY Applications may be submitted by domestic and foreign, for-profit and non-profit, public and private organizations, 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) Awards (R29). Research project grant applications (R01) from foreign institutions are limited to three years. MECHANISM OF SUPPORT Research support may be obtained through an application for a regular research project grant (R01) or FIRST (R29) award. Applications are also encouraged for exploratory/developmental Grants (R21), which are limited to two years for up to $70,000 per year for direct costs. Exploratory/Developmental grants are also available for the secondary analysis of existing alcohol abuse prevention research data. Applicants may submit applications for Investigator-Initiated Interactive Research Project Grants (IRPGs). Interactive Research Project Grants require the coordinated submission of related research project grant (R01) and, to a limited extent FIRST Award (R29) applications from investigators who wish to collaborate on research, but do not require extensive shared physical resources. These applications must share a common theme and describe the objectives and scientific importance of the interchange of, for example, ideas, data, and materials among the collaborating investigators. A minimum of two independent investigators with related research objectives may submit concurrent, collaborative, cross-referenced individual R01 and R29 applications. Applicants may be from one or several institutions. Further information on these and other grant mechanisms may be obtained from the program staff listed under INQUIRIES. Further information on the IRPG mechanism is available in program announcement PA-96-001, NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995. Potential applicants for FIRST Awards or Exploratory/Developmental Grants may obtain copies of the specific announcements for these programs from the NIAAA Home Page at HTTP://WWW.NIAAA.NIH.GOV or from the Office of Scientific Affairs, NIAAA, Willco Building, Suite 409, 6000 Executive Boulevard MSC 7003, Bethesda, Maryland 20892-7003, telephone: 301-443-4375 or FAX 301-443-6077. Further information on these and other grant mechanisms may be obtained from the program staff listed under INQUIRIES. FUNDS AVAILABLE It is estimated that up to $2.0 million will be available to fund approximately ten grants under this RFA. This level of support is dependent on the receipt of sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the NIAAA, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. The earliest possible award date is September 30, 1997. RESEARCH OBJECTIVES Preventive interventions may be initiated and implemented by the investigators themselves for the specific purpose of testing effects of the strategies; or the interventions may occur naturally through the actions of public and private organizations (e.g., reduction in availability and accessibility of alcohol, increased distribution of condoms at bars, health promotion campaigns that highlight linkages between alcohol use and AIDS). Investigator-initiated alcohol-focused interventions may also be nested within the context of naturally occurring HIV interventions, such as vaccine trials, permitting the effects of both types of interventions to be studied simultaneously. These alcohol-focused interventions can be aimed at individuals, social networks, institutions, and specific alcohol settings such as bars and clubs, to change alcohol-related sexual expectancies, behavioral norms, and HIV risk-taking behaviors. Populations at risk for HIV who also abuse or are dependent on alcohol are most in need of study. These special subgroups include gay or bisexual men, alcoholics in treatment, alcohol abusing women and minorities, and adolescents initiating sexual behavior in the context of drinking. Other groups of interest that may be indirectly affected by alcohol use include partners and families of HIV-infected alcoholics. In addition to developing and testing new investigator-initiated interventions or naturally-occurring preventive programs, timely and cost-effective approaches may include: a) developing "augmenting" HIV interventions within the context of clinical or epidemiological studies to address alcohol-related problems (e.g., improving adherence of alcohol abusers to therapeutic regimes involving protease inhibitors). b) supplementing ongoing alcohol-problem intervention studies to include HIV infected or at-risk populations and adapting the intervention to address HIV issues in this subgroup (e.g., including HIV-risk populations in comparisons of brief motivational counseling and cognitive-behavioral interventions.) A wide range of contexts may be appropriate for intervention studies. These include but are not limited to: o Hard-to-reach populations: Alcohol abusers often delay entering medical settings where they could be identified as needing appropriate interventions and are often difficult to retain in controlled clinical trials. Such difficulties in attracting and retaining alcohol-abusing individuals may have particular significance for the testing and evaluation of HIV vaccines and therapeutics. New interventions need to be developed to attract and retain individuals at extremely high-risk for alcohol abuse and HIV infection, and new research designs and analytic strategies need to be developed to adequately evaluate these interventions in settings in which high rates of attrition may occur. Intervention strategies might, for example, include more informal and culturally relevant drop-in clinics, and different analytic procedures, such as case-control or case-based designs, may be necessary to test the effects of these interventions on such variables as HIV exposure, alcohol abuse, and retention in trials. o Health-Care Systems: Increasing attention is being paid to the role of health-care systems and professionals in preventing alcohol-related problems before they occur, in facilitating early detection of alcohol-related high-risk behaviors, and in providing appropriate treatment. Experimental and quasi-experimental designs may be used within health-care settings to test the efficacy of preventive strategies. These strategies may include risk assessment, brief and more extensive advice, case monitoring, and improved linkage to services for alcoholics in treatment or for HIV-infected individuals with alcohol problems. o Application of Basic Behavioral Research to Interventions: A wide range of preintervention studies have addressed the relationship of cognitive and physiological effects of alcohol use on high-risk sexual behavior. These studies have measured the effects of alcohol-related sexual expectancies, physiological disinhibition, decision making while intoxicated, and affect regulation. Interventions need to be developed that take into account these recent findings concerning high-risk behavior under conditions of intoxication. o Media/Communications: Ongoing research is needed to assess the efficacy of media strategies, alone or combined with other strategies, to prevent alcohol-related risky sexual behavior. Applicants are encouraged to develop and test promising media messages, new communications technologies, and special media for cultural subgroups to determine the most effective media/communications approaches for varied target audiences. Of particular interest are communication strategies that reach audiences at highest risk for alcohol abuse and HIV-infection, which include youth, selected ethnic minorities, gay and bisexual men, and male and female partners of HIV-infected individuals. o Family Studies: Research suggests that family involvement, broadly defined, can enhance the effectiveness of school-based and clinic-based alcohol prevention programs among youth at-risk for alcohol problems. Research on homeless and runaway youth indicates a high rate of co-occurring alcohol abuse and unsafe sexual behavior, often resulting in the spread of sexually transmitted diseases. Research needs to be expanded in this area to develop effective interventions among family members to reduce the risk for HIV infection. o College and School-Based Studies: Interventions are needed in school and college environments to alter drinking practices that contribute to unprotected sex, sexual assaults, and spread of sexually transmitted diseases. Late adolescence and the transition from high-school to college is when many young people are initially freed from parental controls, increase their levels of alcohol consumption, and increase sexual activity. Often high rates of drinking and binge drinking are encountered on college campuses. Studies of alcohol-focused interventions that are currently being carried out in school or college contexts could be usefully expanded to evaluate effects of these interventions on high-risk sexual behavior. 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. LETTER OF INTENT Prospective applicants are asked to submit, by March 21, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number of title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIAAA staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: RFA-AA-97-003 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 FAX: (301) 443-6077 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Applications for support mechanisms other than R01 (i.e., an R29) must cite the relevant program announcement on line 2 in addition to listing the current RFA. Applications for FIRST awards (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. Page limits and limits on size of type are strictly enforced. Non-conforming applications will be returned without being reviewed. Submit a signed, typewritten original of the application, including the checklist and three signed photocopies in one package 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) At the time of submission, two additional copies of the application must also be sent to: RFA AA-97-003 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852 (for express/courier service) Failure to forward the above two applications to NIAAA at the above address may delay consideration of an application such that it may not be received in time for FY 1997 funding consideration. Applications must be received by April 24, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique and must be prepared in the format of a revised application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Institute in accordance with the review criteria stated below. As part of the initial merit review, a streamlined review process may be used by the initial review group in which applications may or may not be discussed based on their scientific merit relative to other applications received in response to the RFA. Applications which are fully discussed will be assigned a priority score. Applications which are not discussed will be withdrawn from further considerations and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria Criteria to be used in the scientific and technical merit review of the research grant applications will include the following: 1. The scientific, technical, or medical significance and originality of the proposed research and its relevance to the goals of this RFA: 2. The appropriateness and adequacy of the experimental approach and methodology, including adequacy of quality control methods, proposed to carry out the research such as adequacy of plans to measure biological markers relevant to AIDS behavioral research e.g., seroconversion. 3. The adequacy of the qualifications (including level of education and training) and relevant research experience of the principal investigator and key research personnel. 4. The availability of adequate facilities, general environment for the conduct of the proposed research, other resources, and collaborative arrangements necessary for the research. 5. The reasonableness of budget estimates and duration for the proposed research. 6. When applicable, 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 these subjects will also be evaluated. When applicable, the initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. The review criteria for Exploratory/Developmental Grants (R21) and FIRST Awards (R29) are contained in their program announcements. AWARD CRITERIA Applications recommended for approval by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for funding on the basis of the overall scientific and technical merit of the application as determined by peer review, NIAAA programmatic needs and balance, and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Kendall Bryant, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-8820 FAX: (301) 443-8774 Email: kbryant@willco.niaaa.nih.gov Direct inquiries regarding fiscal matters to: Linda Hilley Office of Planning and Resource Management National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4703 FAX: (301) 443-3891 Email: lhilley@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52, "Grants for Research Projects;" Title 45 CFR Parts 74 and 92, "Administration of Grants;" and 45 CFR Part 46, "Protections of Human Subjects." 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. 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 routine 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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