RFA-MH-00-004: LONG-TERM MAINTENANCE OF HIV/STD BEHAVIOR CHANGE

Department of Health
and Human Services (HHS)

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LONG-TERM MAINTENANCE OF HIV/STD BEHAVIOR CHANGE Release Date: January 11, 2000 RFA: MH-00-004 National Institute of Mental Health National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: February 17, 2000 Application Receipt Date: March 17, 2000 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The National Institute of Mental Health (NIMH) and National Institute on Alcohol Abuse and Alcoholism (NIAAA) are encouraging research applications that address the issue of relapse to high-risk behaviors after effective interventions that have resulted in significant behavior change. In addition, investigators are encouraged to develop and test interventions to prevent return to unsafe behaviors as a result of mental distress, recurring alcohol or substance abuse. This Request for Applications (RFA) is critical because prevention efforts must be developed in order to sustain the changed behaviors over time and prevent return to unsafe sexual or drug using behaviors that may result in re-exposure to HIV. 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 and maintenance of long-term healthy behaviors. Research is needed to develop methods and techniques to understand, prevent, and/or change high-risk sexual and related alcohol/substance-abusing behaviors and to maintain behavior change in the long-term. In addition, research is encouraged to identify psychological, social, and cultural factors that contribute to relapse in general, and to understand the specific role of alcohol and substance abuse in precipitating relapse situations. 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. While there are effective HIV/STD prevention programs that contribute to behavior change during the intervention, there are a paucity of studies about how to maintain that behavior change beyond one year. This is a major issue in having these effective interventions adopted in public health agencies and managed care facilities because the length of time that the low risk behaviors are maintained determines the cost effectiveness of implementing these preventive interventions. The major objective of research supported under this RFA would be to identify effective ways to prevent relapse to behaviors that place persons at high risk for infection by the AIDS virus. Studies would examine the psychological, physiological, social, and cultural determinants of relapse to high-risk behaviors. Findings from these studies will contribute to a better understanding of different factors may contribute to relapse to high risk behaviors so that these issues can be addressed in the original intervention and booster sessions. For example, the effect of mental distress, alcohol and other substance use on judgment, decision making, and perception of risk associated with relapse to high-risk behaviors would be identified and effective interventions developed using this information. Because social pressure, especially among youth, may be associated with relapse, interventions to change social norms to ensure maintenance of safer sexual behaviors may be tested. In addition to examining issues of maintenance of behavior change in primary prevention, this RFA will also address these issues in secondary 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 Request for Applications (RFA), Long- Term Maintenance of HIV/STD Behavior Change, is related to the priority areas of Mental Health and Mental Disorders, STD, and HIV/AIDS prevention. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000/ ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, 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. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed five years for an R01 application. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. For all competing R01 applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being undertaken at NIH. More detailed information about modular grant applications, including a sample budget narrative justification pages and a sample biographical sketch, is available via the Internet at: http://grants.nih.gov/grants/funding/modular/modular.htm. Applications that request more than $250,0000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. FUNDS AVAILABLE The NIMH intends to commit approximately $1.2 million in total support in FY 2000 to fund three to four new awards in response to this RFA. The NIAAA intends to commit up to $600,000 to fund two new awards. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. It is expected that the direct costs will be awarded in modules of $25,000, however, program and grants management adjustments may be necessary prior to award. Although the financial plans of the Institute provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. RESEARCH OBJECTIVES Background While there are effective HIV/STD prevention programs that contribute to behavior change during the intervention, there is a paucity of studies about how to maintain that behavior change beyond one year. The major objective of research supported under this RFA would be to identify effective ways to prevent relapse to behaviors that place persons at high risk for HIV/STD infection. Relevant research is encouraged to improve knowledge and understanding of determinants of relapse behaviors and strategies to increase long-term maintenance of initially successful behavior change. Areas of Interest The following section suggests areas of research to meet the health promotion and disease prevention objectives of this RFA. However, researchers do not need to limit their research proposals to the following topics: o factors that differentiate persons who relapse from those who maintain low- risk behaviors, o psychological, physiological, social, and cultural determinants of relapse to high-risk behaviors, o understanding how use and abuse of alcohol, may precipitate a return to HIV risk behavior, o developing and testing interventions to control alcohol use or abuse and relapse to unsafe HIV-related behaviors, o understanding how the psychological, physiological, social, and cultural determinants of relapse to high risk behaviors vary by alcohol problem severity and treatment status, o relationship of knowledge and attitudes associated with maintenance of low- risk behaviors, o dose response from intervention and role of mediators in behavior change and long-term maintenance, o role of self-efficacy in relapse to high risk behaviors, o effect of alcohol and substance use on judgment, decision making, and perception of risk associated with relapse to high-risk behaviors, o effects of affective states on the maintenance of low-risk behaviors, o role of social pressure, social norms and culture associated with relapse and ensuring long-term maintenance of safer HIV/STD related behaviors, o role of media and other forms of communication in changing social norms and contributing to the maintenance of low-risk HIV/STD behaviors, o effective coping strategies to handle relapse episodes to stimulate recovery to low-risk behaviors, o testing of relapse models from other health areas (e.g., alcohol, smoking cessation, weight control, etc.) in maintaining low-risk HIV/STD behaviors, o role of the quality of the couple relationship in maintaining safer HIV/STD risk behaviors, and o relapse preventive interventions targeted to specific at-risk populations. SPECIAL REQUIREMENTS In order to assess maintenance of behavior change, the assessments should be conducted at least 24 months after the initial intervention is completed. The Institute will convene an annual meeting of successful grantees in order to share strategies that are being implemented. Provisions for this meeting, to be held in the Washington, D. C. area, should be included in the budget. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). It is also NIH policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html 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 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 and 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 Institute staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Willo Pequegnat, at the address listed under INQUIRIES, by February 17, 2000. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The application is also available at http://grants.nih.gov/grants/funding/phs398/phs398.html SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398 (rev 4/98). It is not required nor will it be accepted at the time of application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget tables on page 5 of the PHS 398 (rev. 4/98) Form. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application and must display the RFA number MH-00-004. A sample modified mailing label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in pdf format. 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, LONG-TERM MAINTENANCE OF HIV/STD BEHAVIOR CHANGE (MH-00-004), must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW 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 be sent to: Dr. Willo Pequegnat Center for Mental Health Research on AIDS Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6209, MSC 9619 Bethesda, MD 20892-9619 Applications must be received by March 17, 1999. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) 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 CSR 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIMH staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 NIMH in accordance with the review criteria stated below. 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 NIMH in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: February 17, 2000 Application Receipt Date: March 17, 2000 Peer Review Date: June 2000 Council Review: September 2000 Earliest Anticipated Start Date: September 29, 2000 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. 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: Willo Pequegnat, Ph.D. Center for Mental Health Research on AIDS Division of Mental Disorders, Behavioral Research, and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6205, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: Wpequegn@nih.gov Kendall J. Bryant, Ph.D Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 505, 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: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Judy Simons Grants Management Branch National Institute of Alcohol Abuse and Alcoholism 6000 Executive Boulevard, Suite 504, MSC-7003 Bethesda, MD 20892-7003 Telephone: (301) 443-2434 FAX: (301) 443-3891 Email: jsimons@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH) and 93.273 (NIAAA). Awards are made under authorization of the Public Health Service 5600 Fishers Lane 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. 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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