COMMUNITY IMPLEMENTATION OF HIV PREVENTION INTERVENTIONS Release Date: February 28, 2001 RFA: RFA-MH-01-006 National Institute of Mental Health ( National Institute of Nursing Research ( National Institute on Drug Abuse ( Letter of Intent Receipt Date: April 13, 2001 Application Receipt Date: May 11, 2001 THIS REQUEST FOR APPLICATIONS (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), the National Institute of Nursing Research (NINR) and the National Institute on Drug Abuse (NIDA) invite research grant applications that target research on the translation and adoption of empirically tested and proven Human Immunodeficiency Virus (HIV) research-based prevention interventions into community-based public health settings. This initiative is intended to foster partnerships among researchers and community-based organizations in the process of adapting and adopting proven interventions. Areas of research appropriate to this RFA include: studies of implementation approaches and organizational and environmental characteristics that impede or foster implementation, cost- effectiveness of efficacious strategies, identification of characteristics of community organizations most prepared to implement research-based interventions, and studies of the impact of efficacious interventions in community settings. Research on characteristics of interventions and of community settings that contribute to the likelihood of sustaining an intervention over time are also of interest. Multidisciplinary teams and collaborative alliances are strongly encouraged. This effort is being initiated in consultation with the Centers for Disease Control and Prevention. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health-promotion and disease-prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA, Community Implementation of HIV Prevention Interventions, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at 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) and collaborative R01 award mechanisms. 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. 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. The anticipated award date is September 30, 2001. 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: Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. For the purposes of this RFA, the guidelines provided in PAR-98-017 ( are to be followed for applications using the collaborative R01 mechanism. FUNDS AVAILABLE NIMH intends to commit approximately $2,000,000 in FY 2001 to fund five to seven grants in response to this RFA. NINR intends to commit approximately $500,000 or the equivalent of two R01s in response to this RFA. NIDA also intends to commit approximately $500,000 or the equivalent of two grants in response to this RFA. 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 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. RESEARCH OBJECTIVES Background The past decade has witnessed numerous advances in preventing HIV infection. Many of these advances have occurred as the result of the efforts of HIV prevention researchers as well as those of many community-based HIV prevention programs. Despite advances in our knowledge, it is clear that information, strategies and models for HIV prevention have not always reached community program coordinators. Likewise, information developed by community programs has frequently not reached or influenced HIV prevention researchers. The future effectiveness of HIV prevention efforts will be greatly affected by the degree to which we are successful in increasing cross-fertilization among researchers and community programs. It is extremely important that working relationships be established between the research community and the community of public agencies and organizations actually delivering prevention programs to high-risk populations. Models of technology transfer need to be developed and validated in large-scale community settings. These models must include effective training for community providers as well as ongoing assessment of what happens to research- based interventions when they are put into practice. Methodologies that include measurable outcomes must be developed to assess the impact of various interventions in the community. Critical to the success of these efforts will be an awareness of the cultures in which the interventions were undertaken and ways in which existing interventions may have to be modified to be successful. Interventions that leave in place infrastructures capable of complex problem solving, program evaluation, and ongoing two-way communication with the research community, should ease the path for future technology transfer. Areas of Interest The following section includes suggested areas for research. The list is suggestive and not exhaustive, but it does place an emphasis on studies that require collaboration between researchers and community-based organizations and stresses issues that will enhance our knowledge and understanding of how best to implement research-based HIV prevention interventions in communities at high risk of HIV. o Studies that assess what happens to research-based interventions when they are implemented on a community level o Studies that develop and test different modes for transferring effective research-based HIV prevention interventions into the community o Studies that identify and evaluate outcome measures appropriate to the evaluation of research-based HIV prevention interventions implemented in community settings o Research on the characteristics of community-based organizations most likely to be successful in implementing research-based interventions o Research on the characteristics of research-based interventions that increase the likelihood that they will be successfully implemented in at-risk communities o Development and validation of effective models for the translation of research-based HIV prevention interventions into the community o Studies of the cost-effectiveness of research-based HIV prevention interventions when implemented in different settings o Research on models for facilitating cooperation among research and service professionals o Studies of the adoption of research-based HIV prevention interventions in ethnically diverse communities and the identification of strategies to adapt proven interventions to these communities o Studies of the organizational environment and how it facilitates or impedes implementation of research-based HIV prevention interventions o Studies that test strategies to enhance facilitating factors and diminish impeding factors o Studies of the development of new technologies to inform, train and assist community-based organizations in implementing and sustaining efficacious HIV prevention interventions including use of the internet, CD-ROMS or other potentially cost-effective modalities o Studies of mechanisms that would enable community-based organizations to advise and communicate with the research community on needed research to improve responses to ongoing or emerging HIV-related public health issues o Studies of clients of community-based organizations to assess their reactions to research-based interventions 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). All investigators proposing research involving human subjects should read the UPDATED NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, published in the NIH Guide for Grants and Contracts on August 2, 2000 (, a complete copy of the updated Guidelines are available at The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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: 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. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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 plan the review. The letter of intent is to be sent to Dr. Louis Steinberg, at the address listed under INQUIRIES, by the letter of intent receipt date listed in the heading of this RFA. 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: The application is also available at 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. Additional information about modular grant applications is available at: 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 o 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. o 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. o 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 nor will it be accepted at the time of application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See 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 all 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 all 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: - 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-01-006]. A sample modified mailing label is available at: 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, Community Implementation of HIV Prevention Interventions, MH-01-006, 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: Louis H. Steinberg, Ed.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room, 6201 MSC 9621 Bethesda, MD 20892-9621 Applications must be received by May 11, 2001. 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 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. 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory Council of the participating institutes. 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. o The adequacy of the proposed plan to share data, if appropriate. Schedule Letter of Intent Receipt Date: April 13, 2001 Application Receipt Date: May 11, 2001 Peer Review Date: June/July 2001 Council Review: September 2001 Earliest Anticipated Start Date: September 30, 2001 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: Louis H. Steinberg, Ed.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6201, MSC 9621 Bethesda, MD 20892-9621 Telephone: (301) 443-6100 FAX: (301) 443-9719 E-Mail: Hilary D. Sigmon Ph.D., R.N. Program Director Office of Extramural Programs National Institute of Nursing Research Building 45, Rm. 3 AN-12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 E-Mail: Helen Cesari, M.Sc. Associate Director for Research Management Center on AIDS & Other Medical Consequences of Drug Abuse National Institute on Drug Abuse 6001 Executive Blvd Room 5198 MSC 9593 Bethesda, MD 20892-9593 Telephone: (301) 402-1918 FAX: (301) 480-4544 E-Mail: Direct inquiries regarding fiscal matters to: William F. Caputo Grants Management Branch, DEA National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-0004 FAX: (301) 443-6885 E-Mail: Robert Tarwater Grants Management Specialist Office of Extramural Programs National Institute of Nursing Research Building 45, Rm. 3 AN-12 45 Center Drive MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-2807 FAX: (301) 480-8260 E-Mail: Gary Fleming, J.D., M.A. Grants Management Branch Office of Planning and Resource Management National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 E-Mail: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH), 93.279 (NIDA), and 93.361 (NINR). 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 NIH 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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