RFA-MH-01-004: INTERNATIONAL INITIATIVES TO PREVENT HIV/STD INFECTION

Department of Health
and Human Services (HHS)

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INTERNATIONAL INITIATIVES TO PREVENT HIV/STD INFECTION Release Date: October 31, 2000 (Revised November 16, 2000 - See NOT-MH-00-017) RFA: MH-01-004 National Institute of Mental Health (http://www.nimh.nih.gov/) National Institute of Nursing Research (http://www.ninr.nih.gov) Letter of Intent Receipt Date: January 15, 2001 Application Receipt Date: March 13, 2001 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 Although some developing countries have implemented successful HIV/STD prevention programs and policies, there is an urgent need to scale up these efforts and to find low-resource, cost-effective prevention programs. According to the World Bank, AIDS has eradicated a half-century of development in most affected countries. The impact on life expectancy among adults between the ages of 25 to 44 is staggering, and one child in ten is orphaned in Africa. AIDS is now considered a national security issue by the United States (U.S.). Under this initiative, the National Institute of mental Health (NIMH) and the National Institute of Nursing Research (NINR) will encourage new and expanded collaborative efforts between U.S.-supported researchers and researchers in other nations to test behavioral interventions to stop the spread of HIV infection and its consequences. This initiative will support co-operative relationships between U.S. and foreign research groups to: 1) identify successful interventions for targeted populations, 2)facilitate the conduct of scientifically valid and ethically sound HIV/AIDS prevention research, and, 3) develop methods to implement prevention programs for large-scale use. Although not participating in this RFA, the National Institute of Child Health and Human Development (NICHD) also maintains an interest in domestic and international HIV-related intervention research. For specifics, see http://www.nichd.nih.gov/about/cpr/dbs/dbs.htm. 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 Request for Applications (RFA), International Initiatives to Prevent HIV/STD Infection, MH-01-004, is related to the priority areas of Mental Health and Mental Disorders, STDs, and HIV. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. 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. Foreign institutions are not eligible for small grants (R03). 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 the Small Research Grants (R03) 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 5 years for an R01 award and 2 years for an R03 award. 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 R03 applications and applications for R01s 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 examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. Because the small grants have special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES) and to obtain the appropriate additional announcements for those grant mechanisms. Special instructions and information for the small-grant program is found at: http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html. R03s are limited to $50,000 direct cost for each of the two years and are not renewable. FUNDS AVAILABLE The NIMH intends to commit approximately $1.8 million in FY 2001 to fund 3 new and/or competitive continuation grants and 6 competitive supplements in response to this RFA. NINR intends to commit approximately $500,000 in FY 2001 to fund one or 2 new grants or 2 competitive supplements. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $350,000 per year for new grants and $200,000 for supplements. 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 an 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. A request for a competitive supplement may not exceed the length of the current project period ending date of the parent grant to which the supplement applies, and will request direct costs in $25,000 modules, up to the total maximum direct cost request of $200,000. RESEARCH OBJECTIVES Background A major area of research under this initiative will be the adoption and adaptation of prevention programs that are appropriate for international studies. Potential applicants will be encouraged to use a behavioral prevention tool developed by NIMH, called the NIMH AIDS Strategic Intervention Simulation Tool, which was demonstrated at the XIIIth International AIDS Conference in Durban, South Africa. This program permits users to select prevention programs likely to have the greatest impact on HIV/STD incidence. This initiative will also encourage the further development and evaluation of theoretical models that explore the relationships among interventions, risk behaviors, and characteristics of the HIV epidemic. This methodology will also be used to evaluate the impact of theoretical research in policy development and strategic HIV/STD prevention plans. This research initiative will support but is not limited to the following research areas: o Identification of the social, economic, and cultural dynamics that contribute to the rapid spread of HIV/STDs in developing countries, o Testing of interventions based on psychological, social, economic, and cultural dynamics of gender and sexual identity that operate in HIV risk, o Development and testing of interventions targeted at HIV-infected persons to reduce their HIV/STD risky behaviors, o Description of effective HIV/STD prevention efforts in countries with different HIV prevalence and high-risk population (nascent = < 5 percent, concentrated = 5 percent in one or more at-risk population, generalized = spread beyond original at-risk groups) by using mathematical modeling procedures, o Testing of comprehensive school-based education programs that include components of life skills and modes of preventing HIV infection in pre- adolescent, adolescent, and young adult populations, o Testing the efficacy of voluntary counseling and testing programs in reducing high-risk behaviors and in reducing HIV/STDs, especially in couples, o Studying the impact of different social marketing and condom-availability strategies on reduction of risk behaviors and HIV/STDs, o Adapting and testing of prevention programs for at-risk populations (e.g., wives of men who are at risk, widows, unskilled women, commercial sex workers, orphans, school dropouts, street children, truck drivers, migrants, bisexual men, rural and tribal populations, slum dwellers, persons with mental illness or cognitive deficiencies), o Testing of combined disease prevention (HIV/STDs) and reproductive health programs in reducing HIV/STD risk behaviors, o Examining the role of HIV medical treatment on risky behaviors of HIV+ persons and designing interventions to increase disclosure and reduce high risk behaviors, o Designing and testing of programs to address the effects of social stigma and disclosure on adoption of risk-reducing behaviors (e.g., use of condoms, seeking testing, telling partners about serostatus, etc.), o Identification of gender roles in acquisition and transmission of HIV/STDs and designing of preventive interventions that address these factors, o Development and testing of mathematical models aimed at examining the relationships among disease epidemiology, patterns of sexual behavior, and intervention strategies, o Evaluation of formal and informal communication patterns, including the mass media and the web through which HIV/STD prevention information can be diffused to at-risk communities, o Testing of HIV/STD interventions to overcome a history of childhood sexual abuse and to prevent revictimization, o Studying the impact of child-headed households and parental loss on childhood development and early initiation of risky HIV/STD behaviors, o Testing of interventions that teach parents how to instruct their children about sexual behavior and AIDS stigma and the impact of these programs on the behavior of children, o Designing of interventions to enhance healthy sexual development and responsible protective behaviors (including access to and use of barrier methods, avoidance of too-early or nonconsensual sex, and abstinence from unsafe sexual behavior), o Development and testing of interventions combining prevention programs at different levels of social organizations (e.g., individual, couple, family, community, and society [media or policy])and examine how these levels interact to impact on HIV risk and protective behaviors and HIV transmission in different countries. SPECIAL REQUIREMENTS A meeting of principal investigators conducting international research under this initiative will be held in Washington, DC, annually. Funds for these meetings 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 sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating 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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. 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: 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. 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 the program staff 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: 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 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 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 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: 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. F&A costs will not be paid (either directly, under a consortium agreement, or through a contract under a grant) to an organization located outside the territorial limits of the U.S. or an international organization regardless of location. There are two exceptions to this: The American University, Beirut and the World Health Organization. (Page III-69 of the NIH Grants Policy Statement). 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. Type the RFA number (MH-01-004) on the label. 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, International Initiatives to Prevent HIV/STD Infection, RFA MH-01-004, must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and 3 signed photocopies, in a 1 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, 2 additional copies of the application must be sent to: Willo Pequegnat, Ph.D. Center for Mental Health Research on AIDS Division of Mental Disorders, Behavioral Research and AIDS 6001 Executive Boulevard, Room 6205, MSC 9619 Bethesda, MD 20892-9619 (Express mail: Rockville, MD 20852) Applications must be received by the application receipt date listed in the heading of this RFA. 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 or NINR 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 the 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 NIMH or NINR 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 deserves 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? Are there appropriate investigators from the country in which the research will be conducted? Is there a history of collaboration among members of the investigative team? (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: January 15, 2001 Application Receipt Date: March 13, 2001 Peer Review Date: May/June 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: 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) 443-1187 FAX: (301) 443-9719 Email: wpequegn@nih.gov Dr. Hilary Sigmon Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 E-mail: hilary_sigmon@nih.gov Direct inquiries regarding review issues to: Jean G. Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6206, MSC 9609 Bethesda, MD 20892-9609 Telephone: (301) 443-3367 Email: jnoronha@mail.nih.gov Direct inquiries regarding fiscal matters to: William F. Caputo Grants Management Branch, DEA Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-0004 FAX: (301) 443-6885 Email: wcaputo@nih.gov Mr. Robert Tarwater Office of Grants and Contract Management National Institute of Nursing Research Building 45, Room 3AN12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-2807 FAX: (301) 480-8260 E-mail: robert_tarwater@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 NIMH 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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