and Human Services (HHS)
EXPIRED
HIV/STD PREVENTION PROGRAMS FOR ADOLESCENTS Release Date: September 21, 2001 RFA: RFA-MH-02-007 National Institute of Mental Health (http://www.nimh.nih.gov/) National Institute of Child Health and Human Development (http://www.nichd.nih.gov/) National Institute of Nursing Research (http://www.ninr.nih.gov/) Letter of Intent Receipt Date: November 14, 2001 Application Receipt Date: December 14, 2001 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS REQUESTING LESS THAN $250,000 PER YEAR IN ALL YEARS. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Mental Health (NIMH), National Institute of Child Health and Human Development (NICHD), and National Institute of Nursing Research (NINR) invite applications proposing studies of school-based and other community-centered prevention programs for adolescents and youth for the purpose of preventing the spread of Human Immunodeficiency Virus (HIV) infection. The purposes of this Request for Applications (RFA) are to: (1) identify the community, school-system, and parental attitudes and concerns associated with establishing the collaborative relationships necessary to plan and implement school-based and other community-centered intervention programs, (2) identify in-school factors such as teacher characteristics, peer influences, or the needs of special populations that are key to delivering developmentally appropriate and effective intervention programs, and (3) develop, implement, and evaluate school-based and other community-centered HIV/Sexually Transmitted Disease (STD) preventive interventions. 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, HIV/STD Prevention Programs for Adolescents, is related to one or more of the priority areas. 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Faith-based organizations are eligible to apply for these grants. 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. 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 June, 2002. For all 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 that have been adopted by the NIH. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE The NIMH intends to commit approximately $1.3 million in FY 2002 to fund three to five new and/or competitive continuation grants in response to this RFA, NICHD will commit $500,000 to fund one new grant, and NINR plans to commit $750,000 to fund one to two new and/or competitive continuation grants. 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 participating Institutes 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 Interpersonal risk behaviors among young people and adolescents can have serious personal and public health consequences, including STDs, HIV infection, and unwanted pregnancies. Although preventive interventions targeting these behaviors have been developed, empirically validated prevention programs in settings specific to youth have not received adequate attention. For example, since most youth attend school, this venue offers an opportunity to develop widely applicable and developmentally appropriate models for understanding and modifying sexual risk behavior. Similarly, recreation centers, after-school programs, mentoring and job-training programs, parent organizations, and community-centered sites that youth frequent (e.g., stores, restaurants, shopping centers, parks) may offer promising settings for studying determinants of adolescent risk behavior and developing HIV preventive interventions. Research in this area presents a unique set of opportunities, along with a unique set of challenges. School-based HIV/STD prevention research requires successful collaboration among researchers, community leaders, school district administrators, local school officials, school teachers and staff, parents, and youth. Successful models for developing these collaborations could be used to guide other types of school-based research (e.g., youth exhibiting behavior problems). Although many school systems recognize the need for and provide developmentally appropriate skills-based HIV prevention programs, others offer less integrated programs required by their States. Many of these latter programs provide general health information, rather than specific HIV risk reduction approaches, such as learning negotiation and refusal skills or correct condom use. Working within these various settings requires sensitivity to the contextual differences and research potentials. Although several promising HIV prevention studies have been conducted with middle and high school age students, additional research with adolescents in these age groups is needed, along with research on interventions for younger youth, in order to fully and effectively address this issue. In order to systematically reach this vast pool of youth, studies are needed that address the following issues: community and school-level factors that influence the school-based research climate including school boards, elected officials, teachers and parents, peers influence on risk and preventive behaviors, characteristics of interventions that maximize their effectiveness for different youth, methods to reach special adolescent populations within and outside the school setting, and measures and interventions that are developmentally appropriate for late elementary, early middle, and high school age youth. Research is also needed to address methodological issues concerning school- based or other community-centered HIV/STD prevention programs, including the identification of the proper unit of randomization and analysis, and the identification of appropriate research designs and data collection strategies. For example, large samples may be necessary to adequately test intervention effectiveness, given the small percentage of sexually active young teenagers in study populations. School-related HIV preventive intervention research also presents research opportunities. For example, schools could serve as recruitment sites for prevention studies or advertising sites for off-campus programs. Applications in response to this RFA should focus on intervention development or pre-intervention research including innovative risk factor research. Illustrative research topics include, but are not limited to the following areas: Research Climate o Examine community attitudes and norms bearing on school-based HIV prevention o Design effective systems-level collaborative efforts with the community, school system, local school administrators, teachers, and parents for the purpose of planning, developing, and implementing HIV preventive intervention research o Evaluate the effectiveness of specific intervention approaches and programs for host communities Teachers and Parents o Evaluate the characteristics and the training experiences of teachers and other intervention leaders that predict their ability to successfully lead HIV/STD prevention interventions o Examine parental attitudes and concerns regarding school-based HIV risk and prevention programs for the purposes of program planning and development o Evaluate the inclusion of parents in program delivery and intervention follow-up activities. Are there ways to increase parental participation in hard to reach populations? Intervention Development o Evaluate innovative school-related risk and protective factors associated with HIV risk behavior in order to design appropriate preventive interventions (e.g., school climate vis-a-vis sexuality) o Examine aspects of interventions that maximize their effectiveness for particular students and school/community climates. Aspects include providers (e.g., classroom teachers, school counselors, health educators, peer educators, popular opinion leaders) and settings (e.g., classrooms, school- based and school-linked health clinics, community centers, and community sites that youth frequent). Do some students benefit more from one-on-one versus group interventions? Are there iatrogenic effects of group interventions for some groups of students? o Examine school-related moderators and mediators to maximize intervention effectiveness. For example, will training peer educators to address discipline problems in the classroom increase effectiveness of peer-led interventions? How are school factors related to individual, peer, and family factors? o Examine additional individual, group, family, or system-level interventions that can help maintain school-based intervention effectiveness over time such as parent involvement, individual booster sessions, condom availability programs, media campaigns, school health fairs, and web-based interventions o Examine the impact of other high-risk behaviors on school-based HIV interventions. How do individual’s risk behaviors impact intervention effectiveness? How are multiple risk behaviors addressed at the systems level? Peer Influence o Examine how HIV/STD information is transmitted through informal discussions by peers at school. How accurate is the information that is transmitted? Are there attitudinal or other differences that can be attributed to peer- transmitted as opposed to adult-transmitted risk information? o Investigate school social network utilization in delivering intervention messages and in fostering HIV/STD prevention skill development o Examine links between school social networks and networks outside of school that are at high-risk for engaging in HIV/STD-related behaviors Developmental Issues o Evaluate developmentally appropriate measures of HIV-related attitudes, beliefs, and intentions o Develop and evaluate preventive interventions that are most appropriate for specific age groups especially for youth in early middle school and late elementary school o Examine the applicability of models developed with adults to school-aged populations, such as the Popular Opinion Leader Model Special Populations and Hard-to-Reach Youth o Develop programs to actively involve special populations of youth in school-based HIV/STD prevention programs, including minority youth, developmentally delayed and handicapped youth, and gay, lesbian, bisexual, and transgender youth o Develop methods to facilitate contact with hard-to-reach and at-risk youth for recruitment into intervention programs including individuals who have dropped out of school, pregnant teens, home-schooled students, youth involved in the juvenile justice system, and youth involved with partners who are significantly older or are engaging in high risk HIV/STD-related behaviors o Develop appropriate interventions to measure and reduce stigma o Develop materials and techniques to effectively increase the social comfort level necessary for individuals and communities to actively participate in HIV/STD preventive activities Methodology o Determine research design characteristics that are most appropriate for school-based research (regarding units of randomization and analyses, data collection, etc.) School-Related Research o Examine the utilization of schools as sites for advertisement and recruitment to community-based intervention research programs SPECIAL REQUIREMENTS The participating Institutes would like to convene an annual meeting, in the Washington, DC area, of grantees supported under this RFA in order to network grantees and exchange information on research models and developments. Provision for participation in this meeting should be included in the development of the budget. Any plans to share data should be included in the application. Reviewers will assess the adequacy of the proposed plan. 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 is 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. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA (PA) in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. 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 PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. 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 NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. Additional information about Modular Grants is also available on this site. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number 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 must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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: Jean Noronha, Ph.D. Division of Extramural Activities National Institute of Mental Health 6001 Executive Boulevard, Room 6154, MSC 9609 Bethesda, MD 20892-9619 Rockville, MD 20852 (for express/courier services) 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 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 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 National Advisory Councils 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: November 14, 2001 Application Receipt Date: December 14, 2001 Approximate Peer Review Date: February/March 2002 Council Review: May 2002 Earliest Anticipated Start Date: June, 2002 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: Nicolette Borek, Ph.D. Center for Mental Health Research on AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6206, MSC 9617 Bethesda, MD 20892-9619 Telephone: (301) 443-4526 FAX: (301) 443-9719 Email: nborek@mail.nih.gov Susan Newcomer, Ph.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6981 FAX: (301) 496-0962 Email: snewcomer@nih.gov Hilary Sigmon, Ph.D. 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 Email: 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 6154, MSC 9609 Bethesda, MD 20892 Telephone: (301) 443-3367 FAX: (301) 443-4720 Email: jnoronha@mail.nih.gov Direct inquiries regarding fiscal matters to: William F. Caputo Grants Management Branch 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 Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Building 61e, Room 8a17 Bethesda, MD 20892-7510 Telephone: (301) 496-5481 FAX: (301) 402-0915 Email: hancockk@nih.gov 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 Email: robert_tarwater@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242 (NIMH), 93.864 (NICHD), 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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