ABSTINENCE AND HIV/STD PREVENTION FOR YOUTH Release Date: February 26, 1999 RFA: MH-99-010 P.T. National Institute of Mental Health National Institute on Child Health and Human Development National Institute on Nursing Research Letter of Intent Receipt Date: April 13, 1999 Application Receipt Date: May 13, 1999 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 Institutes of Mental Health (NIMH), National Institute on Child Health and Human Development (NICHD), and National Institute on Nursing Research (NINR) are encouraging applications for the support of theoretically grounded research on interventions to prevent HIV/AIDS among children and youth. AIDS has become the sixth leading cause of death among youths between the ages of 15 and 24. This Request for Applications (RFA) is critical because effective interventions must be developed to reduce HIV risk-related behaviors in this vulnerable population. Behavior change continues to be the primary way of reducing the spread of HIV. Prevention work with adolescents must reach sufficient numbers of this population to change prevailing norms of sexual behavior. Long-term maintenance of behavior change is particularly critical in this group. Research submitted in response to this RFA should be based on an understanding of the types and range of adolescent sexuality, the contexts in which youths engage in social and sexual activities, perceived group norms about sexual behavior, knowledge of and misperceptions about HIV risk among adolescents from different groups, and adolescent attitudes toward safer sex practices. Culturally and developmentally appropriate interventions must be developed that target a variety of outcomes (e.g., delay in initiation of sex, decreased use of alcohol and illicit drugs, etc.) and that maintain behavior change over the long term. Particularly needed are interventions for high-risk subgroups of adolescents and primary prevention interventions for HIV-infected adolescents. 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), Abstinence and HIV/STD Prevention for Youth, is related to the priority areas of mental health and mental disorders, STDs and HIV/AIDS. Potential applicants may obtain a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html 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 the small grant (R03) mechanism. 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 small research grant (R03) award mechanisms. The total project period for an R01 application submitted in response to this RFA may not exceed five years. R03 grants are limited to two years and are not renewable. The R03 are limited to $50,000 direct costs for each of these two years. Specific application instructions have been modified to reflect the "MODULAR GRANT APPLICATION AND AWARD" process which has been adopted by the NIH (see the NIH Guide, December 15, 1998). For this RFA, funds must be requested in $25,000 direct cost modules. A feature of the modular grant is that no escalation is provided for future years, and all anticipated expenses for all years of the project must be included within the number of modules being requested. Only limited budget information is required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. 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 Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. 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 August 30, 1999. FUNDS AVAILABLE The NIMH intends to commit approximately $1 million in direct costs to support approximately three grants, NICHD commits $600,000 in total costs to support one grant, and NINR commits $250,000 for one R01 or R03. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the 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 The major objective of research supported under this RFA is to develop interventions that are effective in delaying initiation of sexual behavior. However, it is recognized that many youth will eventually become sexually active and therefore interventions are needed to prevent HIV/STD risk-related behaviors among children and youth, thereby preventing transmission of HIV. Although research has identified programs that have been successful in increasing HIV/STD knowledge and recognition of risk among adolescents and reducing their risk-related behaviors, little is known about the efficacy of abstinence programs. This RFA encourages prevention research focused on abstinence-only programs. This RFA will also entertain HIV/STD prevention efforts that test abstinence-based and other more comprehensive sexuality education interventions. Such programs could include components that help adolescents develop personalized knowledge about barriers to safer sex. This could be accomplished via individual or small-group counseling and education, training in skills necessary for HIV-safe behavior (e.g., self-assertiveness, sexual refusal, problem solving, behavioral self-management, etc.) providing a supportive environment, and ensuring the accessibility of resources such as health care. Abstinence and other HIV/STD prevention programs that are found to be successful can be tailored to the population or culture for which they are intended and are developmentally appropriate. Interventions proposed in response to this RFA should be theory-based. Areas of Interest This section suggests areas of interest, but researchers responding to this RFA need not limit themselves to these topics. Among the questions that could be addressed are the following: o How does the type of intervention interact with the mode of delivery to affect behavior change? What are the "active ingredients" of these interventions? o How do aspects of adolescent sexuality (e.g., curiosity, using sex to act out angry feelings from other relationships or to maintain a relationship) and their social context (e.g., peer pressure, media images, perceived group sexual norms) facilitate or obstruct safer sex? Which features lend themselves to the development of effective interventions? o Which type of abstinence-only or abstinence-based HIV/STD interventions are most effective for specific high-risk adolescent subgroups? What components of effective interventions are generalizable to different subgroups? o Are gender-specific abstinence interventions more effective with female adolescents? If so, what are the "active ingredients" of such interventions? o What are effective strategies embedded within an abstinence or other HIV/STD prevention program to maintain abstinence or prevent relapse to high- risk behaviors over the long term (e.g., relapse prevention paradigms and motivational enhancement models from the substance abuse field)? How can initial interventions be improved so that behavior change lasts longer? o What is the "proper dose" of interventions to achieve commitment to abstinence and maintain this behavior over the long term (e.g., how many sessions, what intensity of intervention)? o What is the most appropriate/effective age at which to initiate HIV/STD prevention programs? o Is there an optimal mix of school-based HIV/STD interventions and community-based prevention activities? Are community-based programs more effective when delivered by faith communities, recreational groups, and/or parent-oriented programs? o How can interventions be designed to assist families support young people in maintaining abstinence and/or safer sexual behavior? Interventions should specifically address issues of family dysfunction (e.g., substance abuse and dependence in family, conflicts between adolescents and parents, lack of family support for behavior change) and other factors that mediate HIV/STD risk for adolescents. o What should the interventions target in different adolescent subgroups and how can they best be measured delay of sexual debut, maintenance of abstinence, or reduction in risk-related behaviors (e.g., having sex without condom use, having multiple sexual partners, using non-sterile injection equipment)? o What are the effective components of an HIV testing and counseling program for adolescents and can a "return to abstinence" message be built into these prevention programs? What factors are associated with early detection of HIV/STDs and test-seeking behavior among adolescents? What factors are associated with returning for testing results? Are there effective ways of integrating testing and early detection with HIV/STD prevention programs? 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 "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. Pequegnat at the address listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program contacts listed under INQUIRIES with any questions regarding the responsiveness of their proposed project to the goals of this RFA. 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. It is also available at: http://grants.nih.gov/grants/forms.htm BUDGET INSTRUCTIONS 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. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Use 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. 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. 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. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. 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 current position(s) and then previous positions, - List selected peer-reviewed publications, with full citations, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. o OTHER SUPPORT - Form Page 7. This form must be completed for applications in response to this RFA to allow awards to be negotiated and made on or before September 30, 1999. 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. It is important to identify all exclusions that were used in the calculation of the F&A costs for the initial budget period and all future budget years. 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. Applications not conforming to these guidelines will be considered unresponsive to this RFA and will be returned without further 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. 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, "Abstinence and HIV/STD Prevention for Youth, MH-99-010," 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: Willo Pequegnat, Ph.D. 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 May 13, 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 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 appropriate national advisory council or board. 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 method? 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? The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. Schedule Letter of Intent Receipt Date: April 13, 1999 Application Receipt Date: May 13, 1999 Earliest Anticipated Start Date: August 30, 1999 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. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6209 MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: wpequegn@nih.gov Susan Newcomer, Ph.D. 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 June Lunney, Ph.D., R.N. Division of Extramural Activities National Institute of Nursing Research 45 Center Drive, Room 3AN-12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6908 FAX: (301) 480-8260 Email: June_Lunney@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 Melinda Nelson National Institute of Child Health and Human Development Building 61E, Room 8A07 Bethesda, MD 20892-7510 Telephone: (301) 496-5481 FAX: (301) 402-0915 Email: Nelsonm@nih.gov Jeff Carow Grants and Contracts Management Office National Institute of Nursing Research Building 45, 3AN-12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6869 FAX: (301) 480-8260 Email: jeff_carow@nih.gov NIAAA is not co-sponsoring this RFA but is committed to understanding the complex interaction among psychological/psychiatric processes, drug, and alcohol abuse among populations at-risk for or infected with HIV/AIDS. Please contact Kendall Bryant, Ph.D., Health Scientist Administrator, National Institute on Alcohol Abuse and Alcoholism, 6000 Executive Boulevard, Room 505, Rockville, MD 20892-7003 (Fed Exp 20852), Telephone (301) 443-8820, FAX (301) 443-8774, Email: KBRYANT@WILLCO.NIAAA.NIH.GOV. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH), 93.865 (NICHD), and 93.361 (NINR). 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. Awards will be administered under PHS policy as stated in the NIH Grants Policy Statement (October 1, 1998). 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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