STRUCTURAL INTERVENTIONS TO PREVENT HIV/STD INFECTION Release Date: August 31, 2001 RFA: RFA-MH-02-006 National Institute of Mental Health (http://www.nimh.nih.gov/) National Institute of Child Health and Human Development (http://www.nichd.nih.gov/) Letter of Intent Receipt Date: December 15, 2001 Application Receipt Date: January 15, 2002 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 social and physical environment can support or constrain behaviors related to HIV/STD risks in communities. Increasingly, specific characteristics of the social environment (e.g., social norms held by peers) and the physical environment (e.g., number and types of places for congregating) are being identified as factors associated with HIV risk behaviors (Cohen, Scribner, & Farley, 2000). For example, collective efficacy (the extent to which adults in a neighborhood share and enforce a common but implicit standard of neighborhood conduct) is a powerful predictor of neighborhood violence as well as other behaviors that may be relevant to HIV risk (Sampson, Raudenbush, & Earls, 1997). The code of the streets (where informal social norms are enforced in some contexts using subtle non- verbal and verbal cues) is another dimension that may be relevant to HIV- relevant risk behavior (Anderson, 1999). Similarly, the existence of public spaces (such as parks, abandoned properties) where behavior can occur unobserved by others or where alcohol is available can encourage risky behaviors including those relevant to HIV transmission and prevention (Peirce, Frone, Russell, Cooper, & Mudar, 2000, Skjaeveland & Garling, 1997). Although the causal role of social and physical factors has been extensively studied in relation to violence and physical safety, it has received inadequate attention to date in relation to HIV risk behavior and its prevention (Brown & Altman, 1983). Therefore, research applications will be encouraged that: (1) examine the settings in which HIV/STD risk behaviors take place and the extent to which their physical and social characteristics contribute to HIV risk behaviors, (2) identify through observational and descriptive studies potential ways in which physical and social contexts can be modified to reduce HIV/STD risk behaviors, (3) examine the social ecology of communities to understand the social and physical dynamics of social control affecting individual HIV-related risk behaviors and the processes leading to a change in societal norms, (4) develop preventive interventions to minimize adverse physical and social environmental effects on HIV transmission and strengthen positive effects of such settings on HIV/STD- relevant risk behaviors, and (5) identify factors in the physical and social environment that promote or impede the effectiveness of existing HIV/STD behavioral preventive interventions. The NIH AIDS Strategic Plan has identified structural interventions to prevent HIV transmission as a high-priority area. The HIV/STD prevention program developed under this research initiative would have the potential to affect the AIDS epidemic nationally and internationally by preventing risk behaviors in large groups of at-risk people. 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), Structural Interventions to Prevent HIV/STD Infection, 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, 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 eligible for the R01 but not 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 Grant (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. R03 grants are not renewable. 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 July 1, 2002. For all R03 and 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 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. 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-99-126.html (applicable for both NIMH and NICHD for the purposes of this RFA only). FUNDS AVAILABLE The NIMH intends to commit approximately $1.2 million in FY 2002 to fund three to five new grants under this RFA. NICHD intends to commit approximately $500,000 in FY 2002 to fund one new grant. 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 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 NIMH AIDS program has adopted the following four phases in AIDS prevention research: Phase I: Discovery Studies, Phase II: Exploratory Studies, Phase III: Efficacy Studies, and Phase IV: Effectiveness Studies. This research initiative will support, but is not limited to, the following research areas: Phase I: Discovery Studies These studies are designed to: o Clarify how social norms are formed and determine individual HIV-related behavior in a variety of social contexts at multiple levels, o Assess how well various social-marketing and AIDS prevention campaigns reduce risk behaviors and HIV/STDs in different environmental settings, o Identify the environmental, social, economic, and cultural dynamics that contribute to the rapid spread of HIV/STDs in high-risk communities, o Determine how neighborhood density affects environmental factors associated with increasing or reducing HIV risk behaviors (e.g., alcohol outlets, pharmacies, health clinics, counseling and testing sites, STD clinics, hotels, recreation sites), and o Elucidate how and how well characteristics of social networks can overcome environmental barriers to practicing safer HIV-related behaviors. Phase II: Exploratory Studies These studies are designed to: o Describe settings (public and private) where HIV/STD risk behaviors occur and the extent to which their physical and social characteristics influence risk behaviors, o Assess the preventive impact of community- and family-oriented social control actions and communications that focus on influencing their members HIV/STD risk behaviors, o Identify through descriptive studies of how the physical environment in high-risk areas might be modified to minimize HIV/STD risk behaviors, o Examine the social ecology of communities and development of collective efficacy, with the goal of enhancing the ability of communities to prevent HIV/STD transmission, o Evaluate the 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, and o Explain how physical environments, community efficacy, and social control interact to affect health behaviors related to HIV and STDs. Phase III: Efficacy Studies These studies are designed to: o Demonstrate the impact of comprehensive structural HIV preventive interventions in different settings (e.g., school, work, church, hotels, recreational sites, testing and counseling sites, primary health care clinics), o Test interventions based on psychological, social, economic, and cultural dynamics of gender and social identity that operate in communities to prevent HIV/STD risk, o Evaluate structural interventions (e.g., health policy implemented by public health agencies, laws passed related to health care access or public housing relocation programs) aimed at reducing the HIV/STD risky behaviors of HIV-infected persons, o Test the impact of combined disease-prevention (aimed at HIV/STDs) and reproductive-health programs, as well as HIV medical treatment on reducing HIV/STD risk behaviors, o Test interventions that combine prevention programs at different levels of social organization (e.g., individual, couple, family, community, and society [media or policy]), and examine how these levels of intervention interact to affect HIV risk and protective behaviors as well as HIV transmission in different at-risk communities. Phase IV: Effectiveness Studies These studies are designed to: o Demonstrate effectiveness of structural interventions that have already been tested under controlled conditions when implemented by public health agencies and community-based organizations (CBOs), and o Evaluate the cost-effectiveness of structural interventions that are demonstrated to be efficacious. Ethical and Methodological Studies These studies are designed to: o Identify the ethical and legal issues associated with conducting structural intervention research in communities (e.g., achieving informed consent, confidentiality, privacy, equity for control group, duty to warn, etc.), and o Develop innovative methodology to study the impact of structural interventions on communities. SPECIAL REQUIREMENTS A meeting of principal investigators conducting structural HIV/STD prevention 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 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. 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 beginning on page 13 of the application instructions. 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 20892-9609 Telephone: (301) 443-3367 Email: jnoronha@mail.nih.gov 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 NICHD 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 participating Institutes 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 NICHD 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: December 15, 2001 Application Receipt Date: January 15, 2002 Peer Review Date: March 2002 Council Review: May/June 2002 Earliest Anticipated Start Date: July 1, 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: 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 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 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, Room 8A17M, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: hancockk@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH) and 93.864 (NICHD). 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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