INSTITUTIONAL PATHWAYS TOWARDS STRENGTHENING HIV PREVENTION IN MINORITY COMMUNITIES Release Date: September 20, 2001 RFA: RFA-HD-01-017 National Institute of Child Health and Human Development (http://www.nichd.nih.gov) 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: December 17, 2001 Application Receipt Date: January 18, 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 Scientists concerned with HIV prevention are increasingly recognizing the influence of the social environment on individual risk behaviors. However, the design of prevention strategies that effectively harness environmental influences has lagged behind this important insight. This RFA seeks to expand our understanding of a major feature of the community environment - local community institutions such as churches, voluntary organizations, workplaces, and commercial establishments - and to explore the roles that such community institutions play in contributing to or impeding HIV prevention. The RFA seeks research to examine the potential mechanisms through which local institutions can enhance prevention efforts, beyond providing the venue for individual-level interventions. This announcement is the first phase of a larger initiative to develop innovative intervention approaches that effectively involve local community institutions in HIV prevention. This initial RFA solicits Exploratory/Development Grant (R21) applications for formative research designed to create a body of data that will inform the design and evaluation of such innovative approaches. 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) is related to one or more of the priority areas. Potential applicants may obtain "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. Faith-based organizations are eligible to apply for these grants. 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) Exploratory/Developmental Grant (R21) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This RFA is a one-time solicitation. The objective of the Exploratory/Developmental Grant (R21) mechanism is to encourage applications from individuals who are interested in testing innovative or conceptually creative ideas that are scientifically sound and may advance our understanding of how community-level institutions such as faith based organizations, commercial organizations and work sites influence HIV risk and prevention among their constituencies. The exploratory/developmental mechanism of grant support is intended to enable an investigator to explore the feasibility of an innovative research question or approach. Thus, preliminary data specific to the proposed project are not expected, but evidence supporting feasibility is desirable. 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 NICHD intends to commit approximately $2 million in total costs [Direct plus Facilities and Administrative (F&A) costs] in FY 2002 to fund six to ten new grants in response to this RFA. NINR intends to commit approximately $750,000 in total costs to fund one or two new grants to Principal Investigators who are nurses or scientists from schools of nursing. NIMH intends to commit approximately $250,000 to fund one new grant. An applicant may request a project period of up to three years and a budget for direct costs of up to $200,000 per year. 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 NICHD, NIMH, and NINR 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 meritorious applications. The award is not renewable. RESEARCH OBJECTIVES Background When community institutions are involved in HIV prevention, they may engage in activities such as providing educational interventions, distributing condoms, sponsoring community outreach activities such as street ministries or public awareness campaigns, or coordinating with other community organizations in service-delivery or fund-raising activities. These community-level activities are critically important components of national AIDS prevention strategies, and have been supported by government and private funding agencies such as the Centers for Disease Control and Prevention, NIH, SAMSHA, as well as by foundations and other civic and religious organizations. Despite the impressive involvement of many community institutions in prevention activities, little research exists that systematically examines the diverse ways in which these organizations can contribute to HIV prevention and the factors that make them effective or ineffective in doing so. This initiative seeks to build a body of basic social science knowledge that will lead to innovative and effective approaches to HIV prevention by expanding thinking on how community institutions affect HIV risk and prevention. For purposes of this initiative, an institution is defined as a formal organization that is located in a community, engaged with community residents, and focused around a mission or activity. Examples of community institutions include churches, grocery stores, schools, and voluntary associations. Institutions have formal structures, usually involving a hierarchy headed by a leader who directs what the institution does and acts as a gatekeeper. Institutions also have procedures, rules, and rituals that are part of their culture. Institutions embody norms and values, both in their mission and in their structure and operation. Institutions have constituent groups they serve, benefit from, and depend upon. Institutions depend on in-kind or financial resources for survival, and obtain these resources from a variety of sources including individual members, customers, clients, other organizations, and government or private agencies. Institutions, as structures, have a certain amount of inertia, but because they are fundamentally social creations, they must constantly respond to the changing nature and needs of their constituent groups in order to survive. Thus, they may evolve and re-create themselves over time. Also, institutions have relationships with other institutions, relationships that may reflect shared norms and interests or conflicting values and goals. Institutions at the local or community level may be embedded in an institutional hierarchy, for example, a church that belongs to a larger denomination. Institutions are influenced by many aspects of their context - the institutional hierarchy in which they are embedded (and the norms and expectations that hierarchy sets for them) - and by the community context as well. These must be reconciled in some way in the institution’s norms, operation, and activities. The methods by which institutions influence individuals health and other behaviors have been described by a number of theoretical approaches, including but not limited to social capital theories, social network theories, diffusion theories, and systems theories. They are thought to operate by attaching people to services, bringing meaning to lives, empowering, and strengthening families and communities. They can also act as controls on behavior, supporting and shaping social norms. They can affect the resources that individuals are able to bring to bear on preventing illness, protecting health, and responding to illness. In addition, institutions can provide direct health services and resources, sponsor disease screening, or provide health insurance of various sorts to all or selected members of groups connected to the institution. Or, institutions - intentionally or unintentionally - can provide the opportunity for risk behavior. To be effective, HIV prevention efforts must reach people at high risk for infection and those who are already infected. To the extent that such individuals are disconnected from mainstream institutions (e.g., faith-based organizations, schools or voluntary organizations), community institutions may be challenged to effectively engage in HIV prevention efforts. This initiative seeks research to explore such challenges by examining: (1) the ways in which individuals who are potentially at high risk for HIV connect with community institutions, (2) how the norms and practices of community institutions may affect HIV risk and prevention, either negatively or positively, (3) how institutions initiate and/or maintain connections with potentially at-risk individuals and help to strengthen their ability to avoid risk, (4) how community institutions can effectively reach HIV-positive and at-risk individuals and engage them in effective prevention interventions, and (5) what characterizes institutions that are able to contribute effectively to HIV prevention, either individually or in cooperation with other organizations. Research Scope The RFA solicits exploratory, collaborative, multidisciplinary research to better understand the ways in which the structure and dynamics of community institutions influence HIV prevention and the ways in which individuals at high risk of HIV infection or infected with HIV are linked to community institutions. These exploratory studies are intended to lay the groundwork for (a) interventions at the institutional level, and (b) expanded, theoretically driven studies of the role of institutions in HIV prevention. The RFA focuses on minority communities in the U.S. because of their disproportionate risk of HIV. The objective of this RFA is to create a body of data to guide the design, implementation, and evaluation of future interventions and prevention strategies. Funded research will help to explore the potential for novel approaches to involving various types of community institutions or strengthening their impact on HIV risk behaviors, both within their own constituents as well as more broadly in the community. This announcement seeks applications for formative or exploratory research. An important goal of these exploratory grants will be to develop and refine specific causal models (sometimes called logic models ), based in theory and observation, that describe the mechanisms through which interventions and strategies at the institutional level or involving community institutions are expected to contribute to HIV prevention. Subsequent stages of this initiative, if implemented, would provide support for testing these models through experimental designs and/or fully developed observational studies. This RFA calls for a focus on institutions at the community level, institutions that have ongoing, quantifiable, and direct interaction with at least some proportion of community members. Applicants who propose research involving specific community institutions must provide information on the history, mission, constituency, funding, and structure of the institution, as well as evidence of the institution’s commitment to engaging actively with the research project. Investigators are encouraged to focus on types of community institutions that have not regularly been involved in HIV prevention efforts. However, an application may also address: (1) cooperative arrangements involving institutions that are and are not experienced in HIV prevention, and/or (2) institutional or contextual factors and approaches that enhance the effectiveness with which experienced community institutions address HIV risk and prevention. The research proposed must be informed by clearly articulated theory regarding both HIV prevention and institutional development, change, and influence. This RFA does not point to any particular theory or theories. Potentially applicable theories relating to institutions include, but are not limited to, the following: theories of social stratification, organizational theories, feminist theory, functionalist theories, new institutionalist theories, ecological theories, political economic theories. It is hoped that research carried out under this initiative will contribute to the further development of theory regarding the role of community institutions in HIV prevention. Researchers are encouraged to consider a full range of appropriate qualitative and quantitative methods in designing their research. Multidisciplinary approaches are encouraged. Applicants may consider the involvement of a wide range of scientists, including but not limited to those who study religion, institutional organization, service delivery, behavior change, persuasive communication, and community organization and dynamics. Anthropologists, geographers, economists, political scientists, psychologists, and sociologists all might have skills of use in developing these studies. Each research team must include significant, substantive involvement of individuals from the institution or institutions to be the focus of the study. Relevant research questions include, but are not limited to: o How are individuals who are HIV-positive or potentially at high risk for HIV connected with community institutions of various types? What potential but unexplored mechanisms exist for effectively reaching such individuals? What are the spatial and social relations of HIV risk groups and how might these guide institution-based prevention efforts? o How can community institutions effectively reach HIV-positive and at-risk individuals and engage them in effective prevention interventions? How can institutions effectively link provision of care with prevention? Is this an effective strategy for reaching vulnerable populations? o What are the mechanisms through which community institutions influence health and well being, generally, and health behaviors and HIV risk and protection specifically? o How do institutions maintain connections with potentially at-risk individuals and help to strengthen their ability to avoid risk? o How do institutions shape and enforce community norms relevant to HIV risk? How does this differ by type, structure of institution, relationships among institutions, or community context? o In what ways do community institutions impede effective HIV prevention? What factors are responsible for such barriers and how can they be addressed? o What characteristics of institutional norms, structure, operation, and activities are associated with effective HIV prevention in particular communities and settings? o What is the role of institutional leaders and gatekeepers in creating and sustaining effective prevention efforts? How does institutional involvement in HIV prevention that is initiated by an individual leader at a given institution become institutionalized? o How do institutions network with other community actors and other institutions? When and how do such connections and collaborations improve HIV prevention efforts? When and how do they fail to do so? o What effects do various forms of instability that affect community institutions, their constituencies, and their relations with other organizations have on HIV prevention efforts? Examples of instability include storefront churches that move to new locations, urban renewal that displaces the populations served by institutions, and coalitions that form and dissolve in response to specific funding opportunities. o How does conflict within and between community institutions over norms and intervention strategies, e.g., zero tolerance of certain behaviors VS so- called harm reduction approaches, affect prevention efforts? SPECIAL REQUIREMENTS o Funding under this RFA is intended to support work that will lead to innovative interventions and prevention strategies. Research supported must either lay the groundwork for further in-depth and basic research to inform or guide the development of practical and effective HIV prevention strategies at the community level, or develop a specific intervention strategy. o Applications that propose to conduct research leading to the development and testing of interventions must provide a plan for addressing issues relating to ongoing sustainability of such interventions at the end of the research period. o Applications must present detailed descriptions of past, current and planned collaborations with the community institutions named as participants in the study. This is to include descriptions of the mechanisms planned to ensure successful cooperation. o Applications must include funds in the budget for an annual two-day meeting of grantees in the Washington DC area. 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, published in the NIH Guide for Grants and Contracts, March 6, 1998, and available on the Internet at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies 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 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 this RFA. 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 NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Susan Newcomer at the address listed under INQUIRIES, below, by December 17, 2001. 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. Beginning January 10, 2002, 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 INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS 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. Submission 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 should be sent to: Robert Stretch, Ph.D. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Blvd, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Applications must be received by January 18, 2002. 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 for responsiveness by the NICHD, NINR and NIMH. 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 NICHD Division of Scientific Review in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may 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 Child Health and Human Development Council, the National Advisory Mental Health Council or the National Advisory Nursing 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 their 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, applications will be evaluated with respect to: o The nature and adequacy of cooperative arrangements involving community level institutions. o The adequacy of the proposed plan for addressing issues relating to ongoing sustainability of proposed interventions. o The adequacy of the proposed plan to share data, if appropriate. 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 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 17, 2001 Application Receipt Date: January 18, 2002 Peer Review Date: March/April 2002 Council Review: June 2002 Earliest Anticipated Start Date: August 2002 AWARD CRITERIA 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 answer questions from potential applicants is welcome. A complete listing of contacts for both programmatic and fiscal/administrative inquiries may be found at: http://www.nichd.nih.gov/rfa/HD-01-017.htm. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.864 (NICHD, Population Research), 93.361 (NINR), and 93.242 (NIMH). Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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