DIFFUSION OF HIV INFECTION THROUGH SEXUAL RISK BEHAVIORS OF DRUG USERS RELEASE DATE: December 18, 2002 RFA: DA-03-001 National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov) LETTER OF INTENT RECEIPT DATE: February 20, 2003 APPLICATION RECEIPT DATE: March 20, 2003 THIS REQUEST FOR APPLICAIONS (RFA) CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this RFA is to stimulate collaborative research to further understanding of sexual transmission of HIV within and across drug-using population subgroups and to non-drug using populations. The National Institute on Drug Abuse (NIDA) invites cooperative agreement applications to participate in the Sexual Acquisition and Transmission of HIV Cooperative Agreement Program (SATH-CAP). The goal of this cooperative research program is to support multi-disciplinary research that seeks to better understand the dynamic behavioral, biological, and environmental processes implicated in the sexual transmission of HIV and other sexually transmitted infections (STI) among drug users and the diffusion of infections from drug using populations to non-drug using populations. The SATH-CAP will include a Coordinating Center and multiple Research Centers that will work in concert with other centers, their respective sites, and with NIDA to conduct multi-site collaborative research projects. RESEARCH OBJECTIVES Background Earlier research initiatives have in part contributed to the observed reduction in the annual number of new HIV infections in the United States from its peak of 160,000 in the mid-1980s to approximately 40,000 new infections by 1990. However, the stable annual rate of 40,000 new infections observed throughout the 1990s, which persists to this date, does reflect the need to develop more effective prevention interventions. Attempts to improve the effectiveness of HIV prevention interventions require expanding the current knowledge base, which in turn necessitates being responsive to the dynamic nature of the epidemic. There is a need and urgency to expand the range of prevention interventions, and it is widely recognized that such expansion must be multi-disciplinary in nature and include behavioral, biological, social, environmental, and biomedical elements. In order to expand the current state of knowledge and improve the effectiveness of HIV/AIDS behavioral interventions, several areas must be explored to further enhance our understanding of the dynamic process of managing the myriad aspects of the HIV epidemic and limit the imminent danger it poses to public health. HIV/AIDS surveillance data from the Center on Disease Control and Prevention (CDC) have documented notable shifts in the demographics of HIV/AIDS epidemic in the U.S. since AIDS was first identified in the early 1980s. There have been substantial increases in the proportion of new HIV and AIDS diagnoses among women, racial/ethnic minorities, lower-income groups, and young men who have sex with men (MSM). Heterosexual contact is now the leading cause of new infections among women, especially within minority communities. The most recent annual CDC HIV/AIDS Surveillance Report (CDC, 2001) depicts a significant increase in new AIDS cases attributable to heterosexual transmission in the last few years. With regard to MSM, a growing concern is exemplified by an alarming finding reported at the International AIDS Conference in Barcelona that 77% of those MSM who participated in a recent study and tested positive for HIV were unaware of their serostatus. This finding is consistent with earlier released data, which indicated that the proportion of persons with AIDS whose diagnosis represented the first time they were tested for HIV increased from 25% in 1993 to 42% in 1998. MSM have the highest infection rates among all risk groups with an estimated 42% of annual new infections continuing to occur in this population. Within drug using populations, a San Francisco study reported that within certain IDUs populations, sexual behaviors are the main risk factors that explained HIV seroconversion among IDUs. The strongest predictor of HIV seroconversion for men was having sex with men, whereas among women the strongest predictor was trading sex for money. Furthermore, results from a Baltimore longitudinal cohort study showed that sexual risks among IDUs accounted for a substantial proportion of new seroconversions. These reports underscore the need for better understanding the dynamic processes of sexual transmission but also highlight the potential for substantial misclassification error in current coding schemes used to determine exposure category. In light of the growing importance of sexual transmission in describing the current trends in new infections and the few studies that have closely studied the underlying causal mechanisms involved within drug using populations, it is imperative that new research efforts be devoted to disentangling the dynamic behavioral, biological, and environmental processes implicated in the sexual transmission of HIV among drug users. Moreover, although the subject of many discussions, not much is known about how drug users' sexual risk behaviors affect incidence rates of HIV and other STIs in non-drug using populations (i.e., diffusion of HIV from drug using populations to non-drug using populations). Consequently there is a pressing need to better characterize how dynamic patterns of sexual behaviors impact the spread of infections from drug using population subgroups to non-drug using populations. Furthermore, given recent published findings that show that current behavioral and social interventions have had modest effect in reducing sexual risk among drug users, it is critical that innovative, novel, and efficient sexual-risk-reduction strategies be developed based on a sound understanding of the behavioral, biological, and environmental processes that underlie transmission within drug using populations and bridge to the larger non-drug using populations. The risk of transmission in a population depends in part on the reservoir of infection (as measured by HIV and other blood-borne pathogen seroprevalence), the levels and distribution of risk behaviors that transmit infection, environmental/contextual factors, and social factors. As these parameters evolve, so does the epidemic. In order to minimize the occurrence of new infections, ongoing monitoring systems of HIV seroprevalence, seroincidence, levels and patterns of risk behaviors, key environmental and social factors can help guide interventions aimed at curbing new infections. That is, new research initiatives need to be undertaken in order to develop efficient monitoring systems. The documented connection between drug use, sexual contact, and AIDS points to the need to better understand the underlying dynamics of sexual and drug use behaviors of high-risk groups, and how these networks are linked to other social and sexual networks. Such an understanding could benefit from the development of theoretical research and alternative methodologies for studying such sensitive topic areas as drug use and sexual behavior. Objective and Scope The overall objective of this RFA is to stimulate multi-disciplinary collaborative research to further understanding of sexual transmission of HIV within and across drug-using population subgroups and across to non-drug using populations. This will be accomplished through collaborations among scientists from various disciplines working in the following scientific areas: (1) behavioral, (2) biological/biomedical, (3) medical sociology, and/or (4) mathematical modeling research. The term discipline refers to specialized areas of expertise. Some examples of disciplines associated with the four scientific areas include but are not limited to (1) epidemiology of HIV/STI risk behaviors, psychology, sociology, anthropology; (2) molecular epidemiology, molecular biology, and virology, immunology, infectious diseases (e.g., sexually transmitted diseases); (3) social epidemiology, medical geography, and social determinants of health; and (4) statistics, biostatistics, operational research, and applied mathematics. Applications must include: o All applications must integrate a HIV behavioral epidemiology (i.e., drug use and sexual risk behaviors) component with at least two of the remaining three scientific areas (i.e., biological/biomedical, medical sociology, and/or math modeling) as defined above. o Applications must target both MSM and heterosexual populations with considerations given to minority populations. o The primary drug using populations of interest consist of heterosexual injection drug users and any relatively well-characterized drug using MSM subgroups (e.g., club drug users, IDU, or any other drug using MSM group with relatively well established drug use patterns). o Study participants should not be part of a current ongoing intervention study. o Provisions for the Principal investigator of each Research Center and the Coordinating Center to attend meetings with NIDA staff. Four such meetings are planned for the first year of the award and up to 3 times per year thereafter. Areas of Research Focus: Illustrative examples of research areas within the scope of this RFA are outlined below. The following examples serve as a guide and are not meant to subsume all research topics that would be appropriate to this RFA. o Characterize and assess the influence of community, environmental, and social/contextual factors on the sexual behaviors and risks for transmission of HIV/STIs in drug-using populations. o Develop new and/or improve existing estimation procedures (including enhanced surveillance systems, modeling techniques, and ethnographic methods) to obtain more accurate, immediate, and longer-term forecasting estimates of rates of diffusion of HIV/STIs within and across population subgroups. Develop data systems that allow detailed characterization of specific behavioral, biological, and environmental factors and their interactions in association with the spread or containment of new HIV/STI infections. Explore how partner selection, types of partnerships, and variations in the distribution of partnerships (e.g., drug-using and/or sexual, concurrent, sequential, transitional, experimental) may affect the likelihood of exposure to HIV/STIs and inform the development of more effective, partner-based counseling and prevention intervention programs. Characterize sexual mixing patterns and HIV/STI risk dynamics among drug users and to non-drug users, by type of partner, personal risk group or network, and epidemiological context (e.g., what are the relative risks associated with patterns of partner selection and sexual mixing in different social contexts?). Identify and describe primary contextual (social, environmental) factors that may shape or interact with individual HIV risk factors (e.g., behavioral and biological) to facilitate or impede the acquisition and spread of new infections; identify modifiable contextual factors that may be the target of interventions to reduce or prevent HIV risk behaviors. Elucidate the relationships among biological, behavioral, social, and environmental factors associated with risk of and/or protection from HIV acquisition and transmission among drug users, in order to improve the effectiveness and efficiency of HIV prevention interventions. Assess the relative impact of core groups and bridge populations on HIV infection rates and the conditions (behavioral, biological, environmental) that may limit or magnify that impact (e.g., different phases of the epidemic; socioeconomic stresses; fluctuations in drug supplies, prices, and patterns of use; variations in the accessibility and availability of community-based, public health, and clinical services). Integrate behavioral-biomedical surveillance methods (e.g., social network methodologies and molecular epidemiological techniques) to enhance knowledge of the persistence, distribution, and transmission dynamics of HIV/STIs among core groups and bridge populations, and within and across population subgroups. Utilize multiple methods (venue-based sampling, Geographic Information System (GIS) techniques, molecular epidemiology) to characterize HIV transmission rates and distribution patterns in association with the dislocation, travel, and movement of population subgroups, and with changes in HIV subtypes, in multiple subtypes, and in recombinant viruses. o Characterize the emergence, maintenance, and diffusion of HIV/STIs in the context of drug use. For example, how, and under what circumstances, are patterns of drug use associated with the introduction and spread of HIV/STIs within a community? Are there well-characterized ("core") subgroups of drug users within a community that contribute to the introduction and transmission of HIV/STIs to the general population, and are the characteristics of the "core" group identifiable with dynamic changes in the epidemic? Can changing characteristics of the "core" group help to cue the optimal delivery of targeted interventions to interrupt the epidemic and prevent new infections? o Develop mathematical models and methods for the timely identification of emerging infections and trends in different risk populations and contexts. Develop and test mathematical models aimed at describing and predicting HIV incidence based on current and changing patterns of sexual and drug use risk behaviors, biological factors (host characteristics, viral strains), social and environmental factors, and characteristics (time period, age, stage, background prevalence) of the epidemic. Characteristics of the System The SATH-CAP will provide a stable infrastructure for collaborative research to expand the scientific knowledge base on the dynamic behavioral, biological, and environmental processes implicated in the transmission of HIV among and across drug using population subgroups and in the diffusion of HIV from drug using populations to non-drug using populations. The SATH-CAP will consist of a Coordinating Center and multiple Research Centers. It is anticipated that one Coordinating Center will be established. (See Organization of the System, Section A.) There will be three to five Research Centers (Section B). The Research Centers will collaborate with the Coordinating Center and NIDA in conducting collaborative studies. A SATH-CAP Steering Committee will constitute the primary operating and decision-making body of the SATH-CAP (Section C). Each Center will work in concert with other Centers and NIDA to conduct the multi-center component (i.e., the HIV behavioral epidemiology component) of their respective projects. Center projects are expected to be, for the most part, Center specific with the HIV behavioral epidemiology (i.e., drug use and sexual risk behaviors) project component spanning across all participating centers. A "Coordinating Center" will provide SATH-CAP-wide logistic and data support. As a cooperative agreement, there will be substantial NIDA involvement in the management and administration of the SATH-CAP, including the determination of how the multi-center project component (i.e., the HIV behavioral epidemiology component) will be standardized and implemented across centers. Organization of the System A. Coordinating Center. There will be one Coordinating Center. Coordinating Center personnel would normally be expected to have expertise in epidemiology of infectious diseases and behavioral and social sciences; knowledge of drug abuse; experience in logistics; and experience working with grantees in technical assistance situations. The Coordinating Center principal investigator should be experienced in coordination of large multi-site research studies. It should be noted that the Coordinating Center will provide the primary data management capacities for all aspects of Center projects; each Center will have their own internal data entry, data management and analytical capacities that will provide the primary support for Center specific part of their project. The primary function of the Coordinating Center will be to provide support to all Centers for the multi-center collaborative work of the SATH- CAP (i.e., implementation of standardized method, data management and analyses, and logistic support services). Coordinating Center responsibilities typically may include: o Collaborate with Research Centers and NIDA in refinement of research methods and designs, and assist the Steering Committee in developing and implementing the SATH-CAP cooperative multi-Center project component (i.e., the HIV behavioral epidemiology of drug use and sexual risk behaviors) and implement multi-Center data management systems to facilitate multi-Center collaborative work. o To assist Centers with data quality control checks, including on-site training for data collection, and to assist in data management and analysis. o To facilitate cross-center data comparability, to serve as a repository for data collected under this cooperative study, and to prepare public use data sets. o To develop and maintain a SATH-CAP website to facilitate dissemination of easily accessible project management tools (e.g., progress report forms etc.). o To coordinate logistical functions of meetings of the SATH-CAP Steering Committee, subcommittees, and workgroups, including production and distribution of committee minutes. Funds for participant travel to meetings will not be disbursed by the Coordinating Center; applicants should make adequate provision for these funds in the budgets submitted under the present RFA. o To assist in development of publications, in accordance with Steering Committee procedures to be developed. B. Research Centers. Research Center responsibilities generally may include: o Under guidance of the SATH-CAP Steering Committee the Research Centers establish policies and procedures for conducting periodic reviews to examine recruitment accrual, data accuracy and timeliness, and compliance with study plans. o Within its own Center, each participating Research Center typically have the responsibility for research coordination, data management, and quality control. o Ensure adequate accrual of subjects to meet the requirements of the Center's project in numbers recruited over defined time periods. o To establish and implement mechanisms for data management and analysis that ensure data collection and management procedures are: a) adequate for quality control and analysis, b) in accordance with procedures and requirements established by the Steering Committee, and d) sufficiently uniform across all participating sites. o To ensure that any organizations that are engaged in research, as defined by the Office for Human Research Protections (OHRP), must obtain an OHRP assurance and IRB review and approval before conducting human subjects research. o To establish a mechanism for interim monitoring of progress and results to be reported at least semiannually to the SATH-CAP Steering Committee and to NIDA. o To submit annual progress reports to NIDA's program official. Research Center funding is contingent on progress, including collaborative contributions and satisfactory recruitment accrual. o To publish major findings in a timely manner, in accordance with procedures established by the SATH-CAP Steering Committee. Publication or oral presentation of work done under this agreement requires acknowledgement of NIDA support. o Monitor and manage the implementation of studies, and support operational needs such as quality assurance, data collection, resources for analysis, etc. Responsibilities also generally include executive secretariat functions such as organization of necessary meetings and conference calls, developing meeting agendas, taking minutes of sessions, photocopying and distributing meeting materials to the other Research Centers and NIDA, and preparation of reports to the NIDA Program Official. C. SATH-CAP Steering Committee. The SATH-CAP Steering Committee (or, simply, Steering Committee) will constitute the primary governing body of the SATH- CAP. It will consist of the Principal Investigator of each Research Center, the PI of the Coordinating Center, and the NIDA collaborating scientist, each of who will have one vote on the Steering Committee. This group will direct the research conducted in the SATH-CAP, develop policies and procedures for the implementation of research plans, coordinate the implementation of projects across the SATH-CAP, monitor progress, guide data analysis and interpretation of results, and oversee communications within the SATH-CAP as well as with the greater scientific community and the public. The Steering Committee, by majority vote, will select a Chairperson from the group of SATH-CAP Research Center Principal Investigators. Federal participants may not serve as chair except to organize the first meeting and conduct the election of a permanent Chairperson. The Steering Committee will determine whether other members of the Coordinating Center or Research Centers' teams should attend some or all meetings as nonvoting observers or resources. The Steering committee may also establish subcommittees and workgroups to assist it in carrying out its functions, and these groups may include members of the Centers' teams and others as the Steering Committee sees the need. The Steering Committee will also establish standards and procedures for the SATH-CAP to assure comparability and generalizability across sites. Such standardization will include specifying how the Behavioral Epidemiological component will be operationalized and implemented across all Research Centers. (Note: All Research Center applications still need to specify, in their research plan, how they propose to assess, measure, and implement the Behavioral Epidemiological component in their respective research project.) The Steering Committee will oversee selection or development of measurement tools for use in the SATH-CAP. It will also develop policies on data sharing, on access to materials and data, including making data available beyond the SATH-CAP in a timely manner. Publication policies will be written and authorship decided using procedures developed and approved by the Steering Committee. All publications, whether from a single site or multiple sites, will be submitted to the Steering Committee for review and approval. All major scientific decisions will be determined by majority vote of the Steering Committee. All participating Centers must agree to abide by the policies approved by the Steering Committee, both for the common HIV behavioral epidemiology component spanning across all Centers and study components specific to individual Centers. The Steering Committee may meet up to four times during the first year, and will meet up to 3 times per year thereafter, usually in the Washington, D.C. area. Applicants should include budgets for travel to these Steering Committee meetings and subcommittee/workgroup meetings in their applications and should assure that adequate provisions are made to allow Principal Investigators to participate fully in activities of the Steering Committee and its subcommittees/workgroups. MECHANISM OF SUPPORT This RFA will use NIH U01 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is September 30, 2003. The NIH U01 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award The total project period for applications submitted in response to the present RFA may not exceed 5 years. The earliest anticipated award date is September 30, 2003. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the Institute, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. This RFA is a one-time solicitation. Future unsolicited, competing- continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. FUNDS AVAILABLE NIDA intends to commit approximately $3.5 million to support first year total costs of the SATH-CAP in FY 2003. This level of support is dependent on the receipt of a sufficient number and diversity of applications of high scientific merit. NIDA expects to make four to six awards under this RFA for project periods of up to five years of support. It is anticipated that one award for approximately $400,000 in total costs (i.e., direct, facilities, and administrative costs) per year will be made for the Coordinating Center. Approximately $3.1 million in total costs per year will be distributed among three to five Research Centers. Because the nature and scope of the research activities proposed in response to this RFA may vary, it is anticipated that the size of individual awards will vary also. Budget requests should be carefully justified and commensurate with the complexity of the project. Although this program is provided for in the financial plans of the NIDA, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations Note: Separate applications are being solicited for Research Centers and a Coordinating Center to participate in this collaborative study. If an organization chooses to apply as a research center site and as the coordinating center, separate applications and a separate Principal Investigator for each are required, and there should be no overlap of effort in research or support personnel. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The principal investigator must commit at least 20 percent of his or her time to the SATH-CAP. SPECIAL REQUIREMENTS To promote the development of a collaborative program among award recipients, a number of issues need to be addressed in applications as discussed under Application Procedures, below. Applicants should discuss the rationale for their choice of research questions and design, should document their ability to recruit a sufficient number of participants, and should demonstrate their ability and willingness to work cooperatively with NIDA, the Coordinating Center, other Research Center awardees, and to follow a common research plan for the HIV behavioral epidemiology (i.e., drug use and sexual risk behaviors) component of the research project. The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator(s) as well as the institutional official at the time of award. Cooperative Agreement Terms And Conditions of Award These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism) in which a substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIDA Collaborating Scientist. 1. Awardee Rights and Responsibilities Awardees have primary responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies in collaboration with other awardees, and with assistance from the NIDA Collaborating Scientist. Awardees shall participate in the Steering Committee and abide by decisions of the Steering Committee. Awardee will retain custody of primary rights to their data developed under the award, subject to rules formulated by the Steering Committee, and government rights of access consistent with current DHHS, PHS, and NIH policies. Research Center Awardees Awardees shall develop research plans in conjunction with other awardees for the collaborative component (i.e., HIV behavioral epidemiology component) and submit them for approval by the Steering Committee. Implementation of the collaborative component of the project shall be in accord with Steering Committee policies and procedures, including policies and procedures pertaining to instrumentation, data collection, data and safety monitoring, and publication. Awardees shall take lead responsibility for implementation of the Center-specific project component. That is, Research Centers will be responsible for implementing and monitoring their own internal data entry, data management and analytical capacities to ensure that their Center specific research component is efficiently carried-out. Coordinating Center Awardee The awardee shall provide the primary data management capacities for multi- center collaborative work. Such responsibility will entail implementing standardized multi-Center data management systems for data collection, data entry procedures, data monitoring and analysis of the SATH-CAP cooperative multi-center component (i.e., the HIV behavioral epidemiology of drug use and sexual risk behaviors) as well as providing logistic support services for multi-Center collaborative work (e.g., logistical functions for Steering Committee meetings; develop and maintain a website to facilitate dissemination of project management tools such as progress report forms etc.). 2. Federal Staff Roles and Responsibilities NIDA Collaborating Scientist. A NIDA Collaborating Scientist with expertise in research on HIV/AIDS among drug using populations will cooperate with awardees in development of research plans of the collaborative component. The NIDA Collaborating Scientist will serve as a resource for specific information on NIDA's programmatic intentions and priorities, and will help to foster collaborations between researchers. The NIDA Collaborating Scientist will be a voting member of the Steering Committee, but will not hold the position of chair. He/she will participate in the development of instrumentation, development of study plans, in quality control, and in coordination of projects, but will not participate in activities that directly involve assessment, testing, or treatment of human subjects. Other NIDA staff. A NIDA Program Official, who will not participate in the research, publications, or Steering Committee, will be responsible for the oversight of each cooperative agreement. The Program Official carries primary responsibility for: (1) periodic review and approval of the progress of the research plans in relation to their stated objectives, and (2) making recommendations regarding continuance of the program. The NIDA Program Official will be responsible for monitoring the conduct of the project and overseeing the Coordinating Center and the Research Centers. The Program Official will receive all required progress reports to determine that satisfactory progress is being made. This person also works collaboratively with the Grants Management Specialist to assure high quality business management of the program, including the most effective use of Federal financial assistance provided through this cooperative agreement. Subject to Steering Committee invitation, other NIDA staff may attend and participate as non-voting resources to the Steering Committee and/or its subcommittees. Such individuals would typically be called upon to provide specific scientific expertise (e.g., social epidemiology). 3. Collaborative Responsibilities Steering Committee. The Steering Committee will constitute the primary governing body of the SATH-CAP. Awardees must participate in the Steering Committee. The voting membership will consist of the Principal Investigator of each Research Center, the Principal Investigator of the Coordinating Center, and the NIDA Collaborating Scientist. The Steering Committee formulates and monitors policies and procedures guiding the research activities, and oversees communications. The Steering Committee will develop a Charter of Responsibilities, subject to NIDA's concurrence, defining the roles and responsibilities for the Coordinating Center and the Research Centers. All major scientific decisions are made by majority vote. The Steering Committee will develop policies that will guide the standard operating procedures of the SATH-CAP and will address protocol development for the multi-Center HIV behavioral epidemiology component, data acquisition and management, and analysis and publication. It will monitor progress and establish subcommittees and workgroups as needed. Awardees agree to abide by those procedures and policies. Data Management, Analysis, and Access. Data generated are the property of the awardees. However, the Coordinating Center and all Research Centers must provide NIDA with access to all data generated under this award. Data must be shared upon request with the Steering Committee, and subcommittees reporting to the Steering Committee. The Steering Committee will be convened as soon as possible after the awards are made, and may meet up to 4 times during the first year, and up to 3 times per year thereafter, probably in the Washington, DC area. 4. Program Review In addition to the standard NIH requirement for submission of annual progress reports, awardees will be required to submit semiannual reports on study progress. NIDA will provide a suggested format for this purpose. The NIDA Program Official will review progress through consideration of the semiannual accrual reports, annual report, and program site visits. The inability of a Research Center to meet the performance requirements and responsibilities may result in an adjustment of funding, withholding of support, or suspension or termination of the award. 5. Study Closure NIDA may request that a study be closed for reasons including: a) insufficient accrual rate or other problems with accrual, b) poor site performance, c) study participant safety; and d) emergence of new information that diminishes the scientific importance of the study question. NIDA will not permit expenditure of Federal funds or permit expenditure of NIDA funds after requesting closure (except to ensure safety for enrolled subjects). 6. Arbitration Process Any disagreement that may arise between the awardee Research Center(s)and/or the Coordinating Center and the NIDA Collaborating Scientist on scientific/ programmatic matters that is not resolved by the normal deliberations of the Steering Committee may be brought to arbitration. An arbitration panel will be composed of three members, one selected by the Steering Committee (with the NIDA Collaborating Scientist not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NIDA, and the third member selected by the prior two members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR part 50, subpart D and HHS, Grant Administration Regulations at 45 CFR part 74, and HHS regulations at 45 CFR part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues. o Direct your questions about scientific/research issues to: Jacques Normand, Ph.D. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 5190, MSC 9593 Bethesda, MD 20892-9593 TEL: (301) 402-1919 FAX: (301) 594-6566 Email: jnormand@nida.nih.gov o Direct your questions about peer review matters to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tlevitin@mail.nih.gov o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Chief, Grants Management Branch National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gf6s@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o 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 NIDA staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Blvd., Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) Phone: (301) 443-2755 FAX: (301) 443-0538 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS All Research Center applications must provide a research plan for their proposed project which clearly delineates how the mandatory behavioral epidemiological component of their project will be integrated with the two other required scientific areas (i.e. 2 of the following 3 scientific areas: Biological/biomedical, medical sociology, and/or mathematical modeling) as defined on page 3 of this announcement. Facility/Institution Section. Specific content must be present in the application to document the technical and scientific merit of the applicant's application for a Research Center or a Coordinating Center that will address the fundamental goals and collaborative nature of the SATH-CAP. The application should conform to the general instructions and requirements (e.g., for font size and page limits) of the PHS 398 (rev. 5/2001) with the exceptions noted below. Internal Administration and Collaborative Plans The administrative and managerial qualifications and experience of the PI must be described to provide evidence of skills in managing and coordinating research endeavors. The skills of other personnel involved in administration and management of the research should also be clear. The Principal Investigator must commit 20 percent or more effort to the SATH-CAP. The application should elaborate on infrastructure capabilities for project management, study design and development, and data systems. (For Coordinating Center) Plans for fulfilling the consultative role of the Coordinating Center should be provided. The application should address how the Coordinating Center might collaborate with Research Centers and NIDA to assist the Steering Committee in designing collaborative components of the SATH-CAP and implementing cooperative, multi-Center/multi-site projects. Plans for assisting with data quality control, training for data collection, and analysis should be given. Plans for developing and evaluating ideas for cross-site data analyses and for serving as a repository for data collected, including preparation of public use data sets, should be clear. Potential needs of Research Centers and participants in the SATH-CAP should be anticipated and addressed, as should be the challenges in fulfilling those needs. This section should also include plans for addressing the logistic needs of the SATH-CAP, including coordinating meetings of the Steering Committee, subcommittee, and workgroups, as well as distributing preparatory and post- meeting documents. Plans for the proposed content of a SATH-CAP website and structure of that website should be provided. The plans should describe innovative approaches to data sharing and for the dissemination of research findings, as well as for development of management tools to promote efficient conduct of government supported research. USING THE RFA LABEL: 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: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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/DHHS 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: Director Office of Extramural Affairs National Institute on Drug Abuse/NIH/DHHS 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-2755 APPLICATION PROCESSING 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIDA. 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 NIDA in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 and assigned a priority score o Receive a second level review by the National Advisory Council on Drug Abuse 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: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you 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? (6) Internal Administration and Collaborative Plans (Research Center): How strong are the administrative and managerial qualifications of the PI and key staff? Is there evidence of sufficient dedication of time and other resources to the work? How clear and feasible are plans for project management, coordination and communication? How well developed are the plans for data management? Are intra-center decision-making procedures specified and workable? How sufficient and efficient is the infrastructure for project management and data systems activities? (6) Internal Administration and Collaborative Plans (Coordinating Center): What is the quality of the plans for serving as a consultative center to the SATH-CAP? How developed are the approaches for providing consultation on implementation, and analysis? How well are data quality control, training, and data repository needs addressed? How well are other needs and challenges addressed? What is the quality of the plan for serving as a data repository? How feasible and developed are the logistic support and operational support plans? How well developed are the plans for including a SATH-CAP website, for using appropriate technological resources? How strongly does the record of experience in these areas support the application? (7) Understanding of the Mission of the SATH-CAP How well does the application demonstrate an understanding of the scientific agenda of the SATH-CAP? How innovative is the vision the application presents for utilization of the SATH-CAP? (8) Research Capacity (Coordinating Center): What is the quality of the scientific expertise within the Coordinating Center, especially with respect to complex multi-site studies? How would the Coordinating Center interact with Research Centers to accomplish SATH-CAP goals? What is the capacity of the Coordinating Center to conduct studies unique to the role of the Coordinating Center as specified in the RFA? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans (including data safety monitoring plans), animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 20, 2003 Application Receipt Date: March 20, 2003 Peer Review Date: July 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 30, 2003 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. REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phases I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at https://grants.nih.gov/grants/funding/children/children.htm. 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. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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 https://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. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see https://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 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. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.279, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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