NEW APPROACHES TO PREVENT HIV/OTHER INFECTIONS IN DRUG USERS Release Date: December 31, 2001 RFA: RFA-DA-02-009 National Institute on Drug Abuse (http://www.nida.nih.gov) Letter of Intent Receipt Date: March 18, 2002 Application Receipt Date: April 16, 2002 THIS REQUEST FOR APPLICATIONS (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 https://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute on Drug Abuse (NIDA) invites domestic and international research applications on the development and testing of new intervention approaches to prevent HIV and other blood-borne and sexually transmitted diseases (STDs) in drug users and their sexual partners. NIDA- sponsored research has demonstrated that, in the absence of an AIDS vaccine and no cure, comprehensive HIV prevention remains the most effective, sustainable, and cost-effective approach to avert new HIV infections in drug- using populations. This RFA seeks to build on lessons learned since the epidemics of drug abuse and HIV/AIDS emerged in the early 1980s by addressing research gaps in HIV prevention and drug use. Over the past two decades, considerable scientific progress has been made in understanding, preventing, and treating HIV/AIDS and other infections among drug users. Yet much remains unknown or poorly understood today. Emerging drugs of abuse, such as the club drugs ecstasy, GHB, ketamine, and methamphetamine, as well as more potent supplies of heroin, cocaine, marijuana, and other drugs, are rapidly changing the profiles of populations at risk for drug use and its health and medical consequences, including the transmission of HIV and other infections. Racial and ethnic minority populations, women, and adolescents have been deeply impacted by drug abuse, HIV/AIDS, and related infectious diseases in recent years, and new HIV infections have continued in both the U.S. and in other nations. Risk behaviors associated with HIV/AIDS are similar to those for viral hepatitis (i.e., hepatitis B [HBV] and hepatitis C [HCV]) and other STDs. HBV and HCV viral infections have become increasingly prevalent in injecting and non-injecting drug-using populations, as have drug-resistant strains of gonorrhea and tuberculosis. New and improved approaches to prevent the acquisition and ongoing transmission of these infections are urgently needed, as are strategies to improve access to diagnostic screening and care. The purpose of this RFA is to stimulate research on the development of new, improved, and innovative intervention approaches to prevent HIV and other blood-borne and sexually transmitted infections in drug users and their sexual partners. Well-designed, targeted prevention interventions are readily adaptable and responsive to changing patterns of drug use and HIV risk behaviors, to a variety of local settings, and to the diverse characteristics and needs of drug users and their sex partners. It is important to assess the effectiveness, sustainability, and durability of existing HIV prevention interventions and, as appropriate, to modify them to meet changing population characteristics, needs, and circumstances. It is equally important to consider newly developed, tested, and implemented intervention approaches that take evolving scientific findings on drug use and related risk behaviors into account. Moreover, as epidemiological data on HIV and other infections suggest, many injecting and non-injecting drug users who could potentially benefit the most from HIV prevention efforts remain underrepresented in public health interventions and/or inaccessible or resistant to outreach efforts aimed at behavioral risk reduction. Clearly, new intervention approaches to prevent HIV and other infections in drug users must reach the most vulnerable populations and their communities. 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, "New Approaches to Prevent HIV/Other Infections in Drug Users," is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. 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) investigator- initiated research project (R01), small grant (R03), and exploratory/developmental (R21) award mechanisms. The exploratory/developmental (R21) grants are limited to 3 years and small grants (R03) are limited to 2 years. Both are non-renewable and limited in direct cost amount per year (R03, $50,000; R21, $100,000). The R03 mechanism is intended for newer, less experienced investigators, for investigators at institutions without well-developed research traditions and resources, or for experienced investigators wishing to change research directions or test new methods or techniques. The R21 mechanism is intended to encourage exploratory research projects with sound methodology and strong rationales in underdeveloped research areas of HIV prevention interventions for drug users, such as the areas covered in this RFA. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Applicants are advised to contact NIDA program staff listed under INQUIRIES for additional information. Refer to the announcement for the specific eligibility requirements for the small grant (R03) at https://grants.nih.gov/grants/guide/pa-files/PAR-97-038.html and the developmental/exploratory grant (R21) at: https://grants.nih.gov/grants/guide/pa-files/PA-01-012.html. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated the size of an award will also vary. Awards under the R01 mechanism may not exceed 5 years. Awards under the R03 mechanism are limited to 2 years, and R21 awards are limited to 3 years. The anticipated award date is September 30, 2002. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. Applications judged to be nonresponsive to the RFA will be returned to the applicant. 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 https://grants.nih.gov/grants/funding/modular/modular.htm. FUNDS AVAILABLE NIDA intends to commit approximately $2,000,000 in FY 2002 to fund about six new awards in response to this RFA. Because the nature and scope of the research proposed may vary, it is anticipated that the number of awards and the size of each award will also vary. Although the financial plans of the Institute 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 Since HIV/AIDS first emerged in the 1980s, researchers have designed and assessed a range of prevention intervention strategies to reduce transmission risks for HIV and related co-infections in injecting and non-injecting drug users, their sexual partners, and their children. Single, combined, and multiple components of different HIV prevention interventions have been shown to be effective in reaching drug users to help them reduce their behavioral risks for HIV and other infections. While these strategies and/or their components have been implemented among a variety of risk groups and settings, the cumulative evidence has shown that no single approach is sufficient to avert new HIV and other infections in all drug users and their sexual partners. Epidemiological patterns of drug abuse and risk behaviors constantly change and new infections of HIV and other blood-borne and sexually transmitted infections continue to emerge and spread. The emphasis of this RFA is on research gaps in current intervention approaches to prevent HIV and other infections in drug users and their sex partners. It invites researchers to apply new findings on changing patterns of drug use, at-risk populations, and emerging infectious diseases in the development of novel approaches -- and in the strengthening and improvement of existing interventions -- to prevent HIV and other blood-borne and sexually transmitted infections. Researchers are encouraged to utilize and integrate complementary methodological approaches in their study designs, including epidemiology, ethnography, behavioral and prevention science, virology, and clinical medicine. Areas of Research Focus This RFA will support research on topics that include but are not limited to the following: o The development and testing of innovative prevention intervention approaches to address new or changing patterns and contexts of drug use and sexual risk behaviors and their implications for transmission of HIV and other blood-borne and sexually transmitted infections. o Research to develop and improve methods to access and recruit not-in- treatment drug users, including new initiates to drug use and non-injecting drug users at risk of transitioning to injecting drug use, to participate in targeted prevention interventions to reduce drug use and sex-related risk behaviors, HIV disease transmission, co-morbidity, and mortality. o Identification of individual and community-level factors that impact the initiation and sustainability of HIV prevention interventions and their outcomes over time, and how they can be adapted, extended, or replicated across demographically, ethnically, and culturally diverse drug-using groups and community settings. o Development of new strategies to link community-based outreach/risk reduction to hard-to-reach drug users and their sex partners and to referrals and access to prevention interventions and services for HIV counseling and testing, diagnostic screening for related co-infections, drug treatment, and medical care. o Studies of underlying mechanisms that contribute to the effectiveness of existing HIV prevention interventions to extend, strengthen, develop, or re- direct interventions to meet the changing needs and characteristics of drug users, their sex partners, and their communities. o Research to understand why even the most effective HIV prevention interventions may not appreciably benefit all drug users who participate in them, to better characterize drug-using subgroups and individuals at risk who are refractory to existing behavioral interventions, and to develop and test new approaches that engage drug users who are marginalized, resistant, fearful of being stigmatized, or hard-to-reach. o Studies to improve outreach, recruitment, adherence, and retention of HIV- infected drug users and their sex partners in clinical trials of new approaches to prevent HIV/AIDS and other blood-borne and sexually transmitted infections. o Studies to enhance understanding of the social, cultural, and environmental factors and contexts associated with the co-occurrence of HIV/AIDS and other infectious diseases in drug users and their sex partners, and to design new intervention approaches to address such co-occurring conditions. Such factors and contexts may include, e.g., relationships among peer groups, beliefs about gender roles, and social mixing patterns of risk cohorts and their social networks relative to transitions from non-injecting to injecting drug use or from unsafe drug use and unsafe sex. o Development and testing of new prevention intervention strategies that are linked to a variety of ancillary services (e.g., rapid diagnostic assays, HIV counseling and testing, and medical and drug treatment) or that are adapted and tailored to underserved and stigmatized populations, such as drug injecting women, the sex partners of drug injectors, adolescents, new initiates to drug use and new injecting drug users, and men who use drugs and have sex with men. o Evaluation studies to determine the relative effectiveness, cost- effectiveness, and sustainability of new HIV prevention interventions (and/or their single or multiple components) in demographically, ethnically, and culturally diverse populations and their communities. 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 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 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: https://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 these policies. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review the recommendations of the Council before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at http://www.nida.nih.gov/ under Funding or may be obtained by calling (301) 443-2755. 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, clinics, 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 include 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. 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: https://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: 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. 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 IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the letter of intent receipt date listed to: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier or express delivery) Telephone: (301) 443-2755 APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. 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 https://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. 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. 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: Director Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Rockville, MD 20852 (for courier or express delivery) 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 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 receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory 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. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, all applications will 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 (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 The relevance of the proposed work to the purpose of the RFA. Schedule Letter of Intent Receipt Date: March 18, 2002 Application Receipt Date: April 16, 2002 Peer Review Date: June/July 2002 Council Review: September 2002 Earliest Anticipated Start Date: September 30, 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 Potential applicants are strongly encouraged to contact the appropriate staff for additional information and specific application procedures or to clarify any issues. Direct inquiries regarding programmatic issues to: Elizabeth Lambert, M.Sc., or Helen Cesari, M.Sc. Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA) National Institute on Drug Abuse 6001 Executive Boulevard Room 5198, MSC 9593 Bethesda, MD 20892-9593 Telephone: (301) 402-1933 or 402-1918 FAX: (301) 480-4544 Email: el46i@nih.gov or hc30x@nih.gov Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. Office of Extramural Affairs National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, MD 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Blvd., MSC 9541 Bethesda, MD 20892-9541 Telephone: (301) 443-6710 FAX: (301) 443-6847 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. 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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