EARLY DETECTION OF HIV: IMPLICATIONS FOR PREVENTION RESEARCH Release Date: January 6, 2000 RFA: MH-00-008 National Institute of Mental Health Letter of Intent Receipt Date: February 10, 2000 Application Receipt Date: March 10, 2000 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE The role of HIV testing and its implications for prevention and clinical care is changing rapidly. New technologies for HIV testing provide high sensitivity, specificity and results within ten minutes. Early detection creates the possibility of access to early antiretroviral therapy and its potential treatment benefits. In addition, testing has shifted from blood banks and anonymous testing sites to mainstream health care settings. These shifts will present a series of challenges for government agencies involved in HIV surveillance, prevention research and treatment. Approximately one-third of HIV-infected individuals do not know their HIV status. Efforts must be made to find out the reasons why people do not get tested and why many who are tested fail to return for the results. Research is needed to understand the strategic prevention implications of: o rapid, low cost, client controlled testing methods; o innovations in methods and modes of counseling associated with HIV testing; and o health care provider and organizational level interventions to increase client testing. This RFA will solicit applications to study new approaches to increase HIV testing and communication of test results for at-risk individuals, as well as to develop and evaluate innovative prevention strategies associated with emerging technologies in the early detection of HIV. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Early Detection of HIV: Implications for Prevention Research, is related to the priority areas of Mental Health and Mental Disorders, STDs and AIDS. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000/ ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for the NIMH Small Grant program. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Research Project Grants (R01) and Small Grants (R03). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed 5 years for an R01 application and 2 years for an R03 application. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator- initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 29, 2000. Because the small grants have special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES) and to obtain the appropriate additional announcements for those grant mechanisms. Special instructions and information for the Small Grant Program is found at https://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html For all R03s and competing R01 applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being undertaken at NIH. More detailed information about modular grant applications, including a sample budget narrative justification pages and a sample biographical sketch, is available via the Internet at: https://grants.nih.gov/grants/funding/modular/modular.htm. Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. R03s are not renewable. FUNDS AVAILABLE The NIMH intends to commit approximately $1,000,000 in FY 2000 to fund up to five new and/or competitive continuation grants in response to this RFA. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. It is expected that direct costs will be awarded in modules of $25,000, however program and grants management adjustments may be necessary prior to award. 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. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. R03s are not renewable. RESEARCH OBJECTIVES As we enter the millennium, the promise of living with HIV as a chronic, rather than lethal disease, has never been greater. From its initial appearance, HIV/AIDS has been regarded not only as a medical issue, but also as a health problem beset by numerous complex ethical, social and policy issues. Developing a policy consensus on HIV counseling and testing is extremely sensitive and complicated. Policies on surveillance, access to care and prevention remain unresolved. The following four developments have helped intensify and shape the debate on these issues. They are: o the advent of highly active anti-retroviral therapy (HAART), which prolongs the life of HIV-positive individuals and increases the importance of early detection; o the development of antiretroviral therapy to prevent the prenatal transmission of HIV; o the finding that HIV counseling and testing result in safer sexual behaviors, especially among HIV-positive individuals; and o the emergence of new HIV testing technologies that are consistent, inexpensive, quick and easy to administer. These developments are having a major impact on the ways we approach HIV prevention, treatment, surveillance and early detection. Current estimates of the HIV prevalence in the United States are between 650,000 and 900,000 individuals. HIV incidence has remained steady for several years at 40,000 individuals per year. The estimate for the number of Americans who are HIV positive and unaware of it is approximately 200,000. Given the large number of individuals infected with HIV who are unaware of their status, it is extremely important that we identify barriers to testing, counseling and care and also devise new strategies to overcome these barriers. New strategies must examine the critical role of early detection and improve the linkages between testing, counseling and care. In addition, an estimated 19 million Americans are tested for HIV each year. Of those tested, more than half are tested in hospitals and clinics, about one third are tested in blood donation centers and only about ten percent are tested in publicly funded sites. Most of the information gained about counseling and testing comes from analysis of publicly funded sites. Research is needed to investigate the role and effectiveness of counseling and testing in sites other than those that are publicly funded. From a policy perspective, the number of states that mandate name reporting has increased significantly this year. Research is needed to examine the effect of name reporting laws on voluntary testing and early detection of HIV. Also, does HIV surveillance influence test-seeking behavior and, if so, how? Investigations undertaken before the advent of HAART found that name-based reporting had a destructive effect, while post-HAART studies have had mixed findings. This RFA solicits applications to study the implications of the development of early detection technologies on HIV prevention, counseling and access to care, and on test seeking behaviors as they relate to HIV surveillance policies. Examples of additional research include, but are not limited to: o Determine the reasons why the reported one-third of HIV-infected individuals who do not know their status have not been tested; o Identify the reasons why many individuals who have been tested do not return for the results and develop strategies to deal with this problem; o Develop and test innovative techniques to locate individuals at high risk for HIV, and then generate and test new approaches to encourage these individuals to be tested; o Evaluate the impact of name reporting policies on HIV testing behaviors; o Develop and test new approaches to provide counseling to individuals at high risk for HIV who seek testing in primary care settings; o Generate and test new approaches and develop models to train health care providers in a variety of settings to adopt behaviors which will maximize HIV test seeking behaviors by those at high risk for HIV, including pregnant women; o Investigate the degree to which early detection technologies may be better linked to counseling and care; o Develop and assess HIV testing, counseling and prevention programs in managed care environments; o Investigate the degree to which provider behaviors may influence test- seeking behaviors; o Identify real and/or perceived social consequences of HIV disclosure and develop and test strategies to minimize these consequences. INCLUSION OF WOMEN, AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). It is also NIH 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 Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: https://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows Institute staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Louis H. Steinberg, listed under INQUIRIES, by February 10, 2000. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The application is also available at https://grants.nih.gov/grants/funding/phs398/phs398.html SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398 (rev 4/98). It is not required nor will it be accepted at the time of application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, List key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual's qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: https://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page; - List position(s) and any honors; - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations; o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application and must display the RFA number MH-00-008. A sample modified mailing label is available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in pdf0 format. 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, Early Detection of HIV: Implications for Prevention Research, MH-00-008, must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Louis H. Steinberg, Ed.D. Center for Mental Health Research on AIDS National Institute of Mental Health 6001 Executive Blvd., Room 6201, MSC 9621 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: lsteinbe@nih.gov Applications must be received by March 10, 2000. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIMH staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIMH in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the Institute's National Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus 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 to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: February 10, 2000 Application Receipt Date: March 10, 2000 Peer Review Date: April 2000 Council Review: September 2000 Earliest Anticipated Start Date: September 29, 2000 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Louis H. Steinberg, Ed.D. Center for Mental Health Research on AIDS National Institute of Mental Health 6001 Executive Blvd., Room 6201, MSC 9621 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: lsteinbe@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Although not a co-sponsor of this RFA, the National Institute on Drug Abuse has a strong interest in supporting studies on issues pertaining to early detection of HIV in drug abusing populations, e.g., studies which seek to identify and develop methods for circumventing barriers to early detection of HIV in drug abusing populations; research on the impact of name-based reporting in drug abusing populations; research on developing methods to circumvent barriers to retesting among drug abusers with a prior negative test and development and testing of innovative strategies for promoting early detection in child and adolescent drug abusers. For further information, contact Sander Genser, M.D., M.P.H., Center on AIDS and Other Medical Consequences of Drug Abuse, National Institute on Drug Abuse, telephone: 301 443-1801; E-mail: sg73f@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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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