RFA-MH-00-012: HIV PREVENTIVE INTERVENTIONS FOR THE SEVERELY MENTALLY ILL

Department of Health
and Human Services (HHS)

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HIV PREVENTIVE INTERVENTIONS FOR THE SEVERELY MENTALLY ILL Release Date: February 1, 2000 RFA: MH-00-012 National Institute of Mental Health Letter of Intent Receipt Date: April 24, 2000 Application Receipt Date: May 23, 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 National Institute of Mental Health requests applications to be supported under this RFA with the major objective of developing HIV preventive interventions for persons with severe mental illnesses (SMI). A small body of outcome studies shows that relatively intensive, theoretically-based, and culturally-tailored behavior change programs, relying heavily on cognitive behavioral skills training, have been successful as risk-reduction strategies for persons with SMI. However, a number of important HIV prevention issues have not been adequately studied, there are methodological limitations in the few promising HIV intervention models, and psychiatric aspects related to HIV infection require more attention. Some of the more prominent issues that need to be studied include (i) interventions tailored to risk situations encountered by persons with SMI, (ii) gender and age- tailored interventions, (iii) long-term maintenance of behavior change, (iv) community level and population-focused interventions, (v) secondary prevention interventions for HIV-seropositive individuals, (vi) adherence to therapeutic regimens and psychological coping. This RFA emphasizes the need to disseminate empirically validated HIV preventive interventions for persons with SMI to practicing clinicians and community-based programs. 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), HIV Preventive Interventions for the Severely Mentally Ill, is related to the priority area of Mental Health and Mental Disorders. 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 small 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) research project grant (RO1) and small research grant (RO3) award mechanisms. Collaborative R01s will also be accepted. The total project period for an RO1 application submitted in response to this RFA may not exceed five years. RO3 grants are limited to two years and are not renewable. The RO3 is limited to $50,000 direct costs for each of these two years. This RFA is one-time solicitation. 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 RO3 grant program is found at http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html Special requirements and instructions for Collaborative R01s may be found at http://grants.nih.gov/grants/guide/pa-files/PAR-98-017.html Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. 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. For all R03 applications and all competing RO1 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: http://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. FUNDS AVAILABLE The NIMH intends to commit approximately $1,500,000 to fund five to seven new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years for an RO1 application. 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 this RFA will be reissued. RESEARCH OBJECTIVES Background SMI refers to a wide range of psychiatric diagnoses, but they have in common psychiatric symptoms that persist over time and are functionally disabling in daily living skills including family relations, educational attainment, occupational productivity and social role functioning. SMI includes schizophrenia, schizoaffective disorder, bipolar disorder, major depression, autism and obsessive compulsive disorder. These disorders affect at least 2.8 percent of the U.S. population or 5 million people (National Advisory Mental Health Council, 1995). Recent epidemiological trends of the AIDS epidemic indicate that some segments of the US population have been more vulnerable to HIV infection than others, and persons with SMI are perhaps the most vulnerable disenfranchised subpopulation. This emerging association between HIV disease and socially marginalized communities has been revealed for persons with SMI in several studies of an alarmingly high prevalence of HIV infection among men and women with SMI in large urban areas (from 4 to 23 percent). If only 10 percent of persons with SMI were HIV positive, the medical costs associated with such a public health problem would be exorbitant: about $28.6 billion. Some behavioral assessment and behavioral epidemiology studies confirm that adolescents, men and women with SMI are indeed populations at high risk for contracting HIV infection. Published studies of HIV-related risk taking by adults with SMI vary widely in terms of recruitment sites and strategies, sample composition, risk assessment, definition of SMI and other methodological features. In addition, certain factors specific to this population that contribute to HIV risk have rarely been taken into account, including symptoms of mental illness, co- occurring substance abuse and alcohol use, or the sequelae of having a profound mental illness. Therefore, future HIV prevention efforts must be understood within a broader context of mental illness. Additionally, better efforts are needed to link the risk situations and relationships encountered by persons with SMI to the content of HIV preventive interventions. This can best be accomplished by concurrently studying HIV risk and preventive interventions with risk linked to and in the context of specific intervention programs. Because HIV has disproportionately affected persons with SMI as well as other disenfranchised subpopulations (e.g., the urban poor, ethnic minorities), interventions that improve social support and empower individuals who have often faced structural impediments to health and success in our society may more readily lead to long-term behavior change. In general, it will be necessary for investigators to develop and test a broader repertoire of intervention models assessed at multiple levels: individual, system, network, care provider and community. It will be important to establish the sustained integration of HIV prevention programs across the multiple care and social service systems for persons with SMI. Areas of Interest Research studies must target persons with SMI, before or after HIV infection, or the HIV-related neuropsychiatric aspects of mental illness. Examples of research that would be an appropriate response to this RFA include, but are not limited to: o Epidemiological research to develop data bases in diverse geographic regions o Studies of theory-driven multi-modal interventions at the individual, system, network, care provider and community levels in HIV seronegative and seropositive youth and adults o Studies of the influences of substance abuse/alcohol, adverse medical health outcomes or other comorbid/co-occuring disorders on treatment readiness, long term recovery and adoption of safe behaviors o Studies of interventions for vulnerable subpopulations of persons with SMI at risk for, or infected with, HIV (e.g., homeless persons) o Development and evaluation of interacting behavioral and pharmacological interventions for mental health disorders, drug and alcohol addiction o Research to improve coordination and integration of interventions among mental health treatment, drug and alcohol treatment and primary medical care as well as other treatments (e.g., STD, social services, community-based HIV prevention) o Behavioral research on the feasibility and acceptability of female- controlled barrier methods, in particular microbicides, as an alternative prevention strategy o Research on adherence to treatment regimens including communication techniques to improve shared decision making between health care providers and HIV-infected persons with SMI o Research on the impact of HIV therapeutic treatment regimens on adherence, psychological coping, behavioral strategies to manage symptoms secondary to treatment protocols and continued risky behavior o Development and evaluation of interventions to promote treatment adherence o Studies of the effects of HIV-related stigmatization and also of interventions to minimize the impact of stigmatization, to maintain positive behavior change, to enhance quality of life and to assist in psychological coping o Research on psychiatric aspects of HIV infection (e.g., psychiatric symptoms in symptomatic and asymptomatic HIV infection, psychiatric sequelae of notification of infection, violence or suicide and AIDS) o Treatment research on psychiatric disorders in HIV infection (e.g., pharmacologic or nonpharmacologic treatment of mood or psychotic symptoms) o Studies of interventions to address the psychiatric, neurobiological, behavioral and cognitive consequences of HIV disease o Research on distributions and determinants of other infectious diseases associated with HIV/AIDS (e.g., tuberculosis, hepatitis, STDs) among persons with SMI as well as preventive interventions o Research on the cost and financing of preventive intervention programs including cost-benefit, cost-effectiveness and cost- utilization o Studies that disseminate empirically validated HIV prevention interventions into the outreach, transitional living, community services and other ongoing public health programs o Research on HIV-related mental health services and their effectiveness including organization and delivery of services, characteristics and interactions of providers and patients o Studies that translate efficacious interventions to effective interventions ready for adoption by service providers This RFA also encourages the use of collaborative RO1 applications. For example, collaborative research might include: o Large scale treatment (psychosocial and/or psychopharmacologic) prevention trials focused on HIV and mental disorders, using common protocols across sites, o Studies of HIV infected persons with SMI which compare mental health service delivery and/or financing schemes in different regions, o Basic-clinical collaborations of HIV in persons with SMI involving multiple sites, some with access to well characterized clinical samples and others with state of the art laboratory methods (e.g., immunology, virology, STD outcomes), o Studies of low prevalence clinical populations infected with HIV or populations of minority subjects requiring several sites to assemble a sufficiently large sample size. 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). 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: http://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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. David Stoff, listed under INQUIRIES, by April 24, 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 http://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 for RO1 applications and $50,000 per year for RO3 applications (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 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) 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. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o 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 http://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: http://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-00-012. A sample modified mailing label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in pdf 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, HIV Preventive Interventions for the Severely Mentally Ill, MH-00-012, 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: David M. Stoff, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6210, MSC 9619 Bethesda, MD 20892-9619 Applications must be received by May 23, 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 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: April 24, 2000 Application Receipt Date: May 23, 2000 Peer Review Date: June/July 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: David M. Stoff, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6210, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-4625 FAX: (301) 443-9719 Email: dstoff@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 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 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 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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