PLANNING GRANTS FOR HIV/AIDS PREVENTION AND TREATMENT INTERVENTION IN MIDDLE-AGED AND OLDER POPULATIONS Release Date: January 8, 2001 RFA: RFA-AG-01-004 National Institute on Aging (http://www.nih.gov/nia/) National Institute on Mental Health (http://www.nimh.nih.gov/) Letter of Intent Receipt Date: February 23, 2001 Application Receipt Date: March 26, 2001 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The National Institute on Aging (NIA) and National Institute of Mental Health (NIMH) invites qualified researchers to submit applications for planning grants (R21) to assist in the design, testing and preliminary evaluation of prevention and treatment interventions for HIV/AIDS in the middle-aged and older population. Effective strategies for AIDS prevention and treatment through behavior change interventions for the major populations at risk have been identified but not yet applied to the fifty plus population. This announcement solicits planning applications for one-time grants to support pilot and feasibility research important for 1) the implementation and evaluation of behavioral and primary social prevention interventions targeted toward the identification and reduction of risk factors or enhancement of protective factors associated with HIV/AIDS among middle-aged and older people, and/or 2) for the implementation and evaluation of effective secondary prevention interventions that address the needs of HIV-infected middle-aged and older people. The R21 mechanism supports exploratory and open trial studies that will lead to the development of a phase 2 clinical trial testing the efficacy of different intervention approaches for this population. While this RFA is intended to encourage innovation and high impact research upon which significant future research may be built, and while no preliminary data are expected to be described in the application, applications should make clear that the proposed research and/or development is scientifically sound, that the qualifications of the investigators are appropriate, and that resources available are adequate (see review criteria). Because of the lack of randomized controlled studies in this population, there is a need for a planning phase to conduct preliminary research on the application and adaptation of previously successful HIV intervention strategies utilized in younger populations or those used to prevent or minimize other diseases/conditions among older adults. The planning grant application and review process is intended to provide a mechanism for initial peer review of the rationale and basic design of an intervention study which requires further development and testing before a full fledged study is appropriate. This award mechanism is appropriate for interventions whose rationale and basic design are considered sufficiently meritorious, but where sufficient information is lacking to move directly to more formal efficacy trials. This planning grant is intended to provide support for the development of a refined study design, organizational plan, detailed intervention and assessment protocol, preliminary data collection and analysis, manual of procedures, and budget. While the focus of this solicitation is on the application and testing of intervention techniques to the fifty plus population, additional information may also need to be gathered to understand older people’s unique risks as well as settings and situations that place this population at risk. Applicants should be aware that the award of a Planning Grant does not guarantee NIA or NIMH acceptance of the full-scale clinical trial for peer review, nor subsequent funding of the trial following peer review. However, it is expected that the applicant will develop a full-scale clinical trial for submission to a public or private agency if the Clinical Trial Planning Grant is funded. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), PLANNING GRANTS FOR HIV/AIDS PREVENTION AND TREATMENT INTERVENTIONS, 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 foreign and domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanism of support will be the NIH Exploratory/Developmental Grant (R21). The award cannot be renewed. Applicants should note that the funding of a planning grant does not imply a commitment by the sponsoring organizations to fund the proposed full-scale study, nor even to accept a subsequent application for such a study. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by NIH. Complete and detailed instructions and information on Modular Grant applications can be found at: http://grants.nih.gov/grants/funding/modular/modular.htm FUNDS AVAILABLE These planning grants will provide up to $150,000 in direct costs per year (with a total cost cap of $250,000 per year) for up to two years. The participating Institutes (NIA and NIMH) will contribute up to $1.6 million in FY 2001 to fund a total of 5 to 7 meritorious applications that are relevant to the Institutes’ missions. Although the financial plans of the Institutes 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. Direct costs will be awarded in modules of $25,000, less any overlap or other necessary administrative adjustments. Facilities and Administrative costs will be awarded at the negotiated rate. RESEARCH OBJECTIVES Background HIV/AIDS prevention research has shown that interventions that target risk behaviors, improve knowledge, develop and practice skills, and support maintenance of behavior change can be effective in reducing the behaviors associated with the spread of HIV(NIH Consensus Development Conference Panel, Interventions to Prevent Risk behaviors. AIDS 2000, 14 (suppl 2): 85-96). Despite data showing that the proportion of adults fifty and older with HIV/AIDS has remained steady at approximately 10% since the beginning of the epidemic, interventions for primary and secondary prevention have been targeted to younger persons, generally neglecting older adults. There is some suggestion that the HIV/AIDS caseload may be aging, due both to new treatments that improve survival for those already infected and to the growth in new cases among those over age 50. For example, the rate of new AIDS cases is rising twice as fast in the older population compared with the younger population, particularly among specific older populations at risk, including men who have sex with men, substance users, and older women. The majority of older persons do not identify themselves as at risk, even those who engage in drug- or sex-related activities that increase the likelihood of contracting HIV. Thus, it is not surprising that, compared to younger adults, older people know less about HIV infection and are often misinformed about HIV/AIDS risks, that symptoms are often attributed to other causes, including aging, that physicians often under-diagnose older people, and that there is a widening survival gap for older people with HIV/AIDS relative to their younger counterparts. Research efforts are needed that apply and expand interventions with science-based effectiveness to the reduction of risk behaviors among middle-aged and older people and for improvement in the diagnosis and treatment of older adults with HIV/AIDS. While the older population as a whole may be at relatively low risk of contracting HIV, findings show that practices engaged in by some groups of middle-aged and older adults may place them at risk of infection. Due to delays attributable to both patient and health care provider factors, older persons come to medical attention at later stages and experience shorter post-diagnosis survival times and may be at special risk because of age-related and HIV-related immune changes. Moreover, the presence of co-morbidities in older people may complicate adherence to and the effectiveness of HIV/AIDS drug treatments and may have important consequences such as the necessity for multiple therapies, increased disability, increased burden on clinical care and service delivery systems and increased associated costs. An intensified research effort is needed to understand the effectiveness of behavioral and social interventions aimed toward older people. However, intervention efforts need to be informed and targeted by current epidemiological information, both nationally and locally, on incidence and prevalence of HIV at older ages. In order to translate research to practice, intervention research needs to build on existing basic knowledge of HIV, the unique aspects of aging with HIV/AIDS, and settings and situations in which older people are at risk. The merits of individual, social and community level interventions for targeting specific behaviors and persons at risk need to be considered. Other important intervention factors that may vary in effectiveness for older populations include type of intervention facilitator, setting in which the intervention is delivered, duration of the intervention, intervention delivery methods, incentives and compensation, as well as the specific content related to reducing risk behaviors. Prevention programs must be initiated as early as feasible, must consider developmental level of target population, should be delivered at levels with maximum impact and must be based on long-term strategic planning. Specific Objectives HIV/AIDS is a public health problem affecting Americans of all ages. Research on preventing HIV/AIDS or its consequences in the middle and later years is increasingly important. Aging populations need to be integrated into ongoing prevention related studies, and researchers need to focus studies on how age interacts with other behavioral, social, and biological factors to affect the likelihood of middle-aged and older people contracting HIV, transmitting it to others, and living with HIV/AIDS. Drawing on knowledge from the behavioral sciences about HIV transmission and its prevention in younger populations, the research objectives in this RFA focus on preliminary research and background documentation needed to design and implement intervention methods that may increase knowledge and perceived risk, improve skills related to risk reduction (such as needle-cleaning for injection drug users, or negotiating condom use), identify risk settings and situations (life transitions or crises), achieve earlier testing and diagnosis of HIV/AIDS and enhance delivery of, and adherence to, treatment and medical regimens among middle-aged and older adults. The planning grant application should describe the conceptual basis for the proposed intervention study, the basic design characteristics, and preliminary information to be gathered in this initial feasibility phase. Specifically the application should include information on: o Study rationale and hypothesis. Address significance of research area and the principal hypotheses to be tested. o Preliminary studies. Outline of preliminary studies (including analyses of existing data) to guide selection of, and/or refine, intervention strategies targeted to middle aged and older populations. o Study design. Outline the major design elements of preliminary studies to be conducted during this planning phase. These might include topics such as sample size, identification of any control groups, and strategies for assuring recruitment and retention. o Study population. Specify who will be included in preliminary studies, including general eligibility and exclusionary criteria and the sources of recruitment. o Assessment and measurement. Outline covariate, mediating and outcome measures to be employed or pilot tested in this phase, strategies for assessment, and rationale for selection. o Intervention strategy. Describe the conceptual basis for the proposed intervention, outline the major intervention components and implementation plans; and discuss strategies for assuring treatment fidelity and adherence. o Data analytical approaches. Outline methods for data management and analysis with attention to strategies for assuring data quality. o Future Directions. Outline how the proposed research in this planning phase would lead to phase 2 efficacy studies which in turn would lead to phase 3 multi-site controlled trials and phase 4 “effectiveness/dissemination” research. In addition to characterizing proposed new intervention research, information should be included on organizational and logistical aspects of this planning process: o Timeline. Outline timeline and tasks to be accomplished during each year of the planning grant. o Personnel. Identify participants in the planning process, their roles in the development of the plan, and their experience in related studies. o Liaison /Collaborations. Describe other persons or other groups you will be interacting within the planning phase. o Manual of Operations. Identify the study elements to be planned or refined if the planning grant is awarded. Outline factors to be included in the draft Manual of Procedures that awardees are expected to produce at the end of the planning grant award period in order to move to the next stage of intervention research. o Human subjects protection. Identify plans for establishing an external data and safety monitoring board for any randomized controlled studies to be initiated in the planning or future stages of this research. In addition to addressing generic research design and methodological issues, the planning grant activities should indicate what information will be examined in relationship to factors that are specific to the design and implementation of effective prevention and treatment HIV/AIDS interventions among middle-aged and older adults. The bullets underneath the four major categories described below illustrate the type of issues that might be included to indicate an understanding of the complexities involved in designing, testing and evaluating HIV/AIDS prevention and treatment interventions in this targeted population. Population and social context characteristics: The application should discuss population characteristics that may be unique to middle-aged and older people, or people at risk of HIV as they age and that will affect intervention responsiveness and outcomes. These include, for example: o Population diversity. This includes factors such as chronological age, gender, HIV serostatus and care status, and other biopsychosocial factors such as frailty or level of cognitive function. o Social and cultural factors. This includes factors that influence behaviors related to risk of HIV as well as access to and delivery of medical care such as socio-economic status, marital status, social networks, living arrangements, and cultural attitudes and expectations. o Contexts, settings, and situations. The context in which risk behaviors occur may vary by age. For example, research shows that older drug users are less likely than younger drug users to use illicit drugs in “shooting galleries”. o Life course events and experiences. HIV risk may change as a function of life transitions and life course events, such as changing work or family relationships, separation or divorce, and death of a loved one or partner. HIV/AIDS Knowledge, Skills, Attitudes and Behaviors. These factors define persons at risk as well as serve as major intermediary intervention outcomes. Factors to consider include: o Knowledge, skills, and attitudes. Prevention interventions for older people need to consider knowledge of HIV transmission and AIDS among the targeted older population, as well as attitudes regarding adoption of safer sex- and drug-related behaviors. For example, older women may lack the skills or confidence to negotiate safe-sex practices with their partners. In addition, prevention efforts should address the issue of AIDS stigma. o Risk behaviors. The type and frequency of risky activities or behaviors may also vary by age, or be modified by factors related to aging. For example, there is evidence that older men in retirement communities have multiple female sex partners and do not perceive that their sexual behavior places them at risk. Behavioral determinants and correlates of risky behavior may also be important to consider. o Adjustment to diagnosis and treatment. Other factors to consider include the psychosocial needs of older HIV-infected individuals, with particular attention to coping with the chronic and fatal nature of the disease. Intervention Characteristics: The application should address factors in the actual design of optimal interventions. For example, in what way will the proposed research be based on models of behavioral change and target the risk reduction needs of the specific population, use the most effective delivery techniques, and be linked to desired outcomes through appropriate methodology and measurement. Of particular concern is the degree to which effective interventions and intervention strategies work for reducing HIV risk among middle-aged and older adults, or whether modifications related to aging are warranted. The following factors should be addressed in the application: o Consideration of covariates. Several factors unique to an aging population may act as covariates in intervention effectiveness. These include factors such as: comorbidity (medical, mental, psychiatric), functional status (social, cognitive, psychiatric), pharmacology (polypharmacy, interactions, side effects), the type and extent of risky behaviors (e.g., illegal drug use or unprotected sexual behaviors with high risk partners), etc. o Models of behavior change. Researchers should also consider the multiplicity of factors that influence behavior change, and integrate biological, cognitive, psychological, and social perspectives to explain and predict the acquisition and maintenance of preventive HIV-related behaviors among middle- aged and older people. Pathways of influence specifying mediators linking interventions to hypothesized outcomes should be delineated. o Specificity of content. A plan for standardizing the treatment fidelity of interventions should be developed with attention to treatment adherence . Intervention intensity, duration and frequency should be addressed. o Delivery channels of the intervention: The effectiveness of the intervention message may vary depending on how the intervention is delivered to participants and the particular delivery channel specified. It will be important to specify whether the intervention is delivered to individuals, couples, small or large groups, to a community, or to the general population. o Community advisory boards. A strategy for obtaining appropriate community input and participation should be outlined. Measurement, Outcomes, and Evaluation: This area focuses on the need to link our understanding of HIV-related behaviors and behavior change to the appropriate measurement of relevant outcomes for middle-aged and older adults. Topics to consider include factors such as: o Attrition: The ability to evaluate intervention effectiveness is affected by loss of intervention participants. Thus, strategies for recruiting and retaining samples of middle-aged and older adults are needed . o Measurement selection: Researchers should identify methods for obtaining accurate self-report of HIV-related behaviors and behavior change, considering the sensitivity of the information for many older persons, and the diversity of backgrounds, languages, and cultures. Researchers at this stage may not have final assessment batteries and can propose assessment for examining the reliability and validity of assessments as part of the design. o Outcomes: Factors affecting selection of study outcomes should be identified. For example outcomes are likely to vary by targeted risk behavior as well as the type of intervention (individual, social, community), setting (general population, clinic sample, retirement community, drug treatment facility), and the specific hypothesis being evaluated. The use of biological outcomes may also be appropriate. The spectrum of outcome measures might also include cost-effectiveness factors, HIV-specific health outcomes and general health outcomes. SPECIAL REQUIREMENTS Awardees should budget for three trips a year for up to three investigators to Bethesda, Maryland in order to come and discuss common aspects of their protocol development with other awardees and share solutions to common problems in conducting intervention research in middle-aged and older populations. Additionally investigators will be expected to participate in workgroups that will meet electronically and by phone between meetings to discuss issues common to the different intervention studies (e.g., recruitment and retention; developing strategies for cross site assessments; treatment fidelity). This planning phase should provide the necessary information to develop detailed protocols and a Manual of Procedures for subsequent Phase 2 studies to be proposed by the investigative team. The resultant Manual of Procedures is a key product of this planning phase and should be submitted in the final report. Applicants for planning grants for human intervention studies should review the NIA document "Implementation of Policies for Human Intervention Studies". This is available in the "Grants and Contracts" section of the NIH Home Page (http://www.nih.gov/nia/funding/policy/humint.htm). Persons without access to the NIH Home Page may obtain copies of the policy from: Office of Extramural Affairs, National Institute on Aging; Gateway Building, Suite 2C218; Bethesda, MD 20892-9205. Phone (301) 496-9322). INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. 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 to the program staff listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. These forms are available at most institutional offices of sponsored research; from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: grantsinfo@nih.gov; and on the internet at: http://grants.nih.gov/grants/funding/phs398/phs398.html. 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. 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 sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note that this sample label is in pdf format. 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. 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 $150,000 which is the direct cost cap of this RFA) 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 all 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 current 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 all 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. Submit a signed, typewritten original of the application 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, send two additional copies of the application to: Mary Nekola, Ph.D. Chief, Scientific Review Scientific Review Office National Institute on Aging 7201 Wisconsin Avenue, Room 2C212 Bethesda, MD 20892-9205 It is important to send these copies at the same time as the original and three copies are sent to the Center for Scientific Review. These copies are used to identify conflicts and to help ensure the appropriate and timely review of the application. 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 CSR and for responsiveness by the NIA and NIMH. Incomplete and/or nonresponsive 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 NIA and NIMH in accordance with the review criteria stated below. As part of the initial merit review, a process may 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 on Aging and the National Advisory Council on Mental Health. 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?: 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 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. The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. Several criteria specific to this RFA have been identified. These include: o Demonstrate an understanding of the special needs of the HIV/AIDS and aging population and relevant research issues o Show knowledge of intervention research principles and processes in the proposed population o Likelihood that planning grant will yield findings upon which to build a subsequent clinical trial Schedule: Letter of Intent Receipt Date: February 23, 2001 Application Receipt Date: March 26, 2001 Date of Initial Review: June 2001 Review by Advisory Council: August 2001 Anticipated Award Date: September 2001 AWARD CRITERIA The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program priority and balance. Inquiries concerning this RFA are encouraged. Additional information, including sample budget narratives and biographical sketch, may be found at this site: http://grants.nih.gov/grants/funding/modular/modular.htm. The opportunity to clarify any issues or questions from potential applicants is welcome. Email queries are preferred. Further information about Institute priorities and procedures can be found on the Institute Home Pages: NIA (http://www.nih.gov/nia); NIMH (http://www.nimh.nih.gov/). Direct inquiries regarding programmatic issues related to HIV/AIDS research focused on understanding the role of aging processes and aging populations in HIV/AIDS intervention research to: Marcia Ory, Ph.D., M.P.H. Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Suite 533 MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 402-4156 FAX: (301) 496-3136 Email: Marcia_Ory@NIH.GOV Direct inquiries regarding NIA fiscal matters to: Carol Lander Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: Carol_Lander@NIH.GOV Direct inquiries regarding programmatic inquiries focused on mental health aspects of HIV intervention research to: David M. Stoff, Ph.D. HIV/AIDS and Mentally Ill Research Program Center for Mental Health Research on AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6210, MSC 9619 Bethesda, MD 20892-0619 Telephone: (301) 443-4625 FAX: (301) 443-9719 Email: dstoff@nih.gov Direct inquiries regarding NIMH 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. 93.866 (NIA) and No. 93.242 (NIMH). Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review The PHS strongly encourages all grant and contract 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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