and Human Services (HHS)
EXPIRED
ECONOMIC EVALUATION OF DRUG ABUSE TREATMENT AND PREVENTION SERVICES FOR HIV/AIDS RELEASE DATE: September 9, 2002 PA NUMBER: PA-02-164 EXPIRATION DATE: September 30, 2005, unless reissued. National Institute on Drug Abuse (NIDA) (www.nida.nih.gov) THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute on Drug Abuse (NIDA) encourages research on the economics of HIV/AIDS services that are utilized in conjunction with drug abuse treatment and/or prevention services. The catastrophic medical expenses and premature disability due to AIDS can have a devastating impact on the well-being of the afflicted individual. Society also experiences numerous negative consequences from the HIV/AIDS and indeed some nations are experiencing health system failures. Furthermore, persons with HIV/AIDS also face other blood borne infections, and of particular concern, is hepatitis C (HCV). Public health experts maintain that in order to achieve declines in AIDS incidence and deaths, HIV-infected persons must seek testing earlier in the course of their disease, receive and adhere to treatment, and follow prevention guidelines. Research to achieve these goals must involve an economic component concerned with the economic behavior of consumers, providers, government agencies, and third party payers. Applications are sought that would employ the methods of economic analysis to pressing problems in the financing and delivery of HIV/AIDS services and drug abuse treatment and/or prevention services. This program announcement is related to other NIH announcements in this general subject. Investigators interested in economic factors, should refer to PA-01-013, "Economics of Drug Abuse Treatment and Prevention Services," published in the NIH Guide on November 7, 2000. Investigators interested in natural history, epidemiology, etiology, pathogenesis, prevention, and treatment of drug abuse and drug abuse aspects of HIV/AIDS and associated infectious diseases, refer to PA-01-023, "Drug Abuse Aspects of HIV/AIDS and Other Infections," published in the NIH Guide on November 30, 2000. Investigators interested mainly in mental health aspects of HIV infection should refer to PA-95-001 "Economic Evaluation in HIV and Mental Disorders Prevention," October 2, 1998. In many cases, building an economic research project on an intervention already under study or a completed study of an intervention would be beneficial. RESEARCH OBJECTIVES Summary. Health economic research has the goal to inform society about fundamental issues in the production and distribution of health. The public health interventions of drug abuse treatment and prevention have critical roles in saving lives, preventing diseases, and reducing the economic burden of diseases. The research descriptions below are examples to guide potential applicants to determine whether a given scientific topic may be appropriate for this announcement. The examples are illustrative only and investigators should always feel free to propose their own study ideas. Background. As of December 2000, there were 774,467 cases of AIDS reported in the United States and its territories, and 448,060 Americans were recorded to have died from AIDS since the epidemic began in the early 1980s. In 1999, the Centers for Disease Control estimated that 800,000 to 900,000 persons in the U.S were living with HIV or AIDS. In recent years, there has been a marked decline in AIDS incidence and deaths. This began in 1996 and continued into 1998 and was associated with the widespread use of potent combination antiretroviral therapies. However, the rates of decline in AIDS incidence and deaths slowed during the latter part of 1998 and 1999. Reported through June 2001, 331,518 persons were living with AIDS in the United States and its dependencies. In 1999, the numbers of cases and deaths each quarter stabilized or fluctuated slightly in most populations and geographic areas. Much more ominous has been the disproportionate distribution among minority groups. During the 1990s, the epidemic shifted steadily towards a growing proportion of AIDS cases in African-Americans and Hispanics as well as women, and towards a decreasing proportion in men who have sex with men, although this group remains the largest single exposure group. African-Americans and Hispanics, for whom AIDS rates have been markedly higher than whites, have been disproportionately affected since the early years of the epidemic. In absolute numbers, African-Americans have outnumbered whites in new AIDS diagnoses and deaths since 1996, and in the number of people living with AIDS since 1998. Injection drug use is a critical vector for HIV transmission to the extent that more than 24 percent of AIDS cases were amongst injection drug users, their sexual partners, and their offspring in December 2000. Further data indicate that "black, not Hispanic" and "Hispanic" groups have a disproportionately higher rate of injecting drug use associated with AIDS cases. HIV counseling and testing services provided in conjunction with drug abuse treatment, especially methadone maintenance, reduce risky behaviors and infections. Costs associated with these reductions are often not captured in studies of cost-effectiveness or cost-benefit analysis. In less developed countries, the impact of HIV/AIDS has been devastating. In some African nations up to 10 percent of the population may be infected with HIV. Death rates have been rising, health systems disrupted, demographic patterns drastically altered, and country economic growth rates curtailed. The high cost of therapeutic interventions as compared to per capita gross domestic product is a major policy concern that challenges the usual economic calculus of international patent rights and incentives to research, develop, and eventually market anti-HIV drugs. Economics is often called "the science of choice" and the economic evaluation of alternatives in the HIV/AIDS crisis will challenge the skills of economists and other scientists to respond to the research needs. Research Studies. Researchers are encouraged to develop rigorous designs for studies of the economics of HIV/AIDS services and drug treatment and/or prevention services. Studies are sought on: (1) financing, including health insurance and/or payment mechanisms, (2) alternative delivery systems and managed care, (3) cost-benefit, cost-effectiveness, and cost-utility analysis, (4) cost of services and economic burden of the disease, and (5) methodological research. Financing. Within the United States, financing for HIV prevention and treatment services is derived from Federal, State, and local government funds and also private sector funds from health insurance, consumer out-of-pocket expenditures, and charity. The scientific inquiry into financing of health care services requires normative and positive economic analysis on allocation and distribution issues. Because different levels of government are involved in public financing, fiscal federalism is a central issue. Distribution issues must be addressed for the indigent that are at risk or have HIV/AIDS as well as for funding strategies for service delivery. Analysis of both public and private provision of health insurance coverage for HIV/AIDS services is essential to financing studies. Furthermore, payment mechanisms for HIV/AIDS services and drug treatment and prevention services affect the allocation and distribution of the financing and provision of care by private and public health care organizations. In addition, international aspects of financing have numerous issues. The financial burden of providing services may overwhelm development plans for some economies and the drug abuse and medical treatment infrastructure may also be under intense stress. Alternative Delivery Systems and Managed Care. The efficient and equitable provision of HIV/AIDS services requires studies in alternative delivery systems and managed care. A behavioral health care organization, usually for profit, often administers the mental health, alcohol, and drug abuse treatment benefits in private and public insurance plans. Specific HIV/AIDS medical clinics and practices have developed with service needs for patients beyond medical treatment. Clinical services must sequence the treatments for hepatitis A, B, and C infections as well as HIV and drug use, which challenge the organizational and management structures of the health care system. Integration of HIV services and drug abuse treatment and prevention services remains a challenge to the delivery system for which economic factors are deemed of considerable importance. Furthermore, management of such services may require the design of new incentives, contracts, and regulations and as such will require studies of outcomes on patients, programs, and systems. Economic evaluation of well-defined managed care systems on quality, access, outcomes, and costs of service delivery must be done with consideration of the HIV/AIDS service component. Managed care effects on clinical decision- making and on the structure and function of the treatment provider organization also generates considerable interest. Cost-Benefit, Cost-Effectiveness, and Cost-Utility Analysis. Studies of the economic costs and benefits of HIV/AIDS services and drug abuse treatment and/or prevention services are encouraged. Cost-benefit, cost-effectiveness, and cost-utility analyses are collaborative activities involving multi- disciplinary research teams. For the general population, as well as HIV/AIDS patients, economic evaluation of innovative drug abuse treatment or prevention services as well as their effectiveness in real-world settings must be stimulated. Cost-effectiveness studies are useful in comparing novel treatment or prevention technologies to a standard treatment or prevention technology. Examples of such cost-benefit or cost-effectiveness studies include comparing drug abuse treatment integrated with HIV/AIDS services and prevention services to the general, adolescent, and high-risk populations and current drug abuse treatment services. International public health programs require rigorous economic evaluation of alternative treatment and prevention services in order to maximize donor and host country use of resources. Cost of Drug Abuse Treatment and Prevention Services. Costs are separately highlighted to indicate the importance of valuing and producing health care services in drug abuse treatment and prevention organizations as well as care where HIV/AIDS clinical treatment is provided. Improved measures of costs are needed for management decisions that will assist clinical and program treatment staff as well as local, state and national health policy makers. For scientific research, measures of costs must be improved both conceptually and operationally so that precise costs may be determined. Cost-of-illness studies of HIV/AIDS have examined costs of medical treatment although many other economic factors may be identified. At the system level, research on unit service costs must be encouraged in order to achieve pricing of service delivery for innovative and standard services. For programs and systems, conceptualizing and measuring the relationships among accounting costs, marginal costs, average costs, and total costs in programs and systems have received little attention. Research in these areas is needed so that a precise measurement of service costs can be established for economic analysis of multi-product production and cost functions of services. Economics of scale and scope have not been studied and should be examined with management and organizational factors considered. Methodological Research. Research is encouraged that will develop and test the application of new methods of economic analysis in services research for HIV/AIDS and drug abuse treatment and/or prevention. There is a need for improved assessment of economic efficiency and equity. Health insurance theory and practices associated with HIV/AIDS patients and drug abuse treatment services will require additional study. New statistical methods associated with economic analysis of treatment or prevention studies may be developed. Simulation models of health intervention strategies, decision theories, methodologies for cost-benefit, cost-effectiveness, and cost- utility analysis may be advanced. Distribution theory and health disparity studies may require additional methodological development. MECHANISMS OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01), exploratory/developmental grant (R21), and small grant (R03) award mechanisms. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an R01 application submitted in response to this PA may not exceed 5 years. For R21 applications, the project period cannot exceed 3 years and $100,000 in direct costs in each of those years. For R03 applications, the project period cannot exceed 2 years and $50,000 in direct costs in each of those years. Applicants are strongly encouraged to read the R21 and R03 announcements, which specify the goals and guidelines for each program (http://grants.nih.gov/grants/guide/pa-files/PA-01-012.html) and (http://grants.nih.gov/grants/guide/pa-files/PAR-00-059.html). This PA uses just-in-time concepts. It also uses the modular budgeting format (http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith based or community based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: William S. Cartwright, Ph.D. Services Research Branch Division of Epidemiology, Services and Prevention Research National Institute on Drug Abuse 6001 Executive Blvd, Room 4222 Bethesda, Maryland 20892-9565 Telephone: 301-443-4060 Fax: 301-443-6815 E-mail: [email protected] Jean-Craft Comolli, B.S.N., M.B.A. Center on AIDS and Other Medical Consequences of Drug Abuse National Institute on Drug Abuse 6001 Executive Blvd, Room 5194 Bethesda, Maryland 20892-9593 Telephone: 301-402-0630 Fax 301-594-6566 E-mail: [email protected] o Direct your questions about financial or grants management matters to: Gary Fleming, J.D., M.A. Chief, Grants Management Branch National Institute on Drug Abuse, NIH 6001 Exeuctive Boulevard, Room 3131 Bethesda, Maryland 20892-9541 Telephone: 301-443-6710 Fax: 301-594-6849 E-mail: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: Contact NIDA program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study, 2) Obtain agreement from NIDA staff that NIDA will accept your application for consideration for award, and, 3) Identify, in a cover letter sent with the application, the staff member and NIDA who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate national advisory council or board 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available. http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG ABUSE: Researchers funded by NIDA who are conducting research in community outreach settings, clinical, hospital settings, or clinical laboratories and have ongoing contact with clients at risk for HIV infection, are strongly encouraged to provide HIV risk reduction education and counseling. HIV counseling should include offering HIV testing available on-site or by referral to other HIV testing services. Persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners. For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.279, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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