Full Text HL-95-003 BEHAVIORAL INTERVENTIONS FOR CONTROL OF TUBERCULOSIS NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA: HL-95-003 P.T. 34 Keywords: Pulmonary Diseases Disease Prevention+ Behavioral/Social Studies/Service National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: February 15, 1995 Application Receipt Date: March 29, 1995 PURPOSE The purpose of this solicitation is to encourage research to develop, implement, and evaluate behavioral interventions for the control of tuberculosis. Plans that include the development, implementation, and evaluation of programs that can serve as models for other areas of the country will be given priority for consideration. 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), Behavioral Interventions for Control of Tuberculosis, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign for-profit and non-profit institutions, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments and eligible agencies of the Federal government. Applications from minority individuals, women, and new investigators are encouraged. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under this RFA. Awards under this RFA to foreign institutions will be made only for research of very unusual merit, need and promise, and in accordance with Public Health Service policy governing such awards. This solicitation may be of interest to investigators from a broad range of disciplines, including pulmonary medicine, infectious disease medicine, behavioral sciences, public health, biostatistics, and health education. Multidisciplinary approaches will be needed to meet the goals of the research. Applicants must demonstrate access to target and comparison or control populations, and expertise within the research team to conduct research that is sensitive to socio-cultural elements of the study population. MECHANISM OF SUPPORT The support mechanism for this program will be the National Institutes of Health (NIH), individual research grant (R01). While multidisciplinary approaches are encouraged, it is not the intent of this RFA to solicit applications for large studies encompassing a variety of individual subprojects, i.e., program projects. If collaborative arrangements through subcontracts with other institutions are planned, consult the program staff listed under INQUIRIES. Since the emphasis of this program is on behavioral interventions, it is recommended that applicants refer to "The Guidelines for Demonstration and Education Research Grants" (revised 9/87, with 2/93 supplement), which are available from the program administrator, listed under INQUIRIES. Upon initiation of the program, the NHLBI will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program. In the budget for the grant application, applicants should request travel funds for a two-day meeting each year, most likely to held in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings and cooperate with other researchers in this program. Applicants are expected to furnish their own estimates of time required to achieve the objectives of the proposed research; however, the award period for this activity must not exceed five years. Because a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. This RFA is a one-time solicitation. Future unsolicited competing continuation applications may be submitted for peer review and competition for support through the regular grant program of the National Institutes of Health (NIH). It is anticipated that support for this program will begin in September 1995. Administrative adjustments in project period and/or amount may be required at the time of the award. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a case, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. The National Institute of Nursing Research (NINR) also has interest in behavioral interventions for tuberculosis control. Therefore, applications that are of mutual interest are likely to be given a secondary assignment to NINR in accordance with the NIH referral guidelines. FUNDS AVAILABLE Although financial plans for fiscal year 1995 include approximately $1,840,000 for the total cost of the program for the first year, award of grants pursuant to this RFA is contingent upon receipt of funds for this purpose. It is anticipated that no more than five awards will be issued under this program. The specific number to be funded will, however, depend on the merit and scope of the applications received and the availability of funds. RESEARCH OBJECTIVES Background Tuberculosis was on the decline from the 1950s until the mid 1980s; however, the United States is now experiencing a resurgence of tuberculosis. In 1992, approximately 27,000 new cases were reported, an increase of approximately 20 percent from 1985 to 1992. Not only are tuberculosis cases on the increase, but a serious aspect of the problem is the recent occurrence of outbreaks of multidrug resistant (MDR) tuberculosis, which poses an urgent public health problem and require rapid intervention. Tuberculosis is an infectious diseases caused by Mycobacterium tuberculosis, which is spread almost exclusively by airborne transmission. While the disease can affect any site in the body, it most often affects the lungs. Persons with a pulmonary tuberculosis cough and produce tiny droplet nuclei that contain tuberculosis bacteria that can remain suspended in the air for prolonged periods of time. Persons breathing the air containing these droplet nuclei can become infected with tuberculosis. Those who become infected with the tuberculosis bacillus remain infected for years. Those who have a healthy immune system usually do not become ill, however, antituberculosis drugs are often necessary in order to eliminate the infection. Persons with latent tuberculosis infection, as this condition is called, are asymptomatic and cannot spread tuberculosis to others. Generally, a positive tuberculosis skin test is the only evidence of infection. An estimated 10-15 million persons in this country are infected with M. tuberculosis. About 10 percent of the otherwise healthy persons who have latent tuberculosis infection will become ill with active tuberculosis at some time during their lives. Control programs involve two major components. First, and of highest priority, is to detect persons with active tuberculosis and treat them with effective antituberculosis drugs, which prevents death from tuberculosis and stops the transmission of infection to others persons. Treatment of active tuberculosis involves taking multiple antituberculosis drugs daily or several times weekly for at least six months. Failure to take the medications for the full treatment period may mean that the disease is not cured and may recur. If sufficient medications are not prescribed early and taken regularly, the tuberculosis organisms can become resistant to the drugs and the drug resistant tuberculosis then may be transmitted to other persons. Drug resistant disease is difficult and expensive to treat, and in some cases cannot be treated with available medications. The second major goal of control efforts is the detection and treatment of persons who do not have active tuberculosis, but who have latent tuberculosis infection. These people may be at high risk of developing active tuberculosis. The only approved treatment modality for preventive therapy requires treatment daily or twice weekly for minimum of six months and many patients do not complete a full course of therapy. Tuberculosis control poses special problems for a number of groups. One of these is the HIV infected, among whom the risk of tuberculosis is considerably greater than in the general population. Because of the breakdown of the immune system in HIV positive persons, the traditional tuberculin skin test may be unreliable and existence of other pulmonary infections in such persons may complicate the diagnosis, making it difficult to distinguish tuberculosis on chest X-rays. Failure to diagnose tuberculosis rapidly in HIV infected persons has led to higher mortality rates and more rapid transmission among that population. Penal institutions pose another special problem for tuberculosis control. Not only has the population in these institutions doubled, causing severe overcrowding and general decline in living conditions, but inmates generally come from lower socio-economic strata, tend to have poor health status, and are at higher risk for AIDS and tuberculosis as well as other medical conditions. The incidence of tuberculosis among incarcerated persons in 1984 and 1985 has been estimated at more than three times the rate in the general population. The existence of HIV positive inmates, the constant transferring of persons, lack of adequate health services and infrastructures, inadequate communication of medical information, and poor ventilation and overcrowding have contributed to making the transmission of tuberculosis a major medical problem. Not only is transmission of tuberculosis among prisoners a health problem for prisons, but also for the communities into which inmates are released. The disenfranchised are also being particularly hard hit by the resurgence of tuberculosis. The poor, the homeless, and drug users are among the most likely to contract and transmit tuberculosis. The influx of immigrants and refugees from countries with high tuberculosis rates also poses problems in control. Finding and coordinating treatments for individuals without a fixed address, such as migrants, is difficult, but assuring adherence to treatment plans is even more so. Recent outbreaks of multidrug resistant tuberculosis in large city hospitals have indicated the special needs to control tuberculosis in hospitals, nursing homes, and similar facilities. When tuberculosis was a common problem a generation ago, most health care providers had experience in treating the disease. Indeed a survey by the Centers for Disease Control in 1992 indicated that many physicians may not be aware of recommended treatment for tuberculosis. Thus, there is a need to educate and/or to reeducate physicians and other health care providers in modern tuberculosis control methods. In addition, public and patient programs are needed to increase the awareness of the problem among the general population, to promote early diagnosis and treatment, and to encourage adherence to therapy. The future of tuberculosis control will require more effective programs to identify and adequately treat active tuberculosis cases and to identify and prevent tuberculosis among those who have latent tuberculosis infection. Adherence to medical treatment, for example, remains a major problem in both groups. Behavioral interventions should contribute to solving the problems. Objectives and Scope The objective of this initiative is to seek ways of controlling the spread of tuberculosis through behavioral interventions. Studies responsive to this solicitation may focus on a community at large or upon specific population groups such as immigrants, migrants, institutionalized groups, HIV positive individuals, and ethnic minority populations or a combination of groups. As a component of an overall program, physicians and other health care providers as well as patients and their families may also be the target of research efforts. Systems approaches to detection, diagnosis, treatment, and control may be tested. Programs that mobilize community resources to increase access to care, integrate patient education into medical care, educate health professionals about tuberculosis control including patients needs and concerns, provide follow up as patients move among settings (e.g., from long term institutions to community), and increase patient adherence with treatment regimens are encouraged. Examples of questions that could be answered by studies developed through this solicitation include, but are not limited to, the following: o What interventions are effective in bringing persons with tuberculosis into treatment programs early? Are different interventions needed for different age, ethnic, or other special population groups or for differing levels of awareness or concern? o How can provider adherence to environmental controls in hospitals, penal institutions, nursing homes, and/or other sites contribute to reducing the spread of tuberculosis? What are the barriers to adherence with infection control and how can they be overcome? o What interventions result in patient adherence to treatment regimens? What interventions result in persons who have latent tuberculosis infection taking preventive therapy? o How can physicians and other health care providers best be trained to diagnose and treat tuberculosis early? What interventions change provider practice behaviors? o How can interpersonal communications be improved between health care providers and patients with tuberculosis? How can communications within and outside the health care organization contribute to community control programs? o How can significant barriers to tuberculosis control be overcome? o What patient education interventions are most effective? o What roles can families, employers, lay advocates, volunteers, and others play in helping to insure patient adherence to treatment regimens? How can these groups contribute effectively to local public health services? How can target populations be involved in educational and control efforts? o How can patients be assessed for the need for directly observed therapy? Are different sequences or combinations of services more effective in achieving adherence? What are options to supervised therapy to improve adherence? o What is the role of incentives? Which are most effective for what specific purposes? o What predictors (e.g., cultural, social, and personal factors) can be used to identify the factors associated with poor adherence and the development of multidrug resistant tuberculosis? o What are the relationships between interventions and medical outcomes? o What interventions result in improved collaborative efforts between private health care providers, health departments, and other health and community organizations, etc. that ultimately improve control of tuberculosis in the community? Innovative interventions involving patients and their families, use of community resources, special approaches (e.g., combination inpatient/outpatient centers; community coalitions or consortia), and program strategies based upon the cultural characteristics of the population are encouraged. Applications from minority scientists and minority institutions are especially encouraged. There is an interest in obtaining model programs that can be readily adapted for use in several sections of the country. Research designs should include the following elements: o a specified, well-defined population; o reliable and valid assessment of tuberculosis and provisions for monitoring changes, including laboratory services; o an appropriate theoretical basis for the intervention(s); o sufficient population to provide for a control or comparison group and to permit evaluation of the efficacy of the program; o availability of required medical care services and resources, including process data on quality of services; o evidence that the cultural and social characteristics of the study population have been taken into account in the study design and implementation of the program; o measurements of behavior change (e.g. adherence measures) related to control of tuberculosis. Assessment of other factors such as knowledge about tuberculosis, quality of life, use of medical care services, and cost effectiveness are also encouraged. o ability to obtain follow up data on patients for two years after intervention(s) to assess the efficacy of the interventions over time; SPECIAL REQUIREMENTS Although the research design may build from an existing tuberculosis control programs, the studies should test hypotheses specifically related to the targeted population and assess innovative approaches to interventions. Funding requests for support of existing tuberculosis control programs without a research component would not be considered responsive to this solicitation. Investigations of the effectiveness of clinical therapies also will be excluded. Interdisciplinary approaches that include medicine, behavioral science, and education are strongly encouraged. If collaborative arrangements through subcontracts with other institutions are planned, consult the NHLBI Grants Operations Branch (301) 594-7420 regarding procedures. 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 new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 28, 1994, Volume 23, Number 11. 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, by February 15, 1995, 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 subsequent applications, the information that it contains allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. C. James Scheirer, at the address listed under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 710-0267. Use the conventional format for research project grant applications and ensure the points identified in the section REVIEW CONSIDERATIONS are fulfilled. To identify the application as a response to this RFA, check "YES" on item 2a of page 1 of the application and enter the title "Behavioral Interventions for Control of Tuberculosis" HL-95-003. The RFA label found in form PHS 398 application kit must be affixed to the bottom of the face page of the original completed application form PHS 398. 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. Send or deliver the completed application and three signed photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Send two additional copies of the application to the Chief, Centers and Special Projects Review Section at the address listed under LETTER OF INTENT. It is important to send these two copies at the same time as the original and three copies are sent to the Division of Research Grants. Otherwise the NHLBI cannot guarantee that the application will be reviewed in competition for this RFA. Applications must be received by March 29, 1995. If an application is received after this date, it will be returned to the applicant without review. The DRG 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 DRG 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 DRG and responsiveness to this RFA by the NHLBI. Incomplete applications will be returned without further consideration. If an application is judged unresponsive, the applicant will be contacted and given an opportunity to withdraw the application or to have it considered for the regular, investigator-initiated grant program of the NIH. Applications judged to be responsive will be reviewed for scientific and technical merit by an initial review group, which will be convened by the Division of Extramural Affairs, NHLBI, solely to review these applications. Applications should be prepared so that they can be reviewed without the necessity of interaction between applicants and reviewers since no site visit or reverse site visit will be part of the technical merit review. At this initial review a preliminary evaluation will determine the scientific merit relative to the other applications received in response to this RFA (triage); the NIH will withdraw from further consideration applications judged to be noncompetitive and promptly notify the principal investigator and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated for scientific/technical merit by the usual peer review procedures. Review Criteria. The factors to be considered in the evaluation of scientific merit of each application will be similar to those used in the review of traditional research project grant applications including the novelty, originality, and feasibility of the approach; the training, experience, and research competence of the investigator(s); the adequacy of the experimental design; the suitability of the facilities; the appropriateness of the requested budget to the work proposed; and the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. AWARD CRITERIA The anticipated date of award is September 1995. In addition to the scientific merit of the applications, awards will be based on responsiveness to the RFA and the availability of resources. In order to more evenly distribute administrative workload and reduce the number of awards with July 1 or September 30 start dates, the NHLBI will award ten months of time and money for the first competing budget period of this project. This action results in a project period of 46 months rather than 48 months. Investigators should plan their research projects and budgets within these timeframes. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Mary S. Reilly, M.S. Division of Lung Diseases National Heart, Lung, and Blood Institute Westwood Building, Room 640 Bethesda, MD 20892 Telephone: (301) 594-7466 FAX: (301) 594-7487 Direct inquiries regarding review matters and address the letter of intent to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 557 Bethesda, MD 20892 Telephone: (301) 594-7478 FAX: (301) 594-7407 Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Division of Extramural Affairs National Heart, Lung, and Blood Institute Westwood Building, Room 4A17 Bethesda, MD 20892 Telephone: (301) 594-7420 FAX: (301) 594-7492 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.838. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to review by a Health Systems Agency. The Public Health Service (PHS) strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of American people. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |