HIV-RELATED THERAPEUTICS IN DRUG USERS NIH GUIDE, Volume 23, Number 1, January 7, 1994 PA NUMBER: PA-94-023 P.T. 34 Keywords: AIDS Drugs/Drug Abuse Behavioral/Social Studies/Service Clinical Medicine, General Treatment, Medical+ National Institute on Drug Abuse National Institute of Allergy and Infectious Diseases PURPOSE The purpose of this announcement is to stimulate research on HIV/AIDS-related therapeutics among infected drug users. There is a critical need to conduct studies which address HIV-related treatment issues among representative samples of drug users, in order to achieve improved clinical management of infected drug users. Research is needed on behavioral, clinical, and pharmacological aspects of treatment medications specific to drug users, including drug interactions, therapeutic efficacy and effectiveness, and psychosocial and behavioral parameters associated with success or failure of a therapeutic protocol. 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 program announcement, HIV-Related Therapeutics in Drug Users, is primarily related to the priority area of National Health Promotion and Disease Prevention Objectives (HIV Infection, Immunization and Infectious Diseases). Potential applicants may obtain a copy of Healthy People 2000 (Full Report: Stock No. 017- 001-00474-0, or 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 foreign and domestic, for-profit and nonprofit public and private organizations, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. Applications from women and minority investigators are encouraged. Foreign institutions are not eligible for FIRST awards (R29). MECHANISMS OF SUPPORT Support mechanisms for this announcement are the Individual Research Grants (R01), Small Grants (R03), First Independent Research and Transition (FIRST) Awards (R29), and competitive supplements (S01) to existing grants. Support for the small grant (R03) mechanism is available from the National Institute on Drug Abuse. For this program announcement, the National Institute of Allergy and Infectious Diseases will not utilize the small grant (R03) funding mechanism. Research grants are awarded to institutions on behalf of Principal Investigators. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Support for R01 awards for periods of up to five (5) years available and may be renewed at intervals or supplemented through the formal submission and review process. Continued support is subject to availability of funds and progress achieved. For information on the special requirements of the FIRST, Small Grant, and supplement Awards, contact program staff listed at the end of this announcement. Because the nature and scope of the research proposed in response to this Program Announcement may vary, it is anticipated that the size of an award will also vary. RESEARCH OBJECTIVES Background Historically, drug users have been underrepresented in clinical trials, including established clinical trial protocols for HIV- related therapeutics. Underrepresentation has resulted in a lack of available research data specific to the unique issues of treating drug users with HIV-related therapeutics, including data on drug interactions, therapeutic efficacy and effectiveness, the impact of background health status and polydrug use, the psychosocial and behavioral parameters associated with success or failure of a therapeutic protocol, and access barriers to HIV-related medical therapies. Non-inclusion in HIV-related clinical trials has meant restricted access to FDA-approved therapies and has limited available treatment options for drug users. A 3-year collaboration (1990-1992) was undertaken by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute on Drug Abuse (NIDA) to enroll drug users in the established NIAID-sponsored AIDS Clinical Trials Group (ACTG) program. A focused effort at recruitment from established NIDA-sponsored drug treatment programs was made by selected ACTG sites. Although this initial effort was important in demonstrating the feasibility of enrolling drug users in formal efficacy trials, it was not intended to address the many issues specific to implementation of HIV-related therapeutic protocols among drug users. The current joint Program Announcement is an expansion of the NIAID/NIDA collaborative effort. Its purpose is to stimulate research on HIV-related therapeutics among a larger and more representative sample of drug users in a variety of settings. Under this announcement, research on HIV-related therapeutics includes both new and established antiretrovirals and immunotherapeutics, prophylaxis and therapy for HIV-related opportunistic infections, and treatments for other infectious diseases prevalent among drug users. Areas of Research Interest Areas of research that would be responsive to this announcement include, but are not limited to, the following: 1. Research on strategies to enhance recruitment and retention of in- and out-of-treatment drug users in protocols for HIV-related therapeutics (e.g., passive or active referral, voucher programs, referral through drug treatment settings and emergency rooms, outreach efforts and community diffusion programs, and comprehensive health programs). 2. Research on the interactions of HIV-related therapeutics with licit and illicit drugs (e.g., cocaine, alcohol, and heroin), and with methadone and other drug abuse treatment medications, including medications for dual diagnosis patients (e.g., studies of drug metabolism, toxicity, efficacy, and clinical side effects). 3. Studies of the efficacy of HIV-related therapeutics among both in- and out-of-treatment drug users in formal clinical trials protocols; studies of the long-term effectiveness of HIV-related therapeutics on clinical outcomes, HIV disease progression, and development of drug resistance, in the context of episodic or erratic patterns of adherence to treatment protocols and reversion to illicit drug use. 4. Evaluation of new or innovative strategies in drug-using populations, such as depot medications, to enhance adherence with HIV-related therapeutic protocols. 5. Evaluation of the effectiveness of linking trials of HIV- related therapeutics with drug abuse treatment and/or HIV-related research programs in a single setting; evaluation of the impact of such trials on enrollment and retention in drug abuse treatment. 6. Studies of behavioral issues that influence protocol recruitment, retention, and adherence in efficacy trials of HIV therapeutics, such as research on development and testing of predictor instruments to identify patient factors associated with good and poor adherence; studies of the determinants of adherence with HIV treatment regimens, including client decision-making processes and factors in patient adherence to clinical followup, taking of medications, adherence to protocols and related medical recommendations; studies of behavioral factors related to long-term adherence to HIV-related medical treatments among both in- and out-of-treatment drug users. 7. Studies of characteristics of the health care environment that promote utilization of available HIV-related therapeutics and long- term treatment participation, and the development of strategies to enhance access to and utilization of HIV-related medical therapies. 8. Research on cultural characteristics and gender differences in drug-using populations that influence acceptance of available HIV therapeutics and protocol recruitment, retention, and adherence; studies of special drug-using subgroups (e.g., women, adolescents, members of minority groups) that examine access barriers to delivery of HIV-related therapeutics. 9. Research to enhance the effectiveness of services to improve linkage between drug abuse treatment and HIV-related therapeutics, including the level of involvement of service providers, provision and coordination of services, and effective patient utilization of the case management system. 10. Research on development of effective information delivery strategies for in- and out-of-treatment drug users regarding new and established HIV-related treatments and protocols, in HIV testing and counseling programs, drug treatment centers, outreach programs, emergency rooms or other settings where drug users seek care; the impact of education regarding side effects, toxicities and the effectiveness of therapeutics on protocol recruitment, retention, and adherence. STUDY POPULATIONS NATIONAL INSTITUTES OF HEALTH (NIH) POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS IN RESEARCH NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objective of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan and summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of the United States racial/ethnic minority populations (i.e., American Indian or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed and the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications must be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the receipt dates for applications for AIDS-related research found in the PHS form 398 instructions. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892 (Telephone: 301-435-0714). The number and title of the announcement must be typed in Item 2a of the face page of the application. FIRST applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892* *If an overnight courier is used, then the zip code is 20816. Applicants from institutions which 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 letter of agreement from either the GCRC program director or principal investigator should be included with the application. REVIEW CONSIDERATIONS The Division of Research Grants, NIH, serves as the central point for receipt of applications for most discretionary DHHS grant programs. Applications received under this announcement will be assigned to an initial review group (IRG) on the basis of established Public Health Service referral guidelines. The IRGs, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit in accordance with the standard NIH peer review procedures. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by the appropriate National Advisory Council, whose review will be based on policy considerations as well as scientific merit. Only applications recommended for further consideration by the Council may be considered for funding. Small grant (R03) and supplement applications receive a second level review by NIH staff . AWARD CRITERIA Applications recommended for further consideration by an appropriate Advisory Council will be considered for funding on the basis of overall scientific, clinical, and technical merit of the application determined by peer review, appropriateness of budget estimates, program needs and balance, policy considerations, adequacy of provisions for the protection of human subjects, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries regarding programmatic issues to: Katherine Davenny, M.P.H Division of Clinical Research National Institute on Drug Abuse 5600 Fishers Lane, Room 11A-33 Rockville, MD 20857 Telephone: (301) 443-1801 George W. Counts, M.D. Clinical Research Management Branch/TROP National Institute of Allergy and Infectious Diseases Solar Building, Room 2A-04 Rockville, MD 20857 Telephone: (301) 496-8214 Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch, OPRM National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Mary C. Kirker Grants Management Branch National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-22 Rockville, MD 20857 Telephone: (301) 496-7075 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301, and administered under PHS policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 & 92, "Administration of Grants", and 45 CFR Part 46, "Protection of Human Subjects". Title 42 CFR Part 2, "Confidentiality of Alcohol and Drug Abuse Patient Records" may also be applicable to these awards. Title 42 Part 241(d), "Certificates of Confidentiality and Communicable Disease Reporting", may also be applicable to these awards. Applications submitted in response to this announcement are not subject to the intergovernmental review requirements of Executive Order 12372 of Health Systems Agency Review. .
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