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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