DRUG ABUSE HEALTH SERVICES RESEARCH

NIH GUIDE, Volume 23, Number 10, March 11, 1994



PA NUMBER:  PA-94-047



P.T. 34



Keywords:

  Drugs/Drug Abuse 

  Health Services Delivery 



National Institute on Drug Abuse



PURPOSE



The purpose of this Program Announcement is to encourage applications

for a new program emphasis on health services research in the field

of drug abuse.



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 PA,

Drug Abuse Health Services Research, is related to the priority area

of alcohol and other drugs.  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 for-profit and non-profit public and

private organizations such as universities, colleges, hospitals,

units of State or local governments, and eligible agencies of the

Federal government.  Women and minority investigators are encouraged

to apply.  Foreign institutions are not eligible for First

Independent Research Support and Transition (FIRST) (R29) awards.



MECHANISM OF SUPPORT



This program announcement will use the National Institutes of Health

(NIH) individual research grant (R01), interactive research project

grant (IRPG) (see NIH Guide, Vol 22, No. 16, April 23, 1993), small

grant (R03), and FIRST award (R29).  Responsibility for the planning,

direction, and execution of the proposed project will be solely that

of the applicant.  Support will be provided for a period of up to

five years (renewable for subsequent periods) subject to continued

availability of funds and progress achieved.



RESEARCH OBJECTIVES



The ADAMHA Reorganization Act (Public Law 102-321) directed the

National Institute on Drug Abuse (NIDA) to expand its program of

health services research.  Health services research is defined as

research endeavors that study the organization, financing, and

management of health services and their impact on the quality, cost,

access to, and outcomes of care (Section 409).  Subsequent

legislative clarification included research to study the

effectiveness of primary and secondary prevention activities.

Research on the efficacy of services to prevent, diagnose, or treat

medical conditions is excluded (Public Law 103-43), and investigators

contemplating such studies should consult other relevant NIDA

announcements.



NIDA's health services research program includes interdisciplinary

study of the structure, processes, and outcomes of the delivery of

health services.  Factors that influence the availability,

accessibility, and utilization of health services and the efficiency

and effectiveness of these services are studied within established

service delivery settings and at a system-wide level.  Research is

sought on how services are organized, financed, delivered, and

utilized as well as how effective these services are in addressing

health issues and related concerns.



This Program Announcement invites research grant applications in four

major areas of health services research:  (1) primary and secondary

prevention activities; (2) HIV prevention services for drug abusers

and their sexual partners, both in and out of health care settings;

(3) health services for drug abusers in primary care settings, and

linkages between primary care and drug abuse treatment

programs/systems; and (4) drug abuse treatment services research at

system, program, and client levels.



Illustrative general or cross-cutting health services research areas

include:



o  Assessment of need for services and factors influencing

utilization of services;

o  Effectiveness and efficiency of alternative organizational and

manpower configurations;

o  Client/patient, provider, and community/environmental

characteristics that affect service delivery and outcome;

o  Financing and economic research on programs, practices, policies,

and outcomes;

o  Assessment, matching and referral of patients to improve services

and outcomes;

o  Impact of specific policies or cost/utilization control strategies

on outreach, service delivery, retention, and effectiveness; and

o  Methodological development in research designs, analytic

techniques, and measurement, including development of standards and

criteria.



Applications that focus on research within any of the four major

areas or that cut across areas are encouraged.  Topics not mentioned

are not necessarily excluded from consideration under this Program

Announcement.



Applicants are advised to review existing information relevant to

drug abuse health services research and to design studies using the

most rigorous methodological and analytic designs feasible.  Timely

reporting of findings is emphasized.  Applicants should be willing to

participate in research coordination efforts to maximize the utility

of the research, including review and dissemination activities.



If investigators are studying populations that are at risk for HIV,

they are encouraged to explicitly address AIDS-related issues in

their applications.  Investigators are encouraged to offer HIV

testing and counseling in accordance with current guidelines to

subjects identified during the course of the research as being at

risk for HIV acquisition or transmission.  In high-risk populations,

investigators are encouraged to assess the effects of new

interventions on the acquisition and transmission of infectious

diseases, including HIV.  Due to the growing AIDS problem in this

country, special consideration will be given to applications that

focus on AIDS-related issues such as services to reduce AIDS risk

behaviors, services for high-risk subgroups such as prostitutes or

injection drug users, or measures of program effect on AIDS risk

behaviors (e.g., needle sharing, unprotected sex).



Drug Abuse Prevention.  The intent of health services prevention

research is to assess the effectiveness and cost effectiveness of

preventive interventions in reducing drug-related problems.  Research

is needed to improve the quality of prevention services, to expand

access to prevention services to all populations, particularly

minorities, and to lower costs of health care by reducing the extent

of drug use and its adverse medical, psychological, and social

consequences.



In addition to intervention studies in health care settings,

prevention services research may occur in a variety of other settings

(e.g., worksites, schools, and local communities) and may focus on

financing, organization, management, enforcement, and utilization of

prevention services as well as their effectiveness.



Illustrative drug abuse prevention services research areas include:



o  Qualitative and quantitative assessment of the impact of program

service delivery at the community, State, regional, or national

level;



o  Outreach research to assess strategies to expand prevention

services to underserved populations and geographic areas, such as

rural communities and inner cities;



o  Research on methods for diffusion of innovative clinical practices

and management techniques to improve prevention services and lower

costs;



o  Research on consumer choice, prevention program selection, and

service retention resulting from innovative practices; and



o  Research to integrate drug abuse prevention with interventions

directed at other related behavioral and societal problems such as

violence, unwed pregnancy, school dropouts, and domestic abuse.



HIV Prevention.  Behavior change remains the only strategy available

to prevent HIV infection.  To date, research has focused on the

implementation and testing of interventions designed to reduce

drug-using and sexual behaviors that place the individual at high

risk for HIV infection or transmission.  Little research attention

has been given to the need, demand, utilization, effectiveness, and

cost effectiveness of HIV prevention and outreach in various settings

and with specific subgroups.  Further research is needed to develop

and refine service delivery models for outreach to the population at

risk of HIV infection.



Results of community-based research indicate that over 40 percent of

injecting drug users contacted, including many long-term users of

illicit drugs, have never enrolled in drug abuse treatment.  Given

the threat of HIV/AIDS to drug abusers and their sexual partners,

research is needed to develop and refine risk reduction intervention

strategies and methods of referral to medical and drug treatment to

intervene with these high-risk populations.



Illustrative HIV prevention services research areas include:



o  Improving the effectiveness and cost effectiveness of HIV outreach

and prevention services on reducing risk behaviors;



o  Delivery of HIV prevention and outreach services in nontraditional

settings (e.g., in the community; in criminal justice settings), and

barriers to delivery;



o  Delivery of HIV prevention interventions to non-treatment as well

as treatment populations and for specific subgroups at risk,

including criminal justice-involved, HIV+, adolescent, and those with

chronic medical conditions (e.g., tuberculosis) or psychiatric

problems;



o  Improving identification, liaison, and linkages with external

resources, and managing information and access to service networks;



o  Development of valid and reliable measures of high-risk behaviors,

of behavior change, of alternative HIV antibody testing and reporting

strategies, and of measures to assess client need and match services

to need.



Primary Care for Drug Abusers.  Individuals dependent upon illicit

drugs often have limited access to primary medical care, resulting in

overuse of expensive emergency treatment.  The social costs of drug

abuse are multiplied by poor rates of compliance with treatment for

tuberculosis and other diseases.



Health services research in primary care is needed to determine the

effects of organizational and financing arrangements on access to

primary care, on research to improve primary care/drug abuse

treatment linkages, and to provide training opportunities for

prevention, treatment, and primary care providers.



Illustrative research areas in primary care for drug abusers include:



o  Health services research on programs combining drug abuse and

primary care, including cross-training for primary care providers and

drug abuse treatment providers;



o  Studies to improve how health care and other organizations

receive, assimilate, and adopt or respond to knowledge (e.g., new

treatment strategies; clinical records information) bearing on

treatment of drug abusers;



o  Studies to enhance early identification of drug abuse and

associated medical problems (e.g., HIV infection and its

consequences, tuberculosis, hepatitis B, sexually transmitted

diseases) in non-drug abuse treatment settings, such as STD clinics

or educational settings; and



o  Research to enhance client/patient engagement in and compliance

with medical treatment programs.



Drug Abuse Treatment.  Research is needed on treatment services and

service delivery systems, on the influence of financing and health

care coverage, and on the impact of these factors upon treatment

outcomes.  In the context of limited treatment resources, a need

exists to determine the relative costs and benefits of providing

augmented treatment services or improving drug abuse treatment

service delivery systems.



The intent of treatment services research is to assess the impact of

health services and the effects of organizational and financing

arrangements on the quality and outcomes of care provided to patients

with drug abuse as well as medical and other problems related to drug

abuse.



Illustrative drug abuse treatment services research areas include:



o  Effects of financing, reimbursement, regulatory strategies, and

insurance strategies, including the impact of differences in public

and private financing and coverage, on access, quality, outcomes of

care, and subsequent utilization of health care services;



o  Long-term aspects of drug abuse treatment utilization and recovery

processes;



o  Client and program factors that influence treatment-seeking

behavior, retention, compliance, effectiveness, and relapse,

including program factors that influence change in AIDS risk

behaviors, and factors related to engaging and retaining HIV+ drug

users in treatment; and



o  Facility- or system-level studies to investigate the organization,

management, financing, and quality of treatment and ancillary

services in relation to client characteristics, treatment content,

and outcome.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



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 are to be submitted on the grant application form PHS

398 (rev. 9/91) and will be accepted at the standard application

deadlines as indicated in the application kit.  The receipt dates for

applications for AIDS-related research are found in the PHS 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 240, Bethesda, MD 20892, telephone

301-435-0714.  The title and number of the announcement must be typed

in Item 2a on the face page of the application.



FIRST award applications must include at least three sealed letters

of reference attached to the face page of the original application.

FIRST award applications submitted without the required number of

reference letters will be considered incomplete and will be returned

without review.



The completed original and five permanent, legible copies of the PHS

398 form must be delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CONSIDERATIONS



The Division of Research Grants, NIH, serves as a 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) in accordance with established PHS

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

recommended for further consideration will receive a second-level

review by an appropriate Advisory Council, whose review may 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) applications do not

receive a second level review.



AWARD CRITERIA



Applications recommended for further consideration by a National

Advisory Council will be considered for funding on the basis of

overall scientific and technical merit of the application as

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.  Special consideration will be given to applications that

directly deal with AIDS-related issues.



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Direct inquiries regarding programmatic issues to:



Frank M. Tims, Ph.D.

Treatment Services Research Branch

National Institute on Drug Abuse

5600 Fishers Lane, Room 10A-30

Rockville, MD  20857

Telephone:  (301) 443-4060



Direct inquiries regarding fiscal matters to:



Grants Management Branch

National Institute on Drug Abuse

5600 Fishers Lane, Room 8A-54

Rockville, MD  20857

Telephone:  (301) 443-6710



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.  This program is not

subject to the intergovernmental review requirements of Executive

Order 12372 or Health Systems Agency review.



.


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