SUPPLEMENTS FOR THE STUDY OF DRUG ABUSE AND HIV/AIDS

Release Date:  July 8, 1999
        
NIH GUIDE

P.T. Keywords:
  AIDS 
  Drugs/Drug Abuse 
  Epidemiology 
  Behavioral/Social Studies/Service 
 
National Institute on Drug Abuse
 
PURPOSE
 
The National Institute on Drug Abuse (NIDA) announces the availability of 
funds to supplement existing federal research project grants for the study of 
issues related to drug abuse and HIV/AIDS.  Funding will be available through 
administrative supplements.
 
RESEARCH OBJECTIVES
 
Background
 
The HIV/AIDS epidemic has demonstrated an increasing association  with drug 
abuse, through transmission of HIV by contaminated drug injection equipment, 
high-risk sexual behavior with an infected drug user, and perinatal exposure 
of newborns from infected drug-abusing mothers. 

With this Supplement Announcement, NIDA plans to continue to develop a 
strong multidisciplinary basic, clinical, epidemiologic, behavioral, and 
ethics research program in response to the  challenge of the interactions 
of drug abuse with the HIV/AIDS epidemic. The Supplement Program is 
designed to encourage and enhance interactive, multidisciplinary 
collaborative projects involving researchers with primary foci both within 
and outside the area of drug abuse. 
 
Areas of Interest
 
In an effort to improve and expand its research on drug abuse-related
aspects of HIV/AIDS, NIDA will consider requests from current NIDA/NIH 
grantees and those supported by other federal agencies (e.g., the National 
Science Foundation (NSF), the Health Resources and Services Administration 
(HRSA), the Department of Defense (DOD), the National Institute of Justice 
(NIJ), the Department of Education (DOE) to expand and/or enhance ongoing 
research to include drug use related HIV/AIDS issues. The primary intent of 
this Program is to encourage grantees who have not focused on drug use 
related AIDS issues to do so, thus recognizing that drug abuse and HIV/AIDS 
are two diseases that must be prevented and treated in parallel.

Thus, projects which currently focus solely on either AIDS-related or drug 
abuse issues are encouraged to strengthen efforts in this complementary 
area. Grantees are especially encouraged to examine ongoing projects which 
may not have been designed to examine AIDS-related issues for HIV/AIDS 
relevance. For example, those doing basic AIDS research, but who have not 
investigated how drugs of abuse may act within their area of investigation, 
are encouraged to apply.

Current areas of NIDA-supported drug use research that are considered
HIV/AIDS-related include those listed below as well as crosscutting areas of 
relevance; e.g., issues related to race/ethnicity, minority status, 
socioeconomic status, gender differences, and issues that are unique to women 
or to men. For example, gender-related research has shown that women's HIV 
viral loads are not the same as men's, raising the issue of whether women may 
need earlier interventions with anti-viral therapies. Another example may be 
a field such as genetics in which the rapid development of knowledge as well 
as technology (e.g., gene chip arrays, quantitative trait locus analysis) may 
be broadly applicable to a number of research areas. As relevant data emerge 
from laboratory, field, and clinical HIV/AIDS research, investigators are 
urged to include these crosscutting perspectives in their research design and 
analyses, where appropriate. 
 
Natural History and Epidemiology

o  International or national studies of the epidemiology and natural history 
of infectious diseases commonly transmitted by drug injection and/or sexual 
behavior and/or other behaviors associated with drug use (e.g., Hepatitis A, 
B and C; STDs; Tuberculosis; and HIV).

o  Studies of interactions among chronic drug use and the treatment of HIV 
and comorbid mental disorders and other infectious diseases, including 
studies of health seeking behaviors.
 
o  Studies to determine the incidence and prevalence of HIV infection
and AIDS among drug abusers, their sexual partners, and their
newborns, including monitoring the trends in HIV infection and
AIDS-related diseases and addressing specific subpopulations such as 
adolescents, women, and minorities.
 
o  Research on the natural history of HIV/AIDS in the above
populations, including the natural history of the dynamics of HIV and other 
blood borne infectious disease transmission in sexual and drug-using 
networks.
 
o  Research on the nature and extent of HIV risk behaviors and factors that 
affect risk in the above populations.
 
o  Research to develop improved survey designs, including interview
protocols and measurement instruments, and new biostatistical
techniques to detect, measure, and characterize drug use in adolescent and 
adult populations at risk for HIV.
 
o  Studies of the nature, extent, and progression of drug use and abuse, 
which include assessment of knowledge and attitudes regarding HIV/AIDS, 
and/or the incidence, prevalence, and nature of drug-related HIV risk 
behaviors.

Etiology and Pathogenesis
 
o  Studies to define interactions between drugs of abuse and the operation  
of secondary messenger pathways affecting lymphocyte or monocyte function.

o  Studies to define the role of drugs of abuse and related compounds
or drug abuse treatment medications on susceptibility, onset, and
progression of HIV disease.
 
o  Studies to further develop and utilize experimental models to study the 
effects of drugs of abuse on the pathogenesis of central nervous system 
lentivirus infections.
 
o  Studies to investigate the role of drugs of abuse and related endogenous 
substances and other biological and environmental factors in modulating HIV-
induced neuroAIDS.
 
o  Studies to identify and elucidate the role of drug abuse on immune
susceptibility and development and progression of AIDS-related opportunistic 
infections; e.g., "smoking" drugs of abuse and bacterial pneumonias.

o  Studies of the nutritional, metabolic, endocrine, and gastrointestinal 
disorders and their underlying pathophysiology in HIV-infected drug abusers.

o  Research on adulterants/contaminants of drugs of abuse and their roles in 
the etiology, pathogenesis, and natural history of HIV/AIDS and associated 
illness in drug abusers.
 
o  Studies of the role of patterns of drug abuse in HIV/AIDS progression 
among women; e.g., in perinatal transmission of HIV and the effects on the 
fetal and neonate nervous system, immune system, and placenta.
 
o  Studies of the effects of drugs of abuse and drug treatment medications on 
immune function, which may increase our knowledge of the immune dysfunction 
characteristic of HIV infection.
 
o  Studies of how drugs of abuse may modulate the immune system through the 
hypothalamic-pituitary axis and other parts of the central nervous system.
 
o  Basic and clinical research on neurobiologic, neurologic, 
neuropsychological, and psychiatric consequences of drug abuse that have 
relevance for understanding the natural history of HIV/AIDS-related dementia 
in drug users.
 
o  Studies of dual function receptor systems; e.g., opioid, with activation 
receptors of immune cells and subsequent induction of immune cell responses, 
including cytokine responses and other host factors.
 
Therapeutics

o  Research to improve access to health services provided to and long-term
therapeutic strategies designed for HIV-infected drug users, their sexual 
partners, and their children, including studies of:
 
a. Strategies to improve adherence with HIV medications (e.g., simultaneous 
or co-located drug abuse and HIV treatment);

b.  Recruitment and retention of HIV-infected drug users into
    HIV/AIDS treatment;

c.  Delivery of linked medical and drug abuse treatment services
    through drug abuse treatment programs and/or other health services
    delivery programs (e.g., mobile van services);

d.  Strategies to improve adherence with tuberculosis detection and
    treatment; and

e. Methods to improve STD and Hepatitis C prevention, detection, and 
treatment.

o  Evaluation of the safety, efficacy, and acceptability of new agents and 
approaches, including alternative and complementary therapies (e.g., 
chemopreventive treatment with micro- and macronutrients such as vitamins and 
trace elements), in the treatment of wasting syndrome, growth failure, and 
other complications of HIV infection in drug users.

o  Research that investigates interactions between approved and 
investigational medications for drug addiction and HIV pharmacotherapies.

o  Research to test the feasibility of enhancing recruitment of HIV-
infected drug users, their sexual partners, and infants into
HIV/AIDS-therapeutics clinical trials, including specific racial/ethnic and 
hidden subpopulations.

Vaccines
 
o  Research on improving behavioral and/or biomedical methods to deliver
HIV and other infectious disease vaccines to adolescent and adult drug-using 
populations.
 
o  Research to recruit injection and non-injection drug users at high risk of 
HIV infection into clinical trials of vaccines, including developing specific 
strategies to study children, adolescents, and adults.

o  Investigation of how drugs of abuse may affect or modulate cofactors for 
HIV transmission.  Those cofactors include, for example, vaginal/cervical 
epithelium changes during puberty; hormonal changes during pregnancy; and use 
of contraceptives, hormonal replacement therapy, or steroid use.

o  Studies of the genital tract immune system and inflammatory activity that 
might compromise integrity of the genital tract or inductive ability of 
vaccines. Studies of drugs of abuse and genital mucosal inflammation induced 
by drug use behavior which facilitate HIV transmission in injection and non-
injection drug users.

o  In collaboration with institutions and communities being targeted, explore 
behavioral and social issues and prevention activities that might have a 
substantial impact on the design or conduct of a trial, including:

a. Evaluation of other biomedical and behavioral interventions that could 
prove of benefit in decreasing the incidence of HIV infection in the 
populations identified for future vaccine efficacy trials and assessment 
of  their potential impact on the evaluation of vaccine efficacy;

b. Conduct of behavioral research in populations at high risk for HIV 
infection to determine, for example, appropriate risk-reduction 
interventions and to estimate risk behavior and recruitment, adherence, 
and retention strategies pertinent to the design and execution of a 
successful efficacy trial, especially for populations that have been 
historically underrepresented in clinical trials;

c. Determination of possible adverse social, economic, behavioral, or legal 
consequences of participation in clinical trials and development of  
broadly applicable strategies for mitigating potential harm; 

d. Determination of optimal methods of achieving informed consent for vaccine 
efficacy trials; and

e. Research on the ethical conduct of health care workers in performing drug 
use and HIV-related studies.

Behavioral and Social Science Research
 
o  Research to develop, evaluate, and disseminate prevention strategies to 
reduce the incidence of drug use related HIV infection, including high risk 
drug use associated sexual behavior (e.g., in adolescents and perinatal 
transmission in drug-abusing mothers). These include:
 
a. Community-based behavioral and social intervention strategies to reduce
   needle-sharing and high risk sexual behavior among injection drug users,
   crack cocaine users, and methamphetamine users and their sexual partners;
 
b. Behavioral aspects of other prevention and intervention strategies, such    
                          
as compliance with barrier methods, vaccine, and HIV therapeutics 
regimens;
 
c. Prevention strategies targeting adolescents or other groups at high risk 
for initiating injecting drug use and/or initiating sexual risk behaviors 
in association with drug use; and

d. Development of new or improved HIV-risk and drug use risk screening 
questionnaires that are developmentally appropriate for use with specific 
target populations (e.g., early adolescents, older women, young minority 
men) and are adequately predictive of immediate and future exposure to HIV 
infection if preventive intervention does not occur.
 
o  Studies of the determinants of risk behaviors known to transmit HIV and of 
the principles of behavioral change necessary to reduce the risk of HIV 
transmission among adolescent injecting drug users and their sexual partners, 
and adolescent non-injecting drug users who engage in high risk sexual 
behaviors associated with their drug use.
 
o  Studies of simultaneous treatment interventions for drug dependence and 
comorbid conditions that meet all of the following criteria:
 
a. Designed to determine the efficacy or effectiveness of psychosocial and/or 
pharmacological treatment interventions for drug dependence that have a 
high probability of leading to reductions in transmission of infectious 
diseases associated with drug use; e.g., HIV, hepatitis, or other medical 
consequences of drug use (e.g., hypertension, diabetes mellitus); and
 
b. The target population must be in-treatment or out-of-treatment 
   individuals at high risk for HIV infection as a result of either drug 
   injecting or sexual behavior associated with their drug use, or be HIV 
   seropositive drug users where the intervention is intended to prevent 
   further spread of disease; and
 
c. Drug use injection and non-injection practices and/or sexual AIDS risk 
   behaviors must be assessed as part of the research design; and
 
d. HIV risk reduction counseling is either (1) provided to research
   subjects during the course of the study or (2) included as part of
   the intervention under study and evaluated as part of the research
   design.
 
o  Studies of the impact of HIV/AIDS on the drug abuse treatment delivery 
system and on provision of HIV/AIDS services within drug treatment programs, 
including those provided under managed care.
 
o  Studies of the cost, cost-benefit, and cost-effectiveness of interventions 
to reduce HIV risk behaviors and prevent the transmission of HIV.
 
o  Studies of the organization and management of services for HIV-positive 
drug abusers, including studies of the barriers to service access and 
utilization and strategies for overcoming them.
 
o  Studies of the organization and management of drug use and medical 
services provided by mobile care systems (e.g., vans) as a method for 
improving care access.

o  Research to enhance the effectiveness of other HIV prevention 
interventions, such as studies of the recruitment of injecting drug users and 
high-risk non-injecting drug users into drug abuse treatment. 

o  Research to improve the understanding of basic principles of behavior 
change, maintenance of behavior change, and relapse that have implications 
for the prevention of HIV transmission that is drug-related. 

Information Dissemination
 
o  Research on mass media and other education strategies focused on AIDS and 
drug abuse in children (ages 8-12), adolescents, adults, racial/ethnic 
groups, and gender specific groups.
 
o  Studies of HIV and drug use prevention strategies for clinical and 
education professionals involved in HIV risk reduction and/or drug abuse and 
HIV/AIDS treatment with stigmatized populations.
 
Research Mentoring and Career Development
 
o  Support for mentoring and career development opportunities designed to (1) 
attract and support scientists and clinicians entering the HIV/AIDS field 
from every level of the career path and (2) expand NIDA's research workforce 
to better represent the cultural, genetic and age diversity of drug-abusing 
populations and others at risk for HIV/AIDS.

Research Ethics

o  Studies of the ethical, legal, and social interactions and resulting 
issues related to AIDS and drug abuse.  Investigators are referred for 
general topic areas and more background information to three current program 
announcements: Mentored Scientist Development Award in Research Ethics (PAR-
98-006), Short-Term Courses in Research Ethics (PA-99-051), and Research on 
Ethical Issues in Human Studies (PA-99-074).  

International Research Collaboration 

o  Research support for collaborative national and international research 
with a focus on drug abuse-related links to HIV/AIDS. International 
collaborative research may involve, for example, any of the above areas (e.g, 
etiology and pathogenesis, natural history/epidemiology, vaccines, social and 
behavioral sciences, information dissemination, research ethics).

SPECIAL REQUIREMENTS
 
Budget/Administrative Issues
 
For FY 1999, approximately $1,700,000 will be available for the funding of 
administrative research supplements to existing federal grant projects.  
Subject to the availability of funds, similar amounts, as well as funding for 
competing supplements, will be made available in future years.
 
Administrative supplements are provided to cover unanticipated cost increases 
that are associated with achieving the objectives within the original scope 
of a project.  These supplements can include cost increases that result from 
making modifications in the scope of a project in order to take advantage of 
opportunities that would increase the value of the project consistent with 
its originally approved objectives and purposes.  For NIDA grantees, 
administrative supplemental funding in excess of 25 percent of the Council-
approved direct costs of the parent project or $100,000, whichever is less, 
requires NIDA Council approval.  This requirement does not apply  to grants 
supported by other NIH Institutes or grantee applications from federal 
agencies other than NIH.  These applications undergo program, grants 
management, and budget review within NIDA and may be submitted for the 
remainder of FY 1999, but no later than July 26, 1999. An original and two 
copies of the application must be received in the Grants Management Branch 
(see address below) by this date.

Supplements may not exceed the stated life of the parent project.  Parent 
grants that would require no-additional-cost extension during the supplement 
period will not be eligible for supplementation.  Supplement may not 
represent changes in the basic goals or intent of the project nor alter the 
scope of the parent grant.  AIDS-related supplement requests to either non-
AIDS or AIDS-related grants will receive expedited review, according to 
Section 301 of the Public Health Service Act (42 USC241).

Applicants from outside NIDA must inform their Program Officer at their 
Granting Federal Agency with respect to their intention to submit an 
application for these supplements and must submit with the application a 
letter from the granting agency stating that (1) the proposed supplement is 
judged to fit within the scope of the funded grant and (2) the granting 
agency is willing to accept the supplement if funding by NIDA is offered. The 
letter must include the name and contact information for the Program Officer 
at the granting agency. A copy of the letter must be sent to the NIDA Center 
on AIDS and Other Medical Consequences of Drug Abuse at the address listed 
below.   
 
INQUIRIES
 
Inquiries concerning this notice are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues to:
 
Sander G. Genser, M.D., M.P.H.
Center on AIDS and Other Medical Consequences of Drug Abuse
National Institute on Drug Abuse
6001 Executive Boulevard, Rm. 5198, MSC 9593
Bethesda, MD  20892-9593
Telephone:  (301)443-1801
Email:  sg73f@nih.gov
 
Direct fiscal inquiries to:
 
Gary Fleming, J.D.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Rm. 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
Email:  gf6s@nih.gov

Direct inquiries regarding review issues to:

Teresa Levitin, Ph.D.
Director, Office of Extramural Program Review
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD 20892-9547
Telephone: (301) 443-2755
FAX: (301) 443-0538

APPLICATION PROCEDURES

Supplement applications are to be submitted in the grant application form PHS 
398 (rev. 4/98). Application kits are available at most institutional offices 
of sponsored research and may be obtained from the Division of Extramural 
Outreach and Information Resources, National Institutes of Health, 6701 
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301)710-0267, 
E-mail: GrantsInfo@nih.gov.

Submit a signed typewritten original of the supplement application, including 
the Checklist, and five signed photocopies to:

Chief, Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Rm. 3131, MSC 9541
Bethesda, MD  20892-9541
 
To be eligible for consideration for these FY 1999 funds, supplement 
applications must be received by July 26, 1999. If an application is received 
after that date, it will be returned to the applicant without review.

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