Full Text PA-96-074
 
DRUG USE, SEXUAL RISK BEHAVIORS, AND HIV IN MEN
 
NIH GUIDE, Volume 25, Number 32, September 27, 1996
 
PA NUMBER:  PA-96-074
 
P.T. 34

Keywords: 
  AIDS 
  Drugs/Drug Abuse 
  Risk Factors/Analysis 

 
National Institute on Drug Abuse
 
PURPOSE
 
The purpose of this program announcement (PA) is to support
epidemiological and HIV prevention research on drug use, sexual risk
behaviors, and HIV in an especially high risk group: men who use
drugs and have sex with men (DU MSM).  DU MSM use drugs by injection
and/or noninjection means (e.g., crack cocaine and smokable or
intranasal forms of methamphetamine and heroin) and have same-gender
sex regardless of their self-identified sexual orientation (gay,
bisexual, or heterosexual).  Because DU MSM may engage in both high
risk drug use and sexual practices, and may have multiple and
different drug use and sex partners and networks, they not only
constitute an important HIV risk group in and of themselves but also
have the potential to serve as a bridge for HIV transmission to
heterosexual injecting drug users (IDUs) and non-IDU MSM.  Promising
directions for the epidemiology and prevention of HIV in this dual
risk group will draw from cumulative research related to the
epidemiology and prevention of HIV in MSM, IDUs, and noninjecting
drug users. This PA seeks to stimulate research on (1) the
co-occurrence of HIV risk behaviors among men who use injection
and/or non- injection drugs and who have sex with men, and the
adverse health consequences, (2) antecedents and correlates of high
risk, especially social/situational contexts of HIV risk and
protective behaviors among DU MSM and their drug use and/or sex
partners and networks; (3) the efficacy and effectiveness of
behavioral and biological HIV prevention interventions for diverse
groups of DU MSM, including comparative evaluations of intervention
outcomes and costs/benefits of community-based outreach, prevention,
and treatment approaches to averting new HIV infection; and (4)
development and evaluation of new behavioral therapies, drug abuse
treatment approaches, health services, and health care services
delivery to DU MSM.  Within these research themes, investigators are
encouraged to expand, test, and improve current identification and
recruitment strategies, research designs, methods, and measures of
behavioral risk and intervention effects among hard-to-reach
subgroups of DU MSM.
 
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 Use, Sexual Risk Behaviors, and HIV in Men, is related to the
priority areas of reducing alcohol and other drug use and the
transmission of HIV.  Potential applicants may obtain a copy of
"Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1)
through Superintendent of Documents, Government Printing Office,
Washington DC 20402 (Telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by foreign and domestic, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal Government.
Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) (R29) awards.
 
MECHANISM OF SUPPORT
 
Research support mechanisms under this PA will include the
traditional research project grant (R01), small grants (R03), and
FIRST (R29) awards.   Because the nature and scope of the research
proposed in response to this PA may vary, it is anticipated that the
size of an award will also vary.
 
RESEARCH OBJECTIVES
 
Background
 
Historically, HIV epidemiology and prevention research has focused on
the highest prevalence and incidence exposure groups, i.e., either
men who have sex with men or injecting drug users and noninjecting
users of crack cocaine.   Little attention has been given to the dual
risk category of DU MSM, who may acquire HIV infection either
sexually or parenterally.  Nor has much attention focused on DU MSM
who have recently initiated injecting drug use, though a recent
report suggests new drug injectors may be at especially high risk for
the HIV infection and hepatitis B and C, possibly from sexual
activity prior to injecting drugs (Garfein et al., 1996).
 
Fifteen years into the HIV/AIDS epidemic, attention has begun to
focus on exposure groups in which HIV infection is emerging or
increasing in prevalence and on the need to formulate new strategies
for primary prevention and behavior change interventions for these
populations.  Compared to men who report sex with men as their only
HIV risk factor (in whom the incidence of  HIV is stable or
declining), increasing proportions of HIV incidence cases are
occurring among men who report injecting drug use as their only risk
and among men who report dual risks from both drug injecting and sex
with men, especially men of color.  Since first recognized in early
1981,
AIDS has been diagnosed in 434,719 male adolescents and adults in the
U.S.(CDC, 1995).  Of these, 259,672 cases (60%) occurred in MSM;
95,244 (22%) in IDUs; and 33,195 (8%) in the dual risk category of
IDU MSM.  In addition, an estimated half of all HIV incident
infections in the U.S. are occurring among injecting drug users
(Holmberg, 1996).  Drug injection has gained a proportionately
greater share of cases as a HIV risk category among Hispanic, African
American, and American Indian/Alaskan Native men.
 
HIV/AIDS surveillance data do not provide reports about noninjecting
drug use among MSM; however, this group is at high risk, especially
if they trade sex for drugs and/or money or engage in high risk
sexual practices as a result of drug use before or during sex.
Noninjecting drug users may have been former injectors or may never
have injected drugs out of concern of exposure to the HIV infection
from contaminated syringes, but many of these men are using crack,
methamphetamines, and other drugs as well as engaging in high risk
sexual practices.  In certain situations and settings, they are also
at risk of initiating injection drug use and resulting health
consequences.
 
Though the epidemiology, determinants, and mediators of high risk
drug and sex practices, as well as HIV prevention strategies have
been researched for some time with respect to IDUs, crack cocaine
users, and gay men, the risk behaviors, consequences, and prevention
strategies to limit the spread of HIV among the dual risk group of DU
MSM remain inadequately understood.  Only a handful of studies have
focused on this group, though their risks of HIV infection are
strikingly high. A recent multivariate analysis of data from NIDA~s
Cooperative Agreement for AIDS Community-Based Outreach/ Intervention
Research Program found that the strongest single predictor of HIV
seropositivity in a sample of not-in-treatment male drug users was
being homosexual.  Other significant predictors were having ever
injected drugs and residing in a high HIV seroprevalence (15% and
higher) area.  Bisexual status alone was not a significant predictor
of seropositivity, but being both bisexual and African American
increased the likelihood to over 4 times that of heterosexual IDUs.
In 1995, NIDA and CDC initiated a multi-site pilot study of the drug
use and sex risk behaviors of not-in-treatment MSM who injected drugs
or used crack cocaine.  Although all the men reported drug use and
having sex with men, there was a wide range in types and frequencies
of drugs us-ed and in sex partners and sexual risk behaviors as well
as a wide array of age groups and racial/ethnic categories involved.
Findings from this study attest to the diversity of the DU MSM
population and point to the need to go beyond uniform health models
to better address their HIV risk-taking behaviors.  NIDA and CDC plan
to use study data to develop appropriate HIV intervention strategies,
but to date, no prevention programs have been specifically tailored
for this under-researched population.
 
It is important to understand the extent to which HIV research and
prevention efforts designed to study and moderate the risk behaviors
of gay men and/or heterosexual drug users can be adopted and made
effective for the dual risk group of DU MSM, especially with respect
to contextual factors that influence HIV risk behaviors.  Moreover,
understanding the future of this epidemic will improve dramatically
if researchers begin to shift their thinking from an individual-level
perspective of behavior to viewing risk behaviors as social
transactions between individuals and groups and begin to focus on the
contexts in which multiperson use of drug injection equipment and sex
risks take place.  Applicants are encouraged to pay attention to
social factors which can influence the initiation of risk as well as
behavior change among DU MSM and that involve not only the individual
but also couples, groups, or networks to which the DU MSM belongs and
in which norms of behavior are practiced and preserved.
 
Various research approaches, including epidemiology, ethnography,
controlled clinical trials, and evaluation are applicable to a
comprehensive HIV prevention research portfolio alone or in phased
stages of multidisciplinary study.
 
Research Areas
 
This PA will support research on the epidemiology and prevention of
HIV-related behaviors and adverse health consequences among DU MSM.
Researchers are encouraged to review the cumulative literature on the
epidemiology and prevention of HIV in gay men, IDUs, and
non-injection drug users and to adapt and refine research protocols
and models of HIV prevention that have proven to be effective with
drug using men or men who have sex with men.  Investigators are
encouraged to integrate such information into new theory-based
primary prevention and behavior change interventions and health
services.  A broad range of studies are envisioned, including but not
limited to the following research areas:
 
(1) Epidemiology of HIV-related behaviors and health consequences
(morbidity/mortality) in DU MSM.  Suggested topics include, but are
not limited to:
 
o  Studies in areas of high, moderate, and low HIV seroprevalence of
the incidence, prevalence, trends and predictions of DU MSM~s drug
use patterns and the co- occurrence of high risk drug use and sex
behaviors (e.g., types of drug used, multiperson use of injection
equipment, numbers and types of sex partners).
 
o  Studies of syringe acquisition, drug acquisition, drug
preparation, injection practices, and syringe disposal behaviors
among IDU MSM as well as biological/ serological studies of the HIV
transmissibility risks associated with these behaviors.
 
o  Studies of risk and/or protective antecedents and correlates
associated with the initiation of drug injection among MSM, including
factors influencing the transition from non-injection to injection
use (e.g., roles of community culture, social networks, peer
influence) and the continuation of use (may involve
injection/non-injection patterns associated with specific drugs or
drug combinations).
 
o  Research on the epidemiology of physical, sexual, and emotional
violence (including stigmatization) against or among DU MSM, and on
the relationship of such violence to the co-occurrence of HIV-related
risk behaviors and other adverse health consequences.
 
o  Research to improve epidemiologic methods and measures for
monitoring, reporting, and predicting the course and spread of HIV
seroincidence in DU MSM and among their drug use and sex partners.
 
(2) Antecedents, correlates, and contexts of HIV risk/protective
behaviors.  Suggested topics include, but are not limited to:
 
o Studies of the effects of macro-level factors on the epidemiology
and adoption, maintenance, change, and relapse of HIV-related
behaviors of DU MSM (e.g., community policies toward needle exchange
and condom distribution programs, including closures/relocations of
services); law enforcement practices in areas where sex is traded for
drugs or money or where drugs are used in public settings; and other
access and barrier issues related to community-based HIV/AIDS
education and prevention programs.
 
o  Social network research to characterize the HIV-related behaviors
of DU MSM in their immediate injection/non- injection drug use risk
networks, sex risk networks, and combined drug use and sex risk
networks.  Social network research is also needed to understand the
out-group contacts and mixing strategies of DU MSM who act as bridges
to other networks (e.g., networks of non-drug using MSM; networks of
IDUs who do not engage in same- gender sex).
 
o  Research on intrapersonal, dyadic, and group factors affecting the
adoption, maintenance, and change of HIV risk and protective
behaviors among DU MSM (e.g., testing seropositive or learning that
one's drug use or sex risk partner has seroconverted, interpersonal
skills at negotiating behavior change, economic dependence on one~s
partner, affiliative ties, coercion and violence) as well as factors
associated with relapse to risky behavior, relapse prevention, and
recovery.
 
o  Factors which influence HIV seropositive DU MSM to notify
injecting drug use and sex risk partners of their serostatus, to take
precautions against secondary spread of the HIV infection to others,
or to risk transmitting HIV to persons who are not infected by
sharing injecting equipment and/or by engaging in unprotected sex.
 
(3)  Evaluation of behavioral and biological HIV prevention
interventions specifically tailored for DU MSM.  Multilevel,
multicomponent interventions are encouraged, and the complexity of
sexual and drug-related risks should be addressed when developing
appropriate interventions.  Suggested studies include, but are not
limited to:
 
o  Theoretically guided, community-based studies to investigate the
effectiveness and acceptability of new HIV prevention and
intervention approaches, singly or in combination, among divergent
groups and risk networks of DU MSM.  Studies of community outreach,
condom and bleach distribution, syringe exchange, HIV counseling and
testing, and partner notification projects are needed to evaluate
what works, for whom it works, under what circumstances it works, and
how long it works.
 
o  Studies of the optimal sequencing of risk reduction interventions
taking into account the types and levels of risk engaged in as well
as the episodic nature of HIV risk behaviors/ behavior change and
need for intermittent reinforcement.
 
o  Studies of the diffusion of innovative interventions, including
credible opinion leaders and social change processes affecting the
adoption and/or maintenance of lower sexual and drug using risk
behaviors of DU MSM.
 
o  Single-site studies or comparative evaluations are needed to
address the attributes and relative costs/benefits of peer-initiated,
social network-based, and community-based risk reduction
interventions and/or treatment programs with respect to changing
multiple risk behaviors and averting HIV infections.
 
(4) Research on Drug Abuse Treatment and Health Care Delivery for DU
MSM.  Suggested topics include but are not limited to:
 
o  Research to develop and pilot test new behavioral therapies for
drug abuse or to modify existing therapies for use with DU MSM.
 
o  Studies to identify, develop, and pilot test HIV risk reduction
interventions which can be integrated within drug abuse treatment
programs for DU MSM.
 
o  Clinical trials of well-specified behavioral therapies and risk
reduction interventions identified as promising in pilot testing with
divergent groups of DU MSM both within and outside of the gay
community.
 
o  Health services research on the delivery of drug abuse treatment
and other health care to DU MSM, including studies of factors that
impact access and utilization of services, effectiveness of services,
barriers to effective service delivery, and strategies for improving
service delivery.
 
NIDA POLICY ON HIV COUNSELING AND TESTING
 
Researchers funded by NIDA, who are conducting research in community
outreach settings, clinics, hospital settings, or clinical
laboratories, and have ongoing contact with clients at risk for HIV
infection, are strongly encouraged to provide HIV risk-reduction
education and counseling.  HIV counseling should include offering HIV
testing available on-site or by referral to other HIV testing
services.  Persons at risk for HIV infection include injection drug
users, crack cocaine users, and sexually active drug users and their
sex partners.
 
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
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, Volume 23, Number 11,
March 18, 1994.
 
Investigators may also obtain copies of the policy from the program
staff listed under INQUIRIES.  Program staff may also provide
additional relevant information concerning this policy.
 
Confidentiality.  The Public Health Service (PHS) has a formal policy
concerning Certificates of Confidentiality and communicable disease
reporting.  In brief, the policy reflects the expectation that
research projects will cooperate with State and local health
departments to assure that the purposes of reporting are
accomplished, and the expectation that health departments will
develop relationships with research projects that assist their
mission without thwarting the research goals. A description of the
policy as well as Instructions for Applicants can be obtained after
award.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard AIDS receipt
dates indicated in the application kit.  Application kits are
available at most institutional offices of sponsored research and may
be obtained from the Grants Information Office, Office of Extramural
Outreach and Information Resources, NIH, 6701 Rockledge Drive, MSC
7762, Bethesda, MD 20892-7762, telephone 301-435-0714, email:
asknih@odrockm1.od.nih.gov.  The title and number of this PA must be
typed in Item 2 on the face page of the application.
 
The completed original and five legible copies must be sent or
delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE MSC-7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for courier/overnight service)
 
REVIEW CONSIDERATIONS
 
Applications that are complete will be evaluated for scientific and
technical merit by an appropriate peer review group convened in
accordance with standard NIH peer review procedures.  As part of the
initial merit review, all applications will receive a written
critique and undergo a process in which only those applications
deemed to have the highest scientific merit, generally the top half
of the applications under review, will be discussed, assigned a
priority score, and receive a second level review by the appropriate
national advisory council or board.
 
Review Criteria
 
o  scientific or technical significance and originality of the
proposed research;
 
o  appropriateness and adequacy of the research approach and
methodology proposed to carry out the research;
 
o  qualifications and research experience of the principal
investigator and staff;
 
o  availability of resources necessary to the research;
 
o  appropriateness of the proposed budget and duration in relation to
the proposed research; and
 
o  adequacy of plans to include minorities and their subgroups as
appropriate for the scientific goals of the research.  Plans for the
recruitment and retention of subjects will also be evaluated.
 
The initial review group will also examine the provisions for the
protection of human and animal subjects, and safety of the research
environment.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications assigned to the Institute.  The following will be
considered in making funding decisions:  quality of the proposed
project as determined by peer review, availability of funds, and
program priority.
 
INQUIRIES
 
Inquiries are encouraged.  The opportunity to clarify issues or
questions from potential applicants is welcome.
 
Direct inquiries regarding programmatic issues involving
epidemiologic and HIV prevention and intervention research to:
 
Richard H. Needle, Ph.D., M.P.H.
or Elizabeth Y. Lambert, M.Sc. and Helen Cesari, M.Sc.
Division of Epidemiology and Prevention Research
National Institute on Drug Abuse
5600 Fishers Lane, Room 9A-42
Rockville, MD  20857
Telephone:  (301) 443-6720
FAX:  (301) 443-2636
Email:  RN28E@NIH.GOV; EL46I@NIH.GOV; HC30X@NIH.GOV
 
Direct inquiries regarding programmatic issues involving research in
clinical/drug abuse treatment settings to:
 
Robert J. Battjes, D.S.W.
Division of Clinical and Services Research
National Institute on Drug Abuse
5600 Fishers Lane, Room 10A-38
Rockville, MD  20857
Telephone:  (301)443-6697
FAX:  (301) 443-2317
Email:  RB97H@NIH.GOV
 
Direct inquiries regarding fiscal matters to:
 
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 8-A-54
Rockville, MD  20857
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  GF6S@NIH.GOV
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.279 and 93.242.  Awards are authorized under the
Public Health Service Act, Section 301 and administered under PHS
grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74.
Grants will be administered under PHS grants policy as stated in the
Public Health Service Grants Policy Statement (DHHS Publication No.
(OASH) 82-50-000 GPO 0017-020-0090-1 (rev. April 1994).  This program
is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency Review.
 
The PHS strongly encourages all grant recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products.
In addition, Public Law 103- 227, the Pro-Children Act of 1994,
prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care of early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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