Research (OER)
9000 Rockville Pike
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and Human Services (HHS)
RESEARCH ON NEEDLE HYGIENE AND NEEDLE EXCHANGE PROGRAMS
NIH GUIDE, Volume 22, Number 40, November 5, 1993
PA NUMBER: PA-94-010
P.T. 34
Keywords:
Drugs/Drug Abuse
Risk Factors/Analysis
AIDS
National Institute on Drug Abuse
PURPOSE
The purpose of this program announcement is to encourage research on
comprehensive needle hygiene activities in two areas: (1)
intervention studies related to the adoption of NIDA's newly proposed
recommendations to prevent HIV transmission by not sharing drug
injection equipment (directly or indirectly), including new research
findings on efficacy of disinfection of cleaning needles and syringes
and (2) the evaluation of needle exchange programs (NEP) in
combination with other HIV risk reduction strategies. These two
interrelated research initiatives have great implications for
creating and reformulating comprehensive prevention programs in the
midyears of the second decade of the HIV epidemic. The goal of
research on needle hygiene and NEPs is to develop, implement, and
evaluate strategies that reduce HIV risk behaviors and decrease the
probability of HIV exposure.
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
announcement, Research on Needle Hygiene and Needle Exchange
Programs, 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 of 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
Applicants may be submitted by foreign and domestic, for-profit and
non-profit, public and private organizations such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government. Women
and minority investigators are encouraged to apply. Applicants are
encouraged from State and municipal governments with outreach units
and/or State and municipal governments collaborating with
university-based research units.
MECHANISM OF SUPPORT
This program announcement will use the National Institutes of Health
(NIH) individual research project grant (R01). 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 vary also.
RESEARCH OBJECTIVES
Summary
The NIDA initiated the Cooperative Agreement for AIDS Community-Based
Outreach/Intervention Program in 1990. Since that time, NIDA, the
Centers for Disease Control and Prevention (CDC), and other agencies'
grantees have been monitoring the HIV/AIDS epidemic in a population
of out-of-treatment drug users and developing, implementing, and
assessing the effectiveness of selected interventions. During this
period, considerable changes have occurred in community ecologies
(social and biological environments) related to HIV and drug use
(e.g., dramatic increase in tuberculosis and heterosexual
transmission, male heterosexual increase in incidence of HIV of 114
percent; female heterosexual increase 108 percent) as well as in the
behavioral dynamics of at-risk populations and the science of
prevention. More than 300,000 cases of AIDS were reported to the CDC
as of July 1993; of these, 20 percent of the males and 49 percent of
the females were exposed to the virus via injecting drug use.
Changes such as these dictate the need to promote new study
activities.
Fortunately, during this time, knowledge has been gathered about
preventing the spread of HIV through behavioral change interventions
designed to reduce an individual's risk of transmission. In
addition, selected interventions have been effective in facilitating
risk reduction behavioral change among injection drug users (IDUs).
Nonetheless, preliminary findings from NIDA sponsored research
programs suggest that there is room for improvement and expansion of
community-based behavioral change strategies to reduce the spread of
HIV. For example, many IDUs who have tested HIV positive report that
they lend their "works" to others, while many who have tested
negative report borrowing needles and not practicing adequate needle
hygiene. Recent ethnographic observation has uncovered the finding
that injectors are unaware that indirect exposure (i.e., using
potentially contaminated syringes to prepare and divide drug
solutions) may place them at risk for the transmission of HIV.
Although many drug users do make positive behavioral changes, a large
percentage require additional assistance to maintain their lower risk
behavioral profiles.
Whereas behavioral interventions are the most promising prevention
strategy available (near-term prospects for a vaccine or cure are not
favorable), challenges such as those mentioned above suggest that our
research efforts now need to expand their focus by phasing in and
evaluating third generation innovative community-based behavioral
change projects. These new research endeavors should include
populations that have adopted change to facilitate the maintenance of
these safer behaviors and/or those that have yet to adopt lower risk
needle sharing behaviors. Two particular areas deserve special
attention: (1) updated research data on the efficacy of cleaning
needles and syringes with bleach make it incumbent upon us to examine
the extent to which drug users are able to comply with revised
disinfection recommendations (HIV/AIDS Prevention Bulletin, April 19,
1993); (2) an increasing national interest in needle exchange as an
AIDS prevention strategy (GAO/HRD 93-60 and CDC, unpublished report)
raises the need to evaluate the full range of effects of programs
that provide access to unused injection equipment. It is of critical
importance to understand the social context of these behaviors, the
extent to which needles are available and accessible, and the impact
of local laws and regulations concerning needle/syringe availability
and paraphernalia possession on HIV risk behaviors and behavioral
change.
In light of the preliminary findings, proposed bleach disinfection
recommendations, and a growing interest in needle exchange, we are
calling for expanded research designs that will extend ongoing
research activities. There is a need for targeted interventions
focusing specifically on current risk behavior in demographic,
geographic and behavioral subgroups of the at-risk populations to
permit a better understanding of the behavioral dynamics of drug
users in social context and the spread of HIV. For research
strategies to be effective and interpretable, they should be guided
theoretically and should target selective risk behaviors of
individuals and/or networks. Interventions on behavioral norms that
facilitate or discourage behavior change within communities and the
development of strategies for specific subgroups of at-risk
populations are encouraged. Attention should be paid to developing
operationalized definitions and measures that describe the behavioral
dynamics and intervention process. The foci of this research
activity are epidemiologic/ethnographic observations of needle
sharing practices (indirect and direct), use/nonuse of needle
exchange, and evaluation of the efficacy of the interventions.
Methodological problems associated with research related to the
efficacy of needle exchange programs must be addressed if the
findings can prove helpful in developing policy options.
NIDA and CDC have collaborated, and will continue to collaborate, in
the development and implementation of this program announcement.
Program Description
Needle/Syringe Sharing and Needle Hygiene Studies. Studies are
needed to evaluate the impact of proposed recommendations on the
disinfection of injection equipment, the impact of these changes on
members of the injecting drug user community, and the diffusion of
information about needle cleaning procedures. To date, our knowledge
base contains limited information on the sequence and procedures
related to disinfection practices acquired from a few quantitative
surveys and even fewer qualitative studies. Thus, both qualitative
and quantitative data on previous and current needle sharing and
cleaning practices are desired to identify factors that facilitate
and/or inhibit the adoption of recently proposed needle hygiene
practices.
Applicants are encouraged to design and evaluate interventions that
specifically focus on changing behavior in accordance with the
proposed guidelines for needle cleaning. In order to plan
potentially efficacious prevention activities, it will be critical to
assess and evaluate how needle use, needle cleaning, and disease
avoidance behaviors currently vary at the individual/network level as
well as by communities with different prevalence rates of HIV/AIDS.
We anticipate that several intervention strategies will be needed to
take into account the behavioral heterogeneity of groups and
individuals as well as the varying HIV seroprevalence of different
communities. Race/ethnicity, and gender-related factors must be
addressed in the design, implementation, and evaluation of the
interventions.
It is hoped that, in addition to the above, innovative research
studies will obtain new data/information about drug injectors and
practices (e.g., injection settings and situations, how and from whom
users learn to inject, how they understand needle-sharing {direct
sharing via actual use and indirect sharing via drug solution,
cookers, cotton, rinse water}, and the relation to HIV infection)
that can be used to maximize the effectiveness of cleaning drug
equipment.
While not limited in scope, three methodologies are encouraged: (1)
overt, passive participant field observation of
needle-sharing/cleaning practices by trained ethnographers across
diverse settings; (2) life-history interviews that incorporate a
guided interview with respect to past and current needle
sharing/cleaning practices; and (3) biological (e.g., HIV, hepatitis
B virus, amount of blood, blood type, antibody, DNA "fingerprint")
testing of needles/syringes, cotton, cookers, rinse water, etc., to
measure levels of infectivity and sharing. These methodologies will
form the basis for designing the interventions and should be derived
theoretically from the social and behavioral science literature on
behavioral change.
Needle Exchange Programs (NEPs). A relatively new prevention
strategy undergoing extensive review is that of needle exchange
programs, which generally involve the exchange of new, sterile
syringes for used ones. NEPs currently exist and are beginning in a
number of communities across the country. Given the proliferation of
NEPs, it is important to prepare for the possible inclusion of needle
exchange as an intervention strategy to reduce risk behavior
associated with HIV transmission in the future. Applicants are
encouraged to obtain the report of the recent CDC funded study on
needle exchange prepared by the University of California, San
Francisco (Lurie and Reingold, 1993). The NIDA will not support
needle exchange programs, per se, but will support the evaluation of
the efficacy of currently operating needle exchange programs on drug
use, HIV risk behaviors, and HIV serostatus.
Ethnography, epidemiology, and evaluation perspectives must guide the
research activities around needle exchange. Baseline epidemiologic
data are urgently needed, as are efficacy studies of NEP as part of
HIV risk reduction. Such epidemiological data should be based on
longitudinal information and should include data on risk behaviors
and serostatus of identifiable subgroups as a function of gender,
race/ethnicity, and drug using characteristics. Cross-sectional
information may be collected as part of a well-defined strategy.
Efficacy data should focus on NEPs impact on HIV risk reduction as
well as other health-related and economic consequences of such
programs. These data may be qualitative in nature or may derive from
observational studies that attempt to control for diverse factors
related to risk reduction. Studies using a social network
perspective are encouraged.
Research should focus on the comparative effectiveness of existing
needle exchange programs in relation to the more standard needle
cleaning practices and other behavioral risk reduction programs.
Comparison of communities with NEP currently in place is encouraged
to evaluate the impact of such programs on relative risk reduction in
their communities and compare the rate of risk to communities
currently without such programs, taking into account differing HIV
prevalence rates, needle availability in the communities, and the
legality of accessing needles. Such studies, particularly those that
attempt to control as many potentially confounding factors as
possible, will enhance our understanding about the relative
consequence of various community-based intervention strategies.
It is critical to overcome some of the methodological limitations
surrounding the interpretation of data from previous research related
to evaluation of syringe exchange programs. For example,
methodologic issues often cloud the task of collapsing client
characteristics across studies (e.g., convenience sampling is only
adequate if it is a representative sample; random sampling avoids the
potential bias associated with convenience sampling). Careful
attention must be given to design, management, analyses, and
overwhelming limitations in implementing controlled random trials in
community based settings. Interpretation of some studies is
complicated by the choice of central tendency measures, with most
studies choosing to report the value of the median (without
descriptive qualifiers), which makes it impossible to access
information about the statistical 'outliers' (those clients who are
younger, or who inject more or less frequently). Additionally, there
would be an important advantage in comparing groups who have access
to needle exchange versus those who have no access as studies that
include comparison group(s) are able to provide a referent for
describing characteristics of clients. Where feasible, enhancing
ongoing studies focusing on the issues of needle hygiene and/or
needle/syringe exchange, is encouraged.
Investigators are required to offer HIV testing and counseling in
accordance with current guidelines to subjects identified 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.
Methodology
Independent information can include, but need not be limited to:
1. Macro Level Factors/Social Environment. Needle availability,
accessibility, and laws and regulations governing access to and
possession of paraphernalia in regards to both bleach distribution
and needle exchange programs and the effects of these factors on
needle sharing (direct and indirect), bleach distribution,
disinfecting equipment.
2. Social Context of Drug Using Behaviors. Characteristics of
injection locations (e.g., access to running water, bathrooms, etc),
types and amounts of drugs used, drug preparation techniques, types
of injection equipment used, factors that appear to limit or enhance
needle sharing and disinfection.
3. Social Network Factors. Research on the structural
characteristics of drug user networks are encouraged and norms that
govern these behaviors, characteristics of individuals present in the
injection situation (participants and nonparticipants); others with
whom the respondent injects (race/ethnicity, gender, relationships
that may affect the order of who injects first); cleaning or
disinfectant behavior if equipment is shared; conversations that
include discussions of HIV, AIDS, HIV prevention.
4. Micro Level/Individual Factors. Behavioral data on how
respondents usually acquire needles (access), and with what
difficulty (barriers); respondents' participation in an HIV
intervention program and what is recalled; individual changes in drug
use, injection, and disinfection behaviors over time; subgroup
changes in these behaviors; and intervention components, if any, that
account for the change.
5. Efficacy of Interventions. Evaluation of different behavior
change interventions and identifying subgroup characteristics as a
function of which intervention produces risk reduction, analyzing
changes in behavioral risk as a function of intervention, evaluating
the extent (with a special focus on the duration) of change as it
relates to type of intervention employed.
6. Demand for and Utilization of Risk Reduction Services. Bleach
distribution, impact of preventive services on adoption of preventive
behaviors. Cost associated with providing services to various at
risk populations.
7. Interface with Drug/Medical Treatment System. Evaluation of
effective methods of referral to medical and drug treatment;
evaluation of participation in the NEP on medical treatment
adherence; effects on probability and duration of drug relapse and
maintenance of risk reduction during relapse; effects of NEP sites
located close to drug treatment programs (methadone or drug free
programs), hospitals, psychiatric facilities, homeless shelters or
other facilities that attract concentrations of individuals who are
vulnerable to initiating drug injection, relapsing to drug use or
injection, having sex with injection users or becoming victims of
crime associated with injection users, effects on treatment seeking
and retention into treatment.
8. Program Design Issues. Influence on NEP program effectiveness of
hours of operation, distribution of bleach and condoms, distribution
of other paraphernalia, (e.g., cotton, cookers), access to HIV
testing and counseling and medical care on site, availability of
other social services, additional educational efforts, forms of
assurance of confidentiality/anonymity.
9. Equipment Infectivity and Sharing Issues. Use of a syringe
tracking and biological (e.g., HIV, hepatitis B virus, amount of
blood, blood type, antibody, DNA "fingerprint") testing system to
measure the effects of the NEP on levels of infectivity and sharing
as well as circulation times of syringes and effectiveness of
cleaning. Consistent NEP participants may be compared with samples
of inconsistent participants and non-participants with respect to
these parameters; sharing networks may be identified and tracked;
needle/syringe dynamics may be elucidated and equipment from
community sites may be compared with that distributed by the NEP.
Conceptual and methodological research from a social network
perspective is encouraged, and not only relying on the index subject,
but linked data to his or her drug user contact and other network
members will help to address unanswered questions.
In summary, qualitative and quantitative evaluations of NEPs should
contribute to our understanding about what works (intervention
components), in which communities does it work (given varying
epidemiological and social demographic characteristics), with whom
does it work (subgroups), and how much does it cost.
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
women 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 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 objectives 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 United States racial/ethnic minority populations
(i.e., Native Americans (including American Indians or Alaskan
Natives), Asian/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.
If the required information is not contained within the application,
the application will be returned.
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 AIDS-related
application deadlines as indicated in the application kit.
Application kits are available at most institutional offices of
sponsored research and may be obtained from the Office of Grant
Information, Division of Research Grants, National Institutes of
Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone
301-710-0267. The title and number of the program announcement must
be typed in Item 2a on the face page of the application.
The completed original and five permanent, legible copies of the PHS
398 form must be submitted 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 program 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 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.
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
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.
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:
Richard Needle, Ph.D., M.P.H.
Community Research Branch
National Institute on Drug Abuse
5600 Fishers Lane, Room 9A-30
Rockville, MD 20857
Telephone: (301) 443-6720
Direct inquiries regarding fiscal matters to:
Gary Fleming, J.D., M.A.
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
grants policies and Federal Regulations of Title 42 CFR 52 "Grants
for Research Projects", Title 45 CFR Part 74 and 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 be applicable to these awards. Title 42 Part 241(d)
"Certificates of Confidentiality and Communicable Disease Reporting"
will also apply. Program is not subject to the intergovernmental
review requirements of Executive Order 12372.
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