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

301-435-0714.  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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