STRATEGIES TO REDUCE HIV SEXUAL RISK PRACTICES OF DRUG USERS

NIH GUIDE, Volume 23, Number 14, April 8, 1994



PA NUMBER:  PA-94-054



P.T.





Keywords:



National Institute on Drug Abuse



PURPOSE



The purpose of this Program Announcement is to introduce a major

research effort to develop and evaluate the efficacy of multi-phase

behavioral change interventions designed to reduce high-risk sexual

practices among injection drug users (IDUs) and/or crack smokers.  It

is expected that by implementing strategies in different community

settings that are commonly utilized by drug users (e.g., primarily

neighborhood settings, but also drug treatment facilities, sexually

transmitted disease (STD) clinics, storefronts, etc.) there can be a

substantial decrease in the probability of HIV exposure by reducing

drug-related sexual risk behaviors.  As the AIDS epidemic enters the

midyears of the second decade, 339,000 cases of AIDS have been

reported to the Centers for Disease Control (CDC) as of September 30,

1993.  Of the women infected with the virus via heterosexual

intercourse, 60 percent reported their sexual partners to be men who

injected drugs.  Some of these male injectors were also at risk from

sexual contact with other men -- creating a bisexual "bridge"

population to women's infection.  Additionally, with many women being

infected through their own or their sexual partners' drug use,

heterosexual transmission of the virus from women to men is now

occurring more frequently than originally believed possible.  The

goal of this research is to gain knowledge about the social and

behavioral factors related to sexual risk taking and to develop,

implement, and evaluate strategies that reduce sexually and drug

related risk behaviors.



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 program

announcement, Strategies to Reduce HIV Sexual Risk Practices of Drug

Users, is related to the priority area of alcohol and other drugs.

Potential applicants may obtain a copy of Healthy People 2000 (Full

Report:  Stock No. 017-001-00474-0 or Summary Report:  Stock No.

017-001-00473-1) through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by 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.

Foreign institutions are not eligible for First Independent Research

Support and Transition (FIRST) (R29) awards.  Women and minority

investigators are encouraged to apply.  Applications 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) and FIRST (R29) award.

In addition, the Interactive Research Project Grant (IRPG) program

encourages the coordinated submission of related research project

grants and, to a limited extent, FIRST (R29) awards may be used (see

PA-93-078, NIH Guide, Vol. 22, No. 16. April 23, 1993).

Responsibility for the planning, direction, and execution of the

proposed project will be solely that of the applicant(s).  Support

will be provided for a period of up to five years (renewable for

subsequent periods) for R01s, subject to continued availability of

funds and progress achieved.  FIRST (R29) awards must be for five

years.  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.  R29 awards are capped at

$350,000 over a five-year period.



RESEARCH OBJECTIVES



Summary



Since initiating its Cooperative Agreement (U01) for AIDS

Community-Based Outreach/Intervention Research Program in 1990, the

National Institute on Drug Abuse (NIDA) has been monitoring the

HIV/AIDS epidemic in a population of out-of-treatment drug users

across the country.  Concurrently, other high-risk populations

(including drug users) across the country have been monitored by the

CDC.  Behavioral change interventions are still the most promising

prevention strategies available.  All participating sites in NIDA's

Cooperative Agreement program are participating in the development,

implementation, and assessment of the effectiveness of a variety of

community-based outreach intervention strategies to decrease viral

transmission among IDUs and users of crack cocaine.  The programs at

CDC extend these efforts by including other high-risk populations.



Since these program began, many changes have occurred in community

ecologies of risk (social and biological environments) related to HIV

and drug use.  A good deal of knowledge has accrued about preventing

the spread of HIV through behavior change interventions (e.g., NIDA,

1993a, 1993b, 1993c; CDC, 1992, 1993).  The focus of NIDA's

behavioral interventions has been to facilitate IDUs to reduce their

HIV risk behaviors (i.e., to reduce drug use and to increase use of

sterile needles)--for which the interventions appear to have been met

with success.  There is less understanding about sexual risk taking

and success in reducing risky sexual behaviors of injection drug

users and crack smokers.  For example, preliminary data from NIDA's

Cooperative Agreement program (N=6161) show that approximately 75

percent of drug users interviewed reported they were sexually active

in the last 30 days, with almost two-thirds reporting no condom use,

and 50 percent reporting that they had engaged in more than 11

unprotected sexual acts with more than two partners.  Because these

practices did not change significantly, the risk of HIV continues to

threaten the health and well-being of many drug-using persons and

their sexual partners.



Findings from NIDA-sponsored and other research programs have

demonstrated that a range of risk reduction interventions have been

effective in facilitating at-risk injection drug users to enter into

treatment, to reduce drug use, not to share needles, and/or to

disinfect needles prior to re-using them.  There is a compelling need

to improve behavior change strategies to promote HIV related

risk-reduction behaviors and help drug users who have made positive

changes to maintain them and not relapse into greater risk.  The

challenge is to encourage drug users and their sexual partners to

adopt and practice sexual behaviors that reduce their own risks and

their partners' risks for acquiring or transmitting HIV infection.

It is NIDA's intention to support the development, refinement, and

evaluation of innovative interventions which retain a focus on

reducing HIV related drug risks but that are particularly aimed at

eliminating or reducing high risk sexual behavior in the following

high-risk groups:  (1) individuals or networks of sexually active

male and female heterosexual/bisexual/gay injection drug users

(IDUs), crack cocaine users, and/or poly-drug users; and (2)

individuals or networks of male and female IDUs, crack cocaine users

and poly-drug users who exchange sex for money or drugs for sex.



There is a need to improve behavior change strategies, particularly

with respect to high-risk sexual practices, to reduce the further

spread of HIV. NIDA wishes to expand current research efforts by

phasing in and evaluating approaches that focus on reducing drug

risks and are aimed at eliminating or reducing high risk sexual

behavior.  The complexity of sexual and drug-related risks should be

acknowledged when developing appropriate interventions; that is,

risks related to different drugs and multiple injection and

disinfection practices in combination with a range of sexual

behaviors including condom use, number of partners, and partners' HIV

status.  For strategies to be potentially effective and

interpretable, they should be guided theoretically and should target

sexual risks of drug users and/or their partners or networks of

sexual and drug using companions or communities in which sexual

behaviors or norms are enacted or maintained.  Multiple level,

multi-component intervention strategies are encouraged.



Program Description



It is important to understand the extent to which HIV prevention

efforts are needed, already exist, or can be developed and can be

effective for sexually active drug users at risk for HIV/AIDS.  To

this end, NIDA considers epidemiologic, ethnographic, and evaluation

perspectives critical aspects of a multi-phase research effort.  CDC

also supports this approach.  Baseline and longitudinal ethnographic,

sociobehavioral and/or epidemiologic data are needed to identify and

monitor the nature and extent of sexual and/or drug-related risk

behaviors and their interactions, as well as the social settings or

relationships that affect these behaviors.  These data may be

qualitative in nature, using ethnographic field observations and/or

interviews, or they may derive from survey or other quantitative

research.  Baseline and longitudinal epidemiologic data are also

needed on the serostatus of identifiable subgroups as a function of

their risk characteristics. Investigators shall use these

epidemiologic and ethnographic data to develop and refine appropriate

sexual risk reduction interventions.  Finally, controlled evaluation

efforts are necessary to assess the effectiveness of prevention

projects in eliminating or reducing sexual risk behavior and

maintaining risk reduction behavior.  Evaluation efforts may also be

directed at modeling program effects on HIV serostatus.  This program

announcement can be viewed as complementing other Program

Announcements, i.e., Drug Abuse Aspects of AIDS, PA-93-098; Partner

Notification to HIV-Infected Drug Users, PA-93-111; and Research on

Needle Hygiene and Needle Exchange Programs (NEP), PA-94-010 in which

NIDA and CDC have collaborated.



Many previous HIV prevention studies have relied on behavioral change

models that focus on the individual to change high-risk behavior or

utilize generalized approaches to behavior that is not specific to

sexual practices, gender differences, or cultural differences that

influence the social context of risk taking.  Applicants are

encouraged to pay attention to social factors that influence changes

in sexual practices and involve not only individual drug users but

can also involve couples, groups, or communities in which sexual

behaviors or norms are practiced and maintained.  Prevention behavior

change strategies can include, but need not be limited to:

cognitive-behavioral skills training models, community/social norm

change models, community mobilization efforts, diffusion of

innovation models, and/or social networks approaches.

Multidisciplinary perspectives are highly encouraged as is

collaboration between researchers, populations at risk, and

community-based organizations.



Phase I exploratory studies are sought to link macro (community,

group, or network) and micro (individual) level factors influencing

safer sex practices and reduce exposure to HIV by (1) identifying the

nature and antecedents of sexual risk taking and change; (2)

developing (or adapting) behavioral and/or social interaction models

that are theoretically based and that are specifically designed to

change high risk sexual practices (e.g., multiple partners,

unprotected sex), antecedent cognitive and social conditions under

which unsafe sex occurs (e.g., being high, lacking condoms), or

relationship norms that maintain risky practices or affect

negotiations over safe sex (e.g., casual versus steady partners,

paying versus nonpaying partners); and (3) developing and pilot

testing materials, interventions, strategies and methods of locating,

engaging and retaining individuals or networks of crack smokers and

injection drug users with elevated risk of transmitting HIV through

unsafe sexual activities.



Interventions must take into account gender, race/ethnicity, sexual

orientation, and/or risk behaviors and the social context in which

the individual behaviors occur.  We anticipate that multiple

intervention strategies will be needed to take into account the

behavioral heterogeneity among subpopulations at risk for HIV as well

as the varying HIV seroprevalence of different communities.

Applications should address such issues as gender-based outreach

strategies, culturally appropriate HIV prevention strategies, and for

behaviorally and socially specific interventions.



Phase II implementation and evaluation (quantitative and qualitative)

will include interventions developed in Phase I.  Evaluation will

require research plans that include measurement of project

implementation and compliance with protocol, estimates of sample size

and periods of data collection, plans for minimizing attrition,

strategies for client followup, specification of variables to be

analyzed and measures to be used, statistical techniques to be

employed, a discussion of the strengths and weaknesses of the

analytic strategies, as well as a strategy for component analysis to

identify the most and least effective parts of the intervention.  In

addition to measuring specific behaviors, norms, and other outcomes,

the evaluation research must separately analyze intervention effects

by specific subgroups who are at risk for HIV and must be sensitive

to potential negative effects of the project.  The final defining

characteristic of Phase II research is the replicability of the

selected intervention and the development of mechanisms for its

operationalization at other sites.  Attention must focus on the

process of implementation and impact on the target populations to

help us better understand the dynamics of behavior change.



It is critical to address methodological restrictions that can limit

the contributions of Phase I or Phase II research to understanding

HIV prevention.  Much information can be gained if the interventions

are theoretically grounded, specific behaviors clearly identified and

measured, design issues related to sampling, attrition, and followup

specifically planned or controlled and intervention strategies are

specific to the behaviors targeted for change.



It should be noted that the NIDA has developed a valid and reliable

questionnaire (Risk Behavior Assessment) that may be modified and

used to obtain drug and/or sexual risk information in the proposed

study.  Attention to using the most advanced strategies (new

technologies for identifying, accessing, recruiting hidden

populations and for data collection and transfer) are encouraged.  As

well, CDC has additional questionnaires.  If the applicant plans to

modify any currently used instrument, s/he should include an

explanation of how validity and reliability will be assessed on the

revised instrument.



Confidential voluntary HIV antibody testing must be made available to

all study participants.  The NIDA will work closely with each project

to ensure the smooth operation of this requirement.  PHS Policy

requires that every effort be made to inform persons who are tested

of their HIV results.  Policy also requires that counseling and

treatment be provided to all persons testing positive for HIV

infection, and that retesting after six months be offered all persons

testing negative.  Detailed protocols for implementing HIV testing

and pre- and post-test counseling have been previously described by

NIDA and CDC and will be made available upon request.



As noted in this section, NIDA and CDC have collaborated, and will

continue to collaborate, in the development and implementation of

this program announcement.



STUDY POPULATIONS



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 new

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 9, 1994 (FR 59 11146-11151), and reprinted

in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18,

1994.



Investigators may obtain copies from these sources or from the

program staff or contact person listed below.  Program staff may also

provide additional relevant information concerning the policy.



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 Grants

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



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 National 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, program needs and balance, 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

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.  This program is not subject to the

intergovernmental review requirements of Executive Order 12372.



References



National Institute on Drug Abuse 1993a The Behavioral Counseling

Model for Injection Drug Users.  Rockville, MD: The National

Institute on Drug Abuse.



National Institute on Drug Abuse 1993b The Indigenous Leader Outreach

Model.  Rockville, MD: The National Institute on Drug Abuse.



National Institute on Drug Abuse 1993c The NIDA HIV Counseling and

Education Intervention Model.  Rockville, MD: The National Institute

on Drug Abuse.



.

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