DETERMINANTS OF EFFECTIVE HIV COUNSELING

NIH Guide, Volume 22, Number 17, April 30, 1993



PA NUMBER:  PA-93-080



P.T. 34



Keywords:

  Drugs/Drug Abuse 

  Social Psychology 

  Behavioral/Social Studies/Service 



National Institute on Drug Abuse



PURPOSE



The purpose of this program announcement is to initiate and support a

research program that focuses on understanding the psychological,

behavioral, interpersonal, and motivational factors that enhance or

retard the effectiveness of HIV counseling and testing activities in

drug abusers, their sexual partners, and others at risk of HIV

infection who could potentially benefit from counseling and testing

activities.



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, Determinants of Effective HIV Counseling, is related to

the priority area of reducing HIV transmission.  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 organizations, public and private, such as universities,

colleges, hospitals, laboratories, units of State and local

governments, and eligible agencies of the Federal government.

Applications from minority individuals and women are encouraged.

Foreign institutions are not eligible for the First Independent

Research Support and Transition Awards (R29).



MECHANISMS OF SUPPORT



Research support mechanisms include research projects grants (R01),

small grants (R03), and FIRST awards (R29).  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



Background



Initial efforts to prevent the spread of HIV infection were a response

to a public health crisis, and resource priorities were given to

informing, educating, and warning rather than to evaluating the

effectiveness of programs.  Prevention programs began to incorporate

evaluation components, using "pretest/post-test" designs and, later,

randomized trials of effectiveness.  Although there is now a growing

body of literature comparing the effects of different HIV risk

reduction counseling approaches, there is relatively little emphasis on

delineating the effective components of interventions and

systematically relating outcomes to the motivational, psychological,

behavioral, and interpersonal development theories that form the basis

of those components.  Sophisticated evaluation of counseling and

testing programs in relation to their theoretical underpinnings would

allow for better understanding of why and for whom a particular

intervention has effects.  To develop intervention models more

effectively that can be readily transferred to the general HIV

prevention community, it is necessary to "open the black boxes" of

prevention programming to understand better the mediating factors

associated with success.



Research is needed that examines the relationships among risk reduction

outcomes, theoretical mediating variables, fidelity of implementation

of prevention program, the social and environmental context in which

the intervention is delivered, and the social/environmental context of

the client's life.



Treatment of addiction, street outreach to provide education and to

facilitate entrance into drug treatment, and clinic-based counseling

and testing programs continue to be the mainstays of HIV prevention

activities for drug abusers, especially injection drug users (IDUs),

and their sexual contacts.  While most counseling and testing programs

report changes in drug abuse related risk behaviors, and to a lesser

degree in sexual risk behaviors, many comparisons between relatively

minimal interventions and more extensive interventions based on

well-known theories relevant to health behavior have not shown

differential effects of the interventions.



The most commonly used theories to design prevention interventions are

the Health Beliefs Model, the AIDS Risk Reduction Model, and the Theory

of Reasoned Action.  Yet, there are other theoretical perspectives that

might be usefully applied to HIV prevention efforts, such as

conceptualizations of social group processes, psychotherapy/counseling,

personality development, communication, motivation, and drives.



Examples of variables that need to be systematically examined in HIV

counseling are characteristics of the client (demographics, serostatus,

psychological variables), characteristics of the message (mediators),

and characteristics of the intervenor (e.g., similarity to client,

race, history of drug abuse, gender, personality).  The social context

of the client has been examined in some studies, but it has not been

examined extensively for its interaction with other variables of

interest such as type of intervenor, type of message, etc.  Technology

for examining these issues exists in social psychology, studies of

psychotherapy, communication research, and related fields.



Prevention programs are often directed at people with marginal support

systems and with few intrapersonal or interpersonal resources.  The

possibility of negative effects of HIV counseling has been examined

from the viewpoint of negative affective sequelae of the intervention

and short-term increases in risk behavior, but long-term studies of

possible negative effects on risk behavior, psychosocial adjustment, or

disease acquisition and transmission are few.  Studies have not

extensively examined the determinants of negative behavioral

consequences of interventions in drug abusers.



Program Objectives



The primary objective of the Program Announcement is to understand the

determinants of effectively using HIV testing and counseling as a

prevention intervention in drug abusers, their sexual partners, and

others at risk for HIV infection.  Determinants of negative behavioral

outcomes should also be examined.  Risk behavior should be a primary

outcome variable.  In addition, other variables to be investigated

should be drawn from potentially relevant theories of human behavior

and development, and these should be defined, measured, and manipulated

using standardized methodology.  Applications would ideally include a

component whereby differential and mutually exclusive outcomes

predicted by theories of psychological development or psychological

change are examined and related to risk reduction.  For example,

counseling theory would suggest that a counselor who reveals strong,

current ambivalence about facets of his or her own development,

upbringing, or behavior may "reenact" those issues in provision of HIV

risk reduction counseling, thereby failing to achieve effective risk

reduction.  An outcome inconsistent with this theory would be that the

ambivalence would not be evidenced in the interpersonal processes in

the counseling or would not be related to behavioral outcomes.

Applications that attempt to evaluate the effectiveness of a specific

intervention and advance theoretical understanding will be considered

responsive to the intent of this announcement.  Although prospective

studies are encouraged, retrospective studies that examine outcome,

process, and social context variables of programs with documented

successful impact on risk behaviors will also be welcomed.



If the study is planned for a drug treatment program, the proposed

intervention(s) should consist of HIV counseling and testing activities

rather than the treatment of drug abuse itself.  If an applicant elects

to use an out-of-treatment sample, the application should provide

details on the logistics of how adequate information could be

collected.  Consideration could be given to use of treatment samples to

fully explore issues of interest while out-of-treatment samples are

used to replicate and generalize where feasible.



Prospective studies as currently envisioned should incorporate:  (1)

theoretical and operational definition of relevant constructs, with

attention to use of consistent, reliable, and valid measures of

independent and dependent variables; (2) random assignment of clients

to counselors or intervention; (3) study of client cognitions, affects,

perceptions, and behaviors; (4) study of counselor cognitions, affects,

perceptions, and behaviors; (5) statistical or design methods for

accounting for and explaining the effects of counselor training and

technique; and (6) sufficiently thorough description of an intervention

to permit replication, with documentation of the fidelity with which

the intervention is implemented.



The specific areas of interest include, but are not limited to:



a.  Factors that create effective HIV testing and counseling processes

from both the client's and counselor's perspective.

b.  Factors that produce negative outcomes in HIV testing and

counseling processes from both the client's and counselor's

perspective.

c.  Why some risk reduction interventions and intervenors (counselors)

are effective and some are not.

d.  Enhanced methodology for measuring relevant risk related

psychosocial variables.

e.  Delineation of the circumstances in which HIV counseling and

testing has a positive impact, and those in which it has a negative

impact.

f.  Clarification of the relative contribution of the counseling

component to outcomes of "counseling and testing programs," and,

conversely, clarification of the relative contribution of the testing

component to outcomes.

g.  Factors that predict and prevent testing refusal, non-return for

results, deficient learning of critical information, denial of

vulnerability, concealment of attitudes or risk behaviors from

counselors, and failures to develop resistance to risk behavior

relapse.

h.  Interactions between HIV testing and counseling and drug abuse

treatment.

i.  Sexual and drug risk behavior interactions that decrease or

increase overall risk.

j.  Factors related to counseling influencing the risk behaviors of

those who are HIV infected.

k.  Variables that, when studied in the context of HIV counseling and

testing, have implications for advancing theoretical understanding of

human behavior and behavior change processes.



Special Requirements



Grants funded under this program announcement are subject to the

requirements of 45 CFR 46, Protection of Human Subjects.  If the

proposed research includes children as the subject population described

in 45 CFR 46, subpart D, special human subject considerations apply.

These regulations are available from the Office for Protection from

Research Risks (OPRR), National Institutes of Health, Building 31, Room

5B63, Bethesda, MD 20892, telephone 301/496-8101.  Because of the AIDS

relevance of this research, applicants should obtain from their

institutional review board (IRB) a copy of the "Guidance for

Institutional Review Boards for AIDS Studies," which was disseminated

from the OPRR on December 16, 1984.  If a copy is not available

locally, one may be obtained from OPRR at the address and number above.



Because of the expedited schedule of review and award for these

applications, applications from organizations having an approved

Multiple Project Assurance of Compliance on file with the OPRR must be

accompanied by certification of IRB approval.  The latest date of

approval by the IRB of the proposed activities must be not earlier than

one year prior to the receipt date called for in this announcement.  If

appropriate certification of IRB approval is not provided with the

proposal at the time of submission, the application will be considered

incomplete and returned to the applicant without review.



If the applicant organization does not have on file with OPRR an

approved Multiple Project Assurance of Compliance, the applicant

organization, by the signatures on the Face Page of the application, is

declaring that it will comply with 45 CFR 46 by establishing an IRB and

submitting an Assurance of Compliance and certification of IRB approval

within 30 days of a specific request from OPRR.



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 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 Office of Grants Inquiries, Division of Research Grants, National

Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892,

telephone:  301/710-0267.  The title and number of this announcement

must be typed in Item 2a on the face page of the application.



The completed original application and five legible copies must be sent

or delivered to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW PROCEDURES



Applications will be assigned on the basis of established PHS referral

guidelines.  Applications will be reviewed for scientific and technical

merit by an initial review group in accordance with standard review

procedures.



AWARD CRITERIA



Applications will compete for available funds with all other

applications recommended for further consideration by the appropriate

National Advisory Council.  The following will be considered in making

funding decisions:



o  Quality of the proposed project as determined by the peer review;

o  Availability of funds; and

o  Program balance among research areas of the announcement.



INQUIRIES



Written and telephone inquiries are encouraged.  The opportunity to

clarify any issues or questions from potential applicants is welcome.



Applicants interested in studies relevant to drug abusers and their

sexual partners may direct inquiries regarding programmatic issues to:



William C. Grace, Ph.D.

Division of Clinical Research

National Institute on Drug Abuse

5600 Fishers Lane, Room 11A-33

Rockville, MD  20857

Telephone:  (301) 443-1801



Inquiries regarding fiscal matters related to drug abuse relevant

studies may be directed to:



Mrs. Shirley Denney

Grants Management Branch

National Institute on Drug Abuse

5600 Fishers Lane, Room 8A-54

Rockville, MD  20857

Telephone:  (301) 443-6710



Applicants interested in other populations, may direct inquiries

regarding programmatic issues to:



M. Isabel Fernandez, Ph.D.

Office on AIDS

National Institute of Mental Health

5600 Fishers Lane, Room 15-99

Rockville, MD  20857

Telephone:  (301) 443-7281



Inquiries regarding fiscal matters related to NIMH applications may be

directed to:



Diana Trunnell

Grants Management Section

National Institute of Mental Health

5600 Fishers Lane, Room 7C-23

Rockville, MD  20857

Telephone:  (301) 443-3065



AUTHORITIES 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 at 42 CFR 52 and 45 CFR Part 74.  This program

is not subject to the intergovernmental review requirements of

Executive Order 12372 or Health Systems Agency review.  Grants must be

administered in accordance with the PHS Grants Policy Statement (rev.

10/90).



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