BEHAVIORAL RESEARCH IN SEXUALLY TRANSMITTED DISEASES

NIH GUIDE, Volume 22, Number 32, September 3, 1993



PA NUMBER:  PA-93-108



P.T. 34



Keywords:

  Behavioral/Social Studies/Service 

  Sexually Transmitted Diseases 

  Disease Prevention+ 



National Institute of Allergy and Infectious Diseases

National Institute of Child Health and Human Development

National Institute on Aging



PURPOSE



The National Institute of Allergy and Infectious Diseases (NIAID), the

National Institute of Child Health and Human Development (NICHD), and

the National Institute on Aging (NIA) invite applications for

intervention-oriented behavioral research on sexually transmitted

diseases (STDs).  The prevention and control of STDs relies on several

strategies:  blocking transmission, seeking early diagnosis and

treatment, utilizing available vaccines, and altering risk-associated

behaviors over the life course.  Each strategy has a behavioral

component that is critical to the success of STD prevention and

control.  Behavioral research to reduce the incidence, prevalence, and

severity of STDs should include multidisciplinary efforts that

incorporate the measurement of microbiologic and/or disease outcomes as

well as behavioral outcomes.



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, Behavioral Research in Sexually Transmitted Diseases, is

related to the priority area of sexually transmitted diseases.

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

Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary

Report:  Stock No. 017-001-10473-1) through the Superintendent of

Documents, Government Printing Office, Washington, DC 20402-9325

(telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by domestic and foreign, non-profit and

for-profit research institutions; public and private organizations such

as universities, colleges, hospitals, laboratories, units of State and

local governments, and eligible agencies of the Federal government.

Applications from minority and female investigators are encouraged.

Foreign institutions are not eligible for the First Independent

Research Support and Transition (FIRST) award (R29).



MECHANISM OF SUPPORT



This program announcement will use the National Institutes of Health

(NIH) investigator-initiated research project grant (R01) and the FIRST

Award (R29).  Responsibility for the planning, direction, and execution

of the proposed project will be solely that of the applicant.  The

maximum duration of support for a given project period is five years.

Investigators interested in collaborative and interactive research

efforts around the central theme of behavioral research for the

prevention and control of STDs may consider submission of interactive

research project grants (IRPGs).  Such investigators should first

contact NIH program staff listed under INQUIRIES for advice on this

mechanism and the method of application.



RESEARCH OBJECTIVES



Background



In November 1989 and April 1990, the NIAID convened two

interdisciplinary conferences on integrated behavioral research for the

prevention and control of STDs to develop an intervention-oriented

behavioral research agenda.  The reports of these conferences are found

in Appendix 1 of Research Issues in Human Behavior and Sexually

Transmitted Diseases in the AIDS Era, Washington, DC:  American Society

for Microbiology, 1991, available from the publisher.  The research

objectives of this program announcement are based on the

recommendations of those conferences.



Magnitude and Impact of STDs



Despite control efforts to prevent the spread of STDs, including human

immunodeficiency virus (HIV) infection, both bacterial and viral STDs

remain epidemic in many areas of the United States.  Current estimates

predict that there will be 10 to 13 million new cases of STDs this

year, not including HIV infection.  Associated costs are likely to

exceed $5 billion.



Complications of STDs include infertility, ectopic pregnancy,

anogenital cancer, fetal wastage, low birth weight, and

congenital/perinatal infection.  Furthermore, recent studies indicate

that ulcerative diseases as well as the more prevalent non-ulcerative

STDs increase the risk of HIV transmission at least three- to

five-fold.



The long-term sequelae of STDs cause significant morbidity and

mortality, and women and their infected infants bear much of the

associated disease burden.  Additionally, STDs disproportionately

affect the health of several minority populations and a significant

proportion of adolescents in the United States.  Both the incidence of

STDs and their long-term, potentially fatal sequelae are consistently

higher among black and Hispanic Americans than among white Americans.

Over 60 percent of all STD cases occur in people less than 25 years of

age, and 3 million teenagers are infected with an STD each year.



Transmission Dynamics



The persistence, spread, and progression of STDs are related not only

to biological factors but also to behavioral and social factors.

According to May and Anderson's model on transmission dynamics, the

reproductive rate of infection or the average number of sexually

transmitted infections generated by an infected person is a function of

(1) transmission probability, (2 contact rates, and (3) duration of

infectiousness.  In addition to biological factors, transmission

probability is affected by the type and frequency of sexual behavior

and the extent to which each behavior facilitates transmission.

Contact rates are a function of the absolute number of partners as well

as the characteristics of sexual partners encountered over a specified

period of time.  Duration of infectiousness, or the period of time

during which an individual remains infectious, is determined by

recognition of symptoms or risk and health-seeking behaviors, which

lead to diagnosis and treatment.



Behavioral interventions to prevent the acquisition, spread, and

progression of STDs are associated with all three elements of May and

Anderson's model.  Decreasing transmission probability requires

changing individuals' behaviors, including decreasing or eliminating

sexual behaviors known to facilitate STD transmission and increasing

condom use behavior.  Decreasing contact rates calls for reduction in

the number of sexual partners.  Decreasing the period of infectiousness

can be accomplished through symptom recognition, risk awareness, and

increased health-seeking behavior as well as use of effective vaccines.



STD Prevention and Control Strategies



The ultimate outcome of behavioral research activities will be the

design, implementation, and evaluation of interventions to decrease

behaviors associated with STD risk and to increase health-seeking

behaviors.  The sequential research steps needed to build effective

interventions are:



1.  basic research to define antecedents associated with specific

behaviors (including beliefs, perceptions, and motivations);



2.  development of hypotheses derived from basic research concerning

new approaches to STD prevention, treatment, and control;



3.  pilot tests of intervention components on small, well defined

samples;



4.  experimental or quasi-experimental tests of complete interventions

(formed from several components evaluated in pilot tests) to detect

behavioral and microbiological effects.



It should be noted that some of the behavioral research that has been

conducted for HIV/AIDS prevention may augment or accelerate basic

research or hypothesis development related to other STDs.  For example,

frequency of unprotected intercourse, number of sexual partners, and

asymptomatic infection similarly affect the transmission dynamics of

all STDs, including HIV infection.  However, antecedents of preventive

action may differ for STDs that are fatal (e.g., HIV infection),

compared to those that incur long term consequences (e.g., pelvic

inflammatory disease or genital herpes), or those that present only as

an acute disease without long term sequelae (e.g., treatable bacterial

STDs).  Moreover, the factors that affect duration of infectiousness

are different for HIV and many STDs.  Infectiousness may be limited by

curative therapy for bacterial STDs, and there is an available vaccine

for one viral STD (hepatitis B).



While the scientific areas covered in the following research objectives

are very broad, it is not expected that any single application will

cover the range of scientific areas described below.  Applicants are

encouraged to focus their investigations.



A.  Decrease Transmission Probability and Contact Rates



The goal of research to decrease transmission probability and contact

rates is to reduce risk of exposure to and acquisition of STDs through:

(1) postponing coital debut; (2) reducing frequency of sexual practices

associated with higher rates of transmission; (3) reducing numbers of

sexual partners; and (4) increasing use of barrier contraceptives

(e.g., condoms).  While other NIH programs support research on these

behaviors for HIV prevention (see addendum section), research targeted

by this program announcement focuses on the reduction of the incidence,

prevalence, and severity of STDs other than HIV and should include

microbiologic and/or disease outcomes as well as behavioral outcomes.



1.  Individual Factors:  To change behaviors that put people at risk

for STDs or their sequelae, individuals must recognize that there is a

problem in their environment that is both serious and personally

relevant; be motivated to act; and have the relevant knowledge, skills,

and tools to undertake recommended action.  Specific areas for research

include, but are not limited to:



o  identification of antecedents and determinants of behaviors relevant

to STD risk reduction in different populations (i.e., does the threat

of PID and its sequelae motivate women to take preventive action

against STDs);



o  ascertainment of optimal content, format, and venues for delivering

information about acquisition and transmission of STDs and the serious

consequences associated with these infections (i.e., what

misperceptions about STDs are related to sexual risk taking, how is

information concerning STDs conveyed through formal and informal

networks of communication, and how can these networks be used to

deliver programs that will result in a decrease in incident disease);



o  identification of skills needed to prevent STD transmission and

optimal mechanisms to impart those skills (i.e., what is the best way

to increase consistent condom use among individuals with genital herpes

who may be asymptomatic but shedding virus).



2.  Environmental Factors:  In addition, impediments in the social

environment must be identified and removed or diminished if individual

behavioral change to reduce risk of STDs is to be initiated and

sustained. Thus, research may focus on the individual as the target of

the intervention or larger social structures.  Specific areas of

STD-related research on environmental factors may include:



o  determination of key norms that govern behaviors associated with STD

transmission and development of strategies to modify them (i.e., what

are the norms governing sexual intercourse during treatment for a

bacterial STD, how do they vary by subpopulation, and what intervention

strategies would be effective to modify them);



o  increase the adoption and diffusion of new and existing technologies

to prevent STDs, such as barrier methods, that are compatible with

human skills, dispositions, and perceptions related to STDs, including

those technologies that can be controlled exclusively by women (i.e.,

what characteristics of vaginal suppositories enhance or discourage use

among women, and which should be considered in the development of new

topical microbicides to prevent STDs).



On the basis of the findings of this research, STD interventions that

target either individuals, groups, or the social environment will then

be designed, implemented, and evaluated.



B.  Decrease the Duration of Infectiousness



The goal of research in this area is to decrease the infectious period

through increasing health-seeking behaviors leading to early diagnosis

and treatment of STDs.



1. Diagnosis and Treatment:  Behavioral research is needed to increase

appropriate use of diagnostic tests.  Given the high prevalence of

asymptomatic disease, effective strategies should encourage individuals

to seek STD screening on the basis of recognition of risk-related

behavior rather than symptoms, which may not be present or recognized.



For treatment to be effective, the patient must comply with the

prescribed regimen.  Optimal treatment for STDs includes taking

medication, abstaining from sex during treatment (i.e., until the

infection is no longer transmissible), referring partners for

screening, and returning for follow-up screening or care after

treatment, as necessary.



Examples of research areas of interest include, but are not limited to,

the following, and all should include both behavioral and microbiologic

outcomes:



o  identification of antecedents and determinants of health-seeking

behaviors that lead to STD diagnostic screening and medication

compliance;



o  determination of level of current knowledge about benefits

associated with screening, early treatment and medication compliance,

and identification of misperceptions and other barriers to use;

determination of optimal content, format, and venues for information

delivery about screening and treatment;



o  development of behavioral instruments accompanied by microbiologic

or disease measures that can (1) identify women at risk for repeat

infection, (2) distinguish women with infection limited to the lower

genital tract from those at risk for progression to upper genital tract

infection, and (3) distinguish women with upper tract infection from

those at risk for chronic sequelae;



o  determination of characteristics of health care provider-patient

interaction that support and sustain diagnostic screening and

compliance with treatment;



o  identification of barriers (from the perspective of both the patient

and the health care provider) to appropriate use of screening and

treatment; and



o  ascertainment of the impact of product characteristics (e.g.,

programmed timers to prompt pill taking) on medication compliance.



2.  Vaccination:  It is likely that vaccines for several STDs will be

available by the end of this decade.  To make full use of these

powerful tools there is a critical need to dissect and understand the

behavioral aspect of vaccine acceptance and compliance.  Poor

acceptance of the hepatitis B vaccine underscores this need.

Immunization for hepatitis B has been available since 1982, yet the

overall impact on incidence has been negligible.  Rates of infection

remain high even among high risk groups (i.e., homosexual men).  Lack

of use and poor compliance with the hepatitis B vaccine regimen

underscore the need for research on the complex processes by which an

individual arrives at a decision to either accept or decline

immunization. This information will be essential in the development of

clinical trial protocols and will be critical in increasing the

likelihood of use of approved STD vaccines.  Examples of research areas

of interest include, but are not limited to:



o  identification of antecedents, determinants, and motivators of

vaccine acceptance and compliance;



o  measurement of current knowledge about benefits associated with STD

vaccine acceptance and identification of misperceptions and other

barriers to use;



o  determination of optimal content, format, and venues for information

delivery about vaccine availability; and



o  determination of characteristics of patient-provider interaction

that support and sustain vaccine acceptance and compliance.



Research to decrease the duration of infectiousness should produce

detailed and specific information concerning increased use of diagnosis

as well as acceptance of and compliance with treatment and vaccination.

These findings will point to elements of interventions that are

appropriate for pilot testing.  Promising elements can then be folded

into more complete interventions, which will be implemented and

evaluated in experimental trials.



Study Design Considerations



In requiring investigators to measure both behavioral and disease or

microbiologic outcomes, investigators will need to establish linkages

to clinical settings where diagnostic capabilities are present.

Treatment becomes an issue (1) if signs or symptoms make disease

apparent, or (2) if infection is detected upon screening.  In either

case, consideration must be given to providing treatment.  In addition,

intervention research that results in significant benefit to cases

should make provisions to provide a similar program to subjects who

served as controls.



However, other appropriate research designs may go beyond the clinical

setting.  For example, investigators may wish to consider epidemiologic

research or add a component to an ongoing epidemiologic study (i.e.,

piggybacking an STD component on an existing survey that includes the

collection of biologic samples).



Epidemiologic research that expands beyond traditional demographic

factors to include STD-related behaviors and infection status is

integral and complementary to intervention-oriented research.

Traditionally, epidemiologic surveys have focused on demographic and

ecologic risk factors, such as age, race, sex, and population density.

While these may be important indices of risk, they are not amenable to

change.  It is equally important that epidemiologic research monitor

behaviors that may have a demonstrated relationship to STDs and are

theoretically changeable.  In this way, epidemiologic findings will

identify which behaviors are important to consider in constructing

pilot programs.  Additional areas for research include, but are not

limited to:



o  epidemiologic studies focused on factors associated with

transmission probability and contact rates such as age of coital debut,

number of partners, as well as factors influencing selection of

partners from high risk populations; and



o  epidemiologic studies to identify sexual and other behaviors that

increase risk of transmission or disease progression (e.g., douching or

dry sex).



Within the context of the research objectives of this program

announcement, submission of applications that focus on methodologic

research to improve data collected on sexual behaviors, creating valid

and reliable indices of important outcome variables, and to probe

factors that affect the quality of these data are encouraged.



Clinical Assessment and Study Population



As stated earlier, applicants are required to assess change in relevant

behaviors and status of infection.  Therefore, proposed projects must

have ties to clinical facilities to characterize subjects with respect

to sexually transmitted pathogens including, but not limited to,

Chlamydia trachomatis, Neisseria gonorrhoeae, Treponema pallidum, human

papillomavirus (HPV), herpes simplex virus type 2 (HSV-2), and human

immunodeficiency virus (HIV). Although populations at risk for STDs are

also at risk for HIV, studies that focus exclusively on HIV are not

included under this program announcement.



Certain populations continue to be at greater risk of STD acquisition,

transmission, and progression, and they share a disproportionate burden

of related disease; applicants are encouraged to investigate research

questions in ethnic, racial, gender, and age groups as well as social

environments in which risk is greatest.  Special emphasis is placed on

inner-city minorities, women, and adolescents.



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 are 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 must 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 must 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 must be addressed in developing a research design

and sample size appropriate for the scientific objectives of the study.

This information must be included in the form PHS 398 under Research

Plan items 1-4 and item 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 and Pacific Islanders,

Blacks, Hispanics].  The rationale for studies on single minority

population groups should be provided.



For the purpose of this policy, clinical research is defined as 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

applicants 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

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 on the standard application deadlines

for investigator-initiated applications: February 1, June 1, and

October 1.



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 449 Bethesda, MD 20892, telephone

301-710-0267.  The title and number of the announcement must be typed

in Item 2a on the face page of the application and the "YES" box

marked.



Applications for the FIRST Award (R29) must include at least three

sealed letters of reference attached to the face page of the original

application.  FIRST Award (R29) applications submitted without the

required number of reference letters will be considered incomplete and

will be returned without review.



The completed original application and five legible copies must be sent

to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CRITERIA



Applications will be assigned on the basis of established PHS referral

guidelines.  Applications will be reviewed for scientific and technical

merit by relevant study sections of the Division of Research Grants,

NIH in accordance with standard NIH peer review procedures.  Following

scientific-technical review, the applications will receive a

second-level review by the appropriate national advisory council or

board.



INQUIRIES



The opportunity to clarify issues or questions from potential

applicants is welcome.  Direct inquiries regarding programmatic issues

to:



Heather Miller, Ph.D.

Sexually Transmitted Diseases Branch

National Institute of Allergy and Infectious Diseases

Solar Building, Room 3A-26

Bethesda, MD  20892

Telephone:  (301) 402-0443

FAX:  (301) 402-1456



Arthur A. Campbell

Center for Population Research

National Institute of Child Health and Human Development

6100 Executive Boulevard, Room 8B07

Bethesda, MD  20892

Telephone:  (301) 496-1101

FAX:  (301) 496-0962



Marcia Ory, Ph.D., M.P.H.

Behavioral and Social Research Program

National Institute on Aging

Gateway Building, Room 2C234

7201 Wisconsin Avenue

Bethesda, MD  20892

Telephone:  (301) 496-3136

FAX:  (301) 402-0051



Direct inquiries regarding fiscal matters to:



Mr. Todd Ball

Grants Management Branch

National Institute of Allergy and Infectious Diseases

Solar Building, Room 4B-22

Bethesda, MD  20892

Telephone:  (301) 496-7075



Ms. Melinda B. Nelson

Office of Grants and Contracts

National Institute of Child Health and Human Development

6100 Executive Boulevard, Room 8A17

Bethesda, MD  20892

Telephone:  (301) 496-5481



Ms. Vicki Maurer

Grants and Contracts Management Office

National Institute on Aging

Gateway Building, Room 2N212

Bethesda, MD  20892

Telephone:  (301) 496-1472



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic Assistance

No. 13.856 "Microbiology and Infectious Disease Research".  Awards are

made under authorization of the Public Health Service Act, Title IV,

Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241

and 285) and administered under PHS grants policies and Federal

Regulations 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.



ADDENDUM



The National Institute of Mental Health (NIMH) Office of AIDS Programs

supports research to better understand, assess, and treat the

neuropsychiatric, behavioral, and psychosocial aspects of HIV infection

and AIDS.  Preventing or changing high risk behaviors and maintaining

low risk behaviors are the only available strategies to prevent the

further spread of HIV infection.  The NIMH supports both

preintervention and intervention studies in its behavioral and

psychosocial program which includes identification of determinants of

high-risk sexual and drug-using behaviors; determinants of maintaining

low-risk behaviors, especially for hard-to-reach and special

populations; the social contexts in which risk-taking behaviors occur;

the impact of affective states (e.g., depression, anxiety, social

isolation) on risk behavior; the affects of cognitive impairment on

adherence to risk-reduction guidelines; the design, testing, and

evaluation of theory-driven behavioral interventions designed to

prevent and reduce high-risk behaviors for HIV infection and maintain

low-risk behaviors in children, adolescents, and adults; research on

interventions targeted to populations for which current research data

are not available; the promotion of help-seeking behaviors such as

counseling, social support, and early intervention services; adherence

to medical treatment for HIV infection among different populations; and

the psychological and psychosocial impact of HIV and AIDS upon

individuals, families, and communities.  For more information, contact:

Ellen Stover, Ph.D., Director, Office of AIDS Programs, National

Institute of Mental Health, Parklawn Building, Room 10-75, 5600 Fishers

Lane, Rockville, MD 20857, telephone (301) 443-7281.



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