Full Text HD-97-005
 
THE USE OF DUAL METHODS OF PROTECTION FROM PREGNANCY & STDS/HIV
 
NIH GUIDE, Volume 26, Number 21, June 20, 1997
 
RFA:  HD-97-005
 
P.T. 34

Keywords: 
  Contraceptives 
  Behavioral/Social Studies/Service 
  Sexually Transmitted Diseases 
  AIDS 

 
National Institute of Child Health and Human Development
 
Application Receipt Date:  September 24, 1997
 
PURPOSE
 
The NICHD invites applications for demographic and behavioral
research on behavioral determinants and consequences of individuals'
and couples' joint use of prophylaxis to prevent both pregnancy and
STD/HIV.
 
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 RFA is
related to the priority areas of family planning and the prevention
of HIV infection and STDs.  Potential applicants may obtain a copy of
"Healthy People 2000" (Full Report: Stock No. 017-001-0047400 or
Summary Report: Stock No. 017-001-0047301) through the Superintendent
of Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic and foreign for-profit and
nonprofit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government.
Racial/ethnic minority individuals, women and persons with
disabilities are encouraged to apply as principal investigators.  All
institutions may submit singly or in partnerships with two or more
groups.  Foreign institutions are not eligible for First Independent
Research Support and Transition (FIRST) (R29) awards.  MECHANISM OF
SUPPORT
 
This RFA will use the National Institutes of Health (NIH) research
project grant (R01), FIRST award (R29), and small grant mechanisms
(R03).  Responsibility for the planning, direction and execution of
the proposed project will be solely that of the applicant.  The total
project period for an application submitted in response to this RFA
may not exceed five years.  The anticipated award date is April 1998.
Because the nature and scope of the research proposed in response to
this RFA may vary, it is anticipated that the size of an award will
vary also.
 
This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all
investigator-initiated applications and be reviewed according to the
customary peer review procedure.
 
FUNDS AVAILABLE
 
NICHD has set aside $500,000 in direct costs to fund applications of
high scientific merit submitted in response to this request for
applications.  These applications will be reviewed and we expect to
fund two or three with sufficiently high scientific merit.  Levels of
support may increase in out years of the agreement. Although this
program will be provided for in the financial plan of the NIH, the
award of grants pursuant to this announcement is also contingent on
the availability of funds for this purpose.
 
RESEARCH OBJECTIVES
 
Summary
The goal of this request for applications is to encourage research
focussed on improving our understanding of how individuals and
couples behave to provide joint protection from unintended pregnancy
and STD/HIV. Research is needed on the psychological, social and
structural influences that increase or decrease such protective
behavior.  Proposals also could examine the interplay among the
various factors related to people's use of dual methods of protection
from pregnancy and disease.  Applications which propose to design,
implement, and evaluate theoretically grounded interventions testing
approaches to improving behavioral practices are also welcomed.
 
Background
Most heterosexual individuals who have sexual intercourse desire to
protect themselves from unwanted pregnancy most of the time.  At the
same time, almost all individuals all of the time wish to avoid
infection with diseases that can be sexually transmitted.  However,
many of the medical methods available for pregnancy protection do not
provide protection from disease, and the methods available for
disease prevention may not protect as well against unwanted
pregnancy.  Sterilization, IUDs, injectables, implants and oral
contraceptives provide no protection against disease, and the
protective effect of most existing female controlled barrier methods
-- caps, diaphragm, and foams/gels -- is not as well proven as is the
protective effect of condoms.  Furthermore, although a woman is able
to conceive a child only during a rather limited time each month, the
risk of disease transmission is more evenly distributed.
 
Public health messages encourage individuals whose behavior places
them at risk of exposure to HIV or other sexually transmitted
infections and unintended pregnancy to use condoms as well as an
effective pregnancy prevention method consistently and correctly.
However, existing data suggest that such dual use is not the norm.
For example, there is troubling information that women who have been
contraceptively sterilized, and are not in mutually monogamous
relationships, are failing to protect themselves against disease.
Other evidence suggests that condom use is less likely among women
who are using oral contraceptives.  Although recent evidence suggests
that the proportion of women using dual means of protection may have
risen, particularly among groups at elevated risk of infection,
relatively little is known about the factors that promote or inhibit
dual use, and the prevalence of consistent dual protection among
those at risk of both pregnancy and disease.
 
Willingness and ability to combine effective contraception with
disease protection may depend on a variety of factors, including
perceived and actual risk of pregnancy and disease, partnership
characteristics and dynamics, and other individual, social and
cultural influences.   For example, there are suggestions that
individuals who believe that their method of choosing sexual partners
protects them from exposure to disease are less likely to use
condoms.  However, such methods as are used -- "looks clean," "seems
trustworthy," or informal conversations or assumptions about sexual
histories, to name a few -- may provide little or no protection from
disease.  Understanding the psychological, social, and cultural
dynamics underlying decisions about dual method use is essential to
developing effective interventions for increasing protection against
disease and unintended pregnancy among at-risk individuals and
couples.
 
Research Sought
Applications must propose to examine the simultaneous use of two or
more medical or barrier methods to provide effective protection from
both disease and pregnancy during heterosexual intercourse.  One of
the methods must be a method of contraception that is highly
effective in preventing pregnancy when used alone (e.g., oral
contraceptives, IUD, implant or injectable contraception, emergency
contraception, male or female sterilization) or that is highly
effective when used in combination with condoms (e.g., other barrier
methods such as spermicides or the diaphragm).  The other must be the
male or female condom (both or which are recognized to have value in
preventing HIV transmission).  Throughout the remainder of the
announcement, the simultaneous use of two such methods will be
referred to as "dual method use." Applications which do not conform
to this definition will not be considered responsive to the RFA.
Dual method use may be contrasted with other patterns of
contraceptive use, including condom only, use of an effective medical
method only, or use of relatively ineffective or no methods.
 
Researchers are invited to address one or more of the following three
issues.
 
1.  The determinants of dual method use, including individual
characteristics and intentions, couple dynamics, contextual factors,
and the interactions among determinants at different levels.
 
o  Given the need to combine condom (or other barrier) use with
hormonal contraception or sterilization to achieve the highest levels
of protection against both pregnancy and disease among at-risk
sexually active people, what factors promote the consistent use of
multiple methods? How do individuals and couples balance pregnancy
prevention and disease prevention in making decisions about sexual
behavior and the use of methods to prevent pregnancy and/or disease?
How does this change over an individual's life course?
 
o  Psychological models of risk perception, motivation, and decision-
making may be useful elements of study designs.  However, applicants
are urged to consider, as well, the application of theoretical
approaches derived from other social science disciplines, integrating
these with psychological approaches where feasible and appropriate.
Such alternative approaches may provide useful frameworks for
addressing the influence of life course, social, and cultural
influences that affect dual method use.
 
o  Applicants are also encouraged to consider the development of
study designs that permit examination of dual method use at the
couple level.  Method use occurs in the context of a  relationship;
sexual intercourse involves two people.  What are the couple
interactions and couple characteristics that contribute to dual
protection?  Do these change over the life of the relationship?  How
do the circumstances under which sexual partnerships are formed and
the nature and the duration of such relationships affect the
perceptions of disease and pregnancy risk within a given partnership
and the protective behaviors that occur within it? Researchers are
encouraged to develop ways to obtain non-biased samples of couples of
various ages and in various stages of relationship formation.
 
o  Researchers may also consider factors in the larger social
context, including family, social networks, institutional structures
(e.g., access to health services), and cultural influences that may
govern behavior within the sexual dyad.  Situational influences on
dual method use -- such as alcohol consumption, drug use, and the
circumstances of sexual encounters, including reproductive histories
-- may also be considered.  These may vary in systematic ways with
contextual factors.
 
2.  The extent to which patterns of dual method use or non-use
increase risk of HIV infection.
 
o  Perceived and actual risk of HIV infection (or other sexually
transmitted infections (STIs) and pregnancy may be critical to
understanding patterns of dual method use and evaluating whether
existing patterns provide appropriate levels of protection.
Investigators may want to consider indicators of risk as:  (a)
objective indicators, such as prior fertility/infertility history and
current menstrual status, knowledge of own and partner's disease
history and serostatus, and prevalence of HIV and other STIs in the
local community or sexual network; (b) individuals' and partners'
perceptions of risk of pregnancy and HIV/STI; and (c) risk-modifying
or risk-controlling behaviors that may modify actual or perceived
risk, such as regular HIV testing of both partners, degree of sexual
exclusivity, frequency and timing of intercourse, and the explicit
use of partner selection criteria believed to screen out risky
partners.
 
3.  Identification and evaluation of promising approaches to
increasing the prevalence and consistency of dual method use where
appropriate.
 
o  How can behavior-change intervention programs and health care
providers improve the prevalence and consistency of dual method use?
When is such promotion appropriate and when inappropriate?  What
interventions are most/least efficacious in promoting dual
protection? How does the match between the nature of protective
products available and individual/couple preferences influence the
potential impact of such interventions? How/does the nature of the
source from which individuals receive information and the ways in
which messages concerning dual method use are conveyed influence
subsequent behavior?
 
Data Sources
Whenever scientific goals can be met by its use, the analysis of
existing data is strongly encouraged for its cost-efficiency.  There
is a wide range of such data collected in the U.S., each data set
with its particular strengths and weaknesses.  The investigator is
encouraged to examine for suitability the HIV/STD archive at
Sociometrics.  Other sources include, but are not limited to, the
various rounds of the National Survey of Family Growth, the National
Study of Adolescent Males, Add HEALTH, and the Chicago Sexual Health
and Life Project. It is not expected that studies include nationally
representative samples, although the applicant must clearly specify
the appropriateness of the sample for the study proposed.
 
New data collection is justifiable if existing data sources are not
appropriate or sufficient to address the aim of the study.  In such
cases, scientific sampling procedures are highly desirable to ensure
that sample biases do not vitiate the research objectives.  For
example, reliance on clinical samples may over represent individuals
who are motivated to seek effective contraceptive methods or to
follow through on treatment for sexually transmitted disease.  Biases
inherent in such samples should be carefully evaluated in relation to
study aims.  Applicants proposing new data collection are encouraged
to make their data available for use by other researchers and should
outline plans for accomplishing this in the application
 
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 policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
 
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 20, 1994 (FR 59 14508-14513) and in the NIH
Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994.
 
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
 
The research grant application form PHS 398 (revised 5/95) is to be
used in applying for these grants.  These forms are available at most
institutional business offices and from the Office of Extramural
Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda MD 20892, telephone
301.435-0714, Email asknih@odrockm1.od.nih.gov; and from the program
administrator listed under INQUIRIES.  The RFA label available in the
PHS 398(revised 5/95) application form must be affixed to the bottom
of the face page of the application.  Failure to use this label could
result in delayed processing of the application such that it may not
reach the review committee in time for review.  In addition, the RFA
Title and number must be typed on line 2A of the face page of the
application form and the YES box must be marked.
 
FIRST (R29) award applications must include at least three sealed
letters of reference attached to the face page of the original
application.  FIRST (R29) award applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.
 
Submit a signed, typewritten original of the application including
the Checklist, and three signed photocopies, in one package, to:
 
Division of Research Grants
National Institutes of Health
6701 Rockledge Dr. Room 1040, MSC 7710
Bethesda, MD  20892-7710
 
At the time of submission, two additional copies of the application
must be sent to:
 
Susan F. Newcomer, Ph.D.
NICHD, Demographic and Behavioral Science Branch
Building 61E Room 8B13
Bethesda, MD  20892
 
Applications must be received by September 30, 1997.  If an
application is received after that date, it will be returned to the
applicant.  Also, the Division of Research Grants (DRG) will not
accept any application in response to this announcement that is
essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  Nor will the DRG
accept any application that is essentially the same as one already
reviewed.  This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications
must include an introduction addressing the previous critique.
 
REVIEW CONSIDERATIONS
 
Applications will be received by the NIH Division of Research Grants.
Upon receipt, applications will be reviewed by NIH/NICHD program
staff for their responsiveness to the objectives of this RFA.  Any
application judged to be nonresponsive will be returned to the
applicant without further consideration.  DRG staff may, however,
contact the applicant who has submitted such a proposal to determine
whether to return the application to the applicant or submit it for
review in competition with unsolicited applications at the next
review cycle.  Applications that are complete and responsive to this
RFA will be evaluated for scientific and technical merit by an
appropriate peer review group convened by NICHD in accordance with
the review criteria stated below.
 
As part of the initial merit review, a process may be used by the
initial review group in which applications will be determined to be
competitive or non-competitive based on their scientific merit
relative to other applications received in response to the RFA.
Applications judged to be competitive will be discussed and be
assigned a priority score.  Applications determined to be non-
competitive will be withdrawn from further competition and the
Principal Investigator and the official signing for the applicant
organization will be notified.  Following review by the Initial
Review Group, applications will be evaluated by NICHD's Advisory
Council for program relevance and policy issues before awards for
meritorious proposals are made.
 
Review Criteria
 
Significance: Does this study address an important problem?  If the
aims of the application are achieved, how will scientific knowledge
be advanced?  What will be the effect of these studies on the
concepts or methods that drive this field?
 
Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project?  Does the applicant acknowledge potential problem areas
and consider alternative tactics?
 
Innovation: Does the project employ novel concepts, approaches or
method?  Are the aims original and innovative?  Does the project
challenge existing paradigms or develop new methodologies or
technologies?
 
Investigator: is the investigator appropriately trained and well
suited to carry out this work?  Is the work proposed appropriate to
the experience level of the principal investigator and other
researchers (if any)?
 
Environment: Does the scientific environment in which the work will
be done contribute to the probability of success?  Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements?  Is there
evidence of institutional support?~
 
The initial review group will also examine: the adequacy of plans to
include both genders and minorities and their subgroups as
appropriate for the scientific goals of the research and plans for
the recruitment and retention of subjects; the provisions for the
protection of human and animal subjects; and the safety of the
research environment.
 
AWARD CRITERIA
 
Awards will be made based on the scientific merit as determined by
peer review, on programmatic priorities and on the availability of
funds.
 
INQUIRIES
 
Written, email and telephone inquiries concerning this RFA are
encouraged.  The opportunity to clarify any issues or questions from
potential applicants is welcomed.
 
Direct inquires regarding programmatic issues to:
 
Susan F. Newcomer, Ph.D.
Demographic and Behavioral Science Branch
National Institute of Child Health and Human Development Building 61E
Room 8B13
Bethesda, MD  20892
Telephone: 301/496-1174 FAX: 301/496-0962
Email: NewcomeS@hd01.nichd.nih.gov
 
Direct inquiries regarding fiscal matters to:
 
Ms. Melinda Nelson
NICHD, Office of Grants and Contracts
Building 61E Room 8A
Bethesda, MD  20892
Telephone:  301/496-5481  FAX: 301/402-0915
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.864 (Population Research). Awards are 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 grant policies and Federal
Regulations, 42 CFR Part 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of Executive
Order 12372, or to Health Systems Agency review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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