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 301.710-0267, 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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