Full Text PAS-97-093 DEMOGRAPHIC RESEARCH ON SEXUAL BEHAVIORS RELATED TO HIV NIH GUIDE, Volume 26, Number 27, August 15, 1997 PA AVAILABLE: PAS-97-093 P.T. Keywords: National Institute of Child Health and Human Development National Institute of Dental Research National Institute of Mental Health Application Receipt dates: May 1, September 1, January 1 PURPOSE NICHD, NIDR and NIMH invite qualified researchers to submit applications to study the social and behavioral aspects of the transmission of HIV through sexual intercourse, including oral sexual practices. NICHD has a longstanding commitment to research focusing on sexual behavior, behavior change and HIV prevention, especially among men and women of reproductive age (including adolescents), and among vulnerable populations. NIDR supports biomedical and behavioral research on the oral transmission of HIV, including research on sexual behavior relevant to oral routes of transmission. NIMH supports an extensive program of HIV prevention research related to various aspects of mental health. This program announcement describes NICHD's, NIDR's and NIMH's programs of behavioral research in the sexual transmission of HIV, which includes four general areas: (1)demographic studies of sexual behaviors related to HIV transmission; (2) studies of the interrelationships among social, institutional, economic and cultural contexts and sexual behavior; (3) studies of the interrelationships between pregnancy, pregnancy prevention and HIV prevention; and (4) theoretically grounded intervention studies within these areas. 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 PA 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 "Healthy People 2000" (Summary Report: Stock No. 017-001-0047301) through the Superintendent of Documents, Government Printing Office, Washington, D.C. 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) research project grant (R01) and FIRST award (R29) mechanisms. 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 PA may not exceed five years. FUNDS AVAILABLE This program announcement has $2.7 million dollars in total costs set aside for the first year of awards. The NICHD set aside will total $1.7 million. The NIDR set aside will be total of $1.0 million. Additional funding or co-funding will also be available from NIMH. The number of awards and level of support will depend on receipt of applications of high scientific merit. The usual policies governing grants administration and management, including facilities and administrative costs, will apply. Although this program is provided for in the financial plans of the NICHD and NIDR, awards pursuant to this program announcement are contingent upon availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. New applications submitted for the September 1, 1997, January 2 and May 1, 1998 receipt dates will be eligible for funding under this announcement. Competing continuation applications for already funded projects will NOT be eligible. Although the NICHD, NIDR and NIMH have continuing interest in the research area of this PA, the latest anticipated date for new awards to be made with set-aside funds from NICHD and NIDR is February, 1999. RESEARCH OBJECTIVES Background Until such time as vaccines and cures for infection with the HIV virus are a practical reality, prevention of infection must rely upon individuals' practicing protective behavior. Specific sexual behaviors that prevent infection - such as avoiding sexual intercourse with infected individuals and using condoms - are influenced both by personal factors such as attitudes, knowledge, and abilities and by more distal factors characterizing the contexts in which individuals' behaviors are carried out. While most behaviors that are protective have been well-defined, new information may require altered messages regarding risk and protective behaviors. For example, recent reports have suggested that oral sexual practices (e.g. oral-genital receptive sex) previously considered to be relatively risk-free may actually pose significant risks for HIV transmission. Social and cultural environments may predispose people to act in certain ways, and may also influence how easy it is for them to change their behaviors or to maintain protective behaviors. Competing motivations for establishing and maintaining sexual relationships and for pregnancy or pregnancy prevention may interact with HIV prevention motives and with the social environment to influence behavioral outcomes. Such motives are in turn likely to be shaped in important ways by life course experience: health and development; educational and economic achievement, migration, marriage and marital dissolution, and fertility. These personal and contextual factors can interact in powerful and complex ways to determine behavioral risks for HIV infection and the most promising pathways to reducing risk. Methodological advances in data collection and data analytic techniques are beginning to make it possible to examine in detail the contextual factors in which individuals and couples exist, and to understand more clearly the structural factors influencing their sexual decisions. NICHD, NIDR and NIMH seek research applications that draw on both innovative theory and innovative methodologies to address four general areas of study, as described below. The goal of this program announcement is improved knowledge applicable to behavioral strategies for the prevention of sexual transmission of HIV infection. Other sexually transmitted diseases and other sequelae of sexual behavior as well as relevant aspects of sexual behavior itself also may be used as endpoints of proposed research as long as the relationship of the specific research question to HIV prevention is adequately justified. Research Sought (A) Demographic studies Population-based studies of sexual behaviors related to the risk of HIV infection contribute to HIV prevention in many ways. They provide essential information for identifying population groups whose sexual behaviors increase vulnerability to HIV infection as well as groups in which the potential for increasing infection rates may exist; they provide a means of monitoring trends in the prevalence of risky sexual behavior as well as protective behaviors within population groups and they permit the testing of models of the determinants of such behavior over the life course within population samples (that is, not samples recruited from clinics or on the basis of some particular personal behavior or characteristic). Population-based data provide perspectives on the prevalence of such behaviors. For example, they can elucidate changes in behaviors, norms, and status that permeate a larger population and contribute to the characteristics, resources, and behaviors of those most vulnerable to HIV. They can be used to examine processes that influence sexual behavior regardless of HIV risk and to examine how, whether and when heightened risk of, or the perception of heightened risk of HIV affects those processes. Specific topics include but are not limited to: Trends in HIV-related sexual behaviors and the determinants of those trends. (Note: new data collection for the purpose of studying trends in sexual behavior will not be supported unless it makes a substantial scientific contribution beyond that made by ongoing data collection activities conducted by CDC, NIH and other federal and private groups). Studies characterizing trends in the content of information provided to students in the health professions, health care professionals, the public or members of high risk groups about sexual practices (e.g. oral sex) as related to risks for HIV transmission. Group differences in the determinants of HIV risk behaviors. Changes in family structure, organization, marriage and cohabitation, and patterns of partner selection in relation to HIV infection and the risk of such infection. The relationship of HIV-risk sexual behavior to life course transitions such as cohabitation, marriage, separation and divorce, parenthood, and changes in school enrollment, labor force, and economic status. Factors that predispose individuals to initiate sexual behaviors that place them at risk of HIV at an early age. Studies evaluating changes in sexual behaviors in individuals and populations associated with new information on risk and protective behaviors (e.g. concerns regarding oral routes of HIV transmission). Studies of norms and values related to sexual behavior, sexual partnerships, and disease prevention, their variation among population groups and over time, and their relationship to behavioral patterns. Cross-cutting studies that link data collected in large population samples with samples selected based on high risk behaviors. Methodological studies that extend and improve techniques for data collection and analysis in studies of HIV-related sexual behavior. Development of methodologies for identifying populations in which the potential for widespread HIV infection is increasing, and for studying the spread of infection in relation to population characteristics, dynamics, and behaviors (e.g., network studies). Demographic studies must be grounded in an appropriate theoretical framework. Although new data collection may be justifiable under some circumstances, potential applicants are encouraged to consider secondary analysis of existing data. A number of population-based sample studies have been conducted in recent years, some with NICHD funding, and the data are available to researchers (see "Research Designs and Data Sources," below). Several of these have extended traditional survey approaches in ways that improve and enrich data, such as methodological improvements in the quality of self reports, utilization of biospecimens, e.g. salivary or oral measures, and integrating contextual or social network data. B) Contextual Determinants of Sexual Behavior A significant body of evidence suggests that sexual and prophylactic behaviors are influenced in important ways by the contexts in which they occur. Relevant dimensions of context include the social (relationships with partners, family, friends and co-workers), institutional (legal, educational, religious, health infrastructure); cultural (norms, values, and beliefs shared within and across social groups), and physical (community composition, prevalence of disease risk, poverty and housing). The specification of the ways in which these aspects of context can influence behavior is far from complete, yet there is reason to believe that improved understanding of contextual influence could provide a powerful tool for prevention of HIV. Research designs which capture contextual influences as well as individual determinants of behavior are called for. For example, studies might address the following questions: How do individuals' social networks influence their sexual behavior; how does sexual behavior influence change and stability in social networks? How do the economic, social, and institutional characteristics of communities in which social and sexual networks are embedded influence sexual behavior? Do individuals whose lives involve frequent changes of residence change their social and sexual networks? How do social and sexual networks overlap and what are the implications of this for HIV-risk behavior? What principles and processes govern the selection of sexual partners and participation in sexual networks that place individuals at risk of infection with HIV? How does the process of partnership formation vary by age or maturational status, gender, sexual orientation, socioeconomic status, and the prevalence of HIV in the individual's community? How do the circumstances under which sexual partnerships are formed affect the perceptions of HIV risk within the partnership and the behaviors that occur within it? What factors influence the stability and exclusiveness of sexual partnerships, and how do HIV-risk behaviors vary with the duration and other characteristics of partnerships? How does earlier experience of involuntary sex or violence or the fear of violence within a current partnership influence risk behavior in that and subsequent partnerships? How do norms and values -- about morality, marriage, monogamy, childbearing, or appropriate sexual behavior -- develop and change within and across social groups? How do such norms and values interact with other contextual and individual factors to influence individuals' and couples' sexual behavior? How can research methods for studying contextual influences on sexual behavior be improved? How can non-biased but cost-effective methodologies for network studies be developed? How can contextual studies account for the processes by which individuals self-select into social networks, communities, and other contexts? How can studies of sexual partnerships account for partnership formation processes and other sources of sample bias? How can non-biased samples of couples at elevated risk of HIV infection be obtained? There may be challenges in obtaining samples in which one partner is HIV+, or in following samples in which partners are in various stages of relationship formation, change and dissolution. What are appropriate models and analytic methods for examining sexual behavior in the context of a couple, and in relation to networks and the larger social context? C) Integrating pregnancy and HIV prevention 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 HIV. However, many of the medical methods available for pregnancy protection do not provide protection from disease, and condoms, male and female, which are most effective at disease prevention, may not protect as well against unwanted pregnancy. Research is sought which examines the inter-relationships among individuals' and couples' desires for pregnancy, pregnancy prevention and avoidance of the risk of infection with HIV. How do individuals at risk of HIV infection balance pregnancy prevention and disease prevention in making decisions about sexual behavior and the introduction and use of methods to prevent pregnancy and/or disease? How do concerns regarding pregnancy or perceived health risks or attitudes concerning contraception influence oral sexual behaviors? How does the duration and intimacy of the partnership influence the partners' decisions concerning issues of pregnancy, pregnancy prevention and the avoidance of disease? Does this vary over the life course? How do individuals' estimations and abilities to accurately estimate risk -- their own and their partner's for pregnancy and HIV -- influence their use of protection? How do knowledge and beliefs concerning their own or their partner's serostatus affect use of protection? How does actual, objective, epidemiological risk of exposure to disease and to pregnancy affect individuals' use of protection from unwanted pregnancy and from disease? D) Intervention Studies Intervention studies are needed to build on the basic science findings concerning behavior change. Designing, implementing and evaluating interventions which utilize mediating variables such as, for example, communication skills concerning condoms, or sensitivity to peer or media pressure, to enable individuals to acknowledge and modify risky behavior are appropriate research proposals for this program announcement. Understanding of local issues is critical to the successful implementation of targeted interventions. Accordingly, interventions are encouraged which involve community organizations in design, implementation and replication of the project. Such proposals may target any population vulnerable to HIV and may include consideration of co-morbid conditions such as other STDs and oral conditions. This PA particularly encourages studies of populations most vulnerable to the sexual transmission of HIV -- minority men and women, men who have sex with men, and disadvantaged youth. Particular questions of interest include but are not limited to: How can the social context in which individuals live and the changes in those contexts via migration or change of residence -- their social networks, communities, schools, homes, work environment -- be taken into consideration when designing and implementing interventions? How can the influence exerted by elements of the social, institutional and cultural contexts be harnessed in the development of more effective interventions? How can HIV-related behavior change interventions be improved to take account of individuals' potentially competing concerns about pregnancy and disease prevention? 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 heterosexual people, what interventions, delivered by which agencies or individuals, are effective? How do local conditions, such as condom distribution programs, or support for or opposition to behavior change interventions from the community's civic, educational and religious institutions impact individual behavior? Research Designs and Data Sources The utilization of existing data is strongly encouraged for its cost-efficiency whenever scientific goals can be met by its use. There is a wide range of such data collected in the U.S. and available for research purposes. Each data set has its particular strengths and weaknesses, which the investigator must understand and deal with. Such resources include, but are not limited to, the various rounds of the National Survey of Family Growth, the National Survey of Adolescent Males, the National Survey of Men, The National Longitudinal Study of Adolescent Health, the National Health and Social Life Survey, the Chicago Sexual Health and Life Project, and data made available through the Sociometrics STD/HIV archive. Researchers may be aware of, and have access to, other data that are appropriate for answering the HIV/AIDS behavior questions they wish to pose. Data collected in or from other countries can provide powerful resources for addressing many of the research questions in this announcement. New data collection is justifiable if existing data are not appropriate to 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. Prior contact with the staff named below is strongly encouraged for any applicant considering such an effort, and is mandatory should the direct cost of the project exceed $500,000 in any year. 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. Applicants proposing research that draws on social scientific approaches that have not been widely applied to research on HIV-related sexual behavior are particularly encouraged to apply. As noted recently by an Institute of Medicine workshop, "Assessing the Social and Behavioral Science Base for HIV/AIDS Prevention and Intervention", improved strategies for behavioral intervention will require broader perspectives than have been applied in the past. Collaborations involving anthropologists, historians, economics, sociologists, political scientists, epidemiologists, and psychologists may be needed to advance theoretical and methodological approaches to HIV prevention. Therefore applicants are encouraged to consider research designs which are innovative, integrative of multiple perspectives, and which utilize, as appropriate, a range of methods and analytic techniques. In addition, the recent Ad Hoc Panel on NIDR AIDS Research (June, 1997) strongly recommended pursuing collaborative research on behavioral and/or biological factors influencing oral transmission of HIV. STUDY POPULATIONS Research may focus on samples in the United States and other nations, and on individuals of either or both sexes and of all ages as appropriate to the scientific questions being examined. Studies of populations at heightened vulnerability to the sexual transmission of HIV -- e.g., minority men and women, men who have sex with men, and disadvantaged youth-- are particularly encouraged. 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@odrockml.od.nih.gov; and from the program administrator listed under INQUIRIES. In order for the application to be considered for set-aside funds, the PA Title and number must be typed on line 2A of the face page of the application form. 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 Maryland 20892-7710 At the time of submission, one additional copy of the application must be sent to: Susan F. Newcomer, Ph.D. Demographic and Behavioral Sciences Branch Center for Population Research National Institutes of Child Health and Human Development 6100 Executive Boulevard, Room 8B13 Bethesda, Maryland 20892-7510 EXPRESS MAIL: Rockville, Maryland 20852 Applications must be received by the regular deadlines for AIDS-related applications, May 1, September 1 and January 1. REVIEW CONSIDERATIONS Applications will be received by the NIH Division of Research Grants. 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. 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 taken to the NICHD, NIDR or NIMH Advisory Council for a second level of review and Institute program staff will make a final funding decision based on scientific merit, program relevance and the advice of Council. REVIEW CRITERIA FOR AND RATING OF UNSOLICITED RESEARCH GRANT APPLICATIONS (as per the NIH GUIDE, Volume 26, Number 22, June 27, 1997) Reviewers will be instructed to (a) address the five review criteria below and (b) assign a single, global score for each scored application. The score should reflect the overall impact that the project could have on the field based on consideration of the five criteria, with the emphasis on each criterion varying from one application to another, depending on the nature of the application and its relative strengths. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) 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? (2) 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? (3) 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? (4) 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)? (5) 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? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: The adequacy of plans to include both genders, minorities, and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The reasonableness of the proposed budget and duration in relation to the proposed research The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. The initial review group will also examine the provisions for the protection of human 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 PA 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 for Child Health and Human Development 6100 Executive Boulevard, Room 8B13 Bethesda, Maryland 20892 Telephone: 301/496-1174, FAX: 301/496-0962 Email: NewcomeS@hd01.nichd.nih.gov OR Patricia Bryant, Ph.D. Director, Behavior, Health Promotion and Environment National Institute of Dental Research Natcher Building, Room 4AN 18A 45 Center Drive MSC 6402 Bethesda, Maryland 20892-6402 Telephone: 301/594-2095 FAX 301/480-8318 Email: BryantP@de45.nidr.nih.gov OR Willo Pequegnat, Ph.D. Office on AIDS National Institute of Mental Health Parklawn Building 5600 Fishers Lane, Room 10-75 Rockville, Maryland 20857 Telephone: 301 443-6100, FAX 301: 443-9719 Email: wpequegn@nih.gov Direct inquiries regarding fiscal matters to: Ms. Melinda Nelson NICHD, Office of Grants and Contracts Building 61E Room 8A Bethesda, Maryland 20892 Telephone: 301/496-5481 FAX: 301/402-0915 Mr. Martin R. Rubinstein Grants Management Office National Institute of Dental Research Natcher Building, Room 4AN 44A 45 Center Drive MSC 6402 Bethesda MD 20892-6402 Telephone: 301/594-4800 Email: Rubenstein@de45.nidr.nih.gov Ms. Diana Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building 5600 Fishers Lane, Room 7C-08 Rockville, Maryland 20857 Telephone: 301 443-2805 OTHER INSTITUTES HIV-RELATED RESEARCH INTERESTS The interests of the three co-sponsoring Institutes are complemented by those of several other Institutes at NIH. NIAID funds studies which focus on vaccine development, biological endpoints of behavior and treatment of HIV infection; NIAAA supports research which links HIV prevention to alcohol use and abuse; NIDA supports studies which relate to drug use and abuse as a primary focus of HIV infection, including the linkage of drug use to risky sexual behaviors. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.864 (Population Research) NO.93.121 and No. 93.242 (NIMH). 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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