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SEXUAL RELATIONSHIPS, SEXUAL CONCURRENCE AND HIV RELEASE DATE: April 9, 2002 RFA: HD-02-010 National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) LETTER OF INTENT RECEIPT DATE: June 24, 2002 APPLICATION RECEIPT DATE: July 23, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA This Request for Applications (RFA) invites applications for research on the multiple processes and influences that contribute to the risk of HIV infection or transmission in sexual partnerships and the ways in which people manage risk by managing their partnerships. An equally important goal is the support of methodological research on improved approaches for conducting this research. The ultimate goal of the RFA is to advance the development of sound scientific knowledge that can generate new intervention models for reducing the risk of HIV infection by changing the characteristics and dynamics of sexual partnerships. The knowledge base to be advanced includes the behavioral dynamics involved in partner choice, partnership formation, stability, and exclusivity, and the monitoring and managing of HIV risk within partnerships. RESEARCH OBJECTIVES Scientific Background Any sexual relationship outside of mutually faithful life-long monogamy has some degree of risk of exposure to disease, including HIV, regardless of the levels of protection adopted by each partner. In high prevalence areas, HIV dissemination is much more rapid under conditions of concurrent partnerships, that is, when one sexual partnership has not ended before a second one is initiated. The pattern of concurrency, the duration of overlap, and the frequency of sexual relations with each partner, also have significant implications for the spread of the epidemic. Within a given partnership, the risk of HIV infection or transmission depends on a variety of factors. First and foremost, it depends on the partner"s infection status, which, in turn, depends on his or her current and past drug-use and sexual behavior, and the risk status of the social and sexual networks in which the partner is embedded. Partner choice i.e., choosing an uninfected partner is thus of direct relevance to HIV risk. Second, risk within a partnership depends on the chance that a partner will become infected during the course of a partnership. This, in turn, depends on patterns of concurrency, the level of infection in the sexual network, and protective behaviors within the partnership. Third, HIV risk within a partnership may also depend on the ability of partners to accurately assess, manage, and respond to risk within their partnership. Partners may adopt a variety of strategies for monitoring the exclusivity of the partnership, including direct communication with the partner and intelligence gathered from friends and relatives. Partners may invest in relationship "quality" to promote exclusivity and stability, or insist on the use of condoms when exclusivity is in doubt. In many cases these strategies may be mutually incompatible. For example, it is difficult to demand condom use in the context of a partnership in which one or both partners believe that their risk is avoided through mutual fidelity. Finally, partners may choose to end relationships when it becomes impossible to effectively manage risk. Interpersonal dynamics within partnerships play an important role in risk management. The importance of power dynamics in negotiating condom use has been given considerable attention, for example, it is known that young teenaged women are less likely to use condoms the older their male partner is. Similarly, the level and quality of communication may reduce risk by contributing to relationship strength, commitment, and stability while also helping in the monitoring and managing of risk. The ability of men and women to communicate concerning risk and to end relationships that pose risk is often a function of differential social and economic resources, which may vary across cultures. While variables such as numbers of partners and risk status of partner have been used widely in studies of HIV risk and protective behaviors, relatively little research has focused on the processes of partner choice, relationship formation and dissolution, and the dynamics of relationships. Similarly, while intervention programs often teach some types of "relationship skills" (e.g., how to say "no" to sex, how to insist on condom use), or outline ways to avoid risky situations, there has been little basic scientific research on relationship dynamics related to HIV risk that can assist in designing interventions. A better understanding of partnership dynamics, their relationship to HIV risk, and the factors that assist individuals in choosing and navigating relationships in ways that reduce risk will contribute to the design of more effective skills-based interventions. The characteristics, course, and dynamics of partnerships are influenced by context, by factors specific to the partnership, and by the individual characteristics of both partners. Examples of individual characteristics include age or developmental stage, race/ethnicity, personal values, attractiveness, socioeconomic status, mental health, and the history of personal experience each person brings to a relationship. Examples of factors specific to the partnership include compatibility, communication, and mutual attraction. In addition, the emotions that partners experience for each other may be highly relevant to decision-making and behavior. Aspects of the social context that may influence partnerships are equally diverse. Third parties, such as parents or friends, may influence the dynamics of relationships, either supporting or opposing them. Opportunities for meeting new partners away from home, such as business trips or military service may facilitate sexual relationships outside of committed partnerships. Characteristics of sexual "marketplaces," whether based in geography, the Internet, or defined by a common sexual orientation or membership in an ethnic group or class, also have important implications for partnerships. Culture and norms also influence people"s partner choices, the "scripts" that guide behavior in relationships, the acceptability of engaging in extra-pair sexual relationships, and the stability of relationships. Laws and regulations provide barriers to certain types of relationships and incentives for others. Research on these topics poses important methodological challenges. These include the logistical and ethical challenges of recruiting unbiased samples of sexual partners into research studies, the need to gather valid behavioral data on sensitive topics and events that may not be well defined (e.g., the start or end of a relationship), and the complexities of measuring and modeling the dynamics of dyadic relationships, especially when members of a dyad give divergent accounts of the relationship. In addition, research that bridges individual-level and social/environmental influences on behavior often requires the creative use of multiple methods, for example, the integration of complementary qualitative and quantitative data. Some of these challenges pose significant obstacles to advancing knowledge about sexual partnerships and HIV risk, and research to address them is badly needed. Scope This RFA invites applications for research on the multiple processes and influences that contribute to varying degrees of risk for HIV in sexual partnerships and the ways in which people manage risk by managing their partnerships. An equally important goal is the support of methodological research on improved approaches for conducting this research. The RFA encourages applicants to conceptualize sexual partnerships broadly. Partnerships may be brief or sustained, casual or committed. In some relationships, sexual intercourse is an immediate and central focus, in others, it may variously be deferred until a close emotional tie is established, be deferred until the relationship is formalized in marriage, or never occur at all. All relationships that involve the potential for sexual intercourse are relevant to the questions posed by this RFA. Proposed substantive studies must be grounded in well-developed conceptual models of the factors and mechanisms that influence the risk of HIV infection or transmission by affecting the behavioral dynamics, course, and characteristics of sexual relationships and the monitoring and management of risk within relationships. Applicants are encouraged to consider a broad range of explanatory variables, including individual-level factors (biological, psychological, demographic, and socioeconomic), partnership- specific characteristics, and social, cultural, and economic characteristics of the broader context. The latter may include such factors as family influences, social networks, characteristics of "sexual marketplaces," community norms, cultural expectations such as bridewealth or dowry, job and housing markets, and public policies. Methodological studies that address important challenges to valid research on sexual partnerships and their relation to HIV are also strongly encouraged. Applicants are invited to propose and test innovative approaches to study design, sampling, recruitment and retention, measurement, and data analysis. Cross-disciplinary work is encouraged, as is work in a variety of populations, both domestic and foreign. Applicants are encouraged to consider a variety of research and measurement approaches (including, for example, longitudinal, comparative, qualitative, and experimental study designs) in selecting the most scientifically valid and appropriate design for their research. (1) Illustrative examples of substantive topics relevant to the goals of the RFA include: o Partner selection, including whether and on what basis people calculate risks (emotional and physical) associated with potential sexual partnerships. How do patterns of partner selection change over time for the same individual, and what influences these changes? o Transitions in partnership status, including initiation of intercourse, development of commitment, dissolution, etc. For example, what contributes to sustaining healthy and mutually exclusive sexual relationships? What attributes of relationships and individual partners are associated with longer duration? What are the factors that lead to a decision to terminate a given sexual relationship? Do these vary and, if so, how and what influences the variation? o Factors that contribute to the extent and pattern of concurrency in sexual partnerships. o Strategies that partners use to monitor, respond to, and manage HIV risk and the conditions under which they succeed or fail. o The influence of the dynamics (e.g., competition for partners) and characteristics (e.g., social cohesion) of sexual marketplaces on sexual partnerships and the management of HIV risk. o The ways in which legal, religious, or other institutional factors facilitate or inhibit the formation, maintenance, and ending of sexual relationships, and the prevalence of concurrency. This is especially important for studying HIV in men who have sex with men. o The influence of the Internet on the process of partnership formation and the dynamics of sexual partnerships. o The impact of economic conditions (e.g., poverty, job opportunities, wages) in a community or sexual marketplace on partnership formation, partner choice, concurrency, and relationship duration as well as values and expectations concerning sexual relationships. o The influence of partnership-specific characteristics (e.g., similarities and differences between partners with respect to age, ethnicity, class, income, or attractiveness, power differentials, and jointly constructed role expectations) on the dynamics of partnerships and the monitoring and management of HIV risk. o The role of psychological and biological factors (e.g., personality attributes, developmental stage, motivations, emotions, attitudes, and abilities) in the formation, stability, dynamics, and exclusivity of partnerships. How do individuals" motivations and goals for both sexual (e.g., pleasure, connection, procreation) and non-sexual (e.g., status, attention, affection, protection, support) aspects of relationships influence partnership choices and decision-making and behavior within partnerships? (2) Examples of methodological topics relevant to the goals of the RFA include: o Innovative ethical strategies for recruiting and retaining partners in studies of sexual and romantic relationships. o Innovative methods for measuring the attributes and dynamics of relationships over time, e.g., the conceptualization and measurement of duration, power differentials within relationships, and negotiation and communication processes. o Methods for increasing validity and reliability in the measurement of sexual behaviors and other sensitive topics relating to sexual partnerships. o Statistical techniques and strategies for modeling the dynamics of sexual partnerships over time, especially in the context of incomplete or conflicting data. o Development and integration of biomarkers for biological attributes that influence relationship processes, e.g., hormones, pheromones. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is April 2003. This RFA uses just-in-time concepts. It also uses the modular budgeting format. (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $350,000 or less, use the modular format. FUNDS AVAILABLE The NICHD intends to commit approximately $1.5 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2003 to fund three to seven new and/or competitive continuation grants responsive to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $350,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Susan Newcomer, Ph.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-435-6981 Email: [email protected] o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-496-1485 Email: [email protected] o Direct your questions about financial or grants management matters to: Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17M, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-496-5482 Email: [email protected] LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Susan Newcomer, Ph.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-435-6981 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone 301-710-0267, Email: [email protected]. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Robert Stretch, Ph.D. Acting Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Blvd, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the National Advisory Child Health and Human Development Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: 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. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 24, 2002 Application Receipt Date: July 23, 2002 Peer Review Date: October/November 2002 Council Review: January 2003 Earliest Anticipated Start Date: April 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice- files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.3864, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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