PA-01-139: RESEARCH ON HIV/STD PREVENTION MESSAGES

Department of Health
and Human Services (HHS)

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This Program Announcement expires three years from the release date, unless reissued. RESEARCH ON HIV/STD PREVENTION MESSAGES Release Date: September 20, 2001 PA NUMBER: PA-01-139 National Institute of Child Health and Human Development (http://www.nichd.nih.gov) National Institute of Mental Health (http://www.nimh.nih.gov) National Institute of Nursing Research (http://www.ninr.nih.gov/) National Institute on Drug Abuse (http://www.nida.nih.gov) THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398 (REVISION 5/2001) AVAILABLE AT http://grants.nih.gov/grants/funding/phs398/phs398.html. PURPOSE The National Institute of Child Health and Human Development (NICHD), the National Institute of Nursing Research (NINR), the National Institute of Mental Health (NIMH), and the National Institute on Drug Abuse (NIDA) invite qualified researchers to submit applications to study the creation, dissemination and consumption of messages created to deter the spread of HIV. Well into this, the third decade of HIV/AIDS, prevention messages designed and presented through mainstream media have had limited success in deterring the spread of the disease in many populations, both in the U.S. and in other nations. This announcement invites research that will improve our understanding of how communication can best facilitate HIV prevention efforts. It encourages studies that examine the interrelationships among various attributes of communication about HIV risk and prevention, and the consequences of communication for individuals, groups, and populations. It also seeks research that examines how people consume, understand, retain, and use or act upon information about HIV risk and prevention. 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 Program Announcement (PA) is related to one or more of the priority areas. Potential applicants may obtain Healthy People 2010 at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of State and local governments, and eligible agencies of the Federal government. Faith-based organizations are eligible to apply for these grants. 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) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been adopted by the NIH for applications requesting up to $250,000 per year. Complete and detailed instructions and information on Modular Grant applications have been incorporated into the PHS 398 (rev. 5/2001). Additional information on Modular Grants can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. Applicants requesting more than $250,000 in any year must follow the instructions for detailed budgets in the PHS 398 (rev. 5/2001) 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. Even with a vaccine, protective behavior will continue to be important. Behaviors that reduce the risk of HIV infection or transmission -- such as using condoms, avoiding sexual intercourse with infected individuals, and avoiding drug use that may lead to unsafe sexual practices or needle sharing -- are influenced by a complex set of determinants. These include personal factors such as demographic and psychological variables (e.g., attitudes, knowledge, and abilities), interpersonal processes, as well as more distal factors characterizing the contexts in which individuals and couples behaviors are carried out. Ever since HIV infection was recognized as a serious public health threat, public health professionals have used a variety of communication approaches to inform about HIV risk and prevention, and to encourage behavior change that would reduce the spread of infection in the population. It is by now well recognized that informing people about HIV risk and prevention is not sufficient to induce behavior change. However, most public health professionals agree that providing information is a necessary part of prevention efforts and, furthermore, that prevention messages can help to change attitudes and motivations as well as to inform. Various theories in the prevention sciences address the readiness of individuals to obtain and act upon information relating to HIV prevention. Individuals own circumstances and attributes as well as their social contexts influence the information they seek out, or are ready to receive, and their readiness for behavioral change. Although communication has been and remains a critical component of HIV prevention efforts, our understanding of the factors that make such activities more or less successful remains incomplete. Research in other areas of prevention science, such as sunscreen use for skin cancer prevention and smoking cessation, has demonstrated that the ways in which information is presented have a great influence on how it is perceived and whether it is acted upon. However, research on the effective design, delivery, and reception of messages is scattered across a wide number of disciplines. Relatively little research has examined how communication concerning HIV prevention and risk contributes to informing and instigating behavior change in various populations. In this initiative, we define communication as the process by which individuals, agencies, or organizations create and share information with one another. This announcement focuses on a specific subset of communication activities, namely, the creation and dissemination of messages concerning HIV risk and prevention within a public health context. These activities may include the development of written materials, curricula for school health education programs or intervention programs, public service announcements, and one-on-one clinical counseling. They would not include communication between sexual partners, however, such communication plays an important role in HIV prevention and might well be affected by the types of public health communication activities that are the focus of the announcement. Research Scope This announcement invites research on communication related to HIV risk and prevention. It encourages studies that examine the interrelationship between various attributes of communication (e.g., purpose, content, source, complexity) and the consequences of communication for individuals, groups, and populations. It also seeks research that examines how HIV-infected individuals and individuals at risk of HIV infection consume, understand, retain, and use or act on information about HIV risk and prevention provided through various communication channels. Invited research is intended to advance our understanding of how public health communication related to HIV risk and prevention works, and under what circumstances it is most effective in informing and/or instigating behavior change. Proposed studies must be based in sound theoretical models relating to communication and HIV risk and prevention. Research may focus on specific attributes of communication messages or on strategies to enhance the effectiveness of communication with particular populations such as injection drug users. Substantively, the research may address communication relevant to any behavioral prevention strategy that reduces HIV risk, including abstinence, condom use, partner selection, the utilization of HIV testing, other relevant behaviors, or a combination of these. The proposed research must have clear implications for the design and/or implementation of public health communication strategies. Issues that might be addressed include, but are not limited to, the following: The Message: o Specificity: Are messages more effective if they focus on general concepts (e.g., use of condoms protects against HIV) or on specific information (e.g., consistent and correct use of condoms reduces the risk of HIV infection by nn percent?) How does context that is, the goal, format, channels or audience of the communication -- influence effectiveness? Does this differ when talking about sexual versus drug use behaviors associated with HIV? o Framing: Is the message presented in terms of risk reduction or health promotion? Under which conditions and for which people or identifiable groups of people is it more effective to emphasize the benefits of performing or the costs of not performing the advocated behavior? o Complexity/Hierarchy: How simple or complex can prevention messages be? Should messages focus on a single unitary idea or can they include multiple ideas? Do hierarchical messages work? Can people process and act on messages which present differing levels or degrees of protection as options? Under what circumstances are such messages successful? How do length and complexity interact? Does this interaction increase the risk of a message misfiring in a negative fashion? o Channel: Pamphlets, billboards, Public Service Announcements, small group instruction, edutainment, organized peer communication, TV news, web pages. How well do various channels reach different audiences and how do different populations respond to various channels? How do the substance, audience, and purpose of HIV-related communication interact with channel? o Format: Are messages attended to differentially as a function of their physical attractiveness, or design? Are messages in a home language attended to differently from messages in English? How do these variables interact with various demographic factors such as immigrant status, race/ethnicity, gender, and age? o Duration and other dimensions of timing, including length of message, repetition and timing between repeated exposures, overall duration of exposure to a message: How do these dimensions relate to message effect? What are the advantages and disadvantages of brief messages compared to extended ones? For example, are brief messages easier to retain than longer ones? Do they provide information equally well? o Threat Appeals: Under which conditions are they persuasive? What is the impact of HIV-related threat appeals on feelings about sex (e.g., is it possible to scare people about the disease without making them afraid of sex)? Does explaining the connection between drug use and HIV infection scare people out of drug using behaviors associated with HIV infection? The Origin and Destination: o Targeted and Tailored Communications: Are messages more likely to be heard and acted upon if their personal relevance is increased by matching their content to group characteristics (targeting) or to individuals characteristics (tailoring)? Does this effect vary by race, ethnicity, cultural group, age, gender, or other demographic markers? o Origin: Messages may be presented by a range of people. Some options that have been used are authorities on the subject, celebrities, peers, or individuals who are suffering from the negative consequences of behavior choices. What influences the impact of these different messengers? Is this different for different formats? Or, is effect different for different people or at different ages/developmental stages? If so, how? o Destination: How do individuals at varying stages of development and understanding search for, receive, integrate, react to, and act upon messages presented in different manners? What is the importance of prior knowledge or experience upon this? 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 sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research, published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. The revisions relate to NIH-defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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, published in the NIH Guide for Grants and Contracts, March 6, 1998, and available on the Internet at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. 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. This policy announcement is found 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 (PA) 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. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. Although applicants are strongly encouraged to begin using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will continue to accept applications prepared using the 4/1998 revision until January 9, 2002. Beginning January 10, 2002, however, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301-710-0267, E-mail: GrantsInfo@nih.gov. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in applying for these grants, with modular budget instructions provided in Section C of the application instructions. Applicants are permitted, however, to use the 4/1998 revision of the PHS 398 for scheduled application receipt dates until January 9, 2002. If you are preparing an application using the 4/1998 version, please refer to the step-by-step instructions for Modular Grants available at http://grants.nih.gov/grants/funding/modular/modular.htm. Additional information about Modular Grants is also available on this site. Submission Instructions The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and five 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. 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 methods? 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: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. o The adequacy of the proposed plan to share data, if appropriate. AWARD CRITERIA 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. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. A complete listing of contacts for both programmatic and fiscal/administrative inquiries may be found at http://www.nichd.nih.gov/pa/preventionmsgs.htm. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.864 (NICHD), 93.361 (NINR), 93.242 (NIMH), and 93.279 (NIDA). Grants 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant 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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