RFA-MH-01-003: COMMUNICATIONS AND HIV/STD PREVENTION

Department of Health
and Human Services (HHS)

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COMMUNICATIONS AND HIV/STD PREVENTION Release Date: April 17, 2000 RFA: MH-01-003 National Institute of Mental Health National Institute on Aging Letter of Intent Receipt Date: August 18, 2000 Application Receipt Date: September 18, 2000 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS RFA. PURPOSE A mass communications revolution is shaping the social norms, attitudes and behaviors in every aspect of social interactions for the new generation in this country and changing those of the older generation. The purpose of this RFA is to solicit research applications to address communication issues in HIV/STD prevention research, develop models for communication that are appropriate for different developmental levels and at- risk groups, and develop preventive interventions by using the Internet, mass media, and other communication technologies for HIV/STD prevention research. Attention to mass communication is necessary to understand the public context within which those in the HIV/AIDS community provide public health information. In addition to their influence on community norms, the press and other mass media institutions may adopt editorial or other policies that make the acceptance of HIV-relevant interventions easier or harder and address issues of social stigma of HIV. The communications industry is shifting from broadcasting, in which the target audience is largely passive, to interactive communication, in which the person who is receiving the information is shaping the form and coverage. News media are connected by the Internet, an expanding web of networks, that is attracting a million new users monthly. These myriad of mass communication technologies are valuable tools for contacting others and forming new relationships that would not be possible within a community. This explosion of communication technology has not been adequately studied in the context of public health and disease 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 Request for Applications (RFA), Communications and HIV/STD Prevention, is related to the priority areas of Mental Health and Mental Disorders, STDs, and HIV. Potential applicants may obtain a copy of "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, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for R03 grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) and the small grant (R03) award 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 RFA may not exceed five years for an R01 award and two years for an R03 award. This RFA is one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is April 3, 2001. For all competing R03 applications and for R01 applications requesting up to $250,000 direct costs per year, specific application instructions have been modified to reflect MODULAR GRANT and JUST-IN-TIME streamlining efforts being undertaken at NIH. More detailed information about modular grant applications, including a sample budget narrative justification pages and a sample biographical sketch, is available via the Internet at: http://grants.nih.gov/grants/funding/modular/modular.htm. Applications that request more than $250,000 in any year must use the standard PHS 398 (rev. 4/98) application instructions. Because the small grants have special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult with program staff (listed under INQUIRIES) and to obtain the appropriate additional announcements for those grant mechanisms. Special instructions and information for the NIMH Small Grants Program is found at http://grants.nih.gov/grants/guide/pa-files/PAR-99-140.html. R03 awards are limited to $50,000 direct cost for each of the two years and are not renewable. FUNDS AVAILABLE The NIMH intends to commit approximately $1.2 million in FY 2001 to fund three to five new and/or competitive continuation grants in response to this RFA. NIA is planning to commit approximately $200,000 in FY 2001 to fund two new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years for an R01 award and up to two years for an R03 award. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. It is expected that direct costs will be awarded in modules of $25,000, however program and grants management adjustments may be necessary prior to award. Although the financial plans of the Institutes 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 applications of outstanding scientific and technical merit. At this time, it is not known if competing renewal applications will be accepted and/or if this RFA will be reissued. RESEARCH OBJECTIVES Background In the past people relied on health personnel and friends for health-related information. Now the Internet and mass media provide a major alternative information resource. Information about STDs and HIV can be accessed from communication sources throughout the world. The purpose of this RFA is to solicit research applications to: (1) address communication issues in HIV/STD prevention research, (2) describe some major areas that provide opportunities for HIV/STD prevention research, and (3) develop mass communication models for HIV/STD preventions. This research initiative is intended to be broad and is based on the classical definition of communication: who transmits what to whom, when, how, in what context, and with what effect. To recognize the more interactive quality of communication in this electronic age, search is also added. Below are some of the research questions that could be addressed under this RFA. These examples are not intended to limit investigator-initiated topics that relate to the purpose of this RFA. Phase I: Exploratory Studies o WHO: Who is using the Internet to learn new material or make new acquaintances? Who is using it for other purposes? Who is viewed as a credible source of information about HIV/STD prevention in the media (e.g., doctors, nurses, HIV+ persons, peers, family, and counselors)? o WHAT: What are the content and structure of the HIV/STD information being exchanged on Internet or being circulated in mass media messages? What are the characteristics of the messages (frequency, repetition, dose response, framing - loss or gain)? What is the type of appeal (fear arousal, information provision)? What is the purpose of the message (increase knowledge, change attitudes, change perceived norms, increase self-efficacy or social support, change behavior, meet new people)? o WHOM: What are the audience/participant characteristics (intelligence level, gender, ethnicity, age, religiosity)? o WHEN: What is the appropriate developmental level (e.g., pre-teen, adolescent, young adult, adult, older adult) to communicate about sexual behavior and/or drugs? Is different information communicated at different times of day (e.g., during the family hour) and in different formats (e.g., sitcoms, chat rooms for teens, etc.) o HOW: What channels of communication are used to spread information about HIV/STD risk and prevention? Are these channels amenable to an intervention to stop the spread of HIV/STDs? o CONTEXT: What is the setting in which transfer of HIV/STD-prevention information occurs? Is the information received at home, school, work, theatre, or in the car? Is the receiver alone or with others? Is it a private or a public place? o EFFECT: Was the information received, i.e., can people recall the message? How was the message interpreted? Did it change knowledge, attitudes, behaviors related to HIV/STD prevention? Did it influence decision-making about partners and risky behavior? Did it generate new options for behavior? o SEARCH: How do people decide that they need information on a health related topic? How do they decide to go to Internet or pay attention to a media message about HIV/STD prevention? What search strategies do people use for such diverse searches as finding partners or learning about health-related risks or treatments? How do people decide when they have enough information? How does the Internet compare to other information-search strategies? Phase II and III Studies: Efficacy Studies of Prevention Strategies The intent of these studies is to: o Develop prevention strategies that could be used to stop the spread of inaccurate information or messages that encourage risky HIV/STD-related information on the Internet. o Develop interventions to prevent young people from becoming involved with inappropriate people (e.g., those who are significantly older or are engaging in high risk HIV/STD-related behaviors) through chat rooms, bulletin boards, etc. o Develop interventions that use mass-media to change community norms about HIV/STD prevention, AIDS stigma, persons living with AIDS, etc. o Apply knowledge about how middle-aged and older people perceive risk and respond to messages about HIV/AIDS in order to develop communication interventions that will be effective in reducing HIV/AIDS risks in this population. Ethical and Methodological Studies These studies will address the following issues: o Identification of the ethical issues associated with conducting research on the internet (e.g., achieving informed consent, confidentiality, privacy, etc.). o Develop innovative methodology to study the impact of the internet and mass media on HIV/STD risk-related behaviors. SPECIAL REQUIREMENTS The Institutes would like to convene in the Washington, D.C. area an annual meeting of grantees supported under this RFA in order to network grantees and exchange research models and developments. Provision for participation in this meeting should be included in the budget. 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 was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html 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" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. 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 Institute staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Willo Pequegnat, listed under INQUIRIES, by August 18, 2000. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The application is also available at http://grants.nih.gov/grants/funding/phs398/phs398.html SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS 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 Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD: Do not complete Form Page 4 of the PHS 398 (rev 4/98). It is not required nor will it be accepted at the time of application. BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT: Do not complete the categorical budget tables on page 5 of the PHS 398 (rev. 4/98) Form. It is not required nor will it be accepted at the time of application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application and must display the RFA number MH-01-003. A sample modified mailing label is available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in pdf format. 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, Communications and HIV/STD Prevention (MH-01-003), must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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: Willo Pequegnat, Ph.D. Center for Mental Health Research on AIDS Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6209, MSC 9619 Bethesda, MD 20892-9619 Applications must be received by September 18, 2000. If an application is received after that date, it will be returned to the applicant without review. However, an application received after the deadline may be acceptable if it carries a legible proof-of-mailing date assigned by the carrier and the proof- of-mailing is not later than one week prior to the deadline date (See NIH Guide for Grants and Contracts, November 29, 1996). 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIMH staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. 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 NIMH in accordance with the review criteria stated below. As part of the initial merit review, a process will 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 consideration and the Principal Investigator and the official signing for the applicant organization will be notified. 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? The initial review group will also examine: the appropriateness of proposed project budget and duration, the adequacy of plans to include both genders, minorities and their subgroups, and children 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. Schedule Letter of Intent Receipt Date: August 18, 2000 Application Receipt Date: September 18, 2000 Peer Review Date: November 2000 Council Review: January 2001 Earliest Anticipated Start Date: April 3, 2001 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. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Willo Pequegnat, Ph.D. Center for Mental Health Research on AIDS Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6209, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: wpequegn@nih.gov Dr. Marcia G. Ory Behavioral and Social Research National Institute on Aging Gateway Building, Room 533 7201 Wisconsin Avenue MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 402-4156 Fax: (301) 402-0051 E-mail: Marcia_Ory@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Mr. Bob Pike Grants and Contracts Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 Fax: (301) 402-3672 E-mail: Bob_Pike@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH) and 93.866 (NIA). Awards are made 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 grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 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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