FAMILY INTERVENTIONS TO PREVENT AND ADAPT TO HIV/AIDS Release Date: February 3, 2000 RFA: MH-00-009 National Institute of Mental Health Letter of Intent Receipt Date: April 24, 2000 Application Receipt Date: May 24, 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 The National Institute of Mental Health (NIMH) is requesting research applications that address family-process interventions to enhance the ability of families to prevent the spread of HIV/AIDS and/or its consequences. In this Request for Applications (RFA), the term "family" refers to the breadth of family configurations, including biological kin networks and non-related persons who consider themselves to be family through a "network of mutual commitment." Thus, family level of analysis may include the family of origin, family of choice, or a combination of these. Prevention efforts aimed at high-risk individuals and their families, as well as enhanced treatment efforts for families already coping with HIV infection, are still critically needed for the myriad of families being infected and affected by HIV/AIDS. 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 Request for Applications (RFA), Family Interventions to Prevent and Adapt to HIV/AIDS, is related to the priority areas of Mental Health and Mental Disorders, STDs, and HIV. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000/ 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 small (R03) grants. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research grant (R01) award mechanism and the small grant (R03) award mechanism. 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 a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is September 29, 2000. 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 2000 to fund three to four new grants in response to this RFA. An applicant may request a project period of up to five years for an R01 award or 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 the 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 Institute 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 this RFA will be reissued. R03s are not renewable. RESEARCH OBJECTIVES Background The urgency of the AIDS crisis demands that top priority be given to research addressing preventive interventions that reduce the incidence of HIV infection and minimize its negative consequences. Although the role of families with respect to diseases (e.g., cancer, asthma, cardiovascular disease, HIV/AIDS, etc.) has received some attention, additional efforts are needed to identify effective family process prevention strategies relative to HIV/AIDS. These include the role of the family in (1) family-oriented primary prevention efforts to promote healthy behaviors that reduce high-risk HIV/STD-related behaviors and incidence of HIV/STD infection, (2) family-oriented secondary prevention efforts aimed at maintaining physical and mental health status among infected individuals in order to slow the onset of symptoms (e.g., enhancing quality of life, maintaining medical regimens, etc.), and (3) tertiary prevention to mitigate excess disability in symptomatic individuals by minimizing affective, anxiety, or cognitive disorders, and ameliorating general health outcomes. Because family members also experience stress in the caring for AIDS patients-- especially in this new, uncertain treatment environment--additional research efforts should also be directed at identifying strategies to promote effective coping by family members. Families affected by HIV/AIDS must often deal with additional stressors, such as alcohol and drug abuse and mental illness. Methodology development may be necessary to capture meaningful data on nontraditional family relationships and structures in terms of membership, relationship roles, and patterns of interaction and communication. Study designs may need to clarify the nature of interactions among a family of origin, family of choice, and intimate support networks. Innovations in statistical analysis approaches may also be required to describe clearly these family processes and the efficacy of preventive interventions. Areas of Interest In the following sections are suggested areas of research that meet the health promotion and disease prevention objectives outlined above. They are advisory only and researchers should not limit themselves to these topics. Ethnic and Cultural Considerations To plan effective strategies, it is necessary to understand the diverse nature of the at-risk groups that may vary by ethnicity, gender, age, acculturation, and socioeconomic status. Operational definitions of cultural factors should move beyond merely identifying people according to researcher-defined social categories (e.g., race and gender) and include consideration of racial identity theory. In addition, assessments should be culturally competent and should measure dimensions of acculturation. Of particular need are studies of gay and heterosexual men and the role of families in their risk behaviors. A culturally competent system of care acknowledges and incorporates -- at all levels -- the importance of culture, the assessment of cross-cultural relations, and acknowledgement of dynamics that result from cultural differences. Phase I Studies: Family Processes, Risk of HIV Infection, and Course of Disease At-risk individuals have unique needs and characteristics with respect to HIV prevention and intervention efforts. Relevant family processes may vary, depending on the relationship, role (e.g., parent versus child), and context (e.g., high crime neighborhoods, detention centers and prisons, drug treatment centers, mental hospitals) of the family member who is at risk or is infected with HIV, however, there are clearly overlapping areas of interest for different populations. The following sections illustrate some intervention research topics. In designing or adapting family interventions aimed at decreasing HIV-infection risk and minimizing adverse physical and mental outcomes throughout the course of illness, data from studies of family process are critical. Studies are needed to: o Examine family stress and enhance coping strategies of male and female family members in dealing with (a) high-risk drug and sexual behaviors, (b) knowledge of HIV infection and issues related to the stigma of the disease, (c) issues of self-disclosure of disease and to whom these disclosures are made, and/or (d) the progressive decline in physical and mental health of the person with HIV/AIDS, o Describe the interrelationships between alcohol-related behavior and high- risk behaviors for HIV infection among men and women and enhance family strategies (e.g., social control, education, and family modeling) to reduce the influence of alcohol as a risk factor for HIV exposure. Phase II/Phase III Studies: Primary Preventive Interventions Studies should be designed to: o Reduce the conflictive and enhance the supportive relationships between the families of origin (e.g., older parents, adult siblings) and families of choice with respect to decisions about primary and secondary prevention, testing for HIV, treatment of HIV disease, relationships with the health care system and other family members, life-sustaining procedures, bereavement rituals, and disposition of property, o Develop strategies to enhance and maintain social networks that contribute to both heterosexual and gay men"s health-promoting behavior and psychological health, including both formal components (e.g., health care services and support groups) and informal components (e.g., friends and partners), o Mitigate the impact of alcohol-related behavior on unsafe sexual practices among heterosexual and gay men and develop strategies that can reduce the impact of alcohol as a risk factor for unsafe sex, o Enhance the role of the family in promoting safer sexual and drug-using practices, o Support family roles in enhancing the woman"s ability to negotiate and maintain safer sexual behaviors, o Develop primary prevention programs for enhancing women’s ability to negotiate safer sex and use of female-control measures, o Support effective family functioning, parental monitoring of children"s activities and provision of information that encourages abstinence and later initiation of sexual behavior, o Enhance characteristics of families that are successful in preventing or curbing HIV risk-taking behavior such as unprotected sexual activity, non-injection drug use, and the initiation of drug injection, o Strengthen the role of families in supporting adolescents who remain sexually inactive and do not engage in other high-risk behaviors despite environmental conditions in which there are both perceived and actual high levels of these behaviors, o Teach middle-aged and older family members to be agents of behavioral change in their interactions with younger family members. Phase II/Phase III Studies: Secondary Preventive Interventions Of interest are studies to: o Improve the role of families in the care of drug users with asymptomatic and symptomatic HIV disease and support the caregiving process of these families in order to ameliorate physical and mental health outcomes, o Enhance the effectiveness of families in promoting utilization of, and adherence to, medical, mental health, and drug abuse treatment, o Support HIV seropositive men and women who are experiencing stress in regard to reproductive decision making, and mitigate negative effects on their relationships with partners and family, o Enhance access to and utilization of drug treatment, mental health services, and primary and prenatal care by seropositive women and their families, o Reduce the impact of the caretaking role on stress, mental health, and physical health, particularly when multiple members of a family are infected and this role is continued over a long period of time, o Slow disease progression in children by using kinship support and maintaining the stability of living arrangements, o Support effective family functioning that minimizes developmental disabilities in children with HIV infection, such as family-focused interventions that have been effective with at-risk infants (e.g., premature, drug-exposed) and with other diseases, o Address bereavement in families in which a parent has died of AIDS and mitigate short- and long-term negative effects on both seropositive and seronegative children, reduce the negative effects on the child of parental death from a stigmatized disease such as AIDS, o Support the role of older generation family members who have become primary caretakers because of AIDS-related incapacitation or death, or when the family of choice is no longer willing or able to give care, reduce stressors associated with older family members who provide care for a family member with AIDS. Phase IV Studies: Effectiveness Studies of Interventions with Demonstrated Efficacy The aim is to: o Conduct studies translating primary preventive interventions for families that have been demonstrated to have efficacy under controlled conditions, and o Conduct studies translating secondary interventions for families that have been demonstrated to have efficacy under controlled conditions. SPECIAL REQUIREMENTS The awardees from this RFA are expected to attend the Annual NIMH Conference on the Role of Families in Preventing and Adapting to HIV/AIDS, and, therefore, the budget should include provision for this Conference, which is traditionally held during the third week of July. Awardees should assume that it will be held in the Washington, D. C. area. 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). It is also NIH 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 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 April 24, 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 table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the 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-00-09. 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, Family Interventions to Prevent and Adapt to HIV/AIDS, RFA MH-00-009, 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 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 May 24, 2000. 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. 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 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Advisory 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 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, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: April 24, 2000 Application Receipt Date: May 24, 2000 Peer Review Date: August 2000 Council Review: September 2000 Earliest Anticipated Start Date: September 29, 2000 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 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 The National Institute of Child Health and Development (NICHD) is also interested in these issues. For further details, please refer to the information on the HIV Research Agenda of the Demographic and Behavioral Sciences Branch at http://silk.nih.gov/silk/dbsb/ or information on the Child Development and Behavior Branch at http://www.nichd.nih.gov/about/crmc/cdb/cdb.htm. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. 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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