Full Text MH-95-002 FAMILY INTERVENTIONS AND HIV/AIDS NIH GUIDE, Volume 24, Number 13, April 7, 1995 RFA: MH-95-002 P.T. 34 Keywords: AIDS Family Health/Planning/Safety National Institute of Mental Health National Institute on Drug Abuse National Institute on Alcohol Abuse and Alcoholism National Institute on Aging Letter of Intent Receipt Date: April 24, 1995 Application Receipt Date: June 13, 1995 PURPOSE The National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), and National Institute on Aging (NIA) are 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 nonrelated 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 critically needed. 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 RFA, Family Interventions and HIV/AIDS, is related to the priority areas of mental health and mental disorders and HIV infection. "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 783-3238). 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. 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). 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. The anticipated award date is September 1995. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. Applicants are strongly encouraged to include one trip a year for two or three key personnel to attend the Annual NIMH Conference on HIV/AIDS and Families held in July in the Washington area. 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. FUNDS AVAILABLE In fiscal year 1995, a minimum of $2.65 million has been set aside for this RFA for a minimum of five to seven awards. The NIMH will provide a minimum of $1.4 million; NIAAA will contribute $500,000; NIDA will contribute $500,000; and NIA will contribute $250,000. Support may be requested for a period of up to five years. Continuation, noncompeting awards will be made, subject to availability of funds and progress achieved. 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. While the role of families with respect to other diseases (e.g., cancer, asthma, cardiovascular disease, etc.) has received some attention, efforts are needed to identify effective family process prevention strategies relative to HIV/AIDS. These include the role of the family in (1) primary prevention efforts to promote healthy behaviors that reduce the incidence of infection, (2) secondary prevention efforts aimed at maintaining physical and mental health status among infected individuals to slow the onset of symptoms, 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, additional research efforts should also be directed to 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 between 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 The following sections suggest areas of research to meet the health promotion and disease prevention objectives outlined above. Researchers need 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 who 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. 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. Family Processes, Risk of HIV Infection, and Course of Disease In designing or adapting family interventions aimed at decreasing infection risk and minimizing adverse physical and mental outcomes throughout the course of illness, investigators should utilize available data on HIV subpopulations as appropriate. Interventions are needed to: o Reduce family stress and enhance coping strategies in dealing with (a) high-risk drug and sexual behaviors; (b) knowledge of HIV infection and issues related to the stigma of the disease; and/or (c) progressive decline in physical and mental health of the person with HIV/AIDS; o Interrupt the interrelationships between alcohol- related behavior and high risk behaviors for HIV infection 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; Populations At-Risk for HIV Infection Identified at-risk groups 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., incarceration, drug treatment, mental hospital) 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 intervention research topics for specific groups. Men 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; HIV 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. Drug Users o Enhance the role of the family in promoting safer sexual and drug-using practices; 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; and o Enhance the effectiveness of families in promoting utilization of and adherence to medical, mental health, and drug abuse treatment. Women o Support family roles in enhancing the woman's ability to negotiate and maintain safer sexual behaviors; o Develop programs that attend to the unique needs of both seropositive and seronegative lesbian women and their families; o Support HIV seropositive women who are experiencing stress around 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, and primary and prenatal care by seropositive women; and 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. Infants and Children 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) that have been effective with other diseases; o Support effective family functioning, parental monitoring of children's activities and provision of information that encourages abstinence and later initiation of sexual behavior; and 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. Adolescents 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 Enhance 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 high levels of these behaviors; and o Enhance "family of choice" networks that reduce risk taking in very high-risk groups such as run-away or "throw-away" adolescents. Older Populations o Educate family members about the potential risk to older persons, which is often minimized by stereotypic assumptions that older people are no longer engaged in sexual activities and behaviors; and o Teach middle-aged and older family members to be agents of behavioral change in their interactions with younger family members; and o Support the role of older generation family members who have become primary caretakers due to AIDS-related incapacitation or death, or where the family of choice is no longer willing or able to provide caregiving; reduce stressors associated with older family members who provide care for a family member with AIDS. 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 new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. 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, by April 24, 1995, 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 this RFA, "Family Interventions and HIV/AIDS" (MH-95-002). 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 conflicts of interest in the review. The letter of intent is to be sent to: Willo Pequegnat, Ph.D. Office on AIDS National Institute of Mental Health Parklawn Building, Room 10-75 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: WPEQUEGN@A0AMH2.SSW.DHHS.GOV APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research or from the Office of Grants Information, Division of Research Grants, 6701 Rockledge Drive, Room 1040, Bethesda, MD 20892, Bethesda, MD 20817 (for express mail), telephone (301) 710-0267. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. 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, "Family Intervention and HIV/AIDS" (MH-95-002), must be typed on line 2a 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: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express mail or courier service) At the time of submission, two additional copies of the application must also be sent to: Willo Pequegnat, Ph.D Office on AIDS National Institute of Mental Health Parklawn Building, Room 10-75 5600 Fishers Lane Rockville, MD 20857 Applications must be received by June 13, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) 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 DRG 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 Applications that are complete and responsive to the Request for Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIH in accordance with the review criteria stated below. 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 will be discussed, assigned a priority score, and receive a second level review by the national advisory council, where applicable. Review Criteria o significance and originality from a scientific or technical standpoint of the goals of the proposed research; o qualifications and experience of the principal investigator and demonstrated staff expertise in family processes, prevention research, statistics, cultural competence, AIDS, and other areas specific to the questions under investigation; o adequacy of the conceptual and theoretical framework for the research, including cultural relevance to the target populations and evidence of familiarity with relevant research literature; o scientific merit of the research design, approaches, intervention, and methodology; o access to target population(s); o sample selection and retention methods and efforts to determine factors that influence refusal rate; o adequacy of the data analysis plan; o adequacy of the existing and proposed facilities and resources; o appropriateness of the budget, staffing plan, and time frame to complete the project; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. AWARD CRITERIA The following criteria will be used in making funding decision: o scientific merit as determined during the peer review process; o availability of funds; o balance among target populations with priority given to understudied populations; o balance among theoretical and multicultural approaches; and o balance among geographic areas. 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. Office on AIDS National Institute of Mental Health Parklawn Building, Room 10-75 Rockville, MD 20857 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: WPEQUEGN@A0AMH2.SSW.DHHS.GOV Vincent Smeriglio, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse Parklawn Building, Room 11A-33 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-1801 FAX: (301) 443-2317 Email: VSMERIGL@AOADA.SSW.DHHS.GOV Kendall J. Bryant, Ph.D. AIDS Behavioral Research National Institute on Alcohol Abuse and Alcoholism Willco Building, Suite 505 6000 Executive Boulevard Rockville, MD 20892-7003 Telephone: (301) 443-8820 FAX: (301) 443-8774 Email: KBRYANT@WILLCO.NIAAA.NIH.GOV Marcial G. Ory, Ph.D., M.P.H. Social Science Research on Aging National Institute on Aging Gateway Building, Suite 2C-234 Bethesda, MD 20892 Telephone: (301) 496-3136 FAX: (301) 402-0051 Email: ORY@NIHNIAGW Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 5600 Fishers Lane Parklawn Building, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-3065 FAX: (301) 443-6885 Email: DT21a@NIH.GOV The National Institute of Child Health and Human Development (NICHD) has an interest in social and behavioral research on the role of the family in HIV prevention, with specific reference to behaviors that increase or reduce the risk of sexual transmission of HIV in adolescent and adult populations. Of particular interest are studies of DYADIC, social, economic, and cultural influences on sexual behavior, studies that integrate frameworks for disease and pregnancy prevention, and studies that build on the substantial bodies of previously supported research on family structure and intergenerational influences on sexual behavior. For information contact Dr. Susan Newcomer, Demographic and Behavioral Sciences Branch, NICHD, telephone 301/496-1174, email NEWCOMES@HD01.NICHD.NIH.GOV. The National Institute of Nursing Research (NINR) has an interest in family interventions in HIV/AIDS. Therefore, applications that are of mutual interest may be given a secondary assignment to NINR in accordance with the NIH referral guidelines. Contact Dr. June R. Lunney, Health Promotion/Disease Prevention Branch, NINR, telephone 301/594-6908, FAX 301/480-8260, email JLUNNEY@EP.NINR.NIH.GOV. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 93.242, Mental Health Research Grants, 93.273, Alcohol and Alcohol Abuse Research Grants, 93.279, Drug Abuse Research Grants, and, 93.866, Aging Research Grants. 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 and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing 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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