Full Text MH-92-11 THE ROLE OF THE FAMILY IN PREVENTING AND ADAPTING TO HUMAN IMMUNODEFICIENCY VIRUS INFECTION AND ACQUIRED IMMUNODEFICIENCY SYNDROME NIH GUIDE, Volume 21, Number 24, July 3, 1992 RFA: MH-92-11 P.T. 34 Keywords: AIDS Family Health/Planning/Safety Disease Prevention+ National Institute of Mental Health National Institute on Drug Abuse National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: August 15, 1992 Application Receipt Date: September 15, 1992 PURPOSE The National Institute of Mental Health (NIMH), National Institute on Drug Abuse (NIDA), and National Institute on Alcohol Abuse and Alcoholism (NIAAA) are requesting research applications that address family processes related to preventing and adapting to Human Immunodeficiency Virus (HIV) infection and Acquired Immunodeficiency Syndrome (AIDS). This Request for Applications (RFA) is critical because little information is currently available about family processes on a wide variety of family configurations, including those that are at high risk for HIV infection. Results from studies funded under this RFA will be used to develop effective prevention efforts aimed at high-risk individuals and their families or to enhance treatment efforts for families already coping with HIV infection. The urgency of the AIDS crisis demands that top priority be given to research with implications for preventive interventions that reduce the incidence of HIV infection. Even if a vaccine were to be identified in the next few years, prevention efforts would continue to be the primary way to stop the further spread of HIV infection. Because HIV-positive individuals may not experience AIDS symptoms for as long as 10 years, secondary prevention efforts aimed at maintaining physical and mental health status are needed also. A tertiary prevention goal is to prevent excess disability in those individuals already infected by minimizing affective, anxiety, or cognitive disorders. Therefore, the role of the family in promoting healthy behaviors that reduce the incidence of infection, slow the onset of symptoms, and minimize excess disability related to the disease are all of interest. Because family members also experience stress in the caring for AIDS patients, additional research efforts should also be directed to understanding effective coping strategies used by family members. Promoting adaptive strategies may be a viable prevention target in the next stage of research. 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 effort is in accordance with the specific objectives 18.1 to 18.6, 18.8, 18.9, and 18.12. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (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 Applications may be submitted by public and private non-profit or for-profit organizations such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Women and minority investigators are encouraged to apply. MECHANISM OF SUPPORT Support for applications submitted in response to this announcement will be through individual research grants (R01) of up to three years in duration. FUNDS AVAILABLE In fiscal year 1993, a minimum of $1.8 million has been set aside for this RFA. The NIMH will provide a minimum of $1.4 million; the NIDA and the NIAAA will each contribute a minimum of $.2 million to support three to five awards. Support may be requested for a period of up to three years. Continuation, noncompeting awards will be made, subject to availability of funds and progress achieved. RESEARCH OBJECTIVES Background The Department of Health and Human Services has identified AIDS as the foremost public health problem in the United States. As of September 1991, 195,718 cases of AIDS had been reported, with approximately one million Americans estimated to be seropositive for HIV. An estimated 40,000 persons become infected each year. In the last decade, over 126,000 Americans died of AIDS. Although homosexual and bisexual men still account for the largest number of persons infected with HIV, the groups with the most rapid increase in rates are women, adolescents, and children. Subpopulations may experience differences in disease course, but a large number of persons infected with HIV experience brain, cognitive, emotional, and behavioral changes. It is now accepted that HIV enters the central nervous system (CNS) early in the course of the disease, producing a range of nervous system impairments. Researchers, health professionals, and family practitioners have increasingly recognized the importance of the family in health promotion and disease prevention. Researchers have begun to examine the effectiveness of social support from family and friends in promoting adherence to medical regimes, making lifestyle changes, extending life, and providing comfort for sick individuals. Other studies have examined the repertoires used by families coping with a terminal, socially stigmatized disease. While the role of families with respect to other diseases (e.g., cancer, asthma, cardiovascular disease) has received some attention, only limited attention has been devoted to the potent role that families may play in preventing and adapting to HIV infection. Efforts are needed to identify family processes that may be used to develop or enhance prevention strategies. Furthermore, to plan effective strategies, it is necessary to understand the diverse nature of the at-risk groups who may vary by race, gender, age, culture, and socioeconomic status. The HIV epidemic not only takes a toll on the health of those directly infected but also affects the health and well-being of those close to them. Family members are likely to experience the stress of being caregivers or confidants while the AIDS patient is ill and experience grief upon the patient's death. Several examples from existing literature illustrate the potential radiating effects of AIDS on family members: parental death has been found to have adverse effects on surviving children's mental health; family members caring for older persons with dementia have been found to suffer depression and compromised immune functioning. Methodology development may be necessary to capture meaningful data on non-traditional 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. Areas of Interest The following sections suggest areas of research to meet the health promotion and disease prevention objectives outlined above. Researchers responding to this RFA, however, need not limit themselves to these topics. Ethnic and Cultural Considerations Cross-cultural variables deserve special consideration because of the rapidly increasing rates of HIV infection in ethnic minority populations. The explicit investigation of cultural factors as an aspect of family adaptation to HIV infection is encouraged. In such research, operational definitions of cultural factors should move beyond merely identifying people according to researcher-defined social categories (e.g., race and gender) and should include consideration of racial identity theory. In addition, assessments should be culturally competent and should measure dimensions of acculturation. Specific areas of interest include: o Methods for defining cultural, geographic, and ethnic background influences in family process in terms of knowledge, attitudes, and behaviors toward HIV infection are needed. Information on how personal decisions about HIV risk behaviors, the mode of transmission in acquiring HIV, acceptance of infected individuals, and caretaking responsibilities vary by cultural contexts is needed. o Identification of adaptive strategies of families and individuals belonging to different ethnic groups who are coping with HIV infection is needed. This may include patterns of communication and adaptive behavioral techniques that are related to cultural background such as the relative value of extended kinship support or religion. Family Processes and the Course of Illness Basic information on family systems and processes for all subpopulations of persons infected with HIV is needed to determine what family factors serve to increase or decrease risk factors for becoming infected, and to minimize symptomatology (physical and mental health outcomes) at all points in the course of the illness. Specific areas of interest include: o Determination of family stress factors and coping strategies in dealing with (a) high risk-taking 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 AIDS o Studying the influence of pre-existing family dynamics, current dynamics, or changes in family processes on family member risk-taking behaviors, the patient's reaction to learning about the infection, as well as the patient's mental and physical health throughout the progressive stages of the disease o Studying interrelationships between alcohol-related behavior and high risk behaviors for HIV infection (e.g., unsafe sexual practices and/or injection drug use) and identifying family strategies (e.g., social control, education, and family modeling) to reduce the influence of alcohol as a risk factor for HIV exposure o Assessing the impact of a family member's risk-taking behaviors, HIV infection and progressive decline in health on family dynamics, communication patterns, roles, and relationships, including further description of how these family processes change in relation to the various manifestations of the disease o Identifying effective coping strategies used by families in dealing with the risk of infection and course of the disease; the role of religion and spirituality in families at various points in the course of the illness, including adaptation to the death of the patient o Studying older generation family members as primary supports in several AIDS subpopulations, where maternal incapacitation or death has occurred due to AIDS, and in situations where the family of choice is no longer willing or able to provide support; identifying stressors associated with older family members who provide care for a family member with AIDS; and evaluating how pre-existing intergenerational relations affect the process of care after diagnosis Populations At-risk for HIV Infection In the second decade of AIDS, several at-risk population groups, each with its own needs and characteristics with respect to HIV prevention and intervention efforts, have been identified. Relevant family processes may vary, depending on the relationship or role (parent versus child) of the member who is at risk or is infected with HIV; however, there are clearly overlapping areas of interest for different populations. The following sections describe some research questions for specific groups who may be at high risk or infected with HIV. Homosexual and Bisexual Men While work in the last few years has provided good descriptive studies of homosexual culture and subcultures, there is a need for description of the homosexual man's family of origin and his family of choice. These studies should consider the contextual factors (e.g., urbanicity, ethnicity) that influence the way these two family groups respond to issues of homosexuality and HIV illness and the concomitant emotional, cognitive, and physical manifestations. The availability of resources (e.g., health services, family economics) within contexts may influence both disease course and caregiver stress. Specific areas of interest include: o Studies on conflictive and/or 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 of infection; being tested for HIV; treatment of HIV disease; relationships with the health care system and its members; life-sustaining procedures; bereavement rituals; and disposition of property o Studies of how social networks are formed and maintained that may contribute to homosexual men's health-promoting behavior and psychological well-being including both formal components (e.g., health care services and support groups) and informal components (e.g., friends and partners) o Studies on the potential differences between self-identified homosexual men and men who have sex with men in practicing high-risk behaviors; the influence of social and familial contextual factors on the likelihood of engaging in risky sexual behavior and its effect on psychological well-being and mental health o Studies of the impact of alcohol-related behavior on unsafe sexual practices among homosexual men and strategies that can reduce the impact of alcohol as a risk factor for unsafe sex Injection-Drug Users Injection-drug users (IDUs) are often in conflict with their family of origin; their peer group is often more influential in changing their high-risk behavior. With respect to the relationships between the family and IDU or potential IDU members, research and study are needed on the following key issues relating to psychosocial variables and the basic determinants of behavior: o Studies of the extent to which IDUs (and crack users) participate in family relationships and the feasibility of developing preventive interventions with their families o The role of families in the care of IDUs with asymptomatic and symptomatic HIV disease and the difficulties in engaging these families in the caregiving process o The relationship between family support of IDUs with HIV infection and physical and mental health outcomes Women Impoverished women of all ages have limited access to mental health treatment, and this broader problem likely impacts formal support resources to women who are caregivers of AIDS victims. Younger women who may be at risk for HIV infection are particularly vulnerable to minimal access to services, given the limited number of drug treatments programs available to them. Research in the following areas is needed: o How women's traditional roles as health educators and health caretakers in the family can be engaged for prevention, specifically, the impact of the caretaking role on the levels of stress, mental health, and physical health, particularly in older women when several members of a family are infected, and this role is continued over a long period of time o How women experience reproductive decision making when they are HIV positive, and how these decisions affect their relationships with partners and family o Studies on the experience of women who have relationships with men who engage in high-risk behaviors, factors that contribute to the maintenance or dissolution of the relationship and the practice of high-risk behaviors Infants and Children Medical advances may prolong the lives of children (defined as birth to 13 years) infected with HIV infection, but they will remain susceptible to opportunistic infections and neurodevelopmental problems. There is considerable evidence in the literature on other chronic childhood illnesses that parent functioning, family stressors, and family resources are all related to the expression of psychological and physiological symptoms in both ill children and their healthy siblings. Such family stressors include chronic poverty, isolation from communities of the healthy, prejudice, misunderstanding in the schools, loneliness, boredom, and depression. Unlike most children with other chronic diseases, many HIV-infected children are exposed to illness or death in at least one parent and experience major disruptions in their family. Children's dependence on adults for basic survival makes it difficult to study them in isolation from their families. Research is needed that will provide: o Identification of the factors in families that may contribute to the rate of disease progression in children (e.g., kinship support, stability of living arrangements) o Information on the relationship between effective family functioning and minimization of developmental disabilities in children with HIV infection, such as exploring how successful existing interventions with at-risk infants (e.g., premature, drug-addicted) have involved family members, and how such interventions may be adapted for children with AIDS o Information on bereavement in families that are amenable to intervention where a parent has died of AIDS need to be identified. Descriptive information on the short- and long-term effects of these interventions on the children who are seropositive and seronegative is needed. o Information on parental death from a stigmatized disease such as AIDS, and its effects on a child; information on how immediate and extended family members react and adjust to the parent's death, and how these family processes relate to the child's mental and physical health Adolescents During adolescence (defined here as ages 14 to 21), youths can engage in clusters of interrelated high-risk behaviors that put them at risk for HIV infection, such as sexual activity, alcohol use, drug use, and delinquency. This fact has important implications for understanding sexual behavior within the context of the adolescent's life as a whole and for understanding the nature of the culture in which that behavior is embedded. Specific family research issues regarding adolescents might include: o Identifying characteristics of families that are successful in preventing or curbing HIV risk-taking behavior such as unprotected sexual activity or intravenous drug use o Identifying characteristics of families of 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 o Identifying factors in a "family of choice" network that may reduce risk taking in very high-risk groups, such as run-away or "throw-away" adolescents, need to be identified. STUDY POPULATIONS Applicants are advised to obtain from their institutions, a copy of "Guidance for Institutional Review Boards (IRBs) for AIDS Studies," that was disseminated from the Office for Protection from Research Risks (OPRR) on December 16, 1984. OPRR may be consulted for advice on how to deal with difficult human subjects protection issues in AIDS research. These guidelines emphasize the special considerations that must be heeded in AIDS research and stipulate some important protection that should be considered in the design of AIDS research projects. A major one is the requirement that subjects be informed of the results of AIDS antibody testing, if any such testing is done. NIH/ADAMHA POLICY CONCERNING INCLUSION OF MINORITIES AND WOMEN AS SUBJECTS IN RESEARCH Applications for grants and cooperative agreements that involve human subjects are required to include minorities and both genders in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy applies to all research involving human subjects and human materials, and applies to males and females of all ages. If one gender and/or minorities are excluded or are inadequately represented in this research, particularly in proposed population-based studies, a clear compelling rationale for exclusion or inadequate representation should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH and ADAMHA recognize that it may not be feasible or appropriate in all research projects to include minority populations (i.e., American Indians or Alaskan Natives, Asians or Pacific Islanders, Blacks, Hispanics). Investigators must provide the rationale for studies on single minority population groups. Applications for support of research involving human subjects must employ a study design with minority and/or gender representation (by age distribution, risk factors, incidence/prevalence) appropriate to the scientific objectives of the research. It is not an automatic requirement for the study design to provide statistical power to answer the questions posed for men and women and racial/ethnic groups separately; however, whenever there are scientific reasons to anticipate differences between men and women, and racial/ethnic groups, with regard to the hypothesis under investigation, applicants should include an evaluation of these gender and minority group differences in the proposed study. If adequate inclusion of one gender and/or minorities is impossible or inappropriate with respect to the purpose of the research, because of the health of the subjects, or other reasons, or if in the only study population available, there is a disproportionate representation of one gender or minority/majority group, the rationale for the study population must be well explained and justified. The NIH/ADAMHA funding components will not make awards of grants and cooperative agreements that do not comply with this policy. For research awards that are covered by this policy, awardees will report annually on enrollment of women and men, and on the race and ethnicity of subject. Protection of Human Subjects Research activities carried out under this RFA will be governed by HHS Regulations for the Protection of Human Subjects in Research (45 CFR 46). These regulations require the awardee to establish procedures for the protection of subjects involved in any research activities. Prior to funding and upon request of the OPRR, prospective awardee must file an Assurance of Compliance with OPRR and establish or identify an IRB to review and approve the procedures for carrying out any research activities occurring in conjunction with this award. A formal request for the required Assurance will be issued by OPRR at an appropriate point in the review process, and examples of required materials will be supplied at that time. However, applicants may wish to contact OPRR (telephone 301-496-7005 or 301-496-7041) to obtain preliminary guidance on human subjects issues. When calling OPRR, investigators should identify themselves as applicants for RFA MH-92-11. AIDS Human Subjects Certifications and Animal Subjects Verifications If the applicant has an approved assurance covering the research (multiple project assurance for human subjects/full assurance of compliance for animal subjects), the applicant should provide, with the application, certification of Institutional Review Board (IRB) approval if humans are involved and verification of Institutional Animal Care and Use Committee (IACUC) approval if animals are involved. These reviews and approvals should occur PRIOR TO SUBMISSION of the applications and certifications and verifications should be SUBMITTED WITH the applications. Failure to provide required certifications and verifications within applications could result in deferral or rejection. The latest date of approval by the IRB of proposed activities must not be earlier than one year prior to the receipt date in this RFA. If animals or humans will be the subjects at PERFORMANCE SITES OTHER THAN THE APPLICANT ORGANIZATION, the applicants must identify, within the applications, the assurance status of each participant. Failure to provide this information within applications could result in deferral or rejection. If the applicant organization does not have on file with OPRR an approved Multiple Project Assurance of Compliance, the applicant organization, by signing the Face Page, is declaring that it will comply with 45 CFR 46 by establishing an IRB and submitting a Single Project Assurance of Compliance and certification of IRB approval within 30 days of a specific request from OPRR. LETTER OF INTENT Prospective applicants are encouraged to submit a letter of intent, by August 15, 1992, describing the nature of the research proposal, including hypotheses, research personnel, and estimated annual costs. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows ICD staff to estimate the potential review workload and to avoid conflicts of interest in the review. The letter of intent is to be sent to: Office of AIDS Programs National Institute of Mental Health 5600 Fishers Lane, Room 17C-06 Rockville, MD 20857 APPLICATION PROCEDURES Applicants are to use the grant application form PHS 398 (rev. 9/91). The number (MH-92-11) and title (Role of Family in Preventing and Adapting to HIV Infection and AIDS), of this RFA must be typed in item number 2a on the face page of the PHS 398 application form. When using the PHS 398 form to respond to an RFA, applicants must affix the RFA label available in the package to the bottom of the face page. Failure to use this label could result in delayed processing of the application so that it may not reach the review committee in time for review. Application kits containing the necessary forms and instructions may be obtained from business offices or offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. If such a source is not available, the following office may be contacted for the necessary application materials: Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-05 Rockville, MD 20857 Telephone: (301) 443-4414 Application Receipt and AIDS Expedited Review Schedule National Advisory Receipt of Initial Mental Health Earliest Application Review Council Review Start Date Sep 15, 1992 Oct/Nov 1992 Jan/Feb 1993 Mar 1, 1993 Applications received after the above receipt date will be returned without review. Budget Applicants must submit an adequately justified budget for each research component in 12-month segments of requested support. Applicants are encouraged to include travel costs for three investigators from each site to attend one meeting each year (in Rockville, Maryland) in the budgets. Grant funds may be used for expenses clearly related and necessary to conduct the proposed project. All budget items must be fully justified at the level requested. Grantees are expected to be familiar with and comply with applicable cost policies. Submission of Application Completed applications must contain all information needed for initial and Advisory Council Review. The completed application with one signed original and five permanent legible copies of the completed application (with five copies of appendices) must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Review Process Applications received in response to this RFA will be assigned to an ADAMHA initial review group (IRG). The IRG consists primarily of non-Federal scientific and technical experts who will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by the appropriate advisory Council whose review will be based on policy considerations as well as scientific merit. Only applications recommended by the Council may be considered for funding. Review Criteria Criteria for scientific/technical merit review of applications will include the following: 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 families and evidence of familiarity with relevant research literature o Scientific merit of the research design, approaches, 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 o Adequacy of plans to ensure adequate representation of women and minorities in study population o Adequacy of proposed procedures for protecting human subjects AWARD CRITERIA In the decision to fund applications, the following will be considered: 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 o Balance among geographic areas INQUIRIES Prospective applicants are strongly advised to contact an NIMH, NIDA, or NIAAA staff member in order to discuss the proposed research project prior to submission. Staff consultation is available from: Willo Pequegnat, Ph.D. Office of AIDS Programs National Institute of Mental Health Parklawn Building, Room 17C-06 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-6100 Vincent Smeriglio, Ph.D. Clinical Medicine Branch Division of Clinical Research National Institute on Drug Abuse Parklawn Building, Room 11A-33 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-1801 Kendall Bryant, Ph.D. Program Director for AIDS Studies Prevention Research Branch National Institute on Alcohol Abuse and Alcoholism Parklawn Building, Room 13C-23 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-1677 For further information of grants management issues, applicants may contact: Stephen J. Hudak Chief, Grants Management Section National Institute of Mental Health Parklawn Building, Room 7C-23 5600 Fishers Lane Rockville, MD 20857 Telephone: (301) 443-4456 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance 93.242, 93.273, and 93.279. Under statutory authorities of Sections 301 and 504 of the Public Health Service Act, (42 U.S.C. 241 and 290aa), the National Institute of Mental Health, the National Institute on Drug Abuse, and the National Institute on Alcohol Abuse and Alcoholism will accept applications in response to this request under the single receipt date of September 15, 1992. Grants are administered in accordance with the PHS Grants Policy Statement (revised October 1, 1990). Federal regulations at 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Parts 74 and 92, generic requirements concerning the administration of grants, are applicable to this award. .
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