PA-03-027: SOCIAL AND STRUCTURAL IMPACT OF HIV/AIDS

Department of Health
and Human Services (HHS)

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SOCIAL AND STRUCTURAL IMPACT OF HIV/AIDS RELEASE DATE: November 14, 2002 PA NUMBER: PA-03-027 EXPIRATION DATE: August 2005, unless reissued. National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA This Program Announcement (PA) calls for research examining the social, demographic, economic, and other structural impacts of HIV in populations around the globe. As of the end of 2001, 40 million adults and children worldwide were living with HIV/AIDS. Fourteen million children under 15 had lost one or more parents to AIDS. In 2001 alone, five million new infections and three million deaths are estimated to have occurred. An epidemic of this size and scope not only affects the immediate victims of disease but also their families, communities, and many aspects of the larger society as well. Research on the nature of these effects and the mechanisms driving them is crucial to addressing them effectively. RESEARCH OBJECTIVES Background Illness, disability, and death associated with the HIV/AIDS epidemic affect populations at multiple levels and in multiple ways. Families experience the death and incapacity of loved ones and providers and must cope, in addition, with the burden of caring for the sick and dying. Businesses, schools, hospitals, and other institutions lose valuable personnel; absenteeism increases and productivity declines. Food security is threatened, the result of effects on the production of food and the ability of households to afford a nutritious diet. School enrollments decline and the payoffs to investments in education are undercut by high death rates among young adults. The economic costs of addressing HIV and its effects, both in the health sector and in other sectors of the economy, divert resources from other important needs and from investments critical to economic development. The demographic structure of the population is affected, challenging systems for supporting dependent populations such as children and the elderly. In many cases, the impact of the HIV/AIDS epidemic on families, communities, and countries has feedback effects that influence the course of the epidemic - for example, poverty and the breakdown of social and economic systems impair community systems that could help to stem the spread of infection. Many factors are likely to have important influences on these effects as well as the ability of populations to respond to them. Resources initially available to combat the epidemic are likely affected by characteristics of the age structure, economic systems, cultural and political systems, and institutions present in a country before the epidemic gathers momentum. The geographic, demographic, and social characteristics of the epidemic - how infection and death rates are distributed over geographic and social space and the dynamics of change in that distribution -- have important implications for how societies experience and respond to the impact of HIV/AIDS. Concern about the current and potential future impact of the HIV/AIDS epidemic around the globe has increased dramatically in recent years. Many in the international community are recognizing the need for research that measures different kinds of impacts and improves our understanding of them. Such studies have great potential to inform policy makers and planners as they formulate responses to the epidemic. Modeling, based on surveillance data, is a primary tool for assessing the size and future of the epidemic itself, and existing advances in modeling will be essential to studying HIV/AIDS impact. However, other data and approaches will also be necessary for informing policy and evaluating responses to the epidemic. This PA seeks to stimulate innovative approaches to understanding the complex mechanisms underlying the multiple impacts of HIV/AIDS in a variety of populations across the globe. Research Scope Applications submitted in response to this PA should examine the social, demographic, economic, or other structural impacts of HIV in populations. Research may focus on how populations, societies, communities, and families and other institutions are affected by the epidemic and how they adapt. Applications may also address the consequences of particular ways of adapting, and the supports or strategies that might help to protect the viability of social and economic systems, families, and other social units. Research grant applications should be grounded in a theoretical model that traces the mechanisms through which the HIV/AIDS epidemic has its impact. For example, some effects may be a function of age structure changes; others may be the result of changes in the health status of the population; others may relate to the geographical distribution of the disease; others may relate to the cultural, economic, or social structural characteristics that influence how the impact of the epidemic is experienced. A wide range of extant data may be useful for studies submitted in response to this Program Announcement. They include, but are not limited to, local and national censuses, surveys, and administrative records such as death certificates or bequests. Innovative uses of extant data are encouraged. New data collection is permitted in cases where extant data are not adequate to meet the aims of the proposed study. Studies are sought from all parts of the globe where the HIV epidemic is having an increasing or substantial impact, and across a variety of domains (family, business, government, etc.) International and cross-disciplinary work is encouraged. Studies are called for to address the impact of HIV/AIDS on outcomes such as: o Mortality and morbidity, especially the HIV-related morbidity and mortality of working-age adults. This includes but is not limited to: 1. Ramifications of HIV-related mortality on the numbers and conditions of orphans, siblings, surviving grandparents, and extended families. 2. How HIV-related mortality is related to changes or declines in the labor force, through changes in qualifications of employees, age structure of labor force, and/or expenditures for benefits. o Population movement, e.g., changes in temporary migration and remittance flows; migration to seek or provide care. o Fertility, including but not limited to: 1. Changes in fertility due to HIV infection. 2. Effects of HIV-related child mortality on fertility. 3. Effects of HIV infection on fecundity in both men and women. o Other demographic effects, including changes in age structure, dependency ratios, and changes in the spatial distribution of populations o Household/family structure characteristics and processes, including: 1. Changes in household and family structures, burdens of dependency within households and extended families, and patterns of household headship. 2. Provision of basic necessities (e.g., shelter, clothing, nutrition). 3. Changes in the nature and quantity of family resources (money income, home-produced food and goods, social ties and social capital). 4. Parenting, childcare, elder care. 5. Household decision-making and the distribution of power within households and families. 6. Changes in the allocation of family resources. o Community processes and characteristics, such as increasing poverty and widening income inequality, changes in local infrastructure, job opportunities, or social interaction; changes in abilities of traditional sources to provide for social, emotional, or economic support; declines in the social cohesion of communities. o Specific sectors of the economy or society, such as: 1. Health, including loss of workers and declines in productivity and morale among workers at all skill levels; allocation of health sector resources to various aspects of HIV (prevention, VCT, treatment, care) and other health needs; changes in the organization, staffing, and delivery of health services; changes in health service financing. 2. Government and political systems, including effects on levels of civic participation, policy, and law, and the availability of qualified personnel for civil service and political positions. 3. Education, including declines in the supply of teachers and administrators and changes in demand for education as a consequence of impoverishment or population decline in certain areas. 4. Agriculture, food production, and land tenure. 5. Defense sectors, national security, military training and readiness. 6. Business and industry, including changes in investment, productivity, and profitability as a result of absenteeism, or as changing hiring practices are implemented to avoid increasing health insurance obligations. 7. Tourism. 8. Prisons, civil unrest, and crime rates. 9. Social and religious institutions. o Intervening mechanisms producing specific impacts; for example, the role of poverty, disability, and multiple demands on healthy individuals in producing effects on the economic and social health of communities. o Measurement issues in studying the impact of the HIV/AIDS epidemic, with particular attention paid to: 1. Methods to compensate for incomplete vital registration data. 2. The appropriate uses of verbal autopsy data for examination of death by cause. 3. The use of GIS to examine land use in relation to HIV rates. 4. Appropriate measures of the cost-effectiveness of interventions to ameliorate the impact of HIV/AIDS, examining both the input and the outcome of such studies at differing levels of HIV prevalence within a society. 5. The utility of antenatal surveillance as a predictor of HIV incidence in a population. MECHANISMS OF SUPPORT This PA will use the NIH Research Project Grant (R01) and Small Grant (R03) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project This PA uses just-in-time concepts. It also uses the modular budgeting format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct questions about scientific/research issues to: Susan Newcomer, Ph.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6981 Email: Snewcomer@nih.gov Willo Pequegnat, Ph.D. Center for Mental Health Research on AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6-205, MSC 9619 Bethesda, Maryland 20892-9619 Telephone: (301) 443-1187 FAX: (301) 443-9719 Email: WPequegn@mail.nih.gov o Direct questions about financial or grants management matters to: Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17M, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 Email: hancockk@nih.gov William F. Caputo Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-0004 FAX: (301) 443-6885 Email: wcaputo@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. APPLICATION INSTRUCTIONS FOR SMALL GRANT (R03) APPLICATIONS: Application instructions described in PAR-99-126, available at http://grants.nih.gov/grants/guide/pa-files/PAR-99-126.html, should be followed. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: All applications for small grants (R03) and R01 applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least six weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA 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 a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Research project grant (R01) and small grant (R03) applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate all applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate 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 your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: The adequacy of plans to include subjects from genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below.) DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a 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 Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.864, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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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