Notice Number: NOT-AI-10-023
Update: The following update relating to this announcement has been issued:
- December 10, 2013 - See Issuance of PA-14-024.
Key Dates
Release Date: April 5, 2010
Due Date: June 1, 2010
Issued by
National Institute of Allergy and Infectious Diseases (NIAID), (www.niaid.nih.gov)
Components of Participating Organizations
John E. Fogarty International Center (FIC), (www.fic.nih.gov)
National Cancer Institute (NCI), (www.nci.nih.gov)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), (www.nichd.nih.gov)
National Institute on Drug Abuse (NIDA), (www.nida.nih.gov)
National Institute of Mental Health (NIMH), (www.nimh.nih.gov)
National Institute on Alcohol Abuse and Alcoholism (NIAAA), (www.niaaa.nih.gov)
Purpose
The NIH, in collaboration with the Office of the Global AIDS Coordinator, is soliciting applications for one-year supplements which will inform the President’s Emergency Program for AIDS Relief (PEPFAR) on effective and efficient approaches to HIV prevention, care and treatment. This opportunity for an administrative supplement is limited to investigators with current NIH grant funding for research and research training being conducted at PEPFAR funded sites. Applications for supplements must fall within the scope of work of the parent grant and, once awarded, will be managed according to the rules and regulations of the NIH institute through which the project is funded.
Based on the merits of the applications received, it is expected that approximately 35 supplements will be funded pending the availability of funds. The total budget (direct and indirect costs) of each application cannot exceed $500,000. Applications should not exceed 5 pages in length and are to be submitted to the NIH Program Officer assigned to the parent grant. Page count does not include tables, graphs, bibliography, budget and budget justification. Applications should be accompanied by a signed letter of support from all sites involved in the research.
Background
At this stage of the HIV/AIDS epidemic, there is an unmet need for implementation science research to inform approaches and investments for public health programming and policy making. Research is needed to study effectiveness of HIV-treatment and prevention approaches already proven efficacious in ideal conditions (e.g., in clinical trials) and the effectiveness of at scale combination prevention interventions, each with known efficacy. A rigorous implementation science research agenda is also required to improve many aspects of program delivery and to increase the public health impact of proven HIV/AIDS modalities in prevention, treatment, and care.
Research under the umbrella of implementation science is not intended to test the efficacy of a potential intervention; rather, this research seeks to advance the theory and methods which underlie the implementation of a range of interventions and related programs. Thus, while implementation science should improve the operations and efficiency of a proven prevention, treatment, or care intervention or strategy, the goals and findings of such research should also be applicable across a broader range of targets, interventions, settings, and populations.
Research Objectives
The intent of this Notice is to solicit implementation science research of relevance to PEPFAR that will focus on the multiple challenges being encountered by many programs in resource-limited countries when they attempt to deploy effective prevention, treatment, and integrated interventions against HIV/AIDS. Studies should reflect the needs and priorities of the countries or regions in which they are to be conducted, but also produce results that are quantifiable and applicable to diverse circumstances and geographic areas.
Specific Research Areas
Applications submitted for this limited competition will be reviewed jointly by NIH and PEPFAR program staff. Priority will be given to those high quality applications with greatest significance to the needs of NIH and PEPFAR such as but not limited to:
- Impact evaluation studies and studies which demonstrate ways to improve program effectiveness and cost-efficiency.
- Work which focuses on most-at-risk populations (MARPs), including men who have sex with men (MSM) or injection and non-injection drug users, and/or gender-based issues.
- Feasibility studies or efforts to gain the preliminary data needed for the development of more extensive studies in implementation science.
Potential applicants are strongly encouraged to contact the Program Officer for the parent grant prior to submitting applications. Clarifications of any questions regarding NIH and PEPFAR priorities, and how these may fit with their currently funded research, can be discussed at that time.
The list below provides examples of research areas that will be considered responsive to this announcement. It is not an exhaustive list, nor does it limit studies to these areas of investigation. The topics were identified in recent consultations with multiple stakeholders; they were selected because they reflect urgent needs in countries where PEPFAR is active and because research in these domains can optimize PEPFAR services. Therefore, preference will be given to applications in the following areas:
- Role of nutrition in prevention, treatment and care of HIV/AIDS;
- Development of family centered models of care for orphans and vulnerable children;
- Prevention of mother-to-child HIV transmission (PMTCT);
- Engagement and retention of individuals (adults or children) in HIV care and treatment;
- Integration of primary health care, HIV/AIDS services (adult and pediatric), and treatment of common co-morbidities;
- HIV prevention interventions: addressing gaps in social/behavioral implementation science;
- Scaling up proven prevention, treatment, and combination interventions; and
- Optimization of health systems and strengthening of human resources
IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.
Role of Nutrition in Prevention, Treatment and Care of HIV/AIDS
Complex interactions between nutritional status and HIV progression and transmission and between specific nutrient metabolism and antiretroviral therapy have not been well studied. While the mechanisms of these interactions remain unclear, there is evidence that the high rate of hunger and malnutrition among those living in resource-limited countries can affect adherence and outcomes for those in HIV care and treatment programs. PEPFAR has identified nutrition as one of the key areas for linkage with development programs. Current programs which integrate nutritional assessment, counseling and support include PMTCT, pediatric treatment, adult and pediatric care and support, and targeted food and nutrition support for orphans and vulnerable children (OVC). However, in order to design and implement optimal programs in these areas, critical information is needed on the existing nutritional status among program participants, factors which increase the risk of nutritional deficiency, including alcohol use, and the optimal assessment strategies which can be scaled up in routine practice in resources limited countries.
Research addressing nutrition and HIV/AIDS will help PEPFAR in planning cross-cutting nutrition activities. This includes evaluating the impact of nutrition activities on patient outcomes and on community infrastructure for prevention, care and treatment programs; assessing the delivery systems and level of integration of PEPFAR nutrition activities with other nutrition and food support programs available; and assessing the overall effectiveness and cost-efficiency of implementing nutrition activities within PEPFAR programs.
Development of Family Centered Models of Care for Orphans and Vulnerable Children
Current PEPFAR OVC activities are aimed at improving the lives of orphans and other vulnerable children affected by HIV/AIDS. Services to children (0-17 years) are based on the actual needs of the individual child and include ensuring access to basic education, broader health care services, targeted food and nutrition support, shelter, psychosocial support, protection and legal aid, economic strengthening, training of caregivers, etc. Also included are household-centered approaches that link OVC services with HIV-affected families (linkages with PMTCT, palliative care, treatment, etc.) and strengthen the capacity of the family unit (caregiver); activities to strengthen community structures that protect and promote healthy child development (schools, churches, clinics, child protection committees, etc.); and investments in local and national government capacity to identify, monitor, and support children’s well-being. Programs may be included that facilitate the transition from residential OVC care to more family-centered models.
Applications in the area of OVC should assess the impact of existing programs; address linkages with related services, identify quality and programming gaps; and identify best practices to guide PEPFAR in this area. These evaluations should provide the evidence base needed for developing OVC programs and family focused models of care.
Prevention of Mother-to-Child Transmission of HIV (PMTCT)
The implementation of effective PMTCT programs relies on the development and support of the underlying maternal-child health infrastructure. Structural factors within country health systems are one of the challenges to implementing effective PMTCT programs. At the country level, maternal, newborn and child health services are usually separate from programs, laboratories, and services for HIV treatment and care. Thus, ante partum and postpartum care systems are not equipped to test all women for HIV infection, conduct CD4 testing to identify disease stage of HIV-infected women, and provide antiretroviral treatment to women who need it and antiretroviral prophylaxis to the others.
Systematic evaluation of program effectiveness is needed to measure the impact of PMTCT programs and to determine best practices, to identify where programmatic efficiencies can be gained, and the optimal intensity or frequency with which effective interventions are employed. Indicators to measure performance must be defined and systematically collected. Data are needed on the causes of bottlenecks or obstacles within the traditional PMTCT cascade (e.g., antenatal attendance, uptake of HIV testing, use of antiretroviral drugs in pregnancy for treatment or prophylaxis). Implementation science can be used to evaluate and increase the impact of PMTCT programs by identifying successful approaches to expanding access to and generating demand for infant feeding and nutrition interventions; providing follow-up of the mother/infant pair, from maternal counseling and testing to determination of infant HIV serostatus through testing at 18 months; and delivering appropriate care and treatment for the mother.
Provision of safe and effective family planning to women of childbearing age is also a key element of PMTCT. Increased capacity for family planning services in resource-limited countries is needed, as are optimal models that could be adopted to integrate HIV prevention and care services and family planning services.
Engagement and Retention of Individuals (Adults and/or Children) in HIV Care and Treatment
The importance of engaging HIV-infected individuals in care and treatment on an early and consistent basis is critical to the success of PEPFAR programs. Late treatment initiation, poor adherence, and loss to follow-up are particular threats to treatment programs. Treatment failure causes significant morbidity for the individual and the community, and there is significant early mortality and ARV resistance associated with late initiation of therapy and treatment failure.
Continuing the scale-up of PEPFAR treatment services within tight budget constraints requires a strengthened effort to ensure efficiency and effectiveness for both care and treatment services. Implementation science methodology can help to identify and evaluate innovative clinic practices that are beneficial for the early diagnosis of HIV-infected individuals, the speed of enrollment in care, the timely initiation of HIV treatment, and maximizing adherence and follow-up.
Research is needed to identify and strengthen linkages between testing and care services for newly diagnosed patients; to improve the capacity and effectiveness of PEPFAR programs in providing care and addressing the needs of HIV-infected individuals prior to eligibility for antiretroviral therapy; and to guide PEPFAR in promoting smooth transitions into treatment programs while maintaining consistency of care and effectively managing the diseases which most commonly jeopardize outcomes for HIV-positive individuals, e.g., TB, malaria, cervical dysplasia. Approaches are also needed to improve and evaluate progress in programming to provide greater access and improved care and treatment services for women and girls.
Studies are needed to evaluate approaches to improve the effectiveness of treatment programs in reducing morbidity, retaining patients, and maximizing the durability of first-line regimens. Clinic level surveillance of viral suppression; approaches to implementing the PEPFAR strategy for monitoring and preventing HIV drug resistance; and evaluations of the impact of the HIV drug resistance strategy on patients and programs are examples of targeted evaluations that will help to guide programs.
Recent studies have demonstrated high rates of loss-to-follow-up among both children and adults during care and treatment and have identified switching treatment sites, drop-out from HIV care, and high mortality as important factors. Sample-based approaches have been developed for tracking and estimating true mortality. However, methods for accurately predicting those at risk of dropping out of care, tracking and facilitating continuity of care for those who switch care sites, and developing programs to reduce loss-to-follow-up across the spectrum of HIV prevention, testing, care, and treatment services have not been tested and are essential to the success of PEPFAR.
Integration of Primary Health Care, HIV/AIDS Services (Adult and Pediatric), and Treatment of Common Co-Morbidities
As PEPFAR evolves from an emergency plan to a sustainable component of a strengthened health care infrastructure -- consistent with the goals of the Global Health Initiative -- it will become even more important to coordinate and integrate health care services. Although the integration of HIV/AIDS prevention, care, and treatment services with primary health care in resource-limited countries could reach more users and provide better and more efficient services, a close integration between and across the various tiers of a country’s health care system has generally not been achieved.
Integration of services may benefit both the general health care system as well as HIV/AIDS services. Collective strengthening of primary care services and HIV services could improve access to primary care through HIV care delivery sites. Expansion of HIV care services could use a family care approach model that also addresses nutrition; maternal and child health; safe water; malaria and other infectious diseases, including tuberculosis (TB); and maximizes integrated HIV/TB co-infection treatment services. Implementation science studies are needed to determine the relative merits of a closer integration of HIV and other health services, e.g., whether addressing HIV disease and common co-morbidities in primary care facilities can be effectively attained without compromising the quality of either HIV care or of primary health care. Studies might address issues such as patient-flow analyses, functional analyses of relative roles and existing funding mechanisms of HIV/AIDS and other relevant prevention and care services, organizational and management training for health managers and providers, and specific strategies for integration and financing of services.
In addition, there are other co-infections (e.g., TB, hepatitis) and co-morbidities (e.g., cancer, alcohol or substance abuse, mental health conditions) that are not fully addressed in existing HIV care sites. Linkages between HIV care facilities and specialized settings that address these should be established and strengthened.
HIV Prevention Research: Addressing Gaps in Social/Behavioral Implementation Science
Efficacious social/behavioral HIV-prevention interventions (e.g., male circumcision; individual, small-group, and structural HIV risk-reduction behavioral interventions; alcohol, substance abuse, and mental health treatment approaches) are available for implementation by clinics and communities. However, the science-to-practice gaps in this area remain significant, and research regarding how to most effectively implement these interventions has been more limited. Therefore, a wide range of implementation science studies are encouraged, particularly in the areas of dissemination, adoption, fidelity/adaptation, and sustainability, and may include innovative methods for evaluating the effectiveness and added value of incorporating promising but less tested interventions with combination interventions.
Scaling Up Efficacious Prevention, Treatment and Combination Interventions
Research on HIV prevention interventions has identified many effective approaches to reduce the risk of HIV infection and improve health outcomes for individuals living with HIV/AIDS. Translating these effective interventions from selected populations under controlled conditions into real world settings requires an understanding of the elements of the intervention that must be strictly adhered to and those that allow some flexibility in implementation in a given target population. How to best combine these interventions for specific populations and settings also requires further evaluation. Effectiveness should be measured in terms of critical overall objectives such as increased testing, linkage to care, acceptability, adherence, and when possible, viral suppression and decreased HIV incidence.
Optimization of Health Systems and Strengthening of Human Resources
For sustained public health impact, the HIV-prevention and treatment infrastructure needs urgent attention in countries where PEPFAR is active, and questions answered through implementation science can assist in a variety of ways, including research on recruitment and training of personnel, organizational and provider behavior change, and the use of technology in health systems. Measurement tools and evaluation methodology need to be developed and validated for assessing the impact of shifting towards greater integration of health services on the health care system as well as on patient outcomes. Preparatory studies establishing methodology for monitoring and evaluating success and sustainability of elements of the health care system will be particularly helpful to PEPFAR in their continued scale-up of services.
Submission Requirements
- All supplement applications must be submitted on the PHS 398, and include a face page, detailed budget and budget justification, the proposal text, and NIH checklist. Face pages must be signed by the investigator and authorized organizational official of the applicant institution. Modular budget pages will not be accepted even when the parent grant was funded as a modular grant.
- Total costs (direct and facilities and administrative costs) for the supplement application MAY NOT exceed $500,000 for up to one year of funding.
- Text for the proposal should be limited to 5 pages. Tables or graphs conveying preliminary data may be included in an appendix and, along with the bibliography, will not be included in the page count.
- Biographical sketch for all new Senior/Key Personnel.
Applicants are limited to investigators with current NIH grant funding for research being conducted at PEPFAR funded sites in at least one of the 32 PEPFAR partner countries and regions. (http://www.pepfar.gov/countries/index.htm) applications for administrative supplements must fall within the scope of work of the parent grant. The Project Director/Principal Investigator (PD/PI) must be the same as the PD/PI on the parent award. For Multiple PD/PI parent awards, the Contact PD/PI must be the PD/PI listed on the supplement request. Administrative supplements cannot change the Multiple PD/PI team or convert a grant from a single PD/PI to a multiple PD/PI grant.
- A letter of support must be provided by the authorized organizational official for each collaborating institution, particularly any PEPFAR funded implementation sites where data will be collected or study protocols will be implemented.
- Human Subjects/Vertebrate Animal documentation (if applicable). Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if applicable. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made.
- Investigators must identify the relevance of their question to PEPFAR program implementation. Given the limited time frame for this work, feasibility studies or efforts to gain the preliminary data needed for the development of more extensive studies in implementation science may also be proposed. Potential applicants are strongly encouraged to contact the Program Officer for the parent grant prior to submitting applications. Clarifications of any questions regarding NIH and PEPFAR priorities and how these may fit with their currently funded research can be discussed at that time.
- Applications are to be submitted through the NIH Program Officer for the parent grant, not to the Division of Receipt and Referral. At the same time a copy should be sent to the Grants Management Specialist for the parent grant. If your Program Officer is out of the office and not available to receive your application, you may submit it to the Program Officer listed on this announcement for the NIH institute through which you are funded.
- Applicants are strongly encouraged to submit applications electronically as an e-mail attachment in PDF format; however the signature of the institutional official must be clearly visible. Applicants may also submit applications in paper format to the appropriate IC.
Supplement Application Review Process
Applications submitted for this limited competition will be reviewed jointly by NIH and PEPFAR program staff. Priority will be given to those high quality applications with greatest significance to the needs of PEPFAR.
Significance:
- Does this study address one of the identified priority questions?
- If not, has the applicant provided strong justification that this is an important issue related to the implementation of HIV/AIDS prevention, care, treatment, and related programs?
- What will be the effect of these studies on the applications, methods, technologies, treatments, services, or preventative interventions that make up PEPFAR programs?
- Will the answers to the research question be generalizable to different settings that are attempting to scale up HIV prevention, treatment, and care services?
- How large an impact will answering the implementation science research question have on the HIV epidemic profile or the survival of the population of interest?
- How feasible will it be to rapidly and widely implement the results of the research study?
Approach:
- Can the question proposed be answered through well-designed and conducted implementation science research?
- Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project?
- Does the applicant acknowledge potential problem areas and consider alternative tactics?
- Is the research that is proposed logistically feasible, financially possible, and likely to produce timely results?
- Can the proposed research be completed within the life of the grant?
- How is the proposed research related to the scientific objectives of the primary grant?
Innovation:
- Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; or address an innovative hypothesis or critical barrier to success of PEPFAR programs?
- Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area of investigation?
- Does the project incorporate new approaches to answer questions related to program design and incorporation of scientific advances in program implementation?
Investigators:
- Are the investigators appropriately trained and well suited to carry out this work?
- Is the work proposed appropriate to the experience level of the PI and other researchers?
- Does the investigative team bring complementary and integrated expertise to the project?
- Does the research team have the established collaborations necessary to conduct the study?
- Does the research team include host country investigators as integral parts of the study team?
Environment:
- Do the clinical, scientific and programmatic environments in which the work will be done contribute to the probability of success?
- Do the proposed studies benefit from unique features of the scientific environment, program characteristics, or subject populations, and/or employ useful collaborative arrangements?
- Is there evidence of institutional support?
- Are there letters of support from PEPFAR implementation sites involved and collaborating institutions?
Program Contacts
Melanie C. Bacon, RN, MPH
Division of Acquired Immune Deficiency Syndrome
National Institute of Allergy and Infectious Diseases (NIAID)
6700B Rockledge Drive, Rm. 4201
Bethesda, MD 20814
Telephone: 301-451-2747
E-mail: [email protected]
Jeanne McDermott CNM MPH PhD
Division of International Training and Research
Fogarty International Center
Building 31 Rm B2C39
31 Center Drive, MSC 2220
Bethesda MD 20892-2220
(301) 496-1492
Fax (301) 402-0779
E-mail: [email protected]
Geraldina Dominguez, Ph.D.
Office of HIV and AIDS Malignancy
National Cancer Institute (NCI)
31 Center Drive, Building 31, Room3A/33
Bethesda, MD 20892-2440
Telephone: 301-496-3204
Fax: 301-480-4137
E-mail: [email protected]
Lynne M. Mofenson, M.D.
Pediatric, Adolescent and Maternal AIDS Branch
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
6100 Executive Boulevard, Room 4B11
Rockville, MD 20852
Telephone: 301-435-6870
Fax: 301-496-8678
E-mail: [email protected]
Katherine Davenny, Ph.D.
AIDS Research Program
National Institute on Drug Abuse (NIDA)
6001 Executive Blvd., Room 4215
Bethesda, MD 20892
Telephone: 301.443.2146
Fax: 301-594-5610
E-mail: [email protected]
Chris Gordon, Ph.D.
Division of AIDS and Health and Behavior Research
National Institute of Mental Health (NIMH)
6001 Executive Boulevard, Room 6199, MSC 9619
Bethesda, MD 20892-9619
Telephone: 301-443-1613
Fax: 301-443-9719
Email: [email protected]
Kendall J. Bryant, Ph.D.
Coordinator, Alcohol and HIV/AIDS
National Institute on Alcohol Abuse and Alcoholism
Rm 2069
5635 Fishers Lane
Rockville MD 20892-7003
Tel: 301-402-9389
Financial/Grants Management Contacts
Jane Paull
Grants Management Program
National Institute of Allergy and Infectious Diseases
6700B Rockledge Drive, Room 2119, MSC7614
Bethesda, MD 20892-7614
(Express Mail: Bethesda, MD 20817)
Phone: 301-594-1544
Fax: 301-493-0597
E-Mail: [email protected]
Bruce Butrum
Chief Grants Management Officer
Office of the Director
Fogarty International Center, NIH
Building 31, Room B2C29
31 Center Drive
Bethesda, MD 20892-2220
Phone # 301-496-1670
Fax # 301-594-1211
E-mail: [email protected]
Alice Wong
Team Leader
National Cancer Institute, OGA
6120 Executive Blvd., EPS, Room 243
Rockville, Md. 20852
301-496-7800
e-mail: [email protected]
Mario Martinez, MPH
Supervisory Grants Management Specialist
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health
6100 Executive Blvd., Room 8A07D
Rockville, MD 20852
Phone: 301.402.4078.
e-mail: [email protected]
Jane Z. Lin
Senior Grants Management Specialist
National Institute of Mental Health
6001 Executive Blvd., Room 6115, MSC 9605
Bethesda, MD 20892-9605
For Overnight Deliveries:
6001 Executive Blvd., Room 6115
Rockville, MD 20852
Phone: 301-443-2229
Fax: 301-480-1956
E-mail: [email protected]
Pamela G. Fleming
Chief Grants Management Officer
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd
MSC 9560
Bethesda, MD 20892-9560
Phone: (301) 443-6710
FAX: (301) 594-6849
E-mail: [email protected]
Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane
Room 3023
Bethesda, MD 20892-9304
Telephone: 301-443-4704
FAX: 301-443-3891
E-mail: [email protected]
and Human Services (HHS)
