Key Dates

Related Announcements

• October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO PA-20-272.
• September 8, 2021 - Emerging Global Leader Award (K43 Independent Clinical Trial Required) (PAR-21-251)
• September 8, 2021 - Emerging Global Leader Award (K43 Independent Clinical Trial Not Allowed) (PAR-21-252) 
• April 21, 2022 - Fogarty HIV Research Training Program for Low-and Middle-Income Country Institutions (D43 Clinical Trial Optional). See NOFO PAR-22-151
• February 8, 2022 - Global Brain and Nervous System Disorders Research Across the Lifespan (R01 Clinical Trials Optional). See NOFO PAR-22-097
• May 10, 2023 - Interventions for Stigma Reduction to Improve HIV/AIDS Prevention, Treatment and Care in Low- and Middle- Income Countries (R01 - Clinical Trial Optional). See NOFO PAR-23-190
• January 16, 2024 - International Research Scientist Development Award (IRSDA) (K01 Independent Clinical Trial Required). See NOFO PAR-24-114
• January 22, 2024 - International Research Scientist Development Award (IRSDA) (K01) Independent Clinical Trial Not Allowed. See NOFO PAR-24-113

Issued by

Fogarty International Center (FIC)

Office of AIDS Research (OAR)

Purpose

The Fogarty International Center (FIC), supported with funds from the Office of AIDS Research (OAR) at the National Institutes of Health (NIH), invites supplement applications from currently funded HIV/AIDS research or research training grants to initiate research on the emerging need to address critical gaps in understanding the impact of HIV on the health of Women Living With HIV (WLWH) and to get a better understanding of the consequences of the intersectionality of HIV infection and women’s health at a more psychological, biological and physiological level. 

FIC will award up to one-year administrative supplements to FIC grantees working in Low- and Middle- Income Countries (LMICs) on HIV/AIDS projects focused on providing research training to candidates from LMICs. Potential trainees can be early-stage (includes medical students, pre-doctoral or doctoral level students) trainees, early-career researchers at post-doctoral level, and other new investigators and junior professionals interested in women’s health issues prevalent in the LMICs. The administrative supplements are expected to provide advanced mentored training in a much-neglected area of HIV science, namely the plight of WLWH in LMICs, and help them to carve out an independent research career in basic, clinical, and translational aspects of health and well-being of WLWH.  FIC and OAR recognize the need for bolstering interest at the intersection of HIV and women’s health in LMIC settings by providing support to jump-start work in this research area. This initiative is timely and especially responsive to the global challenge of providing adequate and relevant preventive and therapeutic benefits and care to WLWH.

This program will support any one of the following activities:

1. To equip early-stage trainees with research skills through an intensive and mentored research project of up to one year, focused on scientific gaps in research on WLWH across the lifespan.

2. To provide early-career researchers with a year of support to initiate work in HIV and women’s health and begin to build a research portfolio focused on health concerns of WLWH.

3. To provide opportunities for new investigators and junior professionals who want to introduce a women’s health focus to their HIV research program or link their current scientific interest to research on issues related to WLWH.

A brief portfolio analysis of NIH funded research in LMICs indicated that there has not been a concerted effort to develop a network of researchers working at the intersection of HIV and women’s health across the lifespan. This supplement program is a bolstering step in the direction of stimulating the interest of young scientists to take up research careers to address these issues. 

Background - Description of circumstances for which administrative supplements are available.

Recent studies suggest that WLWH face an increased risk of mortality due to coinfections and NCDs. HIV prevalence is higher in LMICs where poverty, lack of adequate health care resources, stigma, and challenges to accessing care among other factors can add to the deleterious effects of compounded health conditions on this population. This applies to both cis- and trans- women, to the older WLWH and to the female children, young adults and adolescents living with HIV who undergo several challenges and roadblocks to attempt a life free from depression, anxiety, hunger, gender-based violence and access to treatment among other issues. There are still critical gaps in understanding the long-term effects of HIV infection from a biological, behavioral, and social sciences perspective that when addressed will benefit development of global public health measures to improve the lives of WLWH. Long-term consequences of maternal infection and ART use on perinatal or in-utero acquired infection on the physiology of young girls still needs to be understood. WLWH are more susceptible to accelerated aging, which deprives young women of useful and productive lives earlier, neurocognitive disorders, loneliness and mental health disorders, arthritis, menopause, osteoporosis, frailty, multimorbidity and polypharmacy. The effects of sex hormones in WLWH on several of these conditions are heavily understudied. The elderly women who are living longer with these conditions add to the public health burden and health economics considerations by the health care systems, especially in LMICs.

Young girls and adolescents are particularly vulnerable to acquiring and transmitting disease due to lack of knowledge about HIV, let alone awareness of their condition and seeking care. Additionally, the administrative supplement will provide the opportunity to initiate research on new societal challenges in LMICs brought on by heightened recognition of health disparities, social determinants of health affecting access to care, increased prevalence in adolescents and young adults among other significant but understudied areas. More research is needed to get a clearer understanding of the intersectionality of the consequences of HIV infection and continuous use of ARTs at a more physiological level across the continuum of the age spectrum. The research and research training initiated through this supplement opportunity will be efficiently built on already ongoing work and will be timely to inform development of strategies to continue to develop better health outcomes for WLWH across the lifespan. Despite the progress over the last 40 years women around the world remain disproportionately affected by HIV. More research is needed to understand optimal ways to prevent, treat and cure HIV and associated comorbidities across women's lifespans, and in diverse populations of women including racial and ethnic minorities and underprivileged communities, which need to be prioritized for prevention treatment and cure related research efforts. Reaching such populations is an essential consideration for ending the HIV epidemic globally.

Supplement Goals:

The supplement is expected to: a) spur formative research for trainee projects as an introduction to research on HIV in relation to the health status of WLWH; b) set the stage for obtaining preliminary data and conducting pilot studies to demonstrate the feasibility of conducting research involving the intersection of HIV and women’s health, or c) add training and pilot research topics to train young investigators and public health workforce on managing health of WLWH across the lifespan. It is expected that this supplement opportunity will better prepare academic and research-intensive institutions to develop future leaders to conduct research in basic, clinical, and translational aspects of HIV-associated consequences and related areas on WLWH.

This initiative will support any one of the following activities:

1. Research Program using the R (R01) and K (K43 and K01) grant mechanisms: To build enhanced capacity to conduct HIV and women’s health research in LMICs through increased understanding of women’s health on HIV/AIDS Prevention, Treatment and Care in WLWH or to understand the contribution of HIV to the disease process in WLWH (including pregnant women, transgender women, adolescent, and young girls). This capacity building activity can include providing a mentored research opportunity to a junior investigator or a doctoral student to initiate work in this scientific area. The impact of this supplement is enhanced if the doctoral student or junior investigator is a female scientist, although not required.

2. Research Training program using the D43 mechanism: To enhance the HIV/AIDS research workforce in LMICs by providing additional training to incorporate the impact on the health of WLWH or to understand the nature of the different comorbid disease process in WLWH (including sex hormone differences, metabolic effects of drugs, cultural and social pressures affecting mental health, stigma among others). This research training activity can include providing a mentored research opportunity to a master’s or doctoral student or to a post-doctoral trainee to initiate work in this scientific area as a steppingstone to a career development path. This also can provide training to health care workers and pharmacists to critically assess and adjust their care provision in a more culturally and patient-tailored fashion. It will also support efforts to conduct studies on the challenges faced by WLWH in LMICs due to the complex cultural and societal challenges that includes stigma and discrimination faced by WLWH.

Research/Research Training Plan

The proposed research or training plan is not restricted; however, the proposals must be within the scope of the parent grant objectives with the novelty of inclusion of a women’s health lens on the original goals. Therefore, an introduction that clearly but briefly states the overall scope of the supplement request, the anticipated contribution of the requested supplement to the parent study, and how the project is within the goals of the parent grant should be included.

For the purposes of the supplement application women’s health is considered broadly to encompass the well-being of females, from childhood through adolescence, reproductive ages and postmenopausal ages. Women in this case also includes all age groups whose sex is assigned at birth as female and whose growth over time could be influenced by early influences of HIV or to in utero exposure to anti-retrovirals as they age into childhood, adolescence and young adult and beyond. Women also includes cisgender, transgender, and gender-diverse women who should receive evidence-based care, prevention, and treatment tailored to their unique needs, circumstances, and goals.

Studies may include but will not be limited to:

1. Studies that will incorporate aspects of basic mechanisms, translational and implementation research, behavioral and social sciences research into the current goals of the parent grant that would help modify prevention, treatment, and care activities for WLWH.
2. Studies that investigate the influence of sex-linked biology, gender-related factors, hormone therapy, polypharmacy on non-communicable diseases and coinfections in WLWH.
3. Understanding and developing intersectional stigma reduction interventions as it applies to cis- and trans-gender women, adolescent girls, pregnant and post-partum women, widowed women, and female children across the lifespan who are living with HIV.
4. Studies to better understand the psychological, physiologic and biological effects of menopause on WLWH.
5. Studies investigating societal challenges faced by WLWH in LMICs brought on by heightened recognition of health disparities, and social determinants of health affecting access to care.

Supplement Budget Allowance:

FIC will provide up to $100,000 Total costs per supplement. However, the requested budget must be commensurate with the scope of the proposed work.

Budget can be used to hire appropriate personnel to carry out required activities under the specific aims proposed; to compensate a training coordinator and support trainees to work on the newly added goals of the supplement; and other costs related to accomplishment of the specific aims.

Funds should be used consistent with the administrative restrictions on the parent award.

A clear budget and budget justification must be provided as indicated in PA-20-272.

All requisite NIH and other local organizations’ required clearances, if appropriate, must be obtained prior to start of any work funded by supplement funds.

Review and Award  Considerations

FIC will review all applications for responsiveness to this announcement. An internal review group convened by FIC in keeping with NIH peer review guidelines will review all responsive supplement applications and assign a priority score.

Applicants should develop their studies in keeping with the NIH HIV/AIDS Research Priorities (https://www.oar.nih.gov/hiv-policy-and-research/research-priorities; https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-018.html) .

The following will be considered in making awards:

• Relevance to the intersection of HIV and women’s health in the LMIC where the proposed work will be done
• Quality of the proposed research project, and training potential
• Funding availability
• Programmatic priorities
• Geographical distribution

Reporting criteria

Awardees of administrative supplements will be required to submit a progress report to be included in the annual progress report of the parent grant. Progress reports should include the Supplement grant number and a summary of the supplement projects and outcomes.

Timeline

Announcement Release Date:  April 2024

Application receipt date: June 20, 2024

Supplements awarded: September 1 – September 30, 2024

Application Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date(s) – June 20, 2024, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include “NOT-TW-24-005” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Requests may be for up to one year of support only. 
• Recipients of currently active FIC (TW) awards working on HIV/AIDS research areas that are not in a no-cost-extension or other funded extension period as of August 31, 2024, may submit a supplement application.
• If the principal investigator (PI) and contact institution of the parent grant is in the US, a Multiple PI (MPI) or co-investigator from the LMIC institution must lead the supplement initiative as the supplement project director (PD).  However, the contact PI of the parent award must submit the application and remains PI of the supplement.
• The trainees supported by the supplement must be from the LMIC, and training and research must be done in the LMIC.
• The Research Strategy or Training Plan section of the application is limited to 6 pages.
• Only existing awardees of FIC D43, R01, K43, and K01 research and training program are eligible to apply.
• The project “summary” should be for the administrative supplement, not the parent grant. However, please include a very brief outline of the parent goals.
• K01 and K43 applicants must include mentor statements from their current U.S. and LMIC mentors in support of the proposed supplement activities.
• K01 and K43 applicants must include a letter signed by the Institutional Business Official that provides a description of institutional support for the PI’s proposed supplement activities.
• Applicants are strongly encouraged to notify the program contact of the parent award that a request has been submitted in response to this NOFO in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries to:

Geetha P. Bansal, Ph.D.
Fogarty International Center
Telephone: 301-496-1492
Email: [email protected]