June 2023 NIH Office of AIDS Research Advisory Council Meeting

OAR updates, HIV & Women, NIH OAR Data Hub launch, Clinical Guidelines updates, and more

August 1, 2023

The National Institutes of Health (NIH) Office of AIDS Research Advisory Council (OARAC) convened its 63^rd meeting in Rockville, Maryland, and virtually via NIH Videocast on June 23. In addition to this summary, the meeting video is available here, and minutes will be made available on OARAC page of the OAR website.

OARAC provides advice to the NIH Office of AIDS Research (OAR) on the planning, coordination, and evaluation of research and other HIV/AIDS activities conducted or supported by NIH. The meeting was the first for Bill G. Kapogiannis, M.D., FIDSA, in his role as Acting Associate Director for AIDS Research at NIH and Acting Director of OAR.

Meeting highlights included a report from OAR’s Acting Director, a series of presentations and discussion on HIV and women’s health; updates on the OAR HIV and Aging and Early Career Investigators Signature Programs; an interactive presentation of the new OAR Data Hub, a data dashboard to explore the NIH HIV research portfolio; and a preview of upcoming updates to HIV clinical practice guidelines.

Report From the Acting Director of OAR

Dr. Kapogiannis provided updates on key OAR activities over the past several months. Notably, OAR recently published the FY 2025 NIH HIV/AIDS Professional Judgment Budget. This congressionally mandated report highlights accomplishments in HIV/AIDS research in the previous year and estimates additional funding needed to advance research in priority areas. The document requests a $659 million increase, for a total proposed budget of $3.953 billion for fiscal year (FY) 2025, an increase of 20 percent over the FY23 enacted budget.

Dr. Kapogiannis highlighted OAR’s recent engagements with external partners and Congress:

• On May 9, OAR presented the importance of the NIH HIV research program at an in-person congressional briefing, organized by the Research Working Group of the Federal AIDS Policy Partnership (FAPP) in conjunction with Representative Barbara Lee.
• OAR provided updates on NIH activities related to the Ending the HIV Epidemic in the U.S. (EHE) initiative at a virtual briefing for House and Senate appropriations staff on May 9, as well as at the 76^th full council meeting of the Presidential Advisory Council on HIV/AIDS (PACHA) in March.

OAR is currently executing the FY 2021–2025 NIH Strategic Plan for HIV and HIV-Related Research (the NIH HIV Strategic Plan). The office has started working on the next iteration of this legislatively mandated NIH HIV Strategic Plan, which defines the goals and scientific priorities that will guide the NIH HIV research program and inform the annual Congressional Budget Justification and Professional Justification Budget. Development of the next NIH HIV Strategic Plan will offer the opportunity to review HIV research priorities and ensure resources are used optimally to meet emerging needs.

In an effort to coordinate research across NIH in cross-cutting, priority research areas, OAR has launched four Signature Programs that are aligned with the NIH HIV research priorities: HIV and Aging, HIV and Women, Technology for HIV Research, and Early Career Investigators (ECIs).

Dr. Kapogiannis noted National HIV Testing Day, held on June 27. This year’s theme, “Take the Test & Take the Next Step,” emphasized that when someone knows their HIV status, they can choose how to stay healthy. OAR, in collaboration with the NIH HIV/AIDS Executive Committee (NAEC), is planning a virtual workshop, November 1–2, 2023, that will expand on the theme of HIV self-testing and viral load monitoring. Additional details will be available soon.    

HIV and Women

• Janine Austin Clayton, M.D., FARVO, Associate Director for Research on Women’s Health at NIH Director of the NIH Office of Research on Women’s Health (ORWH)
• Leslie Marshall, Ph.D., OAR Health Scientist Administrator and Senior Science Advisor
• Elizabeth Barr, Ph.D., ORWH Social and Behavior Scientist Administrator
• Seble G. Kassaye, M.D., M.S., Associate Professor, Department of Medicine Division of Infectious Diseases at Georgetown University Medical Center

A key focus throughout the meeting was the need for increased women-centric HIV research. Despite tremendous advances in HIV research over the last 40 years, women—particularly women of color, young women, and transgender women—remain disproportionately impacted by HIV.[1]^,[2] Intentional women-focused research is critical to understanding how to prevent, treat, and cure HIV and associated comorbidities across the lifespan.

Dr. Clayton set the stage by describing why coordination between ORWH and OAR is crucial to advancing HIV research for women and ensuring an intersectional, equity-informed, data-driven approach to research. She stressed that inclusion of diverse populations of women in prevention, treatment, and cure-related research efforts is an essential component of ending the HIV epidemic.

Drs. Marshall and Barr gave a detailed overview of the joint OAR-ORWH HIV and Women Signature Program, which aims to achieve the NIH vision for women’s health—in which all women, including cisgender women, transgender women, and individuals assigned female at birth—receive evidence-based HIV care, prevention, and treatment tailored to their own needs, circumstances, and goals. The program also will support women in science careers to reach their full professional potential.

As part of the program, OAR and ORWH have convened an HIV and Women Working Group with representation from across several NIH Institutes, Centers, and Offices (ICOs), which is identifying gaps and priorities at the intersection of HIV and women’s health. ORWH and OAR will continue to explore these topics and gather input from the community during a workshop, “HIV and Women: Current and Future Directions at the NIH,” at the 2023 United States Conference on HIV/AIDS (USCHA), scheduled for September 6–9 in Washington, DC. In addition, planning is underway for the NIH HIV & Women Virtual Workshop, March 7–8, 2024, to review the state of the science on HIV and women and inform the future research agenda.

Over the past decade, NIH support for the Multicenter AIDS Cohort Study (MACS)/Women’s Interagency HIV Study (WIHS) Combined Cohort Study (MACS/WIHS-CSS) has led to increased understanding of sex differences in HIV. Dr. Kassaye presented her research on the WIHS cohort, which has helped determine rates of viral suppression among women with HIV in the United States, as well as social and structural factors that contribute to viral suppression.[3]

Discussion following Dr. Kassaye’s presentation focused on the need to address structural challenges that affect treatment access and adherence for women with HIV. Participants also discussed opportunities within the NIH grantmaking process to better address the needs of women and ensure their inclusion in HIV research.  

OAR Updates

• Geetanjali Bansal, Ph.D., OAR Health Scientist Administrator and Senior Science Advisor
• Rahel Abebe, M.H.S., OAR Public Health Analyst
• Robert Cregg, M.S., M.B.A., OAR Supervisor Health Scientist and Senior Analytics Advisor
  

Dr. Bansal and Ms. Abebe provided updates on OAR’s HIV and Aging Signature Program and Early Career Investigators in HIV Signature Program, respectively. As people with HIV live longer due to successful antiretroviral treatment, Dr. Bansal discussed the need to accelerate interdisciplinary research to understand and address the unique challenges faced by people aging with HIV. An upcoming virtual NIH HIV and Aging Workshop on September 5, followed by a panel discussion at USCHA on September 8, will help define research opportunities and facilitate collaborations with community members and other federal agencies. Ms. Abebe highlighted the success of the recent 2023 Workshop for ECIs in HIV and additional resources available on OAR’s ECI Resources webpage.

Mr. Cregg provided a demonstration of a new NIH OAR Data Hub, which synthesizes publicly available data about the NIH HIV research portfolio to promote greater understanding of HIV research at NIH and to allow researchers to identify awards relevant to their specific interests.

Updates: NIH Advisory Councils, HIV Clinical Guidelines

• Carl W. Dieffenbach, Ph.D., Director, Division of AIDS, National Institute of Allergy and Infectious Diseases, NIH
• Coretté Byrd, RN, M.S., Health Science Policy Advisor, HIVinfo Program Manager, OAR

The meeting closed with updates from NIH advisory bodies:

• Dr. Dieffenbach reported on efforts by the AIDS Research Advisory Committee (ARAC) to expand diversity, equity, inclusion, and accessibility in HIV research. ARAC representatives also highlighted current significant HIV research, including CoVPN3008, which will examine efficacy of COVID-19 mRNA vaccines in people with HIV, and the STOMP trial, a placebo-controlled, double-blind study to establish efficacy of tecovirimat in people with mpox.
• Ms. Byrd noted the approval of 26 new and reissued cleared concepts since March 2023, as reported to the NAEC.  

The HIV Clinical Guidelines Working Groups of OARAC shared updates on several clinical guidelines: 

• Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV
• Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV
• Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection
• Guidelines for the Prevention and Treatment of Opportunistic Infections in Children with and Exposed to HIV. 
• In addition, OARAC members voted to archive Guidance for COVID-19 and People with HIV following the end of the COVID-19 public health emergency. 

Next Meeting

The next OARAC meeting is scheduled for October 26. Additional details and an agenda will be made available on the OAR website. OARAC welcomes comments from the public. Members of the public can submit written comments via email to OARACinfo@nih.gov.