Highlights: June 2025 NIH Office of AIDS Research Advisory Council Meeting

Sustainability of HIV clinical practice guidelines, OAR Director’s update, HIV viral load monitoring platforms at the point of care

The National Institutes of Health (NIH) Office of AIDS Research Advisory Council (OARAC) convened its 68th meeting virtually on June 26.

OARAC provides advice to the NIH Office of AIDS Research (OAR) on the planning, coordination, and evaluation of research and other HIV-related activities conducted or supported by NIH.

Meeting highlights included a conversation about the sustainability of the HIV clinical practice guidelines, developed by the HIV Clinical Guidelines Working Groups of OARAC. The discussion drew substantial interest from OARAC members, other attendees, and members of the public. In addition, the meeting featured a report from OAR Director Geri R. Donenberg, Ph.D., and a presentation on research to develop a platform for HIV viral load testing at the point of care.

Report From the OAR Director

• Geri R. Donenberg, Ph.D., Associate Director for AIDS Research and Director, Office of AIDS Research, NIH

Dr. Donenberg acknowledged how recent federal policies and priorities have affected the NIH HIV research portfolio and reaffirmed OAR’s commitment to its mission of supporting NIH HIV research.

She welcomed Luis J. Montaner, D.V.M., D.Phil., as the new OARAC Chair, and thanked outgoing Chair Ivy E. Turnbull, D.L.P., Ed.M., M.A., for her dedicated service. In addition, Dr. Donenberg welcomed two new ex officio OARAC members:

• CAPT Robyn Neblett Fanfair, M.D., M.P.H., Centers for Disease Control and Prevention (CDC)
• Heather Hauck, M.S.W., LICSW, Health Resources and Services Administration (HRSA)

Dr. Donenberg recognized leadership transitions across several NIH Institutes, Centers, and Offices (ICOs) and within the NIH Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) since the most recent OARAC meeting in October 2024.

• Courtney Aklin, Ph.D., Acting Director, National Institute of Nursing Research (NINR)
• Alison Cernich, Ph.D., Acting Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Monica Webb Hooper, Ph.D., Acting Director, National Institute on Minority Health Disparities (NIMHD)
• Andrea Beckel-Mitchener, Ph.D., Acting Director, National Institute of Mental Health (NIMH)
• Jeff Taubenberger, M.D., Ph.D., Acting Director, National Institute of Allergy and Infectious Diseases (NIAID)
• Carolyn Hutter, Ph.D., Acting Director, National Human Genome Research Institute (NHRGI)
• Nicole C. Kleinstreuer, Ph.D., Acting NIH Deputy Director for Program Coordination, Planning, and Strategic Initiatives
• Vivian Ota Wang, Ph.D., FACMG, CGC, Acting Director, Office of Strategic Coordination (OSC), DPCPSI
• Cindy Caughman, M.P.H., Acting Deputy Director, Office of Research on Women’s Health (ORWH), DPCPSI

Dr. Donenberg provided brief remarks on the President’s Budget for fiscal year (FY) 2026, which proposes a reorganization of NIH and a reduced agency budget of $27.9 billion, including $1.9 billion for HIV research. Dr. Donenberg reviewed NIH priorities under NIH Director Jay Bhattacharya, M.D., Ph.D., including: improve population health, ensure reliable research results, make advances in science, maintain safety and transparency in research, and encourage academic freedom. She noted alignment of these priorities with OAR’s efforts to promote data harmonization, sustainable evidence-based interventions, and implementation research.

Consistent with NIH, OAR is emphasizing implementation science to understand the best ways to improve uptake of evidence-based interventions and reduce the documented 17-year gap between a discovery and its implementation into practice. After collaborating with leadership and ICOs that participate in HIV research, OAR plans to develop recommendations and identify ways to strengthen HIV implementation science at NIH. The goal is to develop an implementation science program that engages with community and other partners and creates inclusive, cross-ICO funding opportunities that will foster implementation science to end the HIV epidemic.

Dr. Donenberg also provided an update on the FY 2026-2030 NIH Strategic Plan for HIV and HIV-Related Research, which will be released later this year. The new plan will highlight HIV research priorities across the HIV research continuum—from basic science through implementation research—and will emphasize capacity building in each area.

The Director’s update closed with highlights of OAR events since the last OARAC meeting, including the virtual event, NIH World AIDS Day 2024: Progress, Innovation, and Impact in HIV Research, as well as upcoming events in which OAR planned to participate:

• 13th IAS Conference on HIV Science (IAS 2025) – Kigali, Rwanda, July 13-17: Dr. Donenberg planned to represent OAR at IAS 2025, which highlighted new discoveries in HIV research and addressed current political and financial issues affecting the HIV response both domestically and internationally.
• 2025 U.S. Conference on HIV/AIDS (USCHA) – Washington, DC, September 4-7: The 2025 USCHA theme is “Aging With HIV.” OAR will partner with other NIH institutes and centers, as well as members of the HIV community, to facilitate three sessions on HIV-related comorbidities, menopause in women with HIV, and viral load monitoring.

Advanced Platforms for HIV Viral Load Monitoring at the Point of Care

• Shawn Mulvaney, Ph.D., Health Science Administrator, Division of Health Informatics Technologies, NIH National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Dr. Mulvaney described the Advanced Platforms for HIV Viral Load Testing at the Point-of-Care program, a partnership of NIBIB, OAR, and the National Institute of Allergy and Infectious Diseases (NIAID) that aims to advance HIV viral load monitoring platforms for use at the point of care. Launched in spring 2024, Dr. Mulvaney explained that the Advanced Platforms program harnesses the existing infrastructure of the NIH Rapid Acceleration of Diagnostics Technology, or RADx, program, which began in 2020 to develop COVID-19 diagnostics within a few months, rather than the typical timeframe of three to five years.

Dr. Mulvaney emphasized the need for point-of-care HIV viral load monitoring technologies, noting that the U.S. Food and Drug Administration (FDA) has not approved any such testing platforms for domestic use. He highlighted feedback from members of the HIV community and clinicians who have expressed a preference for availability of point-of-care viral load monitoring technologies to assess responses to antiretroviral therapy and to prevent HIV transmission to others. He explained that the viral load monitoring technologies in development under this program will meet these needs. Criteria for the technologies are a point-of-care quantitative blood test that can determine in less than 60 minutes if a person with HIV is virally suppressed (<1,000 copies/ml). Ideal tests could be completed in less than 30 minutes and would be able to determine a lower limit of undetectable viral load (≤200 copies/ml).

After releasing a call for proposals in spring 2024, the Advanced Platforms for HIV Viral Load Testing at the Point-of-Care program awarded funding to three companies—Cepheid, Baebies, Inc., and Prompt Diagnostics—to develop their HIV viral load monitoring platforms by April 2026. The RADx program is well-positioned following success with COVID diagnostics to support the projects, Dr. Mulvaney noted. He emphasized that the RADx model combines best practices of government, academia, and industry and leverages existing networks and expertise of the Point-of-Care Technology Network (POCTRN). Each of the three projects will receive guidance from a team of technical, clinical, commercialization, and regulatory advisors to provide training and mentorship to Advanced Platforms participants to prepare for usability and analytical testing, as well as for preclinical evaluations.

HIV Clinical Practice Guidelines: Strategy Update

• Geri R. Donenberg, Ph.D., Associate Director for AIDS Research and Director, Office of AIDS Research, NIH

Dr. Donenberg provided an update on OAR’s strategy to plan for the sustainability of HIV clinical practice guidelines, which are developed by the HIV Clinical Guidelines Working Groups of OARAC, also known as the Panels, with management, publication, and dissemination support from OAR. The guidelines are recommended for use by U.S. health care practitioners and inform clinical practice around the world to ultimately improve the health of people with, and affected by, HIV. Amid recent efforts to streamline federal coordination and reduce spending, OAR worked to retain funding for the guidelines for at least one more year to ensure a smooth transition should the guidelines need to be moved to another oversight body. OAR has successfully secured funding for the next 12 months to work closely with Panel members to optimize the process and look for efficiencies while considering the best next steps.

This process was initiated because OAR anticipates that a more limited HIV/AIDS allocation/budget may force it to reallocate resources from guidelines management toward activities directly related to its primary role coordinating the NIH HIV research program. Dr. Donenberg strongly underscored OAR’s commitment to ensuring continued sustainability of the guidelines.

She noted that OAR initially planned to facilitate a longer discussion on the guidelines at the meeting. However, in response to passionate feedback from the HIV community, OAR consulted with guidelines leadership and decided to create additional opportunities for input and in-depth discussions more broadly. The office will convene small group discussions with each of the guidelines Panels, gather and evaluate additional public input, and explore opportunities to transition the guidelines within the U.S. Department of Health and Human Services (HHS) before bringing the topic to future OARAC meetings.

Following this update, OARAC members highlighted the incredible value of the guidelines. Later in the meeting, 32 public comments about the guidelines were read aloud for the record. Comments received before, during, and after the OARAC meeting largely endorsed OAR’s and OARAC’s continued leadership and support of the guidelines. OAR is carefully reviewing each public comment and will share all comments with the guidelines Panels.

Updates and Next Meeting

• Julio Aliberti, Ph.D., Health Scientist Administrator, OAR, NIH
• David Chang, Ph.D., Health Scientist Administrator, OAR, NIH
• Dianne M. Rausch, Ph.D., Director, Division of AIDS Research, National Institute of Mental Health, NIH

The meeting concluded with updates on two OAR programs and one NIH advisory body:

• The OAR Innovation Program: Dr. Aliberti described the program, which provides one year of funding for innovative approaches to address high-priority needs in NIH-sponsored HIV research. He requested feedback from OARAC on metrics to evaluate the long-term impact of the program, as well as how the program can support cross-disciplinary teams and holistic approaches to research by integrating topics such as mental health, stigma, and housing. Dr. Aliberti also highlighted the upcoming Innovation in HIV Research Symposium 2025, September 10, 9:30 a.m. to 4:30 p.m., in Rockville, Maryland, and virtual. The event will be open to the public. Up to 18 investigators who received funding in 2024 will showcase their research updates. An agenda and additional details are forthcoming.
• OAR Early Career Investigator (ECI) Engagement Activities: Dr. Chang provided an update on OAR’s ECI program, which provides resources, guidance, and mentorship opportunities for ECIs interested in HIV research. The program recently hosted several listening sessions for ECIs in HIV to gather information on what they have found helpful in career advancement and ways NIH can support career development. Dr. Chang also highlighted an upcoming virtual 2025 Workshop for Early Career Investigators in HIV on September 26.
• National Advisory Mental Health Council (NAMHC): Dr. Rausch discussed treatment strategies for central nervous system (CNS) complications in people with HIV. Currently, there are few options to treat HIV-related CNS complications. She described a new NAMHC initiative to identify modifiable targets to address CNS complications and design personalized treatment approaches in people with HIV.

The full meeting is available on NIH VideoCast, and meeting minutes will be posted on the OAR website.

The next OARAC meeting is scheduled for September 18. OARAC welcomes public comments via email to [email protected].