As NIH stalls the next funding cycle for major HIV research networks, advocates call on Congress to protect clinical studies—and their infrastructure
In yet another ominous sign for HIV research, the National Institutes of Health (NIH) notified four major research networks that they should “pause” new clinical studies that had not yet enrolled participants and that could not be completed by November 30, 2027, when their current funding expires. This comes after months of delays by the Trump administration in publishing notices of funding opportunities (NOFOs), a formal process that begins a new seven-year cycle of funding. The administration had promised to post the notices by August 25, but by early October there were still no postings.
The latest funding pause would affect Advancing Clinical Therapeutics Globally (ACTG, formerly AIDS Clinical Trials Group), the HIV Prevention Trials Network (HPTN), the HIV Vaccine Trials Network (HVTN) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT).
Research conducted by these networks—which rely on more than $300 million a year in NIH funding, primarily through federal government funding—include hundreds of multi-year clinical trials spanning dozens of countries.
The administration has not clarified why it wants to pause funding. Advocates and activist groups like the Save HIV Campaign are mobilizing and have posted an online open letter that the public can sign, urging Congress to demand that the Department of Health and Human Services (HHS) approve the release of overdue funding to the NIH HIV clinical trials networks and Centers for AIDS Research for the next seven years. The deadline for signing is Thursday, October 15.
The new funding pause, on top of a series of funding delays, will have devastating consequences on all aspects of HIV research, according to Mitchell Warren, executive director of AVAC, a group that advocates for development of HIV prevention options
“This may be one of the most shortsighted, scientifically absurd and ideologically wrong decisions, and there have been a lot of those in the last 20 months,” Warren told POSITIVELY AWARE.
The four clinical trial networks are responsible for almost every major discovery in HIV treatment and HIV prevention for adults and pediatrics, including advanced HIV vaccines and multiple antiretroviral treatments. A base of dedicated researchers, data systems and participants has also been mobilized for other health crises. In 2020, HVTN and HPTN quickly pivoted to developing COVID-19 vaccines and treatments, based on 20 years of mRNA vaccine research.
Some in the research community have become concerned about statements from NIH director Jay Bhattacharya, MD, PhD, who has favored “implementation science,” or focusing on deploying existing tools for treatment and prevention, to the exclusion of developing HIV vaccines and new treatments.
“Implementation science is about how to implement the fruits of research, but if we don’t continue to fund the political channel networks, we won’t have fruits of labor to then implement in the years to come,” Warren said.
It’s unclear whether the funding pause is temporary or permanent. But researchers and HIV advocates have pointed out that leaving research in limbo for any length of time could disrupt advancement toward ending the epidemic. It can take months to write proposals, which can run hundreds of pages, based on NIH requests. And a pause, even a temporary one, can disrupt these networks’ relationships with vulnerable communities that have been crucial to advancements in treatment and prevention. In the worst case, these trial networks could be disbanded completely, letting the federal government fund research on a case-by-case basis. That would be a crushing blow, Warren said.
“The beauty of big networks is the infrastructure—the capacity, both for clinical trial sites, for laboratories—for statistical analyses. All of that comes from what we call big science. That can't be done in individual grants for one study as easily or as well. It's actually very penny-wise and powerful to make if they can just spend it on individual trials. Losing the power of big science would be devastating.”
Warren and other HIV advocates say the U.S. Congress, specifically Senate and House committees that oversee health and human services, could step in and demand that money be spent on these networks.
Warren makes the case that, in addition to innovations in HIV that are stopped or delayed, many jobs could be lost—something lawmakers might want to consider in an election year.
“There are hundreds of clinical trial sites around the country and around the world, and from a U.S. perspective, pretty much every academic institution in America that does biomedical research depends on research funding through these networks: Emory in Atlanta, the University of Alabama in Birmingham, Johns Hopkins, Harvard, the University of Washington, the University of Illinois. Now jobs are at risk all over the country—in red states, in blue states and purple states. So I do hope that members of Congress see this not just as a future engagements research, but it’s the research infrastructure in their districts and states.” g