Travis Roppolo - Managing Director Travis Roppolo - Managing Director

Political Veto: How OMB's Grant Rule Puts EHE at Risk

In February 2025, this blog documented how the Trump administration was using language screens and funding restrictions to make health equity research professionally toxic. At the time, the mechanisms were informal: terms flagged for review, grants quietly pulled, researchers left to guess where the new boundaries lay. That ambiguity is ending. On May 29, 2026, the White House Office of Management and Budget (OMB) published a 412-page proposed rule in the Federal Register that converts informal pressure into binding, government-wide law. Holden Thorp, editor of Sciencewrote that the administration "seems as determined as ever to mortally wound the nation's scientific enterprise," noting that research enjoys bipartisan support and that public trust in science sits above 75 percent. Within days of publication, more than 3,000 public comments had been filed, almost all in opposition. The comment period closes July 13, 2026.

The pattern is familiar. As we noted last year, the Dickey Amendment showed how funding restrictions can suppress an entire field without an explicit ban. This rule removes the need for subtlety.

How We Got Here

The proposed rule is the endpoint of a deliberate sequence. On May 23, 2025, President Trump signed Executive Order 14303, "Restoring Gold Standard Science," which introduced an undefined "Gold Standard Science" standard that agencies would later be required to enforce. On August 7, 2025, EO 14332, "Improving Oversight of Federal Grantmaking," directed agency heads to designate senior political appointees to review all discretionary awards for whether they "demonstrably advance the President's policy priorities." Representative Zoe Lofgren (D-CA) called the order "nothing short of obscene," objecting that unelected appointees would decide what science gets funded.

During the administration's first year, courts found its abrupt termination of thousands of grants to be illegal. The OMB rule is built to insulate that same conduct from future legal challenge by establishing a formal process for it. As the American Council on Education's Sarah Spreitzer observed, the rule attempts to lock in administratively what the administration has spent eighteen months trying to accomplish.

What the Rule Actually Does

Three structural changes matter most for people working in public health.

First, the rule requires senior political appointees to conduct a "pre-issuance review" of every discretionary grant before it is awarded, and explicitly forbids them from deferring to peer reviewers. The criteria they must apply include blocking awards that touch on denial of "the sex binary in humans" and requiring that awards demonstrably advance the President's policy priorities.

Second, the rule downgrades peer review itself. Recommendations from scientific experts "remain advisory and are not ministerially ratified, routinely deferred to, or otherwise treated as de facto binding." This dismantles the post-World War II system in which independent expert review served as the primary measure of scientific merit at the National Institutes of Health (NIH), the National Science Foundation (NSF), and nearly every science agency. Neal Lane, who led the NSF under President Clinton, warned that replacing merit review "with top-down decision-making will destroy that process and result in bad science being funded."

Third, the rule lets agencies terminate active grants at any point, for being "inconsistent with program goals or agency priorities," with only a brief written rationale and no finding of misconduct or fraud required. Multi-year projects that researchers and institutions have built programs around can be ended mid-stream. Elizabeth Ginexi, a former NIH program official of 22 years, described the rule as "a complete political control apparatus layered over every stage of the federal science funding lifecycle."

The Infectious Diseases Society of America stated that, if finalized, the rule would compromise "medical research, public health, and healthcare access for vulnerable populations."

The Collateral Damage

The rule reaches past the award decision into the daily machinery of science. Publication costs, including the article-processing and open-access fees that average more than $3,000 per paper, would become presumptively unallowable, conflicting with the 2022 federal mandate requiring publicly funded research to be publicly available. Conference attendance would require express agency pre-approval written into the award at the time it is issued, and subscriptions to professional journals would be made categorically unallowable. A separate "issue advocacy" prohibition could bar federally funded researchers from speaking publicly about their own findings on contested subjects.

For HIV and viral hepatitis work, these provisions constrain the channels through which prevention and care evidence reaches the field: peer-reviewed publication, conference presentation, and public communication.

Why This Lands Hardest on People Living with HIV

The rule's prohibitions on diversity, equity, and inclusion research, "gender ideology," and disparate-impact analysis target the precise body of evidence that explains HIV transmission and care outcomes. Social determinants of health are the drivers of the epidemic, and we have the data to prove it.

The CDC's 2025 SDOH update found that, of the 38,416 adults diagnosed with HIV in 2023, 82.7 percent were linked to medical care within one month and 70.7 percent achieved viral suppression within six months. The lowest linkage and suppression rates concentrated in counties with the highest poverty, lowest income, lowest insurance coverage, and heaviest housing cost burden. The relationship is dose-dependent. In a 2021 study published in Open Forum Infectious Diseases, Menza and colleagues reported that 83 percent of people with HIV experienced at least one adverse social determinant, and those facing four or more were 3.6 times as likely to miss a medical appointment and 20 percent less likely to achieve durable viral suppression than those facing none.

County-level analysis confirms the pattern. A 2025 study in AIDS and Behavior by Lockhart and colleagues found that uninsurance, rent burden, medically underserved status, and overcrowded housing were associated with higher HIV diagnosis rates across 344 U.S. counties. Ending the HIV Epidemic (EHE) priority jurisdictions averaged 83.16 diagnoses per 100,000 people, compared with 13.76 in non-EHE counties, and carried higher income inequality and larger Black populations.

This is the research the rule puts at risk. Disparate-impact analysis is the method used to determine whether prevention and treatment reach the Black, Latino, and transgender communities most affected by HIV. A study framed around structural barriers to care could now be vetoed by a political appointee before it begins or terminated after it starts. When we lose the ability to document where the epidemic concentrates and why, we lose the map that EHE depends on.

What We Can Do

The comment period is the most direct point of leverage available, and OMB is legally required to respond to every comment it receives. Researchers, clinicians, universities, patient-advocacy organizations, and state health departments can file comments at regulations.gov under Docket OMB-2026-0034 before July 13, 2026. The strongest comments document concrete harm: how termination-for-convenience destabilizes a multi-year research program, or how the disparate-impact ban prevents evaluating whether PrEP outreach is reaching the communities EHE prioritizes. Stand Up for Science and the Infectious Diseases Society of America are organizing structured comment campaigns. Advocates can also press members of Congress, who appropriated these funds expecting merit-based administration, to prepare oversight.

The cost of this rule will be measured in slowed progress and lost capacity. Researchers and manuscripts are already shifting abroad, and the rule's restrictions on international collaboration will accelerate that drift, handing other countries an opening the United States built its scientific leadership to prevent. For people living with HIV, a documented and studyable understanding of social determinants is the foundation of any credible path to Ending the HIV Epidemic. We protect that foundation by populating the comment record before July 13.

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Travis Roppolo - Managing Director Travis Roppolo - Managing Director

CROI 2026: The Tools Are Here. The Infrastructure Is Not.

The 33rd Conference on Retroviruses and Opportunistic Infections (CROI) convened February 22nd – 25th in Denver under extraordinary tension between a pipeline of HIV prevention, treatment, and potential cure tools that could reshape the epidemic's trajectory, and a global funding crisis actively dismantling the infrastructure required to deliver any of it. As Conference Chair Nicolas Chomont of the Université de Montréal stated in the Opening Session, "we share a responsibility to defend and sustain funding for international HIV programs and research." That charge framed every session that followed.

The Funding Crisis: New Data on the Damage

The consequences of disruptions to the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), the dissolution of the United States Agency for International Development (USAID), and National Institutes of Health (NIH) cuts are no longer hypothetical. The CROI session "Sleepless in Denver" presented the first systematic evidence of the damage. Ellen Brazier's survey data from the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium found that across 32 countries, 47% of clinics reported disruptions in HIV services, with similar rates of disruption to medication availability, laboratory services, and clinic operations. In KwaZulu-Natal, South Africa, Lindsey Filiatreau reported that 39% of clinics experienced disruptions affecting an estimated 830,000 people living with HIV.

The damage is not confined overseas. Aaron Richterman presented data from a rapid survey across three U.S. states showing that 47% of clinics reported HIV service disruptions, including medication shortages. He also demonstrated how cuts to the Supplemental Nutrition Assistance Program (SNAP), the country's largest targeted anti-poverty program serving more than 42 million Americans, directly undermine treatment outcomes. During the 2025 government shutdown, ART adherence among people living with HIV who receive SNAP benefits dropped to as low as 40%. The connection between food security and viral suppression is well established; cutting one predictably undermines the other. As Filiatreau put it, "These things [HIV services]… can be taken away overnight, but they can't be rebuilt overnight."

Prevention: An Expanding Toolkit, a Widening Access Gap

Against this backdrop, CROI delivered a prevention portfolio that is broader and stronger than at any previous conference. Final results from the PURPOSE 1 and PURPOSE 2 trials confirmed the efficacy of twice-yearly injectable lenacapavir for pre-exposure prophylaxis (PrEP). In PURPOSE 1, which enrolled cisgender adolescent and young women in sub-Saharan Africa, HIV incidence among lenacapavir recipients was 0.07 per 100 person-years, compared to 1.98 for oral emtricitabine/tenofovir alafenamide (F/TAF) and 1.94 for emtricitabine/tenofovir disoproxil fumarate (F/TDF), with only two seroconversions among more than 2,000 participants. PURPOSE 2, enrolling men who have sex with men and gender diverse people, showed HIV incidence of 0.11 per 100 person-years for lenacapavir versus 0.92 for F/TDF, with three seroconversions among 2,179 participants.

The five total seroconversions across both studies received considerable attention, with four showing lenacapavir-associated resistance mutations that researchers believe developed during PrEP rather than being transmitted. Research into why these breakthroughs occurred is ongoing. As Gilead's Stephanie Cox stated, "We don't know why these occurred… I think the efficacy is very high." San Francisco AIDS Foundation (SFAF) Medical Director Hyman Scott, MD, MPH, added context: "The breakthrough infections are important to evaluate but are extremely rare among the thousands of study participants."

The Prévenir study's final eight-year results from France reinforced that both daily and on-demand oral PrEP are safe and effective, with overall HIV incidence of 0.11 per 100 person-years across more than 3,200 users and 13,000 person-years of follow-up. Switching between daily and on-demand use was the norm rather than the exception, with 59% of daily users changing to on-demand at least once, and 52% doing the reverse. This carries a clear message for implementation: people need flexibility, and rigid one-size prescribing undermines persistence.

The prevention pipeline continues to expand. Merck's once-monthly oral PrEP candidate MK-8527 selected an 11 mg dose maintaining protective drug levels in at least 95% of participants, with Phase 3 EXPrESSIVE trials now enrolling. Gilead's PURPOSE 365 study, testing once-yearly lenacapavir for PrEP, is being designed. The SEARCH study showed that community health workers paired with digital tools reduced HIV incidence by 70% in rural populations, a reminder that prevention tools work best when embedded in community-driven delivery.

The problem is reach. Andrew Hill highlighted that only 2.3 million people are currently on oral PrEP, far below UNAIDS targets, and that injectable cabotegravir and lenacapavir represent just 2.9% and 0.9% of total PrEP use, respectively. We have a growing menu of prevention tools. Getting them to the people who need them is where the system breaks down.

Treatment: More Options, Longer Intervals, Patient Choice

The treatment pipeline at CROI 2026 moved toward a central goal: giving people living with HIV more choices that fit their lives. Merck presented late-breaking data from three Phase 3 trials of doravirine/islatravir (DOR/ISL), the first ever once-daily, non-INSTI two-drug regimen. In treatment-naive adults, DOR/ISL demonstrated non-inferiority to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF), with 91.8% achieving viral suppression at Week 48 compared to 90.6%, including participants with high viral loads and low CD4 counts. The U.S. Food and Drug Administration (FDA) has set an action date of April 28, 2026 for the DOR/ISL application. For people aging with HIV who manage multiple comorbidities, a two-drug, non-INSTI regimen addresses a real clinical gap. Research presented at this same conference linked the widely used INSTI dolutegravir to neuropsychiatric effects, including blocking a brain enzyme essential for memory and emotional regulation, with one study halted for ethical reasons after participants experienced worsening symptoms. For people navigating tolerability concerns, toxicity issues, or polypharmacy, having a non-INSTI alternative with fewer active agents matters.

Gilead's ARTISTRY-1 and ARTISTRY-2 trials demonstrated that a bictegravir/lenacapavir (BIC/LEN) single-tablet regimen can maintain viral suppression for people switching from complex multi-tablet regimens (96% at 48 weeks in ARTISTRY-1) or from Biktarvy (93.5% in ARTISTRY-2). For people who have been on complex regimens for years due to resistance histories, this potential simplification addresses a real quality-of-life gap. Gilead plans to submit these results to regulatory authorities.

Long-acting injectables continued their forward march. In ViiV Healthcare's EMBRACE study, lotivibart (a broadly neutralizing antibody, or bNAb) given as an IV infusion every four months plus monthly cabotegravir maintained viral suppression in 94% of participants at 12 months. Part 2 of EMBRACE, testing lotivibart infusions every six months, is now fully enrolled. ViiV also presented early data on VH-184, a third-generation integrase inhibitor with potential twice-yearly dosing, and VH-499, a capsid inhibitor supporting twice-yearly intervals. The VOLITION study showed that 85% of treatment-naive adults opted to switch from daily pills to bimonthly long-acting cabotegravir/rilpivirine (CAB+RPV LA), with 95% maintaining suppression. Data like VOLITION's 85% opt-in rate reinforce what the HIV community has long argued: when people living with HIV are offered options that fit their lives, they take them. Payers, formulary committees, and ADAP programs should take note. Treatment is not one-size-fits-all, and coverage shouldn’t treat it as such.

Community activist Shari Margolese put it plainly at CROI's final Community Breakfast Club: "As a community we need to get much angrier about the fact that we can't get access to the drugs." Francois Venter of Ezintsha in South Africa warned that without action, "we might be sitting here again in 10 years' time" celebrating breakthroughs that never reach communities.

Cure, Comorbidities, and the Equity Question

On the cure front, the RIO trial's Phase B results offered genuine encouragement. Among the 28 people who received a placebo in Phase A and were then given bNAbs teropavimab and zinlirvimab, 54% had prolonged viral remission after stopping antiretroviral therapy (ART), with two still off treatment after more than a year. Because ART was stopped six months after the bNAb infusions, these results point to an immunological "vaccinal effect" rather than direct viral suppression. A cure remains distant, but these are the kinds of incremental, well-designed steps that build the evidence base forward.

CROI also highlighted the growing urgency of managing comorbidities in aging populations living with HIV. The POPPY study found that depression affects 32.4% of people living with HIV over 50, linked to inflammatory markers rather than psychosocial factors alone. A study of over 1,500 men showed that the combination of age 65 and over, HIV, and metabolic syndrome produced significantly worse cognitive impairment than any factor alone. Metabolic syndrome is the modifiable factor in that triad, which means clinicians and patients can act on it now. CROI data on GLP-1 receptor agonists like semaglutide point toward a potential tool for doing so: in a study of people living with HIV-associated lipohypertrophy, semaglutide produced a 19% reduction in total body fat, a 31% decrease in visceral adipose tissue, and a nearly 50% drop in C-reactive protein, a key inflammatory marker. Separate data presented at the conference found that semaglutide did not worsen depression in people living with HIV, and that people with moderate or severe depression at baseline actually showed improvements. These findings warrant dedicated research into how GLP-1 therapies can address the long-term health consequences of chronic inflammation and aging with HIV. If the evidence continues to support their role, GLP-1 receptor agonists should be evaluated for inclusion in the HIV standard of care, with appropriate insurance and program coverage to match.

The equity question came into sharp focus with data from the ENCORE cohort. Black trans women in the U.S. had an HIV incidence of 15.5 per 1,000 person-years, compared to 1.4 for White trans women. Poverty, houselessness, and lack of insurance were significant drivers, and only 4% of trans women in the cohort used long-acting injectable PrEP. Dr. Sari Reisner of the University of Michigan warned that the current administration's erasure of gender identity data from federally funded datasets will make it harder to monitor disparities and determine what works. We cannot close gaps we refuse to measure, and they know that.

What Comes Next

CROI 2026 produced a clear picture: we have tools that can change the course of the HIV epidemic, and the systems required to deliver them are being actively undermined. The path forward requires specific action. We must defend and restore funding for PEPFAR, NIH, and the global HIV infrastructure that makes science reach people. State ADAP programs and payers must expand coverage for long-acting prevention and treatment options and remove administrative barriers that delay access. To do that, they need to be adequately funded. PrEP implementation must embrace the full range of validated modalities, from daily oral to on-demand to injectable to monthly oral, with flexibility built into delivery. Care for people aging with HIV must shift toward whole-person approaches that integrate cognitive screening, metabolic risk management, and mental health support alongside viral suppression. And we must protect the community-led surveillance and data collection that allows us to see and respond to disparities, especially for trans and gender-diverse communities.

Wes Sundquist of the University of Utah, who helped develop the science behind lenacapavir, reflected at CROI on the decades-long journey that produced this tool. He warned that while the field now has "a really powerful new tool in the arsenal," forces are blocking its use. "It will be a human tragedy," he said, "if we don't overcome those." The science has done its part. The rest is a question of political will, policy design, and whether we as a community can sustain the pressure long enough for these tools to reach the people who need them.

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