We are in a moment of urgent and necessary innovation for HIV prevention. Our present approaches to scale up biomedical prevention options such as pre-exposure prophylaxis (PrEP) have largely failed.

Nearly a decade after the Food and Drug Administration first approved tenofovir disoproxil fumarate with emtricitabine (TDF/FTC, brand name Truvada) for PrEP, we have only provided access to, at best, 23% of the conservatively estimated 1.2 million Americans who most need it. Even worse, we have really only made substantive progress among white gay/bisexual cisgender men leading to increasing disparities for communities of color, transgender people, people who use drugs, cisgender women, and virtually all other key populations.

There is progress for expanded access among most individuals on private insurance following the release of guidance from the Centers for Medicare and Medicaid Services (CMS) mandating that plans cover PrEP-related services, including labs and navigation services for accessing and adhering to PrEP. However, this step will not address the ongoing needs of marginalized communities who find themselves un- or under-insured, particularly communities of color in Medicaid non-expansion states.

To end the HIV epidemic and address the unequal and insufficient use of PrEP in the United States, we must make PrEP access simple. Make. It. Simple. Specifically, the United States should adopt a national program of PrEP purchase and distribution through low-barrier, community-based networks. This could also include a national coordinated federal procurement and broad distribution mechanism for PrEP medication and labs in order to dramatically increase access for the most vulnerable individuals in America.

The patchwork of programs that exist for individuals who lack a source of payment are woefully underutilized, fragmented, and incomplete in what services they will cover. They are also often extremely limited in terms of network and access, meaning that low-resourced individuals have to expend unnecessary effort to seek out PrEP. Many on Medicaid can struggle to come across providers who offer PrEP. All of this continues to play out against a dynamic and challenging environment for the HIV field as we collectively struggle with post-COVID challenges and as 340B funding for community health centers becomes ever more precarious.

Yet, despite these challenges and disappointing outcomes, this is a time of great opportunity and hope for PrEP access. We’ve learned more than ever about the effectiveness of PrEP: oral TDF/FTC has been shown in studies to have population-level impacts on incidence around the world—after even imperfect scale up—from Australia, to Eastern Africa, to the United States, showing that the responsibility of stopping transmission should not fall solely on the shoulders of those living with HIV.

Since April, generic competition has reduced the price of TDF/FTC by greater than 90%, eliminating a major factor in creation of the limited, complex, and inconsistent PrEP system we currently have. The federal government has committed to ending the HIV epidemic by 2030, identifying increased PrEP access as a major component of the initiative. The COVID crisis has opened up new PrEP access points by advancing telehealth and investing in an expanded public health workforce.

In theory, we should be able to combine these opportunities into a cost-effective solution that dramatically scales up PrEP access, allowing rapid, same-day access to this essential prescription wherever individuals who need it can access it.

And there is much need to seize upon these opportunities. Existing programs and funding mechanisms—Ready, Set, PrEP, state PrEP-DAPs, Gilead’s Advancing Access, 340B funded programs—have done some good work, but we must accept that our overall level of success is low. While coverage is only part of the disparate outcomes, these pathways to PrEP-related services are complex and unsustainable, particularly for the vulnerable communities that need PrEP access the most. Outcomes are also not likely to improve through these existing approaches.

Financing strategies for PrEP such as 340B will face their most significant threats in the near future, if not from Gilead’s Advancing Access changes, then from generic competition reducing drug prices and 340B savings generation. RSP and state PrEP-DAPs have been woefully underutilized, most likely due to lack of awareness or incomplete coverage of all related PrEP needs, including labs. Advancing Access has come to be a highly accessible option for Gilead medications, but it does not cover all PrEP related services, and precludes us from taking full advantage of newly available and inexpensive generic TDF/FTC options.

There are examples within and outside of PrEP for us to learn from; the key is to combine the best features of these programs into a politically viable, cost effective, and incredibly simple program that works wherever people who need PrEP live, access health services, work, and play. We need to break out of the limits and rigidity created through expensive medications and services; incentivizing rather than discouraging rapid scale up by learning lessons from the Louisiana “subscription” model for HCV cures that negotiated a reasonable fixed fee for unlimited access to treatment from manufacturers.

We also need to truly leverage the federal government’s ability to simply procure and widely distribute an essential preventive intervention, learning the lessons of the Vaccines for Children Program. We need to comprehend the true meaning of simple, rapid, and comprehensive programs for marginalized communities, learning lessons from same day start PrEP programs like those in the NYC sexual health and wellness clinics. And we need to discuss the potential of all of these programs in relation to all communities with unique coverage and financial barriers including incarcerated populations, people who use drugs, transgender populations, communities of color, and undocumented individuals.

Facing America’s fractured health care system, and enormous political and funding barriers, HIV advocates and public health leaders have done our best to cover the gaps where we can. But by building the feasible pathways we could build rather than the interconnected grid we needed to build for PrEP, we’ve drawn a map that feels more like being lost in Greenwich Village than feeling clearly oriented on the numbered streets of midtown Manhattan.

Particularly for the uninsured, the road you’re on may take you to medication access, but not to lab coverage, or you may be lucky enough to construct a complicated route connecting you to almost everything you need for access, but the complexity makes it incredibly difficult to reconstruct your route time and time again. Worse yet, PrEP access frequently exists outside of the larger healthcare system, completely removed from where individuals who most need it are most likely to reach it.

We must redraw the map and accept that building our work around individual funding mechanisms is not the same as constructing an integrated and financially sustainable pathway to ending HIV. By putting all of our advocacy efforts into protecting existing programs, we may unintentionally neglect those who are poorly served by the current approach, which at present seems to be virtually every community besides white gay/bi cisgender men.

Many vulnerable communities would likely be better served by funding strategies that meet people where they are by making medication and lab access widely scalable through lower costs and unfettered, simple coverage options for all individuals—most notably uninsured individuals—regardless of their proximity to, awareness of, or willingness to access services through an AIDS service organization, a community-based organization or a limited network of PrEP providers.

And now is the time to innovate. With political will, federal funding, improved coverage, cheaper medications, and alignment between public health and community leaders, the potential has never been greater to bring access, hope, and peace of mind to everyone in urgent need of PrEP access.

Amy Killelea heads Killelea Consulting, providing public health policy and financing expertise to governmental public health agencies, nonprofits, payers, and providers.


Derek Dangerfield II, PhD, is an assistant professor at Johns Hopkins School of Nursing. His research targets ways to reduce HIV and other sexually transmitted infections and promote sexual health for sexual minority men.


Jeremiah Johnson, MPH, is an independent consultant, as well as an HIV/AIDS and infectious disease advocate.