Two interventions are giving the world another chance to build better models for equity and impact in HIV, and for public health more broadly.
Following robust, well-run research programs that included essential community and stakeholder engagement components, the monthly dapivirine vaginal ring (DVR) and the every-two-month injectable cabotegravir (CAB) are beginning to enter the global market.
In 2020, two large-scale efficacy trials found that CAB showed a substantial prevention benefit in gay men and other men who have sex with men, transgender women who have sex with men, and cisgender women. ViiV Healthcare, the developer of CAB, received US FDA approval for use as PrEP in late 2021, and Malawi, South Africa and Zimbabwe have also approved CAB for PrEP, with decisions from close to two dozen other countries expected in 2023 and 2024. WHO has recommended injectable CAB as an additional PrEP option as well.
In 2021, WHO also recommended the DVR as an additional PrEP option, and it is now approved in seven African countries (Kenya, Lesotho, Rwanda, South Africa, Uganda, Zambia and Zimbabwe), and pending in five others. Developed by the International Partnership for Microbicides, which is now part of the Population Council, this monthly option for HIV prevention is a crucial new addition to the prevention toolkit.
But the experiences of the first decade of oral PrEP implementation – and the experiences of the past three years of the inequitable access to COVID-19 vaccines around the world – show the impact of delays in delivery and uneven access to life-saving interventions. The experiences also show what needs to be done differently going forward.
Oral PrEP was first shown to be safe and effective in 2010 and was first approved in 2012, but the field moved too slowly. And now 11 years later, approximately 3.8 million people have initiated use of this option, reaching the 2020 target of 3 million PrEP users two years late, and still representing only a tiny fraction of the estimated number of people who could benefit from it. Too many new HIV infections have occurred in the past 11 years because of the fundamental error underlying the drug’s painfully slow roll-out: the public health world’s seemingly single-minded focus on developing products and technologies, without similarly focused and funded efforts to make those products accessible, affordable and responsive to user needs.
There are significant questions about how to deliver CAB for PrEP and DVR, but the world cannot afford to squander another decade navigating these questions. Bold actions, global urgency, and coordinated partnerships are needed now.
Conversations are finally underway about accessible pricing, introduction projects, health systems support, and generic production of these new PrEP options, all of which are essential to ensuring that people in low- and middle-income developing countries can access new forms of PrEP simultaneously with wealthy countries. Regulatory approval, normative guidelines, and conversations on pricing will not prevent infections, however. To do that, the entire global health community – funders, planners, health systems, educators and advocates – must apply some critical lessons to ensure that every person who can benefit from these critical scientific advances has real access to them.
If introduced and supported strategically, these two new products, along with oral PrEP, internal and external condoms, and voluntary medical male circumcision could slow annual HIV infections significantly, saving thousands of lives and billions of global health dollars.
In June 2022, AVAC published A Plan for Accelerating Access and Introduction of Injectable CAB for PrEP, in hopes that global stakeholders could collaborate around a shared strategy to translate scientific advance into public health impact. The overarching focus must be to move faster, more strategically, and with more coordination than was seen with oral PrEP or with COVID-19 vaccines, using the following principles as a guide:
- Lead with equity: Products don’t end pandemics if principles of equity are not embedded in every decision; COVID vaccine delivery is a stark reminder of this reality. People are keenly aware of whether research and development reflects their priorities, if programs speak to their needs, and if essential health products are being distributed according to need or stockpiled by wealthy countries. The tendency of wealthy nations to hoard and waste critical goods, most recently COVID-19 vaccines, has been fatal to the credibility of many essential health products.
- Center the community and user: Centering communities and users in the design and implementation of programs and product delivery is absolutely crucial. We have learned from the Good Participatory Practice Guidelines that effective community engagement builds mutually beneficial, sustaining relationships and strengthens programs. Community engagement is essential at every stage of product development, introduction and access. Many health systems need a 180-degree turn-around in how they approach their customers. No business succeeds by making it difficult to access their product. Bad service, inconvenient hours and stigmatizing attitudes don’t build interest in anything, including health products.
- Accelerate scale and speed: We need to do away with slow, unnecessary waiting games that keep efforts to scale up delivery on hold, while demonstration projects (aka implementation science) tests consumer markets. Part of accelerating scale-up is moving toward a parallel approach where research, implementation science, and rapid scale up of programs are designed, funded and put in place in parallel.
- Deliver impact: Align implementation priorities with targets for the next 12 months to deliver significant benefits and measurable impacts on public health. Wildly ambitious coverage targets cannot be supported with small-scale projects, as seen in the oral PrEP experience. Ambitious targets on coverage, before there’s a clear understanding of capacity, can add confusion. Instead, set deadlines for assessments on operational capacity, and tie those assessments to setting coverage targets.
- Let education and outreach efforts drive product uptake and effective use. Most marketing efforts for health lack the budget, imagination or insight to engage potential users. While many HIV prevention efforts use clinical terminology and focus on HIV risk, research shows that uplifting, aspirational conversations about healthy sexuality and relationships are much more likely to generate and sustain demand for HIV prevention tools.
- Fundamentally reframe HIV prevention products, services and information to emphasize consumer choice. Science has given us pills, long-acting injections and a vaginal ring for HIV prevention in addition to the tools we already had. Implants, antibodies, vaccines, multi-purpose prevention technologies (MPTs) and other potential options are in development. A comprehensive approach to HIV prevention must embrace and support choice, based on the understanding that different prevention options will be right for different people at different times in their lives and for different reasons. This approach is essential to both increasing prevention uptake and ensuring that products are used for maximal impact.
- Work with what we know, while continually adding to the evidence-base. There is still much we don’t know about CAB for PrEP and DVR. But there is also a lot we do know. We have consistently failed at prevention by letting the perfect be the enemy of the good. We can learn from past mistakes and missteps. These two exciting, effective options offer a chance to reorient and re-energize HIV prevention programs.
This is the best chance we’ve ever had, likely in the entire history of the AIDS pandemic, to reimagine prevention and to do it with equity and impact. History will judge us very harshly if in 5 or 10 years we go back to AIDS conferences and report on low uptake, and persistent new infections year in and year out.
And we will be judged even more harshly if we don’t use the opportunity of introducing these new options to build a robust and equity-guided platform to deliver the next generation of prevention options, including, we hope, an HIV vaccine. That’s hard work, and much of it still lies ahead.
Stacey Hannah is the Director of Research Engagement, and Nandisile Sikwana is a Regional Stakeholder Engagement Manager with AVAC.