Tracking PrEP Rollout & Learning Lessons

Accelerating the rollout of the full range of proven HIV prevention options depends on learning from what’s been done in the past and investing in coordination and innovation to put improved solutions in place. The Biomedical Prevention Implementation Collaborative (BioPIC) is doing just that. Over the last two years, BioPIC—a project led by AVAC with support from the Gates Foundation—has been gathering and sharing evidence on these critical lessons to ensure the next generation of HIV prevention products reaches everyone who needs and wants them with much greater speed and equity.  

What We’re Learning—Highlights from 2024 Convenings

An ongoing series of think tanks, convened by BioPIC and WHO since 2021, are generating key insights for people-centered product delivery. Below, read the latest reports from these think tanks that are informing decision-making on priorities for accelerating access to PrEP. Go to the BioPIC’s page on PrEPWatch to find reports on all think tanks since 2021.  

  • Early Insights from EBONI and PILLAR, February 2024: Early insights from ViiV Healthcare, the manufacturer of CAB for PrEP, from two CAB for PrEP implementation studies, EBONI and PILLAR. Conducted by ViiV in the US, these are among the first studies gathering data in real-world settings. Learn more
  • Taking Stock of PrEP Evidence, March 2024: An analysis of current data and priority evidence gaps. This inquiry was not focused on any one PrEP product, and its findings are informing the focus of future think tanks. Learn more
  • Linking Modellers with the Latest Implementation Science Evidence, March 2024: A consideration of the latest modelling data and insights on injectable cabotegravir (CAB) for PrEP. Read about the biggest takeaways from CAB for PrEP modelling here, and learn more about the big questions that require further inquiry here
  • Discussing Early Results from the SEARCH Dynamic Choice Study, April 2024: Professor Moses Kamya of Makerere University shares early insights from the SEARCH Dynamic Choice Study in Kenya and Uganda, which gave participants a choice between oral PrEP, PEP, and CAB for PrEP, and analyzes the role of choice in PrEP coverage. Watch here
  • PrEP and the Role of HIV Self-Testing, May 23: Highlights from the WHO guidance on use of self-testing (HIVST) as an innovative way to increase PrEP access and coverage and further simplify PrEP delivery. Panelists also share experiences with procurement, costing, rollout and scale-up. Watch Here

As other new biomedical HIV prevention products roll out, BioPIC will continue to hold strategic convenings, identify and address evidence gaps, and work to accelerate equitable product introduction. To learn more efforts to coordinate the introduction of CAB for PrEP, check out the JIAS article Shaping and coordinating the implementation science agenda for injectable cabotegravir for PrEP: the role of the Biomedical Prevention Implementation Collaborative (BioPIC). To learn what’s needed to better coordinate rollout for not-yet-approved products in Phase III clinical trials, check out BioPIC’s Adaptable Product Introduction Framework. 

We hope you will book mark these resources, and stay up to date on findings from future think tanks and webinars in 2024 on the BioPIC page of PrEPWatch.

Join Us for Our GPP Webinar Series

Good Participatory Practice Guidelines have been shaping and improving clinical research since 2007. They provide a global reference guide for ethical and effective stakeholder engagement, helping ensure the priorities of trial participants and their communities are centered in clinical trials and broader research agendas.  

However, GPP implementation is far from easy—it looks different in every context, outcomes can be difficult to quantify, engagement work is often seen as secondary to clinical processes, and therefore, undervalued and under-resourced. 

To help solve for this, last year AVAC introduced the GPP Body of Evidence, a new resource that brings together a set of tools highlighting the value of GPP, as well as the nuts and bolts of how to get it done.  

Now join us for a series of webinars in collaboration with The Global Health Network, Wellcome Trust, and WHO, to analyze the current state of GPP and discuss areas of growth and further development as we chart the way forward.

Register for the GPP Body of Evidence Series

It’s Not Just About the Trial: GPP from discovery to delivery in TB research
June 12, 2024 at 10am ET

GPP enhances every stage of the research lifecycle. In this webinar, our partners at TB Alliance and SMART4TB will share their experience, lessons learned, and innovative approaches in integrating GPP at the organizational, network and site level, from drug development through delivery. 

Register.

The GPP Body of Evidence: GPP monitoring and evaluation frameworks, REAL and REAL2
June 27, 2024 at 10am ET

Full details coming soon. Register here!

More webinars coming soon, including Not Your Average GPP: Non-traditional approaches and A GPP Roadmap for the Future: Professionalizing, measuring and requiring!

Watch this space for more details.

It’s time for GPP to become an international standard for clinical research. Making that case and making it happen, using the GPP Body of Evidence, has never been easier.  

Civil Society Voices at World Health Assembly

The annual World Health Assembly (WHA) is convening the last week of May in Geneva, Switzerland. As the decision-making body of the World Health Organization (WHO), amongst many other issues, the WHA will be attempting to finalize the Pandemic Accord after two years of ongoing negotiations.  

The Pandemic Accord aims to strengthen pandemic prevention, preparedness and response (PPPR) by addressing coordination, equity principles, and financing expectations. The agreement will, hopefully, also take on a range of capacity issues, such as disease surveillance, support for healthcare workforces, lab facilities, and resources for non-pandemic related healthcare. 

Civil society, including the Coalition of Advocates for Global Health and Pandemic Preparedness of which AVAC is a part, have been tracking the negotiations, calling out priorities, and demanding inclusion. To get the latest update from the Coalition, read the Joint Statement on the April 18th revised Pandemic Accord Draft. And check out the demands for civil society inclusion in this blog, Fighting the Same Fight Again: Civil Society and Community Engagement in Global Health Initiatives, by Samantha Rick (AVAC), Quentin Batreau (GFAN), and Eolann MacFadden (Frontline AIDS). 

The Pandemic Accord is a once-in-a-generation opportunity to strategize in ‘peace time’ before the next pandemic hits. Civil Society priorities can and must lead this effort. Join us!

Upcoming Webinar

Join us on May 28 for a civil society and community perspective on the Pandemic Accord. Click below for more details and to register.

Fighting the Same Fight Again

Civil Society and Community Engagement in Global Health Initiatives
Authors: Samantha Rick (AVAC), Quentin Batreau (GFAN), Eolann MacFadden (Frontline AIDS)

Pandemic Accord negotiations have so far failed to effectively engage advocate and civil society voices. With key parts of the Pandemic Accord moving toward further negotiation over the next few years, the Coalition of Advocates for Global Health and Pandemic Preparedness calls on advocates in and around the World Health Assembly to continue to rally for meaningful engagement with civil society and community and leadership roles for both in the ongoing multilateral process for pandemic prevention, preparedness, and response (PPPR).

For decades civil society and community organizations have been recognised and legitimately engaged as vital stakeholders and leaders in the HIV response. But this principle of inclusion has been inadequately upheld in other health areas, and vitally important initiatives, including the negotiations of the Pandemic Accord, have failed to build on the success of the HIV response and fully utilize existing models and mechanisms for engagement. Without them, these efforts exclude critical stakeholders when they should integrate civil society organizations (CSOs) as a crucial driver of policy and programming. Although certain initiatives have created some opportunities for CSO involvement, organized campaigns and public outcry have been necessary to garner a seat at the table. With every new program, fund, or secretariat, advocates are compelled to engage in the same repetitive battle to obtain a minimum of two voting seats and consultation prior to decision-making.

Civil society representation at the World Health Assembly has been reduced, a formal mechanism for engagement at UN High Level Meetings has been rejected, requests for even observer status during Pandemic Accord negotiations have also been rejected, and civil society and community advocates have experienced hostility at international convenings such as International Conference on AIDS and STIs in Africa (ICASA). Preventing, preparing, and responding to disease outbreaks requires public trust, understanding of regional or cultural ways of working, geographical limitations, and the true needs of communities. We cannot build effective health infrastructure by erecting barriers to civil society and community leadership. 

It is absolutely crucial that civil society and communities band together to demand meaningful engagement in the processes that follow and refuse to permit governments and institutions from rolling back CSO access and decision-making power even further. 

We have seen throughout the 40 years of the HIV/AIDS response that meaningful engagement  turns the tide when biomedical innovations fall short of their potential because of real-world challenges. Decision makers, government representatives, and multilateral institutional leaders must enshrine a baseline level of meaningful civil society engagement practices where and when international decisions are made. As lessons from the global HIV response show us, it is possible, if not probable, that many of the outstanding issues in the Pandemic Accord could have been solved with civil society input and influence, as knowledge-brokers who bring unique insights, find solution, and foster trust where it’s needed most.

The Coalition of Advocates for Global Health and Pandemic Preparedness is a group of organizations advocating for an integrated and holistic approach to preparedness that emphasizes equity, inclusion, and synergies of multiple global health programs in advancing preparedness. We believe that all global health initiatives should be centered on the key principles of community leadership, equity, access, and human rights and that efforts to fight current epidemics and strengthen health systems are central to equitable pandemic preparedness.

The biggest lesson from the fight against HIV, TB, and malaria is that if space is not reserved for civil society, we must take it – “Nothing For Us Without Us”. Join us at the World Health Assembly or watch the recording of our side event focused on civil society engagement if you can’t make it to Geneva, and keep demanding meaningful engagement in every global health initiative.

HVAD 2024

Keep an eye on avac.org/hvad for any updates!

As we prepare to commemorate HIV Vaccine Awareness Day (HVAD) on May 18, the field continues to see some modest scientific breakthroughs, while still facing extraordinary challenges. Despite having an evolving toolbox of highly effective prevention options including new long-acting PrEP, we continue to see high HIV incidence in hard-hit corners of the world. Many advocates and researchers agree that ending the HIV epidemic globally without a vaccine will be extremely difficult—even with long-acting PrEP products on the market and more on the way. 

“This toolbox of PrEP options will hopefully be transformative, but it is critically important that we still prioritize a vaccine.”

– Nina Russell, Director of TB and HIV R&D, the Bill & Melinda Gates Foundation on the new PxPulse podcast

Scroll through our list below for an exciting new podcast, HVAD webinars, and other key resources to mark HVAD 2024.

New PxPulse Podcast Episode!

Listen to the newest PxPulse podcast, “An HIV Vaccine: Looking into the future with Nina Russell with Nina Russell of the Bill & Melinda Gates Foundation who talks about where she sees promise in the science, the goals for an HIV vaccine, and why it has an essential role to play alongside the scale up of PrEP.


And to round out your vaccine knowledge, listen to these two archived PxPulse podcasts: Evolving Strategies for an HIV Vaccine: In conversation with Katy Stephenson, and Research Fundamentals: An HIV Vaccine — What’s the challenge and what’s the science?.

Two HVAD Webinars!

Just What is Discovery Medicine? And What Does it Mean for HIV Vaccine Research
May 16, 2024 @ 9am ET

Join the Choice Agenda to gain a broad understanding of the current landscape for HIV vaccines and what discovery medicine means for HIV vaccine research and development moving forward, with a focus on community and advocacy priorities.

From the Lab to the Jab: Lessons learned and what’s next in HIV vaccine research
June 3, 2024 @ 9am ET

AVAC’s issue briefs, From the Lab to the Jab, cover the barriers to, and solutions for equitable access to vaccines in low- and middle-income countries. During this webinar, an expert panel will discuss lessons learned, an international initiative for vaccine development, and how research and access can be improved.

Partner Events

Communities across the globe are engaging in a wide array of events focused on HIV vaccine awareness. Watc this space for upcoming details on local and regional activities the Coalition to Accelerate & Support Prevention Research (CASPR) partners are leading.

Infographic

20 years and 12 efficacy trials have delivered two positive signals for vaccines and bNAbs, but unfortunately many more flat results. This infographic provides this historical timeline and key information about each trial.

And, on the heels of last week’s HIV Vaccine Trials Network (HVTN) annual meeting, where much discussion surrounded the potential of role of bNAbs in prevention (see AVAC’s 2023 HVAD spotlight on bNABs) be sure to watch this space for more resources that unpack it all.  

Will the Pandemic Accord Fail to Learn the Lessons of the HIV Response?

STOPAIDS, GNP+, WACI Health, AVAC & GFAN

In their statement at the 8th Intergovernmental Negotiating Body (INB) meeting, the Office of the United Nations High Commissioner for Human Rights (OHCHR) highlighted that from the HIV experience we know that if public health measures do not take human rights into account, we will leave marginalised populations behind, fail to address structural barriers to access to quality healthcare, and miss essential interventions altogether.

At the final negotiation meeting of the Pandemic Accord, Member States risk failing to learn these key lessons from the HIV response. 

Over the last two years we’ve seen the limited references to human rights further reduced with each version of the proposed Pandemic Accord text. In the revised text published in April 2024, Member States propose the Agreement is guided by the principle of ‘full respect for the dignity, human rights, and fundamental freedoms of all persons, and the enjoyment of the highest attainable standard of health of every human being’. Beyond this, key provisions including the need to develop and implement policies to respect, protect and fulfil the human rights of all people has been removed and the text fails to recognise or support the critical role of communities. 

Local communities are pivotal in advancing the HIV response, leveraging local knowledge to enhance policy execution, and reaching groups left behind by government-led responses.This is true in the HIV response, and is true in public health programs more broadly: participation from communities and civil society is crucial to minimise the gaps of public programs, ensuring that they reach all vulnerable populations, including the most marginalised. Engagement at the community level also ensures that large-scale policies are effectively translated for local contexts, reducing barriers to access and strengthening impact. To not include organisations that already have a plethora of expertise in the areas the Accord aims to help with would be irresponsible, and would be ineffective on behalf of the communities they aim to serve. The HIV response is globally recognised for its inclusion of communities in governance and decision-making and it is critical the Pandemic Accord replicates this inclusion in the implementation and governance of this instrument. 

At the final negotiation meeting, we must see Member States agree a Pandemic Accord that is grounded in human rights and supports the critical role of communities. We urge Member States to:

Download the full statement here.

More and More Evidence that Choice is the Key

AVAC convened three important conversations in the last month on new data that delivered the analysis and evidence that choice and equity in access to PrEP products can make the difference between real-world population-level impact or an epidemic marching on for many years to come.  

When taken together, their combined message is irrefutable: when programs offer people-centered choices for what type of PrEP product they want, and where and how to integrate it into their lives, incidence can drop to zero.  

Read on for highlights from the three conversations and links to resources and recordings.

Highlights and Resources

Early Results from the SEARCH Dynamic Choice Study

“This is the evidence we’ve all been waiting for. This is the first time in a community setting that we have scientific evidence that choice matters and choice works.” – AVAC Executive Director, Mitchell Warren

Professor Moses Kamya of Makerere University joined our webinar to discuss the early results of the Dynamic Choice study conducted in Kenya and Uganda by Sustainable East Africa Research in Community Health (SEARCH). First announced at the Conference on Retroviruses and Opportunistic Infection (CROI) in March, these data were among the most exciting of the conference.
 
SEARCH showcased what true choice and person-centered programming can mean – and the difference it makes. The study offered choices in products (PEP, oral PrEP, injectable cabotegravir); in testing (rapid and self-testing); in service locations (clinic, home, other community locations); timing of prescription for oral refills (up to three months); and the ability to switch products at any time. More than a quarter of the participants used two different products during the study. Many who selected injectable cabotegravir had used no form of prevention in the month before, and even oral PrEP use went up in the intervention arm. “It’s expanding the total pie of people using PrEP,” said Kamya. The result: The study arm ended with zero incidence of HIV compared to 1.8% in the control group. Adding to the method mix expands the number of people who continue with prevention—even as their needs change.

See resources and recording here.

We Can’t End HIV in the United States Without Equitable PrEP Access: Strategies for success

A collaboration between HIVMA, PrEP4All and The Choice Agenda, this webinar  looked closely at PrEP uptake in the US and the American system of PrEP delivery. As a case study, these presentations show what happens when programs, policies and political will undervalue choice.
 
Intensifying disparities is one of the most pernicious effects of inequitable access to PrEP as seen in US data. Dr. Patrick Sullivan of Emory University highlighted these disparities by sharing that Black people in the US represent 40% of new HIV diagnosis but only 14% of the PrEP users, while 64% of PrEP users are White but represent only 25% of new diagnoses. Sullivan’s research shows that when states make it easier to choose PrEP by offering PrEP drug assistance programs, Medicaid expansion or both, PrEP coverage goes up and incidence goes down.
 
Rupa Patel of the Centers for Disease Control and Prevention (CDC) charted the patchwork nature of PrEP delivery, which involves numerous and complex processes for getting HIV prevention products to people. Patel underscored the need in the US for interventions in programming and product choice, interventions that should offer the kind of choices that have been successfully delivered by the SEARCH study.
 
Patel’s description of an unpredictable, confusing and costly journey to PrEP was reinforced by a deep dive on cost offered by Dr. Lorraine Dean of Johns Hopkins University. Dean explored the role of cost, showing how even small increases drive down use. And she explained how insurers circumvent protections that require zero cost to the consumer for generic PrEP under the Affordable Care Act. And Jeremiah Johnson of PrEP4All laid out an agenda for change to be integrated into a US national PrEP program. Learn more with PrEP4All’s report, Toward PrEP Access for All.

See resources and recording here.

Evolving our Understanding of PrEP for Cisgender Women

NIAID Director Dr. Jeanne Marrazzo joined the Choice Agenda webinar, The More We Know: Evolving our understanding of PrEP for cisgender women, to present a re-assessment of the safety and effectiveness of PrEP options for women—including oral, vaginal ring, and injectable options. She discussed her recent publication in the Journal of the American Medical Association, HIV Pre-Exposure Prophylaxis with Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women. This study  provides reassuring evidence that oral PrEP can reliably prevent HIV infection in cisgender women— with data that show women taking 4-7 pills per week had very high protection against HIV, comparable to what is seen in cisgender men. The results challenge the notion that cisgender women need to be “super-adherers” to achieve protection utilizing oral PrEP and that a one-size-fits all approach to prevention will not work.

Raniyah Copeland of Equity & Impact Solutions who moderated, noted that Marrazzo’s comments represent a powerful voice among a chorus of champions for choice. She then introduced Joyce Ng’anga’a of WACI Health and the African Women’s HIV Prevention Community Accountability Board, a coalition of women and girls living and working in Africa who are united in calling for continued political and financial support for more choice in HIV prevention. Ng’anga’a updated on the recently launched Choice Manifesto. This global call to action demands investment in choice and calls for enshrining a woman’s right to choose and for African women and girls to lead the HIV response. 

See resources and recording here.

Additional Resources on PrEP Access and Choice

As the world marks twelve years since the FDA approved the first PrEP product, the field is long past due to make good on what advocates have been saying all along, and now the evidence is in hand. Make choice a reality and drive incidence to zero.