AVAC Condemns Court Decision that Tramples Human Rights, Reinforces Homophobia and Denies Life-Saving PrEP Drugs to Individuals in Texas

As a global organization dedicated to health as a human right, to social justice, and to individual autonomy and choice, AVAC condemns the decision by a federal judge in Texas who ruled in favor of a historically homophobic, misogynistic, and discriminatory plaintiff. A conservative activist sued on behalf of a Texas company claiming that adhering to a provision of the Affordable Care Act requiring employers to provide coverage for HIV pre-exposure prophylaxis (PrEP) drugs violates their religious rights.

“This shocking ruling defies evidence, logic, public health and human rights and sets back enormous progress made in the fight to end the HIV epidemic in the US and globally,” said Mitchell Warren, AVAC’s executive director. “It is a blatantly homophobic and misogynistic ruling that will endanger the lives of many gay men and others who rely on PrEP to protect themselves from HIV.”

“This ruling is the latest blow in a campaign to roll back bodily autonomy and human rights for a wide swathe of the American people. The Supreme Court overturning of Roe v. Wade earlier this year was a wake-up call that individual rights are under attack by the far right,” Warren added. “This decision likely won’t be the last we see in a campaign to impose some individuals’ religious beliefs on the broader population. Access to contraception, vaccinations, routine health screenings, prevention services and patient privacy are all under attack.”

While this latest decision is for now limited to the Northern District of Texas, it has ramifications for the rest of the country and for global programs to provide PrEP to people of all genders and sexual orientations who need and want to use it. These kinds of decisions often test the ground for cases that go to the Supreme Court, where the current makeup of the court means such a decision may be upheld and even expanded upon nationally.

“Deciding to use PrEP is a decision between an individual and their healthcare provider, no one else. Another person’s religious beliefs have no place in determining the right to use a safe, highly effective, FDA-approved, life-saving drug,” said Suraj Madoori, AVAC’s director of policy and advocacy.

“Daily oral PrEP was approved by the US FDA a decade ago and still has not reached nearly all of those who would benefit from its use. This decision throws up another substantial barrier between a life-saving intervention and individuals and communities most vulnerable to HIV, further capping the untapped potential of an important prevention option,” Madoori added.

This decision creates enormous, unnecessary barriers for LGBTQ+ people in Texas, as well as heterosexual women who are HIV-vulnerable, from the healthcare they need and is yet another example of oppressive or criminalizing policies in countries around the world that set barriers to health and human rights. We know these barriers drive poverty, epidemics and disenfranchisement from civil society. Policies like this don’t advance anyone’s freedom to live full, healthy lives; rather they undermine community resilience, individual autonomy and public health.

“At a time when science has given us the tools to advance towards the end the HIV epidemic and rational evidence-based public health policies and programs can implement those tools to save millions of lives around the world, one judge’s biased and discriminatory decision could endanger programs and lives far beyond northern Texas,” Warren added. “As advocates, activists and citizens, we at AVAC stand in solidarity with those whom this decision affects. We firmly believe that the ruling must be called out as homophobic and dangerous and that every effort must be made to ensure that it does not stand.”

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic. Follow AVAC on Twitter @HIVpxresearch and find more at www.avac.org and www.prepwatch.org.

Upcoming TCA Webinars On CROI And The Ring!

The Choice Agenda, a global forum for advocacy on the latest in HIV prevention, has two webinars coming up you won’t want to miss:

the Choice Agenda logo

CROI and Community and YOU – Preparing for CROI 2023
Wednesday, September 7 at 10:00-11:00am ET; 2:00-3:00pm GMT

Register here.

Join the conversation with co-chairs of the Conference on Retroviruses and Opportunistic Infections (CROI), as well as researchers, advocates, community educators and members of the Community Liaison Subcommittee. The discussion will touch on what to expect at CROI 2023, which features some of the most consequential research on HIV, monkeypox, SARS-CoV-2 and more. The webinar will also cover how to apply for a Community Scholarship, and key dates and deadlines for engaging with the conference. Remarks from:

  • Dawn Averitt, Member of the Community Liaison Subcommittee
  • Dr. James Hoxie, Chair of the 2023 CROI Planning Committee
  • Drs. Diane Havlir, Vice-Chair of the 2023 CROI Planning Committee
  • Landon Myer, Vice-Chair of the 2023 CROI Planning Committee
  • Jim Pickett, Member of the Community Liaison Subcommittee
  • Ntando Yola, Member of the Community Liaison Subcommittee

RINGing the bell for Choice: Actions and Solutions on Dapivirine Ring Access
Thursday, September 22 at 9:00-10:30am ET; 1:00-2:30pm GMT

Register here.

This webinar will offer the latest from African advocates leading efforts to demand access to the dapivirine vaginal ring. In recent weeks, advocates have been pressing PEPFAR and others to do more to deliver the ring to women who want it. The Population Council will also discuss their plans for moving forward a full agenda for ring technology, including rolling out the approved monthly PrEP Ring, and continuing research on a three-month ring and multipurpose technology. In July, the Population Council announced it had acquired the ring technologies from the International Partnership for Microbicides, the ring’s developer. Speakers include:

  • Yvette Raphael, Advocacy for Prevention of HIV and AIDS, South Africa
  • Leonard Solai, IPM, South Africa
  • Erica Gollub, Pace University
  • Chris Obermeyer, The Global Fund

For previous webinars from The Choice Agenda, check out our archive here! And join more than 600 advocates on the TCA listserve by reaching out to Jim at [email protected].

AVAC’s August Reading List

Yesterday we heard that Dr. Anthony Fauci will step down from his role leading the US National Institute of Allergy and Infectious Diseases (NIAID) after a half a century of public service. His vision, passion and commitment to ending the AIDS epidemic and advancing global health equity has been an inspiration to AVAC and to so many. As we contemplate the huge leadership gap Dr. Fauci leaves, we look forward to working with him and all stakeholders to ensure that hard fought gains in public health under his leadership are not lost and are further built upon.

This August reading (and listening) list is a great place to start building on the legacy of Dr. Fauci and taking charge of the work ahead. As Dr. Fauci reminds us: “much accomplished; much still to do”.

For Your Advocacy – A Research Agenda for Pregnant and Lactating People

For prevention options to meet the real life circumstances of the people who need them, we need an inclusive research agenda. Advocacy for the inclusion of pregnant and lactating populations (PLP) in research has been gaining traction in recent years, building on growing evidence, several global and national initiatives and an increased focus from prevention advocates. AIDS 2022 in Montreal featured exciting discussions advancing this work. If you’ve been taking part or just getting up to speed on the issue, AVAC has resources for you—including An Advocate’s Guide to Research in Pregnant and Lactating Populations; a dedicated page on AVAC.org with background and further resources; and a four-point action plan, Advancing HIV Prevention Research in Pregnant and Lactating Populations: Priority Advocacy objectives and Next Steps.

Pregnancy and the post-partum period after giving birth are times of heightened HIV risk. Cisgender women are two to three times more likely to acquire HIV during pregnancy and four times more likely post-partum than otherwise. Women who acquire HIV during pregnancy have an 18 percent chance of transmitting HIV to their newborn, which goes up to a 27 percent chance if they acquire HIV while breastfeeding. But HIV prevention options for (PLP) are limited, and their inclusion in research has been inadequate, resulting in evidence gaps across the research landscape for new prevention products.

(Image from AVAC’s Advocates Guide)

An approach based on principles of reproductive justice is reframing the research agenda for PLP. But action is needed from a variety of stakeholders to promote ethical inclusion rather than exclusion of pregnant people from clinical trials. A multi-stakeholder think tank led by AVAC and the PHASES project brought together advocates, researchers, ethicists, regulators and donors and resulted in a four point action plan, with additional contributions from Pangaea Zimbabwe AIDS Trust. The plan identifies next steps and four priority goals:

1) Embrace a reproductive justice framework:

(Reproductive Rights Framework, Image from PHASES, 2020)

2) Engage stakeholders in an early and sustained process in the design and conduct of clinical trials

3) Develop the necessary regulations to generate needed data for PLP to safely use new therapeutics

4) Ensure sound ethics reviews that include adolescent girls and young women in HIV prevention research.

An inclusive research agenda for PLP is essential for the HIV response, elemental to equity in global health, and key to having an impact on the epidemic. If you are interested in getting involved in AVAC’s work in this area, contact [email protected]

For other resources toward an inclusive research agenda, check out

  • The Choice Agenda list serve: a global forum for advocacy on the latest in HIV prevention research, with monthly webinars on the hottest topics.
  • No Data No More: A Manifesto to Align HIV Prevention Research with Trans and Gender-Diverse Realities
  • Good Participatory Practice Guidelines: systematic guidance on effective stakeholder engagement in HIV prevention research.

A Look Back at Montreal

In Montreal the pressure was on.

AIDS 2022 showed the global response to HIV at a crossroads. The field has achieved groundbreaking advances in biomedical solutions. But intensifying disparities in HIV prevention and global health at large threaten to eclipse these achievements. Scrutiny of the inequities was center stage in Montreal. While the UNAIDS report In Danger, released at the conference, documents what HIV advocates have known—that during the earliest phases of the COVID-19 pandemic, progress against HIV did not just stall, it actively lost ground—the HIV Prevention 2025 Road Map by the Global HIV Prevention Coalition released just days later navigates a path to get back on track.

Click here to download the issue

Advocates see how much is at stake at this moment and were making the connections to crises across the field of global health. Their call to action was constant. Protests, formal and informal, were diverse and targeted. They demanded political support and full funding to rollout the dapivirine vaginal ring (PrEP Ring), confronted the developer of injectable cabotegravir for PrEP to go further in affordable and transparent pricing, took on an anemic response to monkeypox (POZ coverage here, TheBodyPro coverage here), challenged ongoing criminalization of sex workers and other key populations, and criticized Canada for blocking the visas of hundreds of delegates to the conference.

Veteran voices such as Fatima Hassan of the Health Justice Initiative were calling out the implications of “vaccine apartheid” in the COVID response and the “pandemic profiteering” that drives it. Global health activist and epidemiologist Gregg Gonsalves called on health advocates to go beyond “the technocratic solutions… and fight our way back to equity.” Advocates challenged the legacy of colonial imperialism in global health, and some voices demanded total reform of the intellectual property and trade system, to name a few of the issues and actions raising the heat.

Are They Listening?

Important steps in decolonizing global health are beginning to take shape. Advocates from the Global South hosted and co-hosted meetings with key decision-makers to make the urgent case for faster and more equitable access to new PrEP options—including meetings with Winnie Byanyima of UNAIDS, Amb. John Nkengasong of PEPFAR and Atul Gawande and Han Kang of USAID. These discussions, as they go beyond community engagement and towards community leadership, represent a model for how the global response must change—voices from communities where HIV is hitting the hardest must be in leadership at every stage, for every crucial decision. The UNAIDS, PEPFAR and USAID leaders say they are listening. Advocates are watching this space closely. Accountability, at every level, is essential—for HIV prevention, treatment, human rights, health systems and health equity.

Getting Rollout Right

Fulfilling the current promise of new HIV prevention options requires advancing a people-centered, integrated approach for introducing proven products. This priority was also center stage in Montreal. The Coalition to Accelerate Access to Long-Acting PrEP (with AVAC serving as the secretariat), The HIV Prevention Road Map announced by the Global HIV Prevention Coalition, and the just-launched WHO guidelines for injectable PrEP that simplify PrEP delivery, are helping to lay the groundwork. The agreement between the Medicines Patent Pool (MPP) and ViiV is also a welcome step toward a sustainable market of generic manufacturers for injectable CAB and future products.

But more must be done. Delivering the fruits of science must become as urgent as their development. Putting in place the right programs, policies and investment to deliver choices at scale and bend the curve of the epidemic utterly depends on a commitment to integrated, equitable, people-centered, and community-led approaches. Be sure to read AVAC’s Plan for Accelerating Access and Introduction of Injectable CAB for PrEP, (or a summary of it), which outlines why funding commitments, creating demand, WHO guidelines, implementation studies, technology transfer, generic manufacturing and more must be coordinated and expedited now.

Several sessions and events at AIDS 2022 took a deep dive into why and how this people-centered, integrated approach must frame product introduction. Here are quick highlights on key sessions:

Scientific Advances

The meeting saw incremental progress in research on several of the pandemics destroying life around the world today. Sessions on TB, HIV, COVID-19, monkeypox, and STIs drew lessons from the COVID-19 response. But with all that the world is learning, research and discussion have yet to tackle how to create the integrated systems needed for a truly effective global health response. This kind of pandemic preparedness means advancing health equity.

Our friends at aidsmap provided in-depth reporting on a number of sessions; you can check out their highlights here. In the meantime, here is a brief summary of some of the scientific advances we found interesting at AIDS 2022:

Populations and Products in Focus

The following sessions put an important spotlight on particular populations or products:

AVAC at AIDS 2022

For a look at AVAC’s work at AIDS 2022 go to our dedicated page. And in case you missed it, the latest webinar from The Choice Agenda provided a status update on the rollout of injectable PrEP, with presentations from providers, researchers, the WHO and others.

The picture of HIV prevention today is full of promise and peril. Navigating the challenges is both possible and imperative. Here’s how AVAC Executive Director Mitchell Warren put it at the launch of the new Global HIV Prevention Roadmap:

“In 41 years we’ve never had such opportunity in prevention. We have a package of proven methods for the first time, and global health leaders are offering renewed commitments to spearhead and sustain programs that are designed to reach those who need prevention most. These programs should be focused on integrating HIV services with sexual reproductive health and rights. But we won’t get this done without going beyond simple community engagement and the old siloed models of delivery. Now is the time to integrate, coordinate, and invest. Now is the time for a global response that is community led.”

Injectable PrEP: Upcoming Webinar from The Choice Agenda

AIDS 2022 in Montreal just wrapped up, and stay tuned for our full summary soon. For now, though, a quick update on injectable cabotegravir for PrEP (CAB), which was a hot topic at the conference and the subject of next week’s Choice Agenda webinar.

  • New data from the HPTN 083 and 084 trials re-confirmed the safety and efficacy of CAB for PrEP;
  • WHO guidelines added injectable PrEP as an additional prevention option;
  • ViiV, the drug-maker of CAB for PrEP, and the Medicines Patent Pool announced an agreement to provide a voluntary license and begin the process of identifying generic manufacturers;
  • A new coalition convened by Unitaid, WHO, UNAIDS and the Global Fund, with AVAC serving as the secretariat, will collaborate with civil society, normative agencies, governments, and funders, in accelerating access to longer-acting PrEP; and
  • Advocacy and activism around global access to CAB included on-stage protests, meetings with key decision makers and many, many other discussions led by advocates and partners.
  • Join us Monday, 8 August at 9:00 ET / 15:00 SAST for our next The Choice Agenda webinar, Faster, Smarter and More Equitable – Accelerating Roll Out and Uptake of CAB for PrEP.

    title card for webinar

    As injectable cabotegravir (CAB) as PrEP begins to be introduced, what lessons have we learned from the first 10 years of oral PrEP implementation? How can the field do better with a new PrEP intervention that offers new opportunities and distinct challenges? These are the questions our panel will be discussing and more.

    • Rachel Baggaley, World Health Organization
    • Caroline Carnevale, New York Presbyterian Hospital
    • Monica Gandhi, University of California San Francisco
    • Mitchell Warren, AVAC
    • US cabotegravir (Apretude) user – RJ Mitchell

    Resources

New Issue of PxWire!

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes news, emerging issues and features upcoming events.

The HIV field gathers for its first hybrid International AIDS Conference (IAC) since the start of COVID-19 pandemic at a pivotal moment in HIV prevention. Across research to rollout – accelerated product access, new products reaching the market, new trials starting (and pausing) and recent research results – the ability to deliver two new proven PrEP methods will be determined by conversations and decisions happening now.

After initial approval ten years ago, oral PrEP initiations have surpassed 2M globally, reaching 2,797,304 – with significant progress over the past year, but still well below UN targets.

Check out the full issue of PxWire here and scroll down for important updates.

phases in trial development

bar chart of PrEP uptake worldwide

preparing for new products dashboard

updates on products upstream in clinical trials

Message from Montreal: Which way will we go?

A string of announcements today coming from AIDS 2022 mark a potential turning point for HIV prevention and for the global health field at large, but a grave question hangs in the balance: which way will we go?

The big news yesterday was a dire warning: the launch of the UNAIDS report, In Danger, documenting what HIV advocates have known: that during the earliest phases of the COVID-19 pandemic, progress against HIV did not just stall, it actively lost ground.

The news today included: promising developments with new data from the HPTN 083 and 084 trials testing injectable cabotegravir for PrEP, which re-confirmed its safety and efficacy; WHO announced new guidelines adding injectable PrEP as an additional prevention option; the drug-maker for the first approved product of injectable PrEP (cabotegravir as PrEP), ViiV, announced an agreement with the Medicines Patent Pool to provide a voluntary license and begin the process of identifying generic manufacturers; and a new coalition was announced, convened by Unitaid, WHO, UNAIDS and the Global Fund, with AVAC serving as the secretariat, to collaborate with civil society, normative agencies, governments, and funders, in accelerating access to affordable longer-acting PrEP.

In the whiplash of announcements and headlines, it’s vital to understand how much is at stake at this moment.

Will proven biomedical options become feasible choices for people who need and want them? Will policies, programs and investments come together for equitable access? It’s up to all of us.

PrEP has an important role to play in reaching targets and accelerating an end to the epidemic. But new AVAC data show only around 2.7 million people have initiated use of oral PrEP since it was introduced ten years ago, falling short of the 2020 target of three million users – and representing only a fraction of the estimated number of people who need it and could benefit from it. Now, the dapivirine vaginal ring and injectable cabotegravir (CAB for PrEP) offer additional options – and an opportunity to re-imagine HIV prevention.

The news from Montreal show promise and potential to develop and deliver new PrEP options faster, smarter and with greater equity than ever before.

AVAC’s Plan for Accelerating Access and Introduction of Injectable CAB for PrEP provides a comprehensive view of all the moving parts involved in delivering this new PrEP option and identifies priorities for ensuring time is not wasted and opportunity is not squandered. The plan focuses on learning the lessons from the first ten years of delivering oral PrEP. It shows how to move faster, more strategically, and with greater coordination— to maximize the impact of injectable CAB for PrEP today, and to overcome access challenges for new PrEP options in the future.

thumbnail of the CAB plan

There is enormous work ahead, and it will require all proven prevention methods be available in a marketplace of choice. And these efforts must integrate the involvement of all stakeholders, including civil society, to hold each other accountable. We encourage you to read the plan, or our summary of it, and follow events in real time on Twitter at #AIDS2022. And learn more about the dapivirine vaginal ring and injectable cabotegravir (CAB for PrEP).

African Activists Call for Women and Girls to have a Voice in HIV Prevention Choices

African feminists and HIV prevention advocates are united in their advocacy for ensuring African women and girls in their diversity have a range of HIV prevention options to choose from, including the dapivirine vaginal ring.

While several African countries have approved the licensure of the ring and the WHO has included the ring on the list of essential medicines, some donors are backing away from their support of the ring for rollout beyond the planned Introductory studies as well as support for future research in longer acting rings. Advocates have called for accelerated access to the ring and not to lose sight of the importance of championing choice and respecting the investment African women and communities have made in bringing the ring to this point.

Read more and see the signatories to the statement on the WACI Health website.

AIDS 2022 Montreal Coming Up!

AIDS 2022 logo

The world’s largest conference on HIV/AIDS, AIDS 2022, convenes July 27-August 2 in Montreal, Canada. Hosted by the International AIDS Society, this 24th session of the conference will be the first since the pandemic to offer in-person and virtual access. Register for the full conference here and the pre-conference here.

AIDS 2022 launches at a pivotal moment in HIV prevention. The ability to deliver two new proven PrEP methods will be determined by conversations and decisions happening now. These decisions will impact policies and funding for products in the pipeline and programs to deliver what’s available today for HIV prevention. It’s time to sharpen the agenda for HIV prevention and global health equity. AIDS 2022 will offer opportunities to engage in these conversations while getting up to date on the latest research, rollout, policy and advocacy.

Below AVAC has gathered resources to help you navigate the conference overall and find the sessions on prevention that we hope will interest you, keep you informed, and support conversations that will shape the future of the global response to HIV.

Resources

Panels, Satellites, Sessions and Workshops Featuring AVAC and Partners

Friday, July 29

  • [Satellite] Next Generation PrEP: Science, policy, and community impact
    18:15-19:45 EDT

    How do clinical trials assess efficacy of new and still-needed experimental products, with highly effective options available to the public? This session explores the need to bring key stakeholders including communities, industry and regulators to questions such as: How do regulators approach groundbreaking new trial designs in HIV prevention? How do these trial designs affect patients in the trials and those that may benefit from candidate drugs?

Saturday, July 30

  • [Symposium] Equitable roll out of health products: What will it take?
    14:15-15:15 EDT

    Discussing innovative strategies, collaborative partnerships and transparent processes that engage advocates, government agencies, policy makers, government and non-governmental funders, regulatory bodies and pharmaceutical companies and result in equitable access to new products, the key to achieving rapid and effective product rollout.

Sunday, July 31

flyer for our next shot workshop

flyer for demand, delivery and data for decision-making meeting

Monday, August 1

Find these resources, conference highlights and more at AVAC’s dedicated AIDS 2022 event page. And watch this space for new opportunities to come together and shape what happens next.