The Microbicide 2020 R&D Project: Advancing the Research and Development of Innovative HIV Prevention Products for Women

The Objective of this Addendum is to bring together a collaboration of partners with diverse, complementary, and relevant capabilities that, when combined, will accelerate the research and development (R&D) of new HIV prevention products that women can choose to protect themselves, and address the continuing and disproportionately high rates of HIV incidence in women, especially adolescent girls and young women in sub-Saharan Africa. For more information and to apply, click here.

AVAC Applauds Biden Administration Repeal of the Global Gag Rule

AVAC applauds the executive action taken today by US President Joe Biden to repeal the Mexico City Policy, also known as the Global Gag Rule (GGR), which prohibits many foreign groups receiving US foreign aid from speaking about, referring for, advocating for access to, or providing abortion. The GGR has had an enormous deleterious effect on US-funded global health work and led to loss of life and harm to cisgender women, adolescent girls and young women worldwide.

As COVID-19 exacerbates gender-based violence, disrupts contraceptive programming and threatens HIV prevention for women in all their diversities, this repeal is a welcome, necessary action—and must be the first step in broad, bold US government commitment to the health and wellbeing of girls and women.

There is much more that needs to be done now to undo the damage done by the policy, including immediate communication about the repeal, and proactive outreach to ensure partners who declined US funding while the GGR was in place are brought back into US-supported networks of prevention, care and support. Steps must also be taken to ensure that the GGR is eliminated as an option for controlling women’s health programming. AVAC stands in solidarity with allies, including Health GAP, who have been clear in demanding that the Biden Administration correct the extensive harms already done and end this cycle by establishing a permanent policy that supports sexual and reproductive health and rights for all, in the US and globally.

Four years ago, the Trump Administration reinstated and expanded the GGR (originally enacted by Ronald Reagan in the 1980s and reinstated in all successive Republican administrations). The Trump expansion of the Global Gag Rule vastly increased the range of groups subjected to its lethal restrictions. As it has in every prior era, the 2016-2020 imposition of the GGR resulted in increased unintended and high-risk pregnancies, unsafe abortions and maternal deaths, and hampered introduction HIV and sexual and reproductive health and rights programs that are urgently needed worldwide. It will take years to rebuild the programs that were damaged by this policy, and the damage done to women’s lives is incalculable.

The Biden Administration must ensure immediate, multi-channel communication with partners about the repeal of the GGR; it must also launch an urgent review of all federal guidance and rules to purge the references to the GGR that may still affect funding and programs. The Office of the Global AIDS Coordinator must immediately clarify that section 5.9.4 of its 2021 Country Operational Plan guidance on implementation no longer applies, including to plans for the coming year. The administration must also allow PEPFAR funds to be used to procure a range of contraceptives beyond condoms, as is the current policy. Women’s health should not be divided between one clinic to access HIV treatment or prevention and a separate one to access contraceptives and other sexual health interventions. It is past time for PEPFAR to support integrated health options for women, especially in the context of the COVID-19 pandemic.

Along with expanding PEPFAR support, the administration should immediately reinstate funding for UNFPA to help ensure increased and sustained funding for contraceptive options for women.

The Administration must also work with the US Congress to ensure that the GGR is permanently legislatively repealed so that it cannot be easily reinstated by a future administration. To this end, the Administration should enthusiastically support the Global Health, Empowerment and Rights (HER) Act, which was introduced today by bi-partisan leadership in the House and Senate and would ensure the US could make permanent and long-lasting partnerships in support of women’s health and rights without fear of programs being rolled back with each new administration.

The Biden Administration has spoken of a desire to dismantle white supremacy and racist structures in the US. That commitment must extend to its foreign policy and development programs. For too long, US global health and development support has relied on policies and programs that at their worst are colonialist and antifeminist. Repealing the GGR is an important step in the right direction, but AVAC looks to the Biden administration to work with advocates and public health experts to examine all current policies and programs with a lens of anticolonialism and human rights and make the necessary changes to truly bring US foreign policy for health and development into the 21st century.

The Microbicide 2021 Introduction and Access Project

USAID’s Microbicide Program aims to bridge gaps and reduce barriers among R&D, regulatory approval, introduction, access, and scale-up of close-to-market products through program research and country engagement activities that identify and address obstacles, gaps, and bottlenecks that delay timely access to new prevention technologies and their resulting impact. For more information and to apply, click here.

HIV Research for Prevention Conference Presents Important Research Insights Across a Range of New Options

Today at a press conference hosted by the HIV Research for Prevention (HIV R4P) conference, research teams presented a range of data from ongoing studies of antibody-mediated prevention, long-acting injectable PrEP, a monthly PrEP pill, and trends in daily oral PrEP use. Together, they point to a future of biomedical HIV prevention research and programs with a greater understanding of mechanisms of prevention, enhanced trial designs and a wider range of prevention options.

HIV R4P Virtual 2021 begins officially on January 27th. Today’s press conference offered top-line findings from the full scientific presentations that will be made later this week. These data have not yet been published in peer-reviewed journals but warrant close attention for their implications for the field.

At the press conference, researchers from the NIH-funded HIV Vaccine Trials Network (HVTN) and HIV Prevention Trials Network (HPTN) presented initial data from the Antibody-Mediated Prevention (AMP) trials of an HIV-specific broadly neutralizing antibody (bNAb) called VRC01, delivered intravenously once every eight weeks. The trials enrolled cisgender women in sub-Saharan Africa and gay men and transgender persons who have sex with men in Brazil, Peru, Switzerland and the United States. According to Larry Corey, AMP Studies protocol chair and principal investigator of the HVTN, VRC01 did not significantly reduce the overall risk of HIV acquisition in participants who received the antibody compared to those who received the placebo. However, VRC01 did safely and effectively reduce the risk of acquiring HIV strains classified as “highly-sensitive” to neutralization by VRC01.

“These were complex and well-designed trials of a novel HIV prevention concept, and the results move the field forward in important ways,” said Mitchell Warren, AVAC Executive Director. “The AMP trials show that a broadly neutralizing antibody can reduce the risk of acquiring viruses that are very sensitive to that antibody. This is welcome news; it is the first evidence in humans that intravenous infusions of a broadly neutralizing HIV antibody can reduce a person’s risk of acquiring HIV via sex.”

The AMP results also demonstrate the extent of the challenge that lies ahead for antibody-mediated prevention. There are multiple strains of HIV circulating through communities. The trial team used lab tests to predict how many HIV strains in trial communities would be sensitive to, and blocked by, VRC01. The trial data didn’t match these predictions. Fewer viruses were highly-sensitive to VRC01 than the AMP team had hoped. The trials showed that a bNAb like VRC01 does not offer sufficient protection on its own and that a combination of bNAbs is likely needed if broad protection is to be achieved.

“AVAC is grateful to the research teams, trial participants, clinic staff and community advocates who made these trials possible. The next step for the prevention field is to determine how these results can be used to guide the selection of combination bNAb products to advance to efficacy trials. Advocates should monitor — and be engaged in — these deliberations,” said Stacey Hannah, AVAC’s Director of Research Engagement.

“With new prevention options like the Dapivirine Vaginal Ring and injectable cabotegravir for PrEP advancing towards licensure, people at risk of HIV will have more choices. This is a great thing. As choice expands, efficacy trials of future products will need to be designed in new ways, and advocates’ support for investigation of bNAbs as part of this prevention pipeline is crucial,” said Hannah, who also led the development of AVAC’s Advocates’ Trial Design Academy that is engaging with developers and trial designers in considering the future.

Participants in the AMP trials received one of two different doses of VRC01 or a placebo administered every eight weeks via intravenous infusion. Some participants — in both the placebo and VRC01 arms — acquired HIV in spite of counseling, condom provision and PrEP referrals and counseling at all study sites. Viruses from these participants were isolated from their blood samples, sequenced and analyzed in the laboratory to determine the concentration of VRC01 that blocked viral activity. Viruses neutralized with a

The Curtain Raises on R4P: Findings on the AMP Trials and more…

Today at a press conference hosted by the HIV Research for Prevention (HIV R4P) conference, research teams presented a range of data from studies of antibody-mediated prevention (AMP), long-acting injectable PrEP, a monthly PrEP pill and trends in daily oral PrEP use. Together, they point to a future of HIV prevention, in research and programs, with a greater understanding of the biology that informs effective prevention, enhanced trial designs and a wider range of prevention options.

HIV R4P Virtual 2021 officially kicks off tomorrow, January 27th. Today’s press conference offered top-line findings from the scientific presentations that will be made later this week. These data have not yet been published in peer-reviewed journals but warrant close attention for their implications for the field.

Taken together, this suite of studies offer a set of clear imperatives for HIV prevention: national governments, funders and advocates must work to continue to increase access to daily oral PrEP; and work to ensure that today’s PrEP programs provide a platform for tomorrow’s products, including injectable cabotegravir and the Dapivirine Vaginal Ring. At the same time, research must continue, including efficacy trials of Islatravir and other next-generation PrEP options and research that builds on the AMP results to inform both antibody and vaccine development. Click here to read AVAC’s press statement on these new data.

And just after the press conference, the World Health Organization officially recommended the Dapivirine Vaginal Ring (DVR) be included as a prevention choice for women at risk of HIV. This recommendation, along with a similar, strong statement for choice in the recent PEPFAR Country Operating Plan guidance, represents a critical step in making the DVR available to women who want it, and paving the way for additional prevention options.

As a reminder, here are sessions and a schedule for the Advocates Corner, to tune in as you’re able, where AVAC and partners will be shining light on the prevention agenda.

How to Find and Follow AVAC and Partners at HIV R4P

It’s time to plan for your participation at the 2021 HIV Research for Prevention Conference (R4P) Virtual, the only global conference focused exclusively on biomedical HIV prevention. The conference takes place over the course of four days, January 27-28 and February 3-4, and you can register here. Even if you’re not registered for the conference, there are ways to participate and follow the proceedings in real-time. Check out the Program at a Glance, and read on for how to join the discussions at the Advocates’ Corner and follow the conference using AVAC’s resources for real-time coverage.

Advocates’ Pre-Conference

The Advocates’ Pre-Conference, Community, Comrades and Connection, takes place the day before the conference begins, on January 26, 9-10:30am ET (click here to check the time in your region). This 90-minute session will help advocates prepare for the conference, with strategies for engaging with each other and mobilizing around timely issues. All interested HIVR4P registrants are welcome to join—from first timers to “old” timers. Register here.

Advocates’ Corner

Consider adding regular check-ins at the Advocates’ Corner to your R4P schedule. In the Corner, all are welcome in the exchange of ideas and the chance to network, build solidarity, relax and socialize—you do not need to be registered for the conference to participate in the Corner. The Corner features a series of pop-up conversations and learning labs designed to help advocates and civil society members dive deeper into the research presented during the conference. The corner will also offer “hallway huddles” with daily debriefs to unpack the news of the day, and breakout rooms to interact with colleagues. Check out the full schedule here.

Real-Time Conference Coverage

Look for conference round-ups via AVAC’s Advocates’ Network, follow AVAC on Twitter on @HIVpxresearch and the full conference via #HIVR4P. And finally we love aidsmap’s R4P news coverage—follow along for breaking news from the conference.

Sessions with AVAC and Partners

This collection of satellites, symposia and oral abstract sessions includes AVAC team members and partners confronting key issues on the frontier of HIV prevention science in 2021.

Wednesday, January 27

Thursday, January 28

Wednesday, February 3

Thursday, February 4

Many of the team and partners are also representing AVAC, CASPR and the Prevention Market Manager in posters and publications—click here and scroll to the last page for a full list.

Navigating R4P

To make the most of the sessions above, AVAC has a host of resources for you:

See you in the virtual hallways!

AVAC on PEPFAR Leadership Transition—and Beyond

Today, Ambassador Deborah Birx announced that she would be retiring from leadership of the Office of the Global AIDS Coordinator and the US President’s Emergency Plan for AIDS Relief (PEPFAR). She also announced that her deputy coordinator, Angeli Achrekar, will be the acting US Global AIDS Coordinator. In this week of political transition—Joe Biden will be inaugurated as the 46th United States President tomorrow—AVAC marks Ambassador Birx’s departure with gratitude and a call to future action for PEPFAR and the new administration.

Under Ambassador Birx’s leadership over the past seven years, PEPFAR took critical steps to harness efficiencies in the program, increase transparency in data and ensure robust civil society engagement in planning and monitoring at country and global levels. These steps made the program stronger and delivered significant impact. AVAC and our partners have changed programs, policies and performance through data-driven demands often focused on PEPFAR.

AVAC looks forward to continuing our work to ensure that PEPFAR remains committed to data use, transparency and civil society engagement. Ensuring the continuation and expansion of PEPFAR is just one component of the robust US global health agenda needed to address COVID-19, build pandemic preparedness and drive towards epidemic control of HIV.

Last week, the Biden-Harris Administration announced plans for a US$11 billion global health investment and two health-focused positions on the National Security Council, as well as the appointment of human rights advocate and former US Ambassador to the UN Samantha Power as the next head of USAID. These are critical positions at a time of enormous consequences, and AVAC looks forward to helping to define an agenda that encompasses health security for all. Specifically, we look to the Biden-Harris Administration to:

  • Act quickly to rejoin WHO and voice strong support for a US$4 billion contribution to the Global Fund and US$1 billion to PEPFAR. These multilateral and bilateral mechanisms have played a key role in getting funds to countries to strengthen and set up national pandemic responses; as COVID-19 cases creep up in sub-Saharan Africa and surge in many parts of the world, this emergency funding mechanism is out of funds. Failing to support countries shoring up their health systems, including surveillance, testing, treatment and vaccination systems, will prolong the pandemic globally and will lead to erosion of hard-fought past gains against HIV, tuberculosis and malaria.
  • Sustain and expand support for PEPFAR. Prior to COVID-19, this singular American global health effort had helped drive rates of new HIV infections down by 40-50 percent in many of the countries where it worked. Its use of data, transparency about targets and results, focus on achieving epidemic control, and robust engagement with civil society based in the US and in the countries where it operated must continue. We look to the Biden Administration to ensure strong leadership of the program, which must stay in the State Department, with an empowered US Global AIDS ambassador, and a clear mandate from the White House to continue the critical work of AIDS treatment, prevention and care.
  • Move swiftly on innovative, integrated, long-overdue restructuring of the US approach to global health and health security that coordinates and links investments in ongoing and point-in-time pandemics, and ensures preparedness for biowarfare attacks. Now is the time to develop a truly comprehensive health security agenda that clearly connects American investment in ongoing pandemics like HIV, tuberculosis and malaria, investments in preparedness and prevention of emergent pandemics like Ebola and COVID-19, and broad, country-driven investments like the Global Fund. A single coordinator of this effort, based at the White House and working closely across agencies and disease areas will be able to leverage the enormous expertise and assets of the US global health portfolio. This will help to ensure that the HIV-specific response not only succeeds at supporting countries to reach epidemic control, but also helps build the community-level trust in health systems, surveillance and laboratory capacity, and medications supply chains that will help prevent the next pandemic.

AVAC thanks Ambassador Birx for her service, and we look forward to working with the new administration in 2021 and beyond.

HIV R4P Conference: How to join, learn and follow

HIV R4P Virtual is coming right up, with events starting January 26th rolling through February 4th—don’t miss it. Held every two years, the HIV Research for Prevention Conference (R4P) is the only global conference focused exclusively on biomedical HIV prevention.

This year’s content will help set the stage for the high-stakes year ahead. Get started at the Advocates Pre-conference (click to register) on Tuesday, January 26th. Watch for AVAC’s updates from the meeting on social media and the Advocates’ Network, and bookmark AVAC’s R4P webpage so you can follow along.

The stakes are high for many reasons. COVID-19 is claiming lives across the globe, disrupting health care services and slowing the pace of HIV prevention and treatment research. At the same time, there are unprecedented opportunities to deliver both COVID-19 vaccines and new and emerging HIV prevention strategies. This virtual gathering, which includes access to the IAS COVID-19 Prevention Conference on February 2nd, is a chance to hear the latest data and explore the opportunities and challenges for research and rollout that lie ahead, including:

  • Lessons from oral PrEP programs—and how they could accelerate the introduction of new long-acting options, like the Dapivirine Vaginal Ring and injectable cabotegravir.
  • The latest research findings from interventions moving through the pipeline, such as the Antibody Mediated Prevention trials of a broadly neutralizing antibody, new forms of long-acting injectable and oral PrEP.
  • The implementation science required to translate promising options into real choices and real impact.
  • The innovations in new trial designs in the midst of PrEP rollout.
  • The ongoing challenge to develop an HIV vaccine, an essential component to finally ending the epidemic.

And that’s just for starters… click here for our program at a glance to see what’s planned. In the coming days, watch this space and AVAC’s R4P page for a more detailed roadmap to guide you through the ins and outs of the conference at large; a rich program at the Advocates’ Corner; and in-depth details on conference highlights and featured sessions.

Protecting Global Gains: Local advocacy and knowledge helps safeguard gains in SRH in Bangladesh

The Protecting Global Gains series kicks off 2021 with a story about the motivated and resourceful advocates in Bangladesh who not only safeguarded essential family planning services against the disruptions of COVID-19 but also maximized the impacts of domestic investment. Read on for the latest edition of Protecting Global Gains: Bangladeshi activists help sustain access to family planning services.

In April 2020, the Guttmacher Institute released dire estimates on how COVID-19 is affecting sexual and reproductive health services. Estimates showed that the compounding ramifications of national lockdowns, economic losses, disrupted supply chains, and repurposed health personnel could lead to as many as 15 million annual unintended pregnancies in low- and middle-income countries. Sexual and reproductive health services in Bangladesh experienced some of these challenges—especially as personal protective equipment (PPE) was allocated to staff providing essential health services only.

Advocacy groups and local governments in Bangladesh took action in response to this sexual and reproductive health emergency. Learn about how two Bangladeshi NGOs, Marie Stopes Bangladesh and Shushilan, through the Advance Family Planning initiative, worked with local government to stave off feared setbacks in reproductive and sexual health in the latest story on protectingglobalgains.org, Bangladeshi activists help sustain access to family planning services.

Whether it’s resuming polio vaccinations in remote areas of Pakistan, introducing smarter ways to distribute bed nets in Benin, or safeguarding reproductive health in Bangladesh, community ownership and local innovation have been key to building flexible and resilient health systems and staving off the worst of the COVID-19 pandemic.

Follow the Protecting Global Gains series on social media at @hivpxresearch, @theglobalfight, @Amref_Worldwide and #ProtectingGlobalGains, and consider amplifying these stories on your own social media. Advocates can pressure governments to honor their commitments to family planning services and for continued national and global investment in efforts to minimize the toll of COVID-19 on sexual and reproductive health. Visit www.protectingglobalgains.org to learn more about how to take action.

Justice and Solidarity: Resolutions for a New Year

2020 was, by any measure, a difficult year. A year ago, a pandemic with the magnitude of COVID-19 was, for many, unimaginable. At AVAC, we have sought to respond to all of the events of 2020, from the COVID pandemic to the ongoing fight for racial justice and free and fair elections in so many countries, including the United States. We are proud to work with partners who share and strengthen our commitment to secure long-term gains in HIV, sexual and reproductive health and rights, and equitable access to health with a social justice lens.

In this first week of the New Year, we at AVAC are committing to continue and expand this work. We make this commitment against a backdrop of an escalating pandemic, of inequities in COVID-19 vaccine access, and of continued stress on health systems that are leaving millions around the globe at risk from other health issues. And we make this commitment during a time of division, dishonesty, insurrection and hatred in the United States—all instigated and incited by a delusional president, aided and abetted by people who were meant to be public servants, but who have clearly abdicated their stated commitments to democracy.

The world watched the events of January 6th in Washington, DC, with shock and horror. AVAC’s US-based staff are grateful for the many messages of concern and solidarity from friends and partners around the world. We don’t know what will happen with the US government in the coming days, but are confident that on January 20th, a new administration will take office. And we celebrate the results from two free and fair Georgia Senate races, delivered in the face of manipulation, fear and intimidation.

AVAC looks forward to engaging with the incoming Biden-Harris Administration to ensure more equitable US domestic and global health policies. We will do this as part of our continued work with partners across the globe.

Twenty-five years ago, a group of activists came together to form AVAC in the face of another pandemic and in the certainty that a small group of committed people could call out governments and other institutions for their inadequate and unjust responses. Today we stand on their shoulders and side by side with advocates around the globe calling for health equity, justice and human rights.

As we look to the future, we welcome your thoughts and ideas for our joint work in the year to come.