In Memorium: Inviolata Mwali Mmbwavi

All of us at AVAC are deeply saddened by the untimely demise of Inviolata Mwali Mmbwavi, a fearless leader who devoted her life to fighting for the right to treatment and dignity for people living with HIV in Kenya. She brought this same spirit as a passionate advocate for HIV prevention.

“I would not wish HIV infection to happen even to my worst enemy. I will do whatever it takes within my ability to speak out and support prevention efforts to stop any single HIV infection where I can,” Inviolata told guests at an HIV Vaccine Awareness Day event in Nairobi last May.

Invio, as she was fondly known, worked closely with AVAC around HIV prevention for women, mentoring an AVAC Fellow, advocating for HIV vaccine research and lately around the COVID-19/HIV intersection. At a media webinar this year she presented the results of interviews she had conducted among Kenyan women living with HIV on how the COVID-19 pandemic was impacting their access to treatment.

As one of the first people in the country to publicly declare her HIV-positive status, Inviolata used her oratory gifts to fight HIV stigma and discrimination, from the rural villages of Kenya to the highest national political levels. She became a role model for positive living for youth and adults alike. Her actions contributed directly to the gradual shift in attitudes and HIV policies in the country.

In her life, Inviolata endured HIV stigma, opposition, ridicule and bouts of life-threatening illness, but always rose again to come back to her life’s work for the benefit of Kenya’s women.

Inviolata was the National Coordinator of the International Community of Women Living with HIV- Kenya Chapter (ICW-K). She launched a 3-year strategic plan for the organization in 2018, and worked tirelessly to fundraise and implement its holistic approach to HIV/AIDS care and treatment for women.

We echo the statement by NEPHAK, where she earlier served as founding executive director: “The history of the response to HIV in Kenya will not be complete without the mention of Inviolata Mmbwavi.”

AVAC sends sincere condolences to Inviolata’s beloved daughter and extended family.

Rest in peace and power, Invio.

photo of Inviolata Mwali Mmbwavi

AIDS 2020: Highlights and what you might have missed

Earlier this month, the first ever virtual International AIDS Conference played out over the course of a week. Out of it came both exciting news (injectable PrEP works really well for MSM and transwomen and so does oral PrEP) and disappointing data (we are definitely missing the targets)—all of which will inform AVAC’s advocacy for the months and years to come. For many of us here at AVAC, the week was a whirlwind of adjusting to the new online space, finding the virtual equivalent of a hallway conversation and tracking the firehose of news and session updates from the conference (not unique to the virtual experience).

In this update, we’ve put together news highlights, and links to some of our work at the conference, including recordings of some fun pop-up chats with researchers that were part of AVAC’s Research Literacy Networking Zone (RLNZ) programming. The conversations were a highlight for us—and we hope you find them useful, too!

And please bookmark our AIDS 2020 page, which we’ll update with links to the various session recordings as they become available.

Conference highlights

News and session highlights follow—with the news links courtesy of our friends at aidsmap. For their complete coverage of the conference, click here.

RLNZ Pop-Up Chats

Click below to view sessions with researchers and advocates who discussed hot topics of the day. Have a topic you’d like to see featured in a future pop-up? Let us know!

The satellite recordings aren’t yet up on the AIDS 2020 website, but the conversation at an HIV & SRH integration satellite, co-convened by AVAC and FP2020, was so good that we decided to continue it on a webinar this week. Please watch the recording of One Year After ECHO: Integration in the Time of COVID. And in the meantime, to hear more from the experts on SRH integration, check out our One Expert/One Question/One Minute Campaign mash-up video, and additional videos and resources at

Read about work from AVAC and our partners in various sessions below!

epidemics and what this means in the age of COVID symposium

We’ll keep adding new resources and links to our AIDS 2020 page as they become available, and remind you when they’re loaded up! If you have questions, or want to share with us your personal highlights, be in touch—we love hearing from you!

COVID Action Alert: Today’s Phase III trial and a call for community engagement

In our latest COVID Action Alert, we put today’s news of a Phase III trial launched by the biotech company Moderna in context. Larger trials mean an even greater need for robust community engagement to support the research and plan for uptake of an eventual vaccine. HIV vaccine and prevention advocates can lead the conversations that pave the way for ethical trials and swift implementation. How so? Read on.

On Monday, Moderna announced that enrollment has begun in a 30,000-person Phase III study of its mRNA SARS-CoV-2 vaccine candidate (mRNA-1273). The Moderna study is one of five large-scale, randomized, controlled efficacy trials currently slated to be conducted in partnership with the new NIH-funded COVID Prevention Trials Network (CoVPN) and with US government funding. At the same time, four other vaccine candidates have already entered into efficacy trials in Brazil, China, South Africa and the UK, and at least five more are expected to progress to Phase III by the end of this year. This work is being conducted through a number of global research collaborations, including the CoVPN.

The Moderna study will be conducted exclusively in the US in individuals “whose locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and COVID-19.” The other Phase III trials planned with the CoVPN are expected to be conducted in the US and various international locations.

Anyone can get COVID-19. However, faultlines of racial and socioeconomic disparity run through this pandemic, as with HIV. In order to conduct research in communities and individuals that have been failed by the state and its health system, trials need robust community engagement—meetings with leaders and community members to share information, develop messages, address concerns and answer questions about eventual access plans. As HIV prevention activist Rob Newells said in a Washington Post story over the weekend, “… we have to engage people early in the research end of it, so by the time something gets approved, it’s not something brand new. I think it’s going to take time to talk to people about vaccine research.”

Moderna Phase III participants will be enrolled at 89 sites across the US, 24 of which are affiliated with the CoVPN, which includes groups and researchers with a long history of community-based research engagement. The remaining sites will be enrolled via a clinical research organization called PPD whose commitment to engagement is unknown.

Advocates and activists can take action by:

  • Responding to recruitment announcements with a request for information on the local advisory mechanisms.
  • Working with communities to develop priorities to inform engagement with research. This can include information on future access and health care for individuals in the trials.
  • Push for community-driven inclusion and exclusion criteria. Both the Moderna and Pfizer Phase III protocols indicate that individuals with HIV are not eligible for participation. Many groups, including AVAC, have joined together to raise urgent concerns about how this data gap will impact access for PLHIV, demanding that the trial sponsors review and change the criteria. The trials also exclude pregnant women, raising yet more concerns about how this research will replicate gender gaps that have hindered public health equity for years. Sign-on letters on both issues are in process.
  • Sharing experiences. The world needs a COVID-19 vaccine; activists and advocates can help make sure that speedy research is safe, ethical and inclusive by rapidly disseminating what’s working and what isn’t—because if the research process does not build community trust and confidence now, then future vaccine access will be severely jeopardized.

To help ensure these and other steps happen effectively and efficiently, AVAC, ITPC, TAG and other partners have established a global COVID Advocates Advisory Board (the CAAB), that seeks to connect advocates, build power and elevate core issues. If you’re interested in learning more, please email us at

More about the Moderna candidate

The Moderna candidate uses an mRNA platform. mRNA is “messenger” ribonucleic acid, a single strand of genetic material that contains instructions for a specific protein. The Moderna vaccine contains a synthetic mRNA sequence that teaches the body to produce a protein found on the outside of SARS-CoV-2. The instructions don’t teach the body how to make the whole virus; there is no chance that the vaccine itself will cause SARS-CoV-2. In smaller trials, people who received this candidate made antibodies against SARS-CoV-2 that blocked viral activity in test tubes. This trial will help evaluate whether the vaccine-induced immune responses do the same in humans. Scientists are enthusiastic about the promise of mRNA vaccines, as they would be relatively easy to manufacture quickly and in large numbers. However, there are no licensed mRNA vaccines as of yet.

In July, Moderna published Phase I data from 45 volunteers, split evenly between men and women, at sites in Seattle and Atlanta. The data showed that the vaccine was safe, though it caused side-effects (chills, fatigue, headaches, etc) in many volunteers, particularly at higher doses. The vaccine was shown to elicit neutralizing antibodies; after two doses volunteers had more neutralizing antibodies than most individuals who have recovered from COVID-19. It is important to note that the level and duration of antibodies required for protection is not yet known. Phase II trials are ongoing, but the data were sufficiently promising to warrant launching the Phase III trial, which will randomize volunteers to receive either a placebo or the vaccine. The trial will primarily be looking to see if the vaccine prevents symptomatic COVID-19 disease, but researchers are also interested to see if it prevents severe disease.

For a snapshot of the larger COVID-19 vaccine pipeline, check out this update done in collaboration with TAG, and stay tuned for details on upcoming webinars on this and other COVID-19 vaccine candidates in development.

Major Milestone for Women’s HIV Prevention: EMA recommends Dapivirine Vaginal Ring

AVAC welcomes today’s opinion from the European Medicines Agency (EMA) that recommends the Dapivirine Vaginal Ring as an additional HIV prevention option for cisgender women 18 and older. The EMA action moves a much-needed woman-initiated HIV prevention option one step closer to reaching women who need it. To help advocates understand this key development, AVAC has created a new ‘primer’ on the issue with everything advocates need to know about what’s happened and must happen next.

Read on for more information, links to new resources, next steps for advocates, and registration details for a webinar on Wednesday, July 29 at 10am EDT to discuss this welcome development.

Every day brings fresh news of the ways that the pandemics of HIV, COVID and gender-based violence are harming women and adolescents—along with many other groups. In this context of rising risk, giving women options to choose from is essential. This includes options for HIV prevention, contraception and overall health that work within their lives.

The EMA opinion came from its Human Medicines Committee, which reviewed the existing data under a mechanism that allows the EMA to provide regulatory views on products that are intended for use outside the European Union. The opinion states that the “Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV-1), in combination with safer sex practices when oral pre-exposure prophylaxis (PrEP) is not used, cannot be used or is not available.” It also calls for further safety and efficacy data to be collected in younger women, and for monitoring of women who acquire HIV while using the ring, to understand if drug resistance arises.

AVAC’s partners have been at the forefront, informing conversations about the Dapivirine Vaginal Ring trials and their results. As Manju Chatani-Gada, AVAC Director of Partnerships & Capacity Strengthening said in AVAC’s press release earlier today, “This is a long-awaited day for the thousands of women in Africa, Europe and the US, who participated in clinical trials of the ring and those of us who have advocated for access to the ring and other women-initiated prevention options for two decades. Women have been waiting for an HIV prevention option that they can use discreetly and easily, and for many the ring could be that product,” Click here to see more of the women-led, youth-centered activism on this issue to date.

Advocates, the International Partnership for Microbicides (IPM) which developed the ring, implementers, policy makers and other stakeholders are gearing up for the next stage in securing access to this product. The ring is the first biomedical strategy designed expressly for reducing risk through receptive vaginal sex to receive a positive regulatory opinion since the female condom in 1993.

Join us for a webinar on Wednesday, July 29 at 10am EDT to hear about next steps on the regulatory process and implications for rollout from advocates, IPM and the WHO.

And use these resources to deepen your knowledge of the ring, its implications for cisgender women’s HIV prevention, and the essential next steps to translate positive research and regulatory opinion into impact:

As public health indicators continue to show unacceptably high rates of HIV among adolescent girls and young women, this positive regulatory opinion is a source of hope and a call to action. Now is the time for accelerated work on evidence-based implementation, funding and the political commitment needed to both scale up a choice-based platform of HIV prevention that includes the ring, oral PrEP and the female condom.

Join us in the work ahead, watch for webinars, calls, podcasts and more.

COVID Action Alert: Advocates speak out on human challenge trials

Welcome to the first in a periodic series of “COVID Action Alerts” from AVAC—these alerts are for HIV advocates whose expertise, interests, skills and voices are needed to influence and expedite an ethical, equitable and effective COVID-19 pandemic response. To start, we highlight emergent vaccine trial design issues, and the need to learn from history and apply best practices as the search for a COVID-19 vaccine proceeds with unprecedented speed. This week, a team at Oxford University announced safety data from a Phase I/II trial of its chimp adenovirus candidate that’s also in efficacy trials; next week Moderna is scheduled to begin enrolling 30,000 volunteers in a trial of its mRNA vaccine candidate.

Speed is essential, but not at the expense of cutting corners with ethics, safety, equity, access, peer review, and active, authentic engagement. And HIV vaccine advocates have a critical role to play in guiding the conversation.

One issue we are tracking is the ethics of and community perspectives on “human challenge experiments”. Click here to read and consider a sign-on statement on this issue, co-authored by AVAC and TAG, and read on for more information.

The Oxford University team just released safety data from an ongoing Phase I/II trial of a COVID-19 vaccine candidate. The trial found that the vaccine candidate, which is already in Phase II/III trials in Brazil, South Africa and the UK, was generally safe and that it induced both cellular and humoral immune responses. This trial team is one of many working to find an effective vaccine with all possible speed, and this vaccine candidate is one that is being considered for large-scale, randomized, controlled efficacy trials in the new NIH-funded COVID Prevention Trials Network (CoVPN). At the same time, one of the options the Oxford team is discussing is a human challenge trial—a proposed design that has received backing from more than a thousand scientists and researchers.

As background, challenge trials involve deliberate exposure to a pathogen in order to test vaccines. Typically, they involve pathogens for which treatments are available (malaria challenge studies are probably the best-known example).

AVAC feels that a human challenge with SARS-CoV-2 is not justified given the lack of effective treatments and the poorly understood potential consequences of infection, even in young people. Given the current state of the pandemic, which makes traditional, blinded, placebo-controlled efficacy trials quite feasible, it is not clear that challenge trials would speed the development of a safe and effective COVID-19 vaccine. In order to conduct a challenge study, the trialists would need to develop a stock of standardized virus—a process that could take months. Controlled human infection studies might contribute to vaccine development, but they will not automatically accelerate SARS-CoV-2 vaccine development timelines.

AVAC, TAG and its partners have spent more than two decades tracking trial design issues as they impact people at the epicenter of pandemics, who are also often neglected by the health systems that are supposed to serve them. AVAC and TAG issued a joint statement in May, when the idea of human challenge trials was first proposed in a WHO document, and further drafted guiding principles for choosing a challenge study design.

Now, AVAC and TAG have developed this sign-on statement to provide an expanding group of advocates and activists with a shared platform for articulating priorities and concerns. We hope you’ll add your name and/or organization.

The sign-on statement is just one part of our approach to ensuring HIV expertise and advocacy experience is brought to bear on this new pandemic. And the development of a challenge model, and the debates around them, should not delay the urgency of well-designed clinical trials and robust stakeholder engagement throughout the process.

Next week, a large efficacy trial of a vaccine candidate developed by Moderna (mRNA-1273) is scheduled to begin enrolling 30,000 volunteers in collaboration with the CoVPN. The CoVPN is also collaborating with AstraZeneca, Janssen, Novavax and Sanofi, each of which is expected to begin enrolling 30,000-person Phase III vaccine trials by the end of this year. Each of these trials uses a traditional design, not a human-challenge approach. Community engagement to ensure support for and access to the results of research are essential.

As such, AVAC, TAG and ITPC have launched a global COVID Advocates Advisory Board, which brings years of research engagement best practices to the context and considerations of COVID-19 research and development—-an area that evolves every day. And with the first of five 30,000-person efficacy trials beginning next week, we need a CAAB now, more than ever.

Are you in a community where trials are ongoing, or proposed? If you’d like additional information, background or advocacy support in learning more or gathering views, please let us know!

Statement on Human Challenge Studies for COVID-19 Vaccine Development

Click here to sign the statement.

Two recent developments have brought renewed publicity to proposals to conduct human challenge studies to test COVID-19 vaccine candidates: an open letter from the organization 1DaySooner and media reports that Adrian Hill’s Oxford University research group is planning a challenge study, taking advantage of the lack of regulatory oversight of human challenge experiments in the United Kingdom.

The open letter is addressed to Francis Collins, Director of the US National Institutes of Health, and signed by many eminent signatories including Nobel Laureates. It offers three short paragraphs that attempt to explain how challenge studies might accelerate the development of a vaccine for COVID-19, before entering into a much lengthier and more detailed discussion of how challenge studies should be executed.

This imbalance highlights the critical problem with proposals for human challenge experiments: the ethical justification for their conduct relies entirely on the premise that they would speed the development of a safe and effective COVID-19 vaccine. The evidence supporting this premise is thin to non-existent.

For good reason, regulatory agencies require safety data from large numbers of vaccine trial participants over a long period in order to consider licensure. The US Food and Drug Administration (FDA) guidance on COVID-19 vaccine development specifies thousands of participants followed for at least six months after receipt of all immunizations.

It is not clear if the 1DaySooner open letter is proposing challenge studies of this size—the logistics would be daunting, and it is extremely unlikely that they would significantly accelerate vaccine development given efficacy trials are already underway, with several more due to start soon. These large studies will provide data on safety and efficacy in the real world, where a licensed vaccine would be used. Challenge studies would occur in a controlled setting where it would be unknown whether the virus exposure was mimicking how transmission occurs in nature.

Adrian Hill is one of the signatories of the 1DaySooner open letter. Hill’s plans to conduct human challenge studies were disclosed in an article in the Guardian, which offers very little information what the justification might be, stating only:

“Hill said that the challenge trial, beginning either after or in parallel with the phase three trial, could provide complementary information about optimal dosing and administration of the vaccine, as well as being a way to test how long immunity to the virus endures after exposure or vaccination.”

These hypothetical suggestions of what a challenge trial “could” do are unconvincing. There are other—albeit possibly more expensive—ways to optimize dosing and administration and evaluate the duration of immunity.

As community-based organizations that work to promote scientific research literacy and broaden informed participation in clinical trials, we are concerned that proponents of human challenge studies fail to appreciate the potential to exacerbate mistrust of science. This mistrust is widespread and not necessarily irrational—there is a grim historical record of abuse in research, particularly of people of color. The apparent eagerness to embrace putting people at risk of death or other complications—both known and as yet unknown—from COVID-19 threatens to undermine the critical tenet that science now places the highest priority on the welfare of research participants.

Without sound, detailed evidentiary support for the claim that challenge studies will accelerate the development of a safe, effective, accessible vaccine, we strongly believe there is no ethical justification for human challenge experiments.

The one scenario that might alter the ethical equation is global declines in community spread of COVID-19 that would preclude the conduct of real-world vaccine efficacy trials. This scenario is alluded to in the 1DaySooner letter and explicitly considered in a recent paper from researchers involved in the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Vaccines Working Group. Two of our organizations—AVAC and TAG—have proposed Guiding Principles on the Ethical Conduct of SARS-CoV-2 Vaccine Challenge Studies that address this possible future context.

But much as we wish that this was currently an issue, the disastrous mismanagement of the response to the COVID-19 pandemic in the US and a number of other countries means that efficacy trials are going to be feasible for the foreseeable future. Promoting the ethical conduct of scientifically rigorous vaccine efficacy trials should, therefore, remain the priority.

Sign the statement.

New Advocates’ Primer on HPTN 083 and Webinar

At a time when access, health justice and equity are uppermost for us all, AVAC is pleased to offer a new advocates’ guide to long-acting injectable PrEP, a new prevention strategy that’s shown benefit in some populations and generated a lot of buzz recently.

Want to know what’s known and unknown, who should do what, and what you can do? Click here to read Understanding the Results of HPTN 083.

We’ve also created a webpage of resources for advocates seeking to learn more—click thru to listen to conversations with HPTN 083 and 084 researchers at the AIDS 2020 Research Literacy Networking Zone, learn more about the history of these trials of long-acting cabotegravir (CAB-LA), and more.

Also, save the date for a webinar, this Thursday, July 16, hosted by the HPTN where you can hear the primary results of HPTN 083 and ask all your burning questions! The call is at 10:30am EDT (visit for your local time zone) and dial-in information is here.

In the coming months, we will be convening with prevention research advocates to talk about critical next steps—for CAB-LA and for prevention generally. At AVAC, we will be working to ensure that development and introduction of new PrEP strategies expands equitable access to existing daily oral PrEP, with multi-month prescriptions and self-testing where feasible, to support continued use in COVID-19 contexts. We need your help to advance primary prevention and research agendas that leave no one behind. Join us!

Injectable PrEP is Highly Effective for Some Populations and Must Move Forward as Quickly as Possible

AVAC calls for intensified efforts to increase access to daily oral PrEP

AVAC welcomes new, additional data that shows an injectable antiretroviral for HIV pre-exposure prophylaxis (PrEP) is safe and highly effective in reducing HIV risk cisgender men and transgender women who have sex with men. At the 23rd International AIDS Conference today researchers from the HIV Prevention Trials Network (HPTN) released data comparing rates of HIV among trial participants who received the bi-monthly injection, and those who received daily oral tenofovir/emtricitabine (TDF/FTC). While both strategies reduced HIV risk among participants, the injectable strategy was more effective compared to oral PrEP.

The overall number of infections in both arms of the study was very low, underscoring the high efficacy of both interventions. Importantly, daily oral PrEP is licensed and available now for men, women and adolescents in many communities around the world.

“It’s great to see such a high level of efficacy in a potential additional HIV prevention option and to see the high level of efficacy for an already available option, daily oral PrEP,” said Mitchell Warren, AVAC Executive Director. “As we celebrate this exciting new data, we also must ensure that the companion HPTN 084 study of the same product in cisgender women finishes as quickly as possible and simultaneously work to ensure broader access and support for daily oral PrEP in communities where it is needed now.”

These data add insight to the May 2020 announcement from HPTN 083 that injectable PrEP was highly-effective. Importantly, investigators shared data on adherence among participants taking oral PrEP and found that 76 percent of a random sample had blood levels consistent with daily use. While additional work to understand the results is ongoing, this suggests that the difference in impact might be due to the products. Use of the injection requires an oral “lead-in” phase, and 48 weeks of oral PrEP use after discontinuation. Learning more about preferences and feasibility of both injectable and oral PrEP among people at risk of HIV is a critical next step.

“We need options that will work in people’s lives, we need existing daily PrEP delivered at scale now, and we need multiple additional PrEP options to address diverse needs. CAB-LA, the dapivirine vaginal ring, and future products that show efficacy must be brought to market as quickly as possible,” added Warren.

Given that current data show efficacy in men who have sex with men and transgender women, but not in cisgender women, where rates in adolescent girls and young women are persistently high, messages, licensure and introduction plans need to be swift, clear and strategic with respect to the growing array of PrEP options available for different groups. ViiV, the manufacturer of CAB-LA, must now move quickly to work with regulatory agencies, to share, for community review and input, its plans for seeking review and the timeline for incorporating data from the ongoing HPTN 084 study, while WHO must simultaneously launch a parallel consultative process to support guidance for CAB-LA, so there will be no delay in rolling the drug out.

In 2018, AVAC and the Clinton Health Access Initiative (CHAI) established the Biomedical Prevention Implementation Collaborative (BioPIC) to work with a wide range of stakeholders to develop an introduction plan for long-acting injectables and other next-generation HIV prevention options. Today’s announcement makes planning all the more important if promising research results are to be translated into public health impact.

“Planning for health systems to meet future demands for a drug delivered by injection every two months must also be prioritized,” said Jessica Rodrigues, AVAC’s Director of Product Introduction and Access. “Daily oral PrEP was proven effective more than a decade ago, yet people who want and need this vital prevention option are still unable to access it in many communities. We must not repeat that cycle with new prevention options like CAB-LA and the monthly dapivirine vaginal ring for women, which is currently under regulatory review.”

These clinical trials are an important step in the process, but much additional work is needed. Every product has unique attributes and challenges, and there is much more to be understood about CAB-LA and the way in which it might be effectively delivered in communities and among populations where it is most needed. The HPTN 083 team is still analyzing the safety data on the oral lead-in period as well as the potential need for oral PrEP to “cover the tail” of participants who wish to stop receiving CAB-LA. The research to date suggests that stopping CAB-LA and clearing the drug from the body may not be as easy as stopping daily oral PrEP, since traces of CAB-LA can linger in the body well after discontinuing injections. It will be essential to understand how this can be addressed outside of a clinical trial setting.

“Understanding the potential risk of drug resistance, user preferences, health system capacity needs, the price of the product and the programs to deliver it and support use, amongst other issues, are necessary to move forward as quickly as possible if the product is ultimately approved for use,” said Rodrigues. “AVAC and our partners have already begun this work and have valuable insights; it now needs to accelerate with global collaboration so that the delays that have slowed the rollout of daily oral PrEP do not recur again.”

Also at AIDS 2020, the SEARCH study presented additional information on the impact of oral PrEP in the context of a comprehensive “health-fair” based approach. SEARCH previously found that this approach, which provided ‘universal testing’ and same-day antiretroviral treatment, reduced incidence by about 30 percent. In the latest data, the SEARCH team found that once daily-oral PrEP was offered to SEARCH participants, new HIV infections dropped by about 75 percent, compared to the period when PrEP was not yet available. This underscores the feasibility and urgency of making oral PrEP a part of comprehensive programs, anchored in a universal testing approach.

“The UNAIDS report and much of the news at this conference is reminding us that the world was failing at HIV prevention before the COVID-19 pandemic hit. SEARCH shows us the possibilities for PrEP success in some of the hardest hit communities in East Africa,” Warren said. “It’s critical that we find ways to scale up innovative daily oral PrEP programs even as we plan for access to new HIV prevention options. We can’t afford any more delays.”

The View from AIDS 2020 Virtual – AVAC’s Take

There has never been an AIDS conference like the one currently underway this week—AIDS 2020 Virtual. As a global collective of people concerned with HIV, we also check the daily updates on COVID-19. Both demand real, urgent solutions. Here is AVAC’s take from the early sessions of AIDS 2020 Virtual and the actions that can make a difference right now, and in the future.

As the world works to make sense of the news from AIDS 2020 news, advocates, activists, scientists and global leaders must ensure that COVID-19 doesn’t further exacerbate or distract from the primary prevention crisis in HIV.

UNAIDS’ annual update, released yesterday, shows no change in the global total of new HIV infections. There were roughly 1.7 million infections last year. Five years ago, UNAIDS’ Fast-Track campaign set global sights on slashing rates of infections to 500,000 per year worldwide. At that time, there were roughly 2 million infections per year. Instead of meeting the goal, the world has made marginal progress—a reality that’s been clear for some time. While there are pockets of progress, the picture—even before COVID-19—is one of crisis and unfinished business.

To effect immediate change, AVAC calls for the following five actions:

1. UNAIDS and WHO must lead the call for a “Pandemic Policy-Change Agenda” in which law- and policy makers remove policies that criminalize sex work, drug use, same-sex behavior and HIV status. These policies are barriers to HIV prevention and to accessing prevention and treatment for other pathogens, including COVID-19.

2. National AIDS programs—working with WHO, PEPFAR, GFATM and civil society—must develop and implement differentiated service delivery of oral PrEP, including multi-month scripting with provision of self-test kits at each refill, using the same supply points to offer male and female condoms and contraceptive refills. As just announced new data from the SEARCH study show, access to PrEP is a powerful tool to bring down incidence at the population level. For more on differentiated service delivery (DSD) and the advocacy to go with it, see the satellite session convened by AVAC, IAS and PATH: Bringing PrEP closer to home: Why is now the time for differentiated PrEP?, available on-demand at And read our recent blog entry on the topic.

3. UNAIDS must coordinate the funding and implementation of a rapid assessment of best practices to expand local community health cadres. Among these cadres, peer networks of people living with HIV are especially important to provide safe and local capacity to offer adherence support and to help connect people to food and income assistance and other social support in the context of concurrent pandemics. This rapid assessment should be used to drive funding to civil society and activist groups to implement strategies adapted for local contexts. At AIDS 2020, AVAC is proud to be presenting work from the COMPASS coalition, a vibrant locally grounded, transnational activist effort that provides a model for tying this type of data-driven work to action. (See a related poster to this work, Translational Activism for an Effective, Comprehensive HIV Response, at the On-Demand Poster Channel Track F.)

4. WHO, ViiV and other product developers, must work with regulatory agencies to advance a comprehensive, clearly articulated plan for acting on promising research findings. AIDS 2020 brought news that injectable cabotegravir is highly-effective in reducing HIV risk in men who have sex with men and transgender women. In the HPTN 083 study, participants who received the injection had significantly fewer infections compared to those who received daily oral PrEP—even though early analysis suggests relatively high rates of oral PrEP adherence. This is exciting and challenging news given that current data have yet to show efficacy in cisgender women, and rates of new HIV infections in adolescent girls and young women are persistently high. (A study in that population, HPTN 084, is underway.) Recently, the US FDA licensed F/TAF for people excluding those who have vaginal sex, prompting confusion and concern. It also spurred mobilization, led by cisgender women seeking clarity and equity in HIV prevention. At the same time, the EMA’s regulatory review of the dapivirine vaginal ring for HIV prevention is ongoing for this important prevention tool. For products that work in all bodies and all genders to reach the people who want and need them, the following must happen:

  • Product developers must work with communities to ensure that introduction plans developed for CAB-LA and the dapivirine ring are clear, comprehensive and contextualized—so that the knowns, unknowns and timelines are explicit for the growing array of PrEP options available for different groups.
  • ViiV, the manufacturer of CAB-LA, must move quickly to work with regulatory agencies. This work should be shared with community and reflect that input on plans for seeking review and developing a timeline for incorporating data from the ongoing HPTN 084 study of CAB-LA in cisgender women.
  • WHO must simultaneously launch a parallel consultative process to support guidance for CAB-LA and the dapivirine ring, so there will be no delay in rolling them out once regulatory review is completed.

5. Civil society engagement must be regarded with the same urgency as the research itself for COVID-19, HIV and more. Clinical trial results don’t translate into action without meaningful stakeholder engagement at every stage of a trial, including design, implementation, data analysis, and eventual access to new interventions. AVAC is working with numerous partners on the leading edge of engagement for COVID-19 research to apply the Good Participatory Practice Guidelines and establish a COVID Advocates Advisory Board for these critical times. It is essential for civil society and national governments to have the funding and the space—virtual or otherwise— to make this vital work a success.

In the coming days, AVAC will be bringing more updates on AIDS 2020 news and its relationship to these core recommendations. In the coming months and years, we will be working with advocates worldwide to ensure that the critical issues raised in this moment of “virtual” convening and “paused” activities translate into real and dynamic change.

US Withdrawal from WHO is Reckless Act that Could Delay Americans’ Access to COVID-19 Solutions and Prolong Global Pandemic

AVAC, Health GAP and the Treatment Action Group (TAG) strongly condemn the Trump Administration’s withdrawal from the World Health Organization (WHO). Today’s announcement formalizing the President’s threats from earlier this year is short-sighted and dangerous, and will cost more lives and deepen economic devastation in the United States and around the world, which are already reeling from the ongoing COVID-19 pandemic.

“This virus respects no borders; COVID-19 anywhere can quickly become COVID-19 everywhere. Global health emergencies require global leadership, and that requires a strong and supported World Health Organization,” said Mitchell Warren, AVAC’s Executive Director. “The Administration is playing politics with people’s lives here in the US and around the world. We will be left behind as the world comes together to collaborate and coordinate science as the best strategy to counter the pandemic, and we will lose ground in our historical investments to end HIV, TB, hepatitis C and other health issues.”

The COVID-19 pandemic has brought unprecedented global cooperation among researchers and funders, with WHO playing a critical role in coordinating both the overall global response and many of the global research initiatives. Global cooperation on public health policy, science, data and information sharing is needed more urgently than ever before. The Trump administration makes a dangerous gamble in thinking that the US can act alone in the response to COVID-19.

“We are seeing the disastrous effects of the US federal government’s lack of strategy playing out every day in increased COVID cases and deaths of Americans, particularly in the Black community,” says Suraj Madoori, TAG’s US and Global Health Policy Director. “Withdrawal from WHO will only compound the issues for our nation and for the world by further retreating on shared responsibilities in public health governance.”

The COVID-19 epidemic is devastating already constrained health systems in low- and middle-income countries where COVID-19 is surging, and has further weakened the US healthcare system as well. At the same time, this new pandemic is already having profound implications on responses to HIV/AIDS, TB, viral hepatitis, malaria, vaccination and contraceptive programs and all other public health responses.

WHO plays a key role in coordination, guidance development and mobilization of these public health responses in countries struggling with COVID-19 in addition to limited resources, conflict and other humanitarian and ecological disaster-related crises. As governments and stakeholders position resources against COVID-19, the WHO has taken the lead in forming the Access to COVID-19 Tools (ACT) Accelerator, a new and needed global collaboration to accelerate development, production and equitable access to COVID-19 tests, treatments and vaccines.

The US, as a historic leader and funder of global public health initiatives, and the largest funder of WHO, has a moral responsibility to help ensure an equitable global response to the COVID-19 pandemic. Terminating the US relationship with WHO starves the organization of funding, US staff and US expertise. It likely prolongs the pandemic and will force WHO to cut critical funding and support for other health programs, including those responding to HIV/AIDS, TB, viral hepatitis, and sexual and reproductive health.

“The Trump administration is shameless in its extreme nationalism at the expense of people’s lives. The WHO performs a vital role in getting new HIV treatments to people around the world safely and quickly and providing key technical assistance to strengthen health systems in vulnerable countries. Trump pulling the US out of the WHO is yet another demonstration of his disregard for people living with HIV around the world,” said Matthew Rose, Director of US Policy and Advocacy for Health GAP.

AVAC, Health GAP and TAG call for the Trump Administration to immediately reverse this disastrous decision, restore and protect funding to WHO and work to ensure global cooperation in the pandemic response.

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