Join Us This Week for Important Conversations

Three important conversations are happening this week: in HIV cure research, in COVID vaccines and in Good Participatory Practice (GPP). These discussions help set agendas and direct resources, so please consider joining one or all of them. We’ve also included links to important news and publications.

Breaking Down the Latest in HIV Cure Research
Tuesday, 5 April at 11am ET/5pm SAST
At CROI 2022, a number of exciting updates on HIV cure research were announced, including the most recent case of HIV remission after a stem cell transplant. Join a conversation with researchers as they break down the recent case of HIV cure, which is the first such cure in a woman. Speakers will also provide updates from an ongoing trial studying pediatric remission. Join to learn what these advances mean for science and for people living with HIV. Register here.

COVID-19 GPP Resources
Wednesday, 6 April at 9am ET/3pm SAST
While there are some resources that address stakeholder engagement in COVID-19 research, they may not adequately reflect the needs of advocates. Join AVAC and partners for a conversation to discuss advocates’ needs and shape the development of future resources. Register here.

New COVID-19 Vaccines Trials in Sub-Saharan Africa
Wednesday, 6 April at 10am ET/4pm SAST
Join us for a special webinar on the Ubuntu trial, hosted by the COVID Advocates Advisory Board (CAAB) and our Coalition to Accelerate and Support Prevention Research (CASPR). Led by the COVID-19 Prevention Network (CoVPN), Ubuntu is a new, landmark COVID-19 vaccine trial in sub-Saharan Africa investigating the efficacy of mRNA vaccines in people living with HIV against the omicron variant. Register here.

Must Reads

Now Open Access: Stakeholder Engagement Must Overcome Tokenism and More
The ethics review process is a crucial opportunity for stakeholder engagement. A new article by AVACer Jessica Salzwedel, CASPR partner Cathy Slack and other co-authors appears in the Journal of Empirical Research on Human Research Ethics and explores three themes that can make or break effective engagement: “It’s Almost as if Stakeholder Engagement is the Annoying ‘Have-to-do’…”: Can Ethics Review Help Address the “3 Ts” of Tokenism, Toxicity, and Tailoring in Stakeholder Engagement?

Possibility of Voluntary Licensing for Injectable Cabotegravir for PrEP
Over the past month AVAC has worked with a wide range of advocates calling for faster and more strategic introduction of injectable PrEP, and several public statements were released. Read statements from a leading group of Southern African Women Advocates and two from AfroCAB: Communities demand ViiV/GSK accelerate access to CAB-LA in LMICs and ViiV continues to not meet our demands to ensure CAB-LA is accessible for our communities. Then today, Viiv Healthcare, the maker of injectable cabotegravir, announced that it is working with the Medicines Patent Pool (MPP) to outline a path forward for voluntary licensing of their product. ViiV said this path will include “an assessment of future demand and necessary manufacturing capacity and capability as well as upstream requirements for potential generic manufacturing partners.” Stay tuned for our updated call to action and roadmap to ensure injectable PrEP and the dapivirine vaginal ring get introduced faster and more strategically.

Reading, Resources and Webinars

At AVAC, we are seeing remarkable new developments and opportunities to engage in HIV and COVID research, development and advocacy. Here is a round-up of what’s been happening, essential reading and resources to help in your advocacy efforts, and some upcoming webinars to join.

In PrEP

Dapivirine Vaginal Ring Approved in South Africa

The South African Health Products Regulatory Authority (SAHPRA) approved the monthly dapivirine vaginal ring for use by women to reduce their HIV risk. South Africa joins Zimbabwe as the first countries to announce approval of the ring, which is already recommended by the World Health Organization as an additional prevention option. The ring’s developer, the International Partnership for Microbicides, has also submitted additional applications for review by several other Eastern and Southern African countries, and advocates are actively engaged in making the ring accessible, including the fabulous new EmpoweRing campaign from our colleagues at ICWEA. AVAC’s Nandi Luthuli told Herald Live, “we know that the most effective intervention is the one someone picks for themselves among an array of effective choices.”

Updates on Injectable Cabotegravir for PrEP

Following US FDA approval of injectable cabotegravir for PrEP in December, there has been a cascade of activities—and a huge need for advocacy! Multiple additional regulatory agencies are reviewing the application; WHO convened their Guidelines Review Group meeting earlier this month, and guidelines are expected mid-year; and Unitaid announced funding for the first two implementation science projects to introduce injectable PrEP, in Brazil and South Africa. A key lesson from oral PrEP over the past decade has been the essential role of civil society; and advocates released a number of important statements—AfroCAB released two sign-on statements: Communities demand ViiV/GSK accelerate access to CAB-LA in LMICs and ViiV continues to not meet our demands to ensure CAB-LA is accessible for our communities, and a leading group Southern African women’s health advocates released a statement by Southern African Women Advocates in Advance of ViiV Convening. Stay tuned for our updated call to action and roadmap to ensure injectable PrEP and the ring get introduced faster and more strategically.

In Vaccines

New HIV Vaccine Study Using mRNA Platform Launched

The NIH also announced a new study to test three mRNA-based HIV vaccine candidates. This study follows an announcement in January from IAVI about another mRNA-based HIV vaccine study. AVAC is preparing a suite of materials on the latest in HIV vaccine research, development and advocacy for HIV Vaccine Awareness Day in May, so stay tuned. In the meantime, check out this snapshot that compares the two studies.

In COVID

New Resources for Journalists

The COVID-19 pandemic spawned an infodemic inside the onslaught of COVID-related information. Journalists struggle to identify reliable information in the everchanging pandemic landscape. With support from the Rockefeller Foundation, AVAC is expanding our partnership with Internews and our Media Cafe program conveners to support journalists covering HIV prevention science to include reporting on COVID. Check out the curated resources to help journalists find high-quality, understandable information.

WEBINAR: COVID-19 GPP Resources, 6 April at 9am ET/3pm SAST

While there are some resources that address stakeholder engagement in COVID-19 research, they may not adequately reflect the needs of advocates. Join AVAC and partners for a conversation to discuss advocates’ needs and shape the development of future resources. Register here.

WEBINAR: New COVID-19 Vaccines Trials in Sub-Saharan Africa, 6 April at 1oam ET/4pm SAST

Join us for a special webinar on the Ubuntu trial, hosted by the COVID Advocates Advisory Board (CAAB) and our Coalition to Accelerate and Support Prevention Research (CASPR). Led by the COVID-19 Prevention Network (CoVPN), Ubuntu is a new, landmark COVID-19 vaccine trial in sub-Saharan Africa investigating the efficacy of mRNA vaccines in people living with HIV against the omicron variant. Register here.

In Cure

WEBINAR: Breaking Down the Latest in HIV Cure Research, 5 April at 11am ET/5pm SAST

At CROI 2022, a number of exciting updates on HIV cure research were announced, including the most recent case of HIV remission after a stem cell transplant. Join a conversation with researchers as they break down the recent case of HIV cure, which is the first such cure in a woman. Speakers will also provide updates from an ongoing trial studying pediatric remission. Join to learn what these advances mean for science and for people living with HIV. Register here.

In Integration of Sexual Reproductive Health and HIV

WEBINAR: Consultation on the Dual Prevention Pill, 12 April at 8:30am ET/2:30pm SAST
Join FP2030 and AVAC for a conversation about The Dual Prevention Pill (DPP), a daily oral pill that is currently being developed for the simultaneous prevention of unintended pregnancy and HIV acquisition. This consultative webinar will highlight unique perspectives from stakeholder in the fields of family planning and sexual & reproductive health. Register here.

Just Published: Catalyzing action on HIV/SRH integration: lessons from Kenya, Malawi, and Zimbabwe to spur investment

We’re excited to announce this new publication – Catalyzing action on HIV/SRH integration: lessons from Kenya, Malawi, and Zimbabwe to spur investment – in the Global Health Action journal. This publication builds on the partnership between our HIV Prevention Market Manager project, ministry of health officials in Kenya, Malawi and Zimbabwe, and Georgetown University’s Center for Innovation in Global Health, and is a call to catalyze actions by development partners in support of national strategies to integrate HIV and SRH information and services.

We hope these resources offer you the context and tools you need to use your passion and add your voice to the work ahead.

Essential Reading and Resources

AVAC and our partners have been busy the first couple of months of 2022. Here is a round-up of essential reading and new and updated resources including HIV treatment studies, PrEP, stakeholder engagement, research fundamentals and more.

Highlights From CROI

Our coverage of week one at CROI featured updates on data related to the Dapivirine Vaginal Ring, injectable cabotegravir (CAB) as PrEP, vaccine science and cure research. And our week two summary looked at symposia that explored how to reach key populations, the critical role of choice in effective HIV prevention, and the status of research on preventing sexually transmitted infections (STIs).

HIV Treatment Studies During COVID-19

A February commentary in JIAS, coauthored by AVACer Maureen Luba with a host of other experts on the topic, offered recommendations for the ethical continuation of treatment research among people living with HIV in the context of COVID-19: Mitigation strategies to safely conduct HIV treatment research in the context of COVID-19.

Transgender Voices: Call to action

The Lancet’s February publication included a public letter from leading voices in the transgender community working in HIV research and public health. Titled, Research on transgender people must benefit transgender people, it called out exploitation in academic research and “called in” researchers to pursue priorities that offer direct benefit to transgender communities and to rely on resources such as No Data No More: Manifesto to Align HIV Prevention Research with Trans and Gender Diverse Realities.

Stakeholder Engagement Must Overcome Tokenism and More

The ethics review process is a critical opportunity for stakeholder engagement. AVACer Jessica Salzwedel, CASPR partner Cathy Slack and other co-authors explore three themes that can make or break effective engagement in a new article in the Journal of Empirical Research on Human Research Ethics: “It’s Almost as if Stakeholder Engagement is the Annoying ‘Have-to-do’…”: Can Ethics Review Help Address the “3 Ts” of Tokenism, Toxicity, and Tailoring in Stakeholder Engagement?

South Africa Is Talking About Injectable CAB As PrEP and Getting Rollout Right

Leading South African publication on public interest health journalism, Spotlight, reported on the excitement among advocates – and the need to plan now – to add injectable CAB as PrEP to the HIV prevention options currently available. Check out two new stories: Start planning HIV prevention injection rollout, experts say and Prioritise HIV prevention injection, activists say.

Many Angles On PrEP And Resources For Advocacy

For context on injectable CAB as PrEP, resources to support the rollout of the ring, and a look at the research and development pipeline of next generation PrEP, check out PrEP and more PrEP: An update and important resources.

Research Fundamentals

What is an endpoint in clinical research and why does it matter? POZ magazine’s February issue featured a transcript of AVAC’s Px Pulse podcast on this question. Hear the original nine-minute podcast here. And you can find the Px Pulse archive here.

We hope these resources offer you the context and tools you need to use your passion and add your voice to the work ahead.

Virtual CROI 2022 Roundup for Advocates: It’s all about choice

Welcome to Virtual CROI week two!

Here’s a roundup of the exciting science heard last week across the spectrum of HIV prevention, and on cure research (more on this further down) with a groundbreaking new case of HIV remission. We also want to be sure you are all aware of the CROI Margarita Breakfast Club dialogues—both last week and this week. Superb discussions last week and three more this week are not to be missed—recordings from last week’s conversations and registrations for this week are here.

The overarching message coming from CROI last week was clear: no one biomedical strategy will do the job, the world needs multiple options and real choices. In this round up, the importance of choice leads our coverage. (And listen to Carlos del Rio from Emory University put it all in context in a terrific US National Public Radio interview here.)

Choice and the Ring

New data from the REACH study, which incorporated informed choice into its design, made this point unmistakable. Almost all (98 percent) of the 247 adolescent girls and young women in this study where both daily oral PrEP and the Dapivirine Vaginal Ring were offered, chose one of the products over none at all. All participants tried each product for 6 months, followed by 6 months where they could choose their preferred method. Kenneth Ngure, presenting on the REACH Study, said about ⅔ of the participants chose the ring. But most of the women who had very high adherence to the daily oral pill preferred the daily pills to the ring. Ngure said overall adherence in the REACH trial surpassed levels seen in previous studies. More findings on factors driving adherence is under analysis. “REACH is just a small example of what the potential impact could be in the real world of HIV prevention, simply by allowing young women and girls the ability to choose,” said Ngure.

Choice and Injectable PrEP

HPTN 083, evaluating injectable cabotegravir as PrEP among gay men, transgender women and other men who have sex with men (MSM), presented updated data that evaluated new infections that have occurred since the trial unblinded in May 2020. Raphy Landovitz, from UCLA and HPTN 083 protocol chair, reported that adherence went down during this phase of the trial, but break-through infections among those receiving on-time injections remained rare. (He reported a total of 7 such cases in the life of the study that covers 4,660-person years.) The data continue to confirm both the safety and efficacy of cabotegravir for PrEP. Reflecting on the significance of the drop in adherence to both daily oral PrEP and injectable cabotegravir during the unblinded phase, Landovitz said complex barriers to adherence make it clear that “no one biomedical prevention option will address all issues in HIV prevention”.

Additional data from Susan Eshleman of John Hopkins University School of Medicine and the HPTN 083 team deepened the discussion on effective and feasible testing. Detecting HIV is a crucial part of prevention strategies that rely on antiretrovirals (ARVs). Exposure to a single ARV, which is the protocol for PrEP (in contrast to combination ARV used in treatment), can lead to resistant HIV. Eshleman reported on data showing that using a highly sensitive RNA-based HIV test to confirm a person is HIV negative could reduce the risk of someone with undetected HIV developing resistance to first line treatment. But she said access to these tests should not limit access to this highly effective intervention, “In the context of proven high efficacy, CAB-LA should be considered for HIV PrEP in settings where HIV RNA screening is not readily available.”

Choice and Vaccines

IAVI’s Mark Feinberg summarized the state of vaccine science. One the one hand, two recent large-scale trials showed no efficacy (Uhambo and Imbokodo). On the other hand, Feinberg said cutting edge approaches offer “a strong and vibrant source of promise” for HIV vaccine development, particularly the development of broadly neutralizing antibodies (bNAbs). Looking ahead, Feinberg predicted the next major priority to make a large-scale trial a possibility will be validating a “correlate of protection”, a mark or sign in the immune system that can be linked to preventing HIV acquisition.

As this research evolves, the need for many options that deliver real choices remains clear. In a later session on immune responses, South Africa Medical Research Council and HVTN leader Glenda Gray said the high rate of HIV in hard-hit places (as high as 4 percent) will mean effective prevention may well require a combination of strategies. “We will likely need a combination of PrEP with vaccines to combat high rates—4 percent incidence rate is just too much for a vaccine alone to overcome.”

Another Step in the Journey Toward a Cure

A fourth person was reported to achieve HIV remission, the first case among women, according to data from Yvonne Bryson from the David Geffen School of Medicine at University of California. The New York woman has no detectable HIV since she stopped treatment 14 months ago. Her treatment interruption followed a stem cell transplant from a donor with an HIV resistant mutation. As in the other three cases, the stem cell transplant was an urgent intervention to treat advanced cancer. This stem cell transplant pioneered an innovation where a family donor provided stem cells in combination with stem cells from umbilical cord blood that had the needed mutation. One possible implication for cure research is confirmation of the role of a critical receptor on white blood cells known as CCR5. HIV relies on CCR5 to enter and infect the cells. Mutations to CCR5 have once again led to a case of remission, and two of these cases have endured long enough to be confirmed as a cure. Want to learn more? One of last week’s Margarita Breakfast Club discussion was River Deep, Mountain High: Pathways Toward a Cure for HIV, with a wonderful discussion about these findings.

There’s more CROI coverage coming and please continue to follow along with us this week, www.avac.org/croi-2022, and check out great summaries from our friends at aidsmap.

CUREiculum 2.0

The CUREiculum strengthens community capacity to understand and engage in discussions about HIV cure-related research by providing basic information on a variety of topics in meaningful and accessible language, so that it is understandable to a wide variety of audiences and learning styles. The tools are designed for community educators, funders, media and other stakeholders interested in learning more about HIV cure-related research.

Visit https://www.treatmentactiongroup.org/cure/cureiculum-2-0/

Global Investment in HIV Cure Research and Development in 2020

In 2014, the HIV Vaccines and Microbicides Resource Tracking Working Group and AVAC began a collaboration with the International AIDS Society’s (IAS) Towards an HIV Cure initiative. AVAC, Treatment Action Group (TAG) and the IAS brought together a group to review and allocate grants towards HIV cure research and analyze data on global funding. The working group released a report in July 2021, Global Investment in HIV Cure Research and Development in 2020.

Investment and Engagement in HIV Cure Research: Looking Ahead

Join us on Wednesday, October 27th at 10am ET-11am ET| 5pm-6pm EAT, for a webinar to discuss the state of global HIV cure investment and how Martin Delaney Collaboratory (MDC) is making investments in cure research and working with communities. The webinar will feature the growing investment in both the science and stakeholder engagement of HIV cure and include an overview of the HIV cure research funding landscape, a history of the MDC program and a panel discussion. Register here.

New Resources and Opportunities!

In this round-up you’ll find opportunities to register for a webinar on cure research and preview a new course on GPP. In case you missed them, scroll down for resources that cover a spectrum of issues crucial to the progress of HIV prevention today. We hope you’ll watch, read, learn and join the conversation!

Coming up

  • Starting soon! Register for a free live session previewing AVAC’s newest GPP course for funders, sponsors and principal investigators at the Union World Conference on Lung Health, today, October 20, 12:00-12:45pm EDT. Don’t miss the live Q&A with the developers of The GPP Compliance Course from 12:30-12:45pm EDT!
  • Wondering about funding for HIV cure research and how communities can engage on the issue? Register for the webinar, Investment and Engagement in HIV Cure Research: Looking Ahead on Wednesday October 27, 2021 at 10am EDT.

Integrated Products, Integrated Services

Pushing the Frontier of R&D

Many Angles on the Ring

Research Literacy Zone Roundup

Alongside last week’s IAS 2021 Conference, AVAC and partners hosted a range of dynamic sessions in the virtual Research Literacy Zone, where researchers and advocates explored timely topics including: Dapivirine Vaginal Ring rollout, advances in vaccine and cure research, U=U, new approaches to understanding social factors that impact health, vaccine hesitancy and more. The Zone is a gathering place for researchers and community advocates to dive deep on critical topics in a small-scale environment.

All Zone sessions are available on our Research Literacy Zone page and on ENGAGE, AVAC’s online platform for peer-to-peer resource-sharing and collaborative learning. Register for your free account today, join the conversation, and access all that ENGAGE has to offer.

Also, the Zone isn’t just for conferences! AVAC hosts virtual events and conversations throughout the year (including an August 11 rectal microbicides webinar with AFC!). Have a topic idea for a future session? Drop us a note!

RESEARCH LITERACY ZONE @ IAS 2021

HIV Cure Research in Africa: Challenges and opportunities included a panel of researchers and advocates exploring some of the challenges and opportunities of HIV cure research on the African continent, strategies that are currently being pursued, and the science of the cases of HIV cure reported in the news. Listen to the recording.

Pushing U=U Jigsaw Puzzle into the HIV Prevention Agenda focused on efforts to use the science of U=U to promote HIV treatment uptake, enhance adherence and eliminate stigma and discrimination, so that PLWHIV can live longer and have healthy relationships while protecting their partners from contracting HIV. Listen to the recording.

Models, Maps and Measures: What advocates need to know about new strategies assessing social determinants focused on how to assess the social determinants of HIV and a special NIH-funded initiative on the issue. The expanding pipeline for HIV prevention was one of the driving factors motivating the NIH to fund an initiative examining new ways of measuring social determinants.. The discussion focused on two new strategies: using models to determine what factors enhance the effectiveness of cash transfers in adolescent girls and young women in South Africa, and the use of GPS tracking to determine barriers to PrEP access in young MSM in NYC. Listen to the recording.

A Conversation with Advocates on Vaccine Hesitancy provided attendees a space to reflect on the urgent need for vaccine equity and potential vaccine hesitancy. Panel members discussed why some individuals are hesitant in their communities. The discussion also focused on solutions, with panel members and participants sharing what has worked in their contexts and resources they are developing to engage communities in the discussion now. Listen to the recording.

Inclusion of Pregnant and Breastfeeding Women in HIV Prevention Research: What can you and I do to move this agenda forward centered on the importance of including pregnant and breastfeeding women in HIV prevention trials. The discussion outlined barriers to participation and implementation and focused on steps to move the field forward. Listen to the recording.

Ring Roundup covered updates in the research program and rollout plans for the Dapivirine Vaginal Ring (DVR). Attendees learned about IPM’s DVR research program and the early-phase research pursuing a longer-acting formula and dual prevention (HIV and pregnancy). Discussion also focused on the current regulatory approval process of the ring as a prevention option for women and the steps advocates can take to secure national approvals. Listen to the recording.

Stay tuned for our full roundup of IAS conference news later this week, and remember, check out ENGAGE for future events and conversations, and let us know if you have an idea to share!

Dec 8 Webinar and Resources: Paving the way for an HIV cure

On Tuesday, December 8 at 11am ET, the International AIDS Society’s Towards an HIV Cure initiative is hosting a webinar, Paving the way for an HIV cure: Introducing Target Product Profiles (TPP) and the HIV Cure Africa Acceleration Partnership (HCAAP), to unpack two new articles just published in The Lancet HIV.

REGISTER HERE.

The articles argue why now is the time to focus on advancing HIV cure research. Outputs of a 2019 meeting of global stakeholders, these articles—The case for an HIV cure and how to get there and Multi Stakeholder Consensus on a Target Product Profile for an HIV Cure—make the case for the role an HIV cure can play in ending the epidemic, and share a roadmap to get there, including the role of community advocates.

As described in the articles and to be discussed on next week’s webinar, there is a need now for community advocates to provide input on acceptability of potential cure interventions, help to shape the policy environment, and enhance the capacity needed for cure trials, such as robust HIV and viral load testing. To that end, the proposed HCAAP plans to coordinate key stakeholders (e.g., regulators, funders, civil society, Ministries Of Health, researchers, etc.) across the public and private sectors to drive the development of a community-led cure research agenda and speed up access to a potential strategy in the future.

The companion article describes how multiple stakeholders came together to develop a TPP for an HIV cure strategy in Africa. A TPP is a living document that sets goal posts for what an ideal and acceptable product might look like for a specific population, which gives researchers, product developers, policy makers and advocates a roadmap to develop a strategy that can be delivered right away.

Register here to join!

We hope you will join next week’s conversation and happy reading!