Apr 2 Webinar—Pandemic Vaccine Development and Lessons for COVID-19

[UPDATED: Recording now available.]

Please join an upcoming webinar on pandemic vaccine development, scheduled for Thursday, April 2, 10am EDT.

In the second installment of AVAC’s webinar series on COVID-19 and its relationship to HIV, Dr. Mark Feinberg, CEO of IAVI, shared experiences and lessons from Ebola and HIV vaccine development that might be applied to COVID-19 vaccine development. Dr. Feinberg was joined by Dr. Helen Rees of Wits RHI to discuss the history and role of the Coalition for Epidemic Preparedness Innovations (CEPI), which supports vaccine development against emerging infectious diseases, including COVID-19.

Access the recording, listen to excerpts or read the transcript.

The first webinar in the series featured a range of voices on COVID-19 and HIV. Dr. Carl Dieffenbach, Director of the Division of AIDS (DAIDS) at the US NIH answered questions about risk for people living with HIV, the impact of COVID-19 on HIV research, and the status of research into treatments and vaccines for COVID-19. Lillian Mworeko of ICW-EA and Yvette Raphael of APHA framed issues that must be incorporated into a robust advocacy agenda for sub-Saharan Africa, a region bracing for a tide of COVID-19 cases already seen in Asia, Europe and North America. The advocates also shared their Call to African leaders to accelerate action on COVID-19.

Additional Resources

Our partners at the Global Health Technologies Coalition (GHTC) have a COVID-19 R&D Tracker. It summarizes the latest updates on:

AVAC maintains a Resources for Advocates sheet that provides links to the latest COVID-19 information on prevention and transmission, the research pipeline and a growing list of country-specific resources.

Also a work in progress, AVAC has a table of Ongoing Studies for 2019-nCoV Prevention and Treatment tracking the development of COVID-19 diagnostics, therapeutics and a potential vaccine.

While there is anxiety and uncertainty right now, we take great comfort in our relationships, knowing we have each other for support, solace and motivation. Thank you, as ever, for your partnership and commitment to our important work together.

Resources you need for COVID-19 and HIV

There’s much we do and don’t know about COVID-19 and the virus that causes it, SARS-CoV-2. The effort to stop this new virus also has implications for the still imperative effort to stop HIV. The global response to COVID-19, which is evolving rapidly, can and must benefit from lessons learned in the fight against HIV.

AVAC is committed to data-driven, evidence-based advocacy, and we hope these resources help us all stay up-to-date on the facts, share experiences and make sure interventions for COVID-19 and HIV reach those who need them the most.

  • Use these Resources for Advocates for the latest COVID-19 information on prevention and transmission, the research pipeline, and a growing list of country-specific resources.

In the weeks and months ahead, while we all maintain physical distance, we’ll be reaching out—because now more than ever it’s vital to connect. We will be organizing additional webinars and other virtual platforms for information-sharing and action; please do stay tuned. Together, we can get out the facts, demand data, set milestones and call on global leaders to bring solutions that work to the people who need them.

Global Advocates’ Teleconference: COVID-19 & HIV update

As we watch COVID-19 spread across the globe, we see a virus that must be stopped. Drawing from decades of work on HIV, we know that confronting this novel virus demands the same data-driven, evidence-based advocacy that has been at the center of our work with all of you for 25 years.

There are still a lot of unknowns—and many myths circulating—but the scientific community is working to advance our understanding of COVID-19 and develop potential treatments and vaccines. Understandably, this new disease also raises many questions about the implications for HIV research and the global communities of people affected by HIV.

On Monday, March 23 we were joined by Dr. Carl Dieffenbach, Director of the Division of AIDS (DAIDS) at the NIH, Lillian Mworeko of ICW-EA and Yvette Raphael of APHA, to answer questions about what we do and don’t know about COVID-19 and HIV, how to track research developments on the HIV front, what this new pandemic might mean for ongoing HIV research, and how the HIV community can contribute to the fight against COVID-19.

The recording can be found here.

The HIV advocacy community has a unique role to play in countering myths, developing an advocacy agenda that brings solutions to the people who need it most, and demanding those solutions be data-driven, evidence-based and centered in human rights.

In the weeks and months ahead, we encourage you to sort the myths and facts on COVID-19 with these resources, and to keep watching this space to engage with crucial developments.

Activism in Action: Week 2 reporting from the frontlines of the PEPFAR planning process

In late February, we reported back from week one of the Regional Planning Meetings (RPM) in Johannesburg where representatives from programs under the US Government’s President’s Emergency Plan for AIDS Relief (PEPFAR) meet to make plans, set targets and define approaches, ultimately captured in Country Operational Plans (COPs) for more than 50 countries around the world. At the RPMs, PEPFAR country staff, PEPFAR Washington staff, national ministry of health representatives, national and international civil society organizations (CSOs), WHO, UNAIDS and Global Fund gather for three weeks to lay out the priorities for the PEPFAR program for the next year, which starts the following October.

Week two, which wrapped up the last week of February, focused on Angola, Botswana, the Dominican Republic, Haiti, Namibia, Mozambique, South Africa, Zambia and Zimbabwe. AVAC was there, along with civil society partners from the Advocacy Core Team—the Zimbabwe country team from COMPASS as well as GALZ and other activists from Zimbabwe. Here are some highlights, issues and what was won in week two.

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COMPASS in Action in the Zim Room

COMPASS partners came to the RPMs with a list of community priorities, reflected in the Community COP20 Zimbabwe. These demands were informed by over 50 Zimbabwean CSOs. The final version of the Zimbabwe COP, adopted in week two, reflected many of the Community COP priorities, including:

  • Increased staffing and scale-up of viral load testing, and new approaches to connect clinics and laboratories to improve the coverage of viral load testing from the current 44 percent coverage to 85 percent.
  • Increased PrEP targets by 177 percent by delivering PrEP to 28,600 people in 22 districts with a focus on key populations and adolescent girls and young women with supporting communications and PrEP literacy efforts to increase demand, normalize PrEP and improve continuation.
  • Commitment to continue funding human resources for health, such as lab technicians, community adolescent treatment supporters (CATS), data clerks, peer and lay workers, nurses and pharmacists in PEPFAR priority districts.
  • Elimination of all formal and informal user fees for HIV and related services in the public sector by September 2021.
  • Increased Community ART Refill Groups (CARGS) as an option in up to 50 percent of treatment facilities to increase retention of treatment among PLHIV.
  • A buddy-system as a model for key and vulnerable populations to access HIV related services, and the expansion of drop-in centers.
  • Beginning scale-up of 3HP, the more tolerable and preferred TB preventive therapy, as the current TB therapy, is expanded cover to 100 percent of PLHIV by end of COP20.
  • CSOs won US$1m for community-led monitoring of services at 200 facilities in 40 districts in Zimbabwe. The focus will be on services for young people and key populations.
  • Rollout of electronic medical records to over 500 sites.

Coverage for viral load testing was a top priority for civil society. Last year, COMPASS partners worked with PEPFAR staff to develop a US$6.8m plan to expand coverage. Power outages greatly impact the stable functioning of the labs that are critical to measure viral loads. Activists pushed for staff hirings and backup solar power to avoid lab processing delays. Since it had no funds this year to commit, PEPFAR agreed to request those funds from Global Fund, and the Global Fund agreed to consider the request at the country level in the next few weeks. Activists will follow up on this.

Wither Testing?

This year’s PEPFAR Country Operational Plan (COP) Guidance, an annual statement of PEPFAR priorities and requirements used by country teams to develop their COPs, continued ambitious scale-up of index testing. In week two, AVAC and other civil society continued to voice their concern about harm from index testing. See recent Call to Action. Current index testing in the Guidance still stands, but there’s movement to allow community monitoring of index testing programs, funded by PEPFAR, to test compliance with WHO testing guidelines. Still, the continuation of high targets for index testing remained. As Naïké Ledan from Haiti said at the closing plenary, “Failing on targets [should be] more acceptable than failing on human rights.”

In 2018, PEPFAR tested 95 million people in provider-initiated testing centers (PITC) such as hospitals or clinics, and through modalities such as self-testing and index testing. According to PEPFAR leader Ambassador Birx, PEPFAR programs have significantly overspent on testing with an investment in COP19 of US$401m against a budget of US$285 million. (In contrast, PEPFAR underspent on prevention by 10 percent, spending US$475m from a budget of US$520m.) As countries approach over 80-95 percent of PLHIV on treatment, those testing positive for HIV from provider testing have fallen. The implication of these data came to the fore in different country plans as index testing was scaled up and funding for PITC testing was signficantly cut. COMPASS partners voiced concerns about the 90 percent reduction in PITC testing in Zimbabwe in COP20. PITC testing repesented half of all of new HIV positive diagnoses in Zimbabwe, so advocates pushed for and were able to retain PITC testing targets in the final COP plan.

Another Virus Steals the Spotlight

In week two, another virus was consuming public attention, and Ambassador Birx was appointed to be the White House Coronavirus (COVID 19) Response Coordinator, in addition to her PEPFAR role. The PEPFAR program, and the US$900m in labs that PEPFAR has built across Africa will help prepare the continent from this new threat. As Birx noted, COVID-19 represents a challenge that PEPFAR understands, surveillance, finding asymptomatic patients and working with community.

Zambia Moves on Prevention

As a number of countries approach their 90-90-90 targets, they have been encouraged by PEPFAR to look to investments in treatment retention and HIV prevention. For Zambia, discusions focused on how to push PEPFAR funded programs beyond the 90-90-90 fast track targets set by UNAIDS, which have now been met. Zambian CSOs, along with COMPASS partners AVAC and amfAR, pushed for communities to lead the way on closing long-standing gaps in primary prevention. A strategy of pushing an agenda early in the week worked well, getting changes included before budgets were locked down. By the end of the week, PrEP targets for the Zambia program went from 44,000 to 110,000, including increases for KPs.

Stay tuned for week three! We’ll provide updates on Tanzania and Malawi, where COMPASS Africa worked to implement the Malawi Community COP.

Want to learn more about the issues above and engaging with PEPFAR? Check out these resources:

Spotlight on HVTN 702: AVAC’s Latest Podcast Episode

The latest installment of AVAC’s podcast, , is up. In this episode, AVAC puts a spotlight on HVTN 702, or Uhambo, one of the most anticipated HIV vaccine efficacy trials in the field. Data show the vaccine tested is safe, but vaccinations were stopped early after a scheduled review showed it did not offer protection.

The news delivered disappointment to local communities, to the thousands of South Africans who participated in the study, and to the field worldwide. Meanwhile, the trial team will continue to follow participants over the next year to monitor safety and gather data to help answer urgent questions raised by the trial results. While the vaccine in the trial did not work, the trial was extremely well-conducted and got an answer quickly.

In this episode of Px Pulse:

  • HVTN 702 Protocol Co-chair and AVAC Board Member, Linda-Gail Bekker, explores what the trial team hopes to learn during the follow-up period and how these answers might impact the ongoing pursuit for an HIV vaccine;
  • AVAC’s Regional Stakeholder Engagement Advisor, Nandisile Luthuli, also joins the conversation to shed light on the trial team’s plans for continuing community engagement;
  • and AVAC’s Director of Research Engagement, Stacey Hannah, talks about the successes of the trial.

For more resources on the issue go to AVAC.org’s HVTN 702 Updates and Next Steps.


For the full podcast episode, highlights and more resources, visit avac.org/px-pulse. And subscribe on Apple Podcasts, Spotify or wherever you get your podcasts!

CROI Goes Virtual: Next steps for advocates’ sessions and more

As many of you may have heard, next week’s Conference on Retroviruses and Opportunistic Infections (CROI) is now going to be a virtual meeting. The CROI organizers will be updating their site with additional details and opportunities to participate virtually in the conference next week.

AVAC and partners had a range of events planned for the in-person meeting that will now not be taking place. We will be working over the coming days to reprogram those events virtually. Please stay tuned for details and looking forward to continuing the conversation!

CROI 2020 Preview: Follow from near and afar

[UPDATE: CROI 2020 is now a virtual meeting. More information from CROI is available here. AVAC will continue updating our event page.]

The annual Conference on Retroviruses and Opportunistic Infections (CROI) kicks off this coming Sunday, March 8, in Boston. Whether you’re en route to Boston for the four-day meeting or following the proceedings from afar, this update is for you.

As limitations on travel related to COVID-19 may continue to change, CROI will be offering additional ways to share information virtually. AVAC will provide updates on our 2020 CROI page. But, whether you come in person or follow remotely, AVAC will be there and looks forward to connecting with you however you join the conversation!

This year’s program covers a range of topics of interest to advocates including new data from early-stage prevention trials, additional data on F/TAF for PrEP, long-acting treatment data, a symposium on contraceptives, a workshop on clinical trial design, a special session on the HVTN 702 vaccine trial, and more!

Saturday, March 7, AVAC and partners will host an all-day, pre-conference community workshop on cure research that will offer updates on current studies such as HIV gene therapy and discussion of complex issues in cure research. Come in person (RSVP here) or join remotely!

AVAC is also pleased to invite you to join a special session on Monday evening, The Future of HIV Prevention Research: How to do trials in the era of oral PrEP, co-organized by AVAC, Fenway Health and The Forum for Collaborative Research. During the session we’ll explore and discuss next-generation trial designs for biomedical HIV prevention research, including design, regulatory and ethical considerations, and mechanisms for community engagement. Join us in person at Fenway Health or register to watch a livestream of the event.

Check out the CROI website for a look at this year’s program, search abstracts, view sessions via webcast and follow the conference hashtag on your favorite social media platform at #CROI2020. And be sure to subscribe to AVAC’s social media updates.

Daily CROI press conferences will be webcast live and available for playback. Download the press conference schedule here, which includes information on how to view the webcasts.

Stay tuned for more from Boston!

Diversifying PrEP delivery models—what about DSD for PrEP?

Help us collect examples and evidence that supports differentiated service delivery (DSD) models for PrEP—fill out this survey!

As part of an effort by The Differentiated Service Delivery Initiative of the International AIDS Society (IAS), AVAC and CHAI’s HIV Prevention Market Manager project and PATH are reaching out with a survey to better understand DSD models currently being piloted and implemented for oral PrEP. The survey should take approximately 10 minutes to complete.

Responses will help inform guidance and development of DSD models, which we hope will ultimately help improve access to oral PrEP and new interventions on the horizon. All data will be kept confidential and will be aggregated to inform a planned satellite session at AIDS2020.

This effort will collect and share what countries are doing to diversify PrEP service delivery models, what models are moving beyond the clinic to reach PrEP users, and what DSD models can be borrowed from treatment and family planning programs to significantly increase oral PrEP use now and for next-generation HIV prevention options as they become available.

Thanks in advance for your time and please send on to relevant networks and colleagues!

Activism in Action: Week 1 reporting from the frontlines of the PEPFAR planning process

Every year, representatives from programs under the US Government’s President’s Emergency Plan for AIDS Relief (PEPFAR) meet to make plans, set targets and define approaches for more than 50 countries around the world. This year, the meetings began on February 17, and will run for three weeks in Johannesburg, with countries arriving for the Regional Planning Meetings (RPM). At the RPMs, PEPFAR country and Washington staff, national ministry of health representatives, national and international civil society groups, WHO, UNAIDS and Global Fund gather for three consecutive five-day meetings to lay out the priorities for the PEPFAR program for the next year, which starts the following October.

The first week, which wrapped this past Friday, focused on PEPFAR countries in West Africa and Ukraine. AVAC was there, along with civil society partners from around the world, to make change in real time. We are there to hear the fresh program data, PEPFAR’s plans for addressing gaps, but most importantly to influence outcomes and plans through the filter of our prevention lens and our partners’ priorities. With two more weeks of meetings—and additional opportunities still to come for input into the final Strategic Direction Summaries—here are some highlights, progress and issues to follow.

National Policy Commitments Require Vigilance

These PEPFAR planning meetings focus on US government funding, but the impact of those dollars depends on the policy environment in a given country. Policy change in West Africa was a strong civil society focus at last year’s RPMs, and significant commitments were made. Country government representatives committed to, among other things, eliminating user fees, expanding populations that could benefit from PrEP and removing barriers, particularly for women living with HIV, in transitioning to dolutegravir (DTG) for treatment. Activists returned in 2020 to find that some policy changes had taken hold—expanded DTG uptake among women in Nigeria and over 60 percent user fee elimination in Côte d’Ivoire—but others had not.

Most notably, despite oral PrEP targets, many countries failed to roll it out, denying a critical prevention tool to communities in West Africa. With strong support by activists, PrEP targets were increased in Côte d’Ivoire, Nigeria and Ukraine. As Ambassador Birx noted at her Stakeholder Town Hall meeting for week one, West Africa remains behind in PrEP rollout.

User fee elimination was also off to a slow start everywhere, Côte d’Ivoire as the exception. For example, Nigerian activists, armed with community surveys collected just a few weeks ago, were able to call out the continued existence of user fees in the two states where official statements from the government claimed they had been eliminated. State officials were not in the room to respond, but community activism made it clear that there was more for the Government and PEPFAR to do, and that community monitoring would be needed to hold state and national governments accountable.

Getting Specific, Saving Lives: A human-rights approach to index testing

This year’s PEPFAR Country Operational Plan (COP) Guidance—an annual statement from the Office of the Global AIDS Coordinator (OGAC) of PEPFAR priorities and requirements that PEPFAR country teams must use to develop their COPs, continued ambitious scale-up of index testing. This is an approach that asks a person who has tested HIV-positive to provide the names and contact information of his or her biological children and sexual and needle-sharing partners, who are then followed up for testing. In COP19, OGAC told country teams that a minimum of 30-50 percent of newly diagnosed individuals should come from index testing. The draft COP20 Guidance raised this to up to 75 percent in some areas with high ART coverage. PEPFAR also set a presumption that most (80 percent) of those asked to identify partners will do so.

The escalation of the index-testing target up to 75 percent raised significant and immediate concerns by AVAC and partners. While this approach to HIV testing has potential benefits for individuals and communities when it is done ethically, with consent and without coercion, it can also be aggressively implemented in ways that can cause harm to individuals, undermine their rights to consent, privacy, safety and confidentiality, and can erode the trust of communities with health care providers as AVAC stated in recent Advocates’ Call to Action. Specific attention to promoting and protecting the human rights of women and girls, along with key populations, is essential in index testing. Last year, AVAC, amfAR and CHANGE together co-authored an issue brief on HIV testing strategies.

This year, a rapid survey of sites where expanded index testing occurred revealed a number of examples of coercion and even withholding of ARVs for clients who did not consent to provide the names of their sexual partners. A letter from a number of global and national civil society organizations (CSOs) was sent to OGAC calling for a pause on all index testing while risk-mitigation and mediation efforts are put in place, and that no targets for index testing as a percentage of new diagnoses should be part of COP20. OGAC halted index testing but only for key populations.

This conversation continued in week one, as global and national CSOs together interrogated index-testing programs in different countries. At the end of the week, civil society representatives acknowledged the importance of index testing but remain opposed to high targets for percent diagnoses from index testing.

Good index-testing programs, such as the one in Ukraine, found that they had 45–75 percent acceptance rates signaling that people were free to decline. Comprehensive programs to address intimate partner violence (IPV) are essential to a human rights-based approach to index testing, as is strong accountability for administering these programs.

Community-Led Monitoring Comes of Age

Index testing wasn’t the only hot topic in week one. For the first time, the COP Guidance directed that country programs fund community-led monitoring (CLM). Community-led monitoring is a community led and designed study of the quality and scope of services and the barriers to accessing them; often focusing on key populations and others who are highly vulnerable. CLM is another process by which groups can act as watchdogs to help improve accountability.

Building on initiatives like the People’s COPs in Malawi, South Africa, Uganda and Zimbabwe, as well as other community-led planning and monitoring, OGAC committed funds in each county program for this purpose. Importantly, the design for these programs was not prescribed, allowing CSOs to suggest planning and budgets. CLM programs must be able to evolve, going beyond a simple adjunct to existing PEPFAR evaluations. CLMs must be designed to allow CSOs to pivot in response to emerging issues like stockouts or coercive index testing. CLM program design, and the CSOs to be funded, will be determined in each country as part of the final COP approval after the RPM.

Will the Key Population Investment Fund have impact?

PEPFAR’s Key Population Investment Fund (KPIF), announced two-and-a-half years ago, will finally see resources flowing, via USAID and CDC, directly to local organizations. As we noted last year, tying performance to these Site Improvement Through Monitoring System (SIMS) indicators could mean lost funding for frontline groups that do the essential work of keeping key and vulnerable populations alive and healthy. These organizations combat injustice, stigma and human-rights abuses, and they advocate for mental health and education. AVAC and COMPASS partners amfAR, CHANGE and MPact and are actively monitoring the rollout of the newest iteration of the KPIF.

In week one from Nigeria, we learned how PEPFAR programs are layering treatment of anal warts into larger KP programming, and this has led to a dramatic increase in HIV case finding. Specifically, 70 percent of MSM who tested for HIV came in through anal warts treatment. This kind of layering of services shows the potential impact of KPIF, and equally the need for PEPFAR to evaluate that impact. To that end, one key demand in week one was that PEPFAR provide a plan—and budget—for how they will evaluate, learn and scale up successful interventions from KPIF. AVAC will work with activists coming to weeks two and three of RPMs to carry these demands forward.

Stay tuned for an update from week two! We’ll provide a range of updates, including one from the Zimbabwe room, where COMPASS Africa partners, including the Advocacy Core Team (ACT), will be working to implement the Zimbabwe Community COP.

Want to learn more about the issues above and engaging with PEPFAR—from Johannesburg or from afar? Check out these resources:

What’s New on AVAC.org and PrEPWatch!

In case you missed them, this round-up includes links to updates on PrEP and the vaccine field, advances on pioneering work using human-centered design to inform prevention programs, and essential resources for advocates focused on PEPFAR’s COP planning process, opportunities to engage on the issues of next generation trial design and resources that arm you for smart advocacy in 2020 at large.

 

Dive Into Next Generation Trial Design at CROI

Join our participatory dialogue on next generation trial design! Advocates, researchers and community members will discuss what’s on the table for next-generation HIV prevention trials, including design, regulatory and ethical considerations and mechanisms for community engagement. Co-hosted by AVAC, The Fenway Institute at Fenway Health and The Forum for Collaborative Research, on the sidelines of the Conference on Retroviruses and Opportunistic Infections (CROI).

  • Monday, March 9, 2020 6:30-9:00 PM EST
    The Fenway Institute, 1340 Boylston St., Boston.
    Register Here.

 

The latest Updates on HVTN 702

On Feb 3, HVTN 702 trial leaders announced that vaccinations would be stopped early because the vaccine candidate did not prevent HIV. Importantly, there were no safety concerns. To help advocates understand the results and the implications for the future of HIV vaccine development check out:

 

New Findings from Breaking the Cycle of Transmission

AVAC’s Anabel Gomez and Shawn Malone report on their research exploring the factors that influence decision-making among young women who are at high risk of HIV. Check out the chapter they authored, Understanding HIV prevention in high-risk adolescent girls and young women in two South African provinces, in the 22nd edition of The South African Health Review (SAHR) 2019-12-31. And watch this recorded webinar discussion, featuring this research—one in a monthly series on PrEP rollout produced by the PrEP Learning Network. These research findings are part of the Breaking the Cycle of Transmission project, conducted under AVAC and CHAI’s HIV Prevention Market Manager (PMM) project.

 

Tools for Advocates Engaging with PEPFAR

This FAQ on index testing—a testing approach that tracks the contacts of people who test positive for HIV—provides background on the issue and frames advocacy priorities. While index testing holds potential benefits if ethically done, it’s being implemented now in ways that cause harm and undermine human rights. Changes must be made to protect individuals and foster community trust in their healthcare system.

New factsheets on PEPFAR’s performance and funding by country are now available. They are produced by amfAR as part of our Coalition to build Momentum, Activism, Solidarity & Strategy Africa (COMPASS Africa), and found on amfAR’s PEPFAR Monitoring, Evaluation and Reporting Database! You’ll find details on funding by program area, testing program results, key population size estimates and more. Be sure to search by country and find a downloadable fact sheet on the upper right of each country page.

 

How Does PrEPWatch Work for You?

Calling all PrEPWatch users! Help us understand how the website is being used, what tools and resources you find most useful, and how we can improve with this 3-minute survey. Your responses are highly valued and will be kept confidential.

 

Advocacy Priorities in 2020

The latest episode of AVAC’s podcast, Px Pulse, lays out AVAC’s view of the state of the field in light of certain failure to meet UNAIDS Fast-Track targets by the 2020 deadline. In this episode of Px Pulse, AVAC’s Emily Bass and lead author of our report Now What? talks about AVAC’s blueprint for course correcting. Tune in to learn more!

 

Lastly, the latest figures are up on AVAC’s Global PrEP Tracker.