The COVID-19 pandemic is a global health emergency that may demand new, safe, and expedited ways of conducting ethical research to find the solutions we need, including a safe and effective vaccine. With most of the world’s population pinning hopes of a return to work and life outside of isolation on the development and delivery of a SARS-CoV-2 vaccine, research is moving at unprecedented speed. As researchers look for ways to shave off a few months in the time to discovery, development, expedited approval, manufacture to scale and equitable delivery of a COVID-19 vaccine, controlled human infection studies (or “human challenge trials”) are now being discussed as a way to possibly shorten the timeline for vaccine efficacy studies.

On Wednesday, May 6, 2020, the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 released a report which stated that well designed challenge studies could accelerate COVID-19 vaccine development. The WHO Working Group lays out eight criteria for SARS-CoV-2 challenge studies that would need to be satisfied for studies to be ethically acceptable.

The WHO Working Group has articulated important criteria for assessing a challenge study, but we believe that they left out the most important one: Until there is an approved treatment, a challenge trial with a potentially fatal and as-yet untreatable pathogen is unacceptable.

In recent times, live pathogen challenge trials have been conducted in diseases where a safe, effective approved treatment is available, or for which pathogenesis and risks are reasonably well characterized. That is not the case for COVID-19, which means that adequately communicating about and assessing potential risks and benefits of participating in a challenge study and ensuring appropriate informed consent may be impossible.

Challenge trials are also most useful when it is difficult to recruit enough participants at high risk of measurable incidence to carry out a regular placebo-control study. As COVID-19 cases grow exponentially in communities around the world, it is clear that researchers will be able to enroll placebo-controlled efficacy trials among participants at high risk of SARS-CoV-2 acquisition who will be able to understand the risks and benefits and give true informed consent. Moreover, in this case, a placebo is highly likely to be safer than a live challenge for a significant number of those at risk in a disease with a currently estimated case fatality rate (CFR) greater than 1 percent.

While there has been increased coverage of the potential for live virus challenge vaccine studies in SARS-CoV-2, we do not believe that individuals’ expressed willingness to participate in such a trial is an adequate or appropriate measure of informed consent. The current discussion in scientific journals and in social and mainstream media cannot substitute for the needed stakeholder engagement to ensure that individuals and communities have input into what amounts to a radical and potentially dangerous, destructive and distracting change in the way research is done.

Moreover, before any challenge studies can be designed and conducted, researchers will need to develop and validate a challenge virus, a time-consuming process in its own right. During that time, it is possible that treatment(s) will emerge that will change the equation. But that is not guaranteed. If researchers move to develop a challenge model for SARS-CoV-2 vaccines, there must be a parallel process of rigorous ethical review and stakeholder engagement that addresses community and individual concerns and questions about this research.

Stakeholder engagement, as guided by Good Participatory Practice Guidelines, is a cornerstone of biomedical research. Expedited research timelines cannot short change robust engagement across a broad range of stakeholders. It is possible and necessary to ensure stakeholder input in plans for potential challenge studies.

Since the early days of the HIV epidemic, TAG and AVAC have each engaged with and advocated for accelerated research timelines, innovative trial designs, and meaningful community engagement for HIV, TB and health research. We are working with our global partners representing communities severely impacted and at risk for COVID-19 and other community and stakeholder representatives to develop a global community advisory mechanism that could work with WHO, vaccine developers and researchers, and research sponsors to ensure SARS-CoV-2 vaccine research happens to the highest possible scientific, ethical and public health standards and in the fastest possible way.

We call for the WHO to empanel a standing committee that includes researchers and ethicists involved in the WHO working group along with community representatives, policy makers, regulators, vaccinologists, infectious disease and public health experts to address the ethics of live SARS-CoV-2 challenge trials and review protocols. We must all work to ensure no unnecessary delays, but also no short-cuts which place participants at unacceptable risk of illness and death.

To make headway against both HIV and COVID-19, we must demand commitment to science and evidence, collaboration and innovation. And we must work together with undaunted commitment.

Drawing on 25 years of expertise and engagement, AVAC and partners have been highlighting how these two epidemics impact each other, and developing key resources to carry the work forward—against both epidemics and in support of a sustainable global health infrastructure for the future. Check out these resources and join us to:

1. Speak Truth to Power: Demanding evidence-based decisions

• Learning lessons from HIV
• Fighting for evidence-based policies
• Prioritizing ethical research

2. Track and translate the research in real-time

• Providing real-time updates on critical issues
• Tracking the fast-evolving COVID research landscape
• Tracking COVID implications on HIV prevention research and safeguarding its progress

3. Build the structures we need for the future of global health

• Fighting for the WHO
• Seizing this moment to work on a more sustainable future—one in which the next global pandemics—unfortunately inevitable—land in a more prepared, more secure and healthier world

Giving Tuesday Now is a global day of giving in response to the unprecedented need caused by COVID-19. AVAC is as committed as ever to ending HIV—AND we are connecting dots and applying our 25 years of expertise and engagement to the COVID response. Please consider donating to AVAC so we can continue both fights.

For women all over the world, getting the products and services they need and want for HIV prevention and for sexual & reproductive health (SRH) are mired in challenges – and COVID-19 is intensifying the struggle. Siloed care, stock outs, and too little input from women themselves on the design of programs and products are among the long-standing barriers to women’s healthcare, and COVID-19 exacerbates these difficulties. AVAC is expanding our partnerships and programs to meet these challenges.

Effective integration of HIV/SRH requires multilayered prevention, an issue highlighted in AVAC Report 2019: Now What?. Multilayered prevention can—and should—encompass both SRH and HIV services and products, including multipurpose prevention technologies (MPTs), and embed these services and products in “multisectoral strategies”, such as policy reform, community norms-changing and economic empowerment.

The need for integration isn’t new, but the current global COVID-19 crisis makes stark the challenge and the need.

While AVAC has long promoted a research agenda centered on women, the ECHO trial results, on the one hand, and the opportunities and challenges of oral PrEP programs, on the other, underscore the urgency to reach women and girls with integrated HIV and family planning products and services.

In partnerships with civil society, Ministries of Health, product developers and program implementers, we’re taking a comprehensive approach to advancing the integration of HIV services and SRH—including advocacy, research and implementation. To learn more about what we’re doing, check out the following resources:

• In our latest blog, we outline our approach to advancing HIV/SRH integration.
• A suite of new resources offers tools for developing integration strategies, drawn from insights learned from experiences to date with integrating HIV and SRH.
• And our new page on avac.org devoted to HIV/SRH integration provides a look at key partnerships with civil society, governments, donors and product developers to strengthen integration in research, policies, products and services.

This work reflects a renewed urgency to identify and overcome obstacles to the integration of services for HIV and SRH, and to bring new resources to the field so that women’s too-often-neglected needs become the priority.

Keep checking our webpage for the latest updates on work to integrate HIV and SRH.

New COVID-19 mathematical models are emerging to predict trends in new infections and deaths in cities, countries and globally. These models can forecast medical supply shortages, and influence policy makers and investment of resources. Over the past four months, multiple models to understand COVID transmission have been developed–with different assumptions, outputs and implications. Strengthening our understanding of current models, how they are developed, and their limitations, allows us to better apply modeling to public health policies and programs.

Please join us for an upcoming webinar, The Power–and Pitfalls–of Modeling for COVID-19 and HIV, on Thursday, May 7, 8am EDT to discuss current COVID-19 models, and the benefits and limitations of mathematical models as they apply to both COVID-19 and HIV prevention.

REGISTER HERE.

In the fourth installment of AVAC’s webinar series on COVID-19 and its relationship to HIV, John Stover, Vice President and founder of Avenir Health, will discuss the current state of COVID-19 modeling. Mr. Stover will be joined by his Avenir colleague Nadia Carvalho who will discuss a new learning opportunity for advocates wishing to use modeling in their work. This online course was developed by Avenir as part of the Coalition to Accelerate & Support Prevention Research (CASPR) led by AVAC and supported by USAID.

We hope you’ll check out the first three webinars in our series, and find other essential resources for advocates confronting COVID-19 and its impact on HIV at avac.org/covid.

In these challenging times for research, we take comfort in your continuing commitment and support for the work ahead.

In the midst of the global response to COVID-19, everyone and everything is affected, and HIV prevention research is no exception.

Research sponsors and networks, product developers and clinical trial sites are adapting to address how best to follow up with participants, minimize the impact on data and timelines, and ultimately protect the participants, communities and the integrity of the trial findings. Most HIV prevention trials are pausing enrollment of new participants, and constantly reviewing how best to manage follow-up of existing participants, prioritizing the safety of trial participants and the study teams.

AVAC has developed new resources to help track how COVID-19 is impacting HIV prevention research:

• Revised infographic showing COVID-19 effects on key HIV prevention trials.
• A downloadable table, Status Updates on Ongoing and Planned HIV Px Trials.
• A new page on avac.org—COVID 19 Implications on HIV Prevention Trials—features a round-up of guidance from regulatory bodies and updates by research entities.

We hope you’ll use these resources in your HIV prevention research advocacy. AVAC will continue to monitor these fast-moving changes to the field—watch this space!

More than 260 organizations and individuals have joined an Advocates Call for Ethical Research for COVID-19 Solutions.

In the wake of offensive and misleading statements about research in the midst of COVID-19, the need to explain, defend and advance the role of ethical research has never been more important.

We’ve heard political leaders minimize and confuse the scale of COVID-19. We’ve heard them offer incorrect and oversimplified solutions for the development of treatment or a vaccine. We’ve heard offensive remarks from two French researchers speculating that COVID-19 research might be more efficient in Africa, where people might be “more exposed to the virus”. Misguided, failing leadership such as this must be confronted and countered.

Advocates and researchers signing the call state clearly: There are currently no approved treatments, cures, vaccines or other biomedical prevention options for COVID-19. Treatment and prevention options are needed across the globe, and ethical and inclusive global research and development is critical to meet this need.

Read the letter reiterating the essential role of ethical research, and the need to move forward based on facts and evidence, and help us carry this message forward!

AVAC, Health GAP, Knowledge Ecology International (KEI) and Treatment Action Group (TAG) strongly condemn the Trump Administration’s decision to halt funding to the World Health Organization (WHO) in the midst of the urgent COVID-19 global health crisis.

“In a time where international cooperation on public health strategy, science, data and information sharing is more urgently needed than ever before, the Trump Administration has made an incredibly shortsighted decision to pull critical commitments to the WHO,” commented Mark Harrington, Executive Director of TAG. “Cutting global health funding in the middle of a pandemic will only prolong the devastating loss of life and economic damage in the US and across the world, and undermine the response to other infectious diseases, including HIV, tuberculosis and hepatitis C.”

WHO plays a central role in developing normative guidance, and coordinating data and best practices in public health for its member states to implement through national programs and policy. This ensures in-country public health responses on-the-ground are backed by data and science, particularly in countries where COVID-19 continues to surge.

“WHO coordination, guidance and mobilization of the public health response is tremendously important for supporting countries with struggling with limited resources, conflict and other humanitarian and ecological disaster-related crises,” explains Suraj Madoori, TAG’s US and Global Health Policy Director. “The COVID-19 epidemic will devastate already constrained health systems without the good global governance, cooperation, transparency, protection of human rights, access to health technologies for all—principles embodied by the WHO.”

The US contributes $893 million to WHO over two-years, accounting for nearly 15 percent of the agency’s budget. According to the WHO, funding contributions from the US government support a range of pandemic response activities, including prevention and control of outbreaks, emergency operations, strengthening surveillance and early warning management. Moreover, roughly $89 million (10 percent) of US funding to WHO supports tuberculosis (TB), HIV and hepatitis programming at the agency – placing even more pressure on the global response to these diseases, which has been significantly impacted by COVID-19 and the COVID-19 response in many countries.

“The Trump administration’s efforts to deflect and distract will be deadly for people living with HIV, particularly in countries that are in desperate need of increased emergency funding to bolster health systems that could be pushed to their limit by COVID-19,” said Asia Russell, Executive Director of the Health Global Access Project (Health GAP). “Defunding the WHO shows the administration’s callous disregard for human life. Congress should take immediate steps to protect and in fact increase the US investment in global health.”

Developing the guidance, surveillance, treatments, diagnostics and vaccines needed to curb the COVID-19 pandemic requires increased resources and international cooperation. To date, in the US there are an over 600,000 confirmed cases, and an estimated 26,000 deaths.

“Even with a perfect response to COVID-19 in the US, which is far from the case, we would still need WHO’s global efforts to help ensure that the pandemic is brought under control across the globe,” said Mitchell Warren, AVAC’s Executive Director. “Without robust international cooperation and WHO leadership, we cannot end this pandemic.”

This virus respects no borders. COVID-19 anywhere can quickly become COVID-19 everywhere. The US government must immediately restore and protect funding to WHO and work to ensure global cooperation in the pandemic response.

“The WHO needs to be fully operational and Trump’s comments are a massive distraction. The US already has enormous influence on WHO policies, but Trump’s comments and actions will reduce this, and breed deep and lasting resentment to the US around the world,” warned James Love, Executive Director for KEI.

AVAC, Health GAP, KEI and TAG urgently calls on Congress to take action to ensure that no appropriated funding to the WHO and global health partners is withheld in a time of critical need to address the growing COVID-19 crisis.

Thank you for helping us carry this message forward! And stay tuned for continuing resources and key messages that advocates can use to fight the epidemics we face today.

The 2019 results of the ECHO (Evidence for Contraceptive Options in HIV Outcomes) trial, which evaluated differences in risk of acquiring HIV among women using three different forms of contraception, revealed astoundingly high rates of HIV incidence in women across the study. Though none of the methods themselves comparatively increased one’s risk of HIV, the high incidence alone elevated a long-standing call for the integration of HIV prevention and sexual & reproductive health (SRH) services. The recent early stop of the HVTN 702 vaccine trial in South Africa showed similar rates of new infections among women—as with ECHO, over 4 percent incidence rates, well above the WHO definition of “substantial risk” at 3 percent in their oral PrEP recommendation.

Taken together, these results underscore the need to bring integration to service delivery, programs and products, including the need for new multipurpose prevention options as a public health imperative.

Integrating HIV and SRH has been successfully put into practice for family planning in HIV care and treatment clinics and prevention of mother-to-child transmission (PMTCT) services in maternal and child health clinics. But integrating HIV prevention—most recently the addition of oral PrEP—and SRH services has been slow.

Effective integration of HIV/SRH requires multilayered prevention, an issue highlighted in AVAC Report 2019: Now What?. Multilayered prevention can—and should—encompass both SRH and HIV services and products, including multipurpose prevention technologies (MPTs), such as condoms or the dual prevention pill (see below); and embed these services and products in “multisectoral strategies”, such as policy reform, community norms-changing and economic empowerment.

More MPTs must be developed and ultimately brought to market. Imagine a single pill that combines both oral PrEP and oral contraception, or, eventually, combining both strategies in a vaginal ring, injectable or implant. For young women who are inconvenienced by going to one clinic for PrEP and another for family planning, likely traveling far and waiting in long lines for both, a dual prevention pill could lessen the burden and provide the same protection against HIV and unintended pregnancy. In a multilayered context, that dual prevention pill would be available at whatever clinic they prefer to use, and once there they are connected to other services that speak to their most pressing needs.

AVAC, as part of its HIV Prevention Market Manager (PMM) project, worked with partners to understand what it will take to integrate HIV prevention and SRH services, and has developed a number of new resources:

• HIV & SRH Integration: Key Learnings from Research and Projects
• Literature review: Exploring Integration of Family Planning and HIV Services
• Applying Lessons from Family Planning to HIV Prevention Product Introduction

It’s time to act on tried and tested approaches as well as spur new efforts to deliver comprehensive services that address the comprehensive health needs of girls and women.

In addition, to learn further from integration efforts to date, AVAC began rapid assessments of HIV/SRH integration in Kenya and Zimbabwe in late 2019, in collaboration with both countries’ Ministries of Health.

In early 2020, AVAC co-convened a meeting with Kenya’s National AIDS and STIs Control Programme (NASCOP) and the Department of Family Health to build on the findings and develop tangible ways to integrate HIV prevention and SRH. A multisectoral group of national and county-level Ministry of Health officials, implementing partners, researchers, frontline providers, civil society and youth lent their diverse perspectives and agreed on several next steps. Among them, a technical working group (TWG) on integration and policy guidance will be formed, and select health facilities will pilot integrated services to better understand what approaches work and can be replicated.

Stronger integrated services can help improve existing delivery, particularly where reaching adolescent girls and young women has been a challenge, and help pave the way for a smooth introduction of MPTs. Initiative and innovation are needed in both services and products. AVAC is leveraging its strong partnerships to push for integration in both:

• A dual prevention pill that combines oral PrEP with an oral contraception is in development now. Because both products in separate formulations are currently safe, effective and available, the combined product may have an accelerated path to market. Currently, the drugs are being tested for compatibility in a combined form. This will be followed by a smaller study to determine that the drugs are just as safe and effective when combined in one pill as when taken separately. AVAC, CHAI, Mann Global Health and the Population Council, with funding from the Children’s Investment Fund Foundation (CIFF) are collaborating to plan for its market introduction. Population Council (with funding from CIFF) and Mylan (with funding from CIFF and the Bill and Melinda Gates Foundation) are concurrently developing the product.

• The USAID-funded Coalition to Accelerate and Support Prevention Research (CASPR) is building a cadre of advocates who understand the overall women’s HIV prevention research agenda as well as the MPT pipeline and are prepared to engage with policymakers, product developers and communities around the introduction of new options. In the near-term, a positive regulatory opinion on the dapivirine vaginal ring could lay the foundation for a future multipurpose vaginal ring.

• Following the ECHO results, the Civil Society Advocacy Working Group on HC-HIV led by and for women in Africa is working to develop funded country plans for integrated services that center women and affirm the right to full information and informed choice.

• A North-South collaboration of civil society organizations, known as COMPASS, is advocating for ambitious targets—in PEPFAR, Global Fund and locally-funded programs—to be set around integration of services in national and regional programs.

A health system that is responsive to the lives of girls and women will recognize that pregnancy, HIV, and STI prevention options should be readily available, accessible, and layered with behavioral and structural interventions. Integration of HIV prevention and SRH is a critical step toward providing this holistic, person-centered care.

Check out AVAC’s new webpage focused on HIV/SRH integration, where these and future resources will be housed to help inform evidence-based approaches to integration.