The Trial Design Academy (TDA): For next generation HIV prevention research
As clinical trials in HIV prevention grow in complexity, advocacy for future trial design is more important than ever
Why Now?
Global rates of new infections remain high, even as the options for proven prevention increase. Trials to test new HIV prevention methods continue to be imperative, to ensure that communities in need of prevention will be able to find choices that work for them.
As daily and long-acting PrEP products roll out, innovative trial design is a focus and challenge for the field. Advocates and communities must play a central role in shaping future trial design. Their input is essential for both community acceptance of clinical trials and for trial results that advance the field. As trial designs grow more complex, this need is greater than ever.
About This Project
Launched in September of 2019, AVAC’s Trial Design Academy convenes HIV prevention advocates from across the globe to confront the technical challenges, engage with researchers, statisticians, product developers and regulators, and help shape the decisions to move the research agenda forward.
The academy is built on the belief that meaningful community engagement is critical. This is why it draws on frameworks like the People’s Research Agenda and the Good Participatory Practice to ensure that trial design and conduct is transparent, inclusive and aligned to community priorities.
HPTN Ethics Guidance Research — The updated guidance covers ethical considerations and their integration into the design and implementation of HIV prevention research.
Ethical Guidance in Focus — This blog post by AVAC’s Jeanne Baron highlights and compares what’s new in two updated guidance documents, from UNAIDS/WHO and the HPTN, both addressing where PrEP fits in HIV prevention trials
Advancing Cure Research Through Advocacy & Engagement
Partner Spotlight
Advocacy-for-a-Cure alumni are leading efforts to combat misinformation around HIV cure globally.
Doreen Maraa and Skegabo Seselamarumo are utilizing their influence with young people to combat rumors around HIV cure and disseminate accurate information around the state of HIV cure science in Africa. Both women engage with leading researchers on their social media platforms and help connect scientific advances to everyday lives. Doreen’s pediatric video series from CROI has reached over 100,000 people on TikTok, shedding light on the differences and importance of curing perinatal HIV. Both women are leading voices for young people to turn to for information.
Josephine Nabukenya, Miles of Smiles Executive Director, created The Series of Jojo, that goes through the HIV life cycle and strategies to cure HIV. She is currently working on two new animated videos focused on antibodies as a cure strategy and analytic treatment interruptions. Her culturally tailored videos ensure information regarding upcoming clinical research is accessible.
Finding strategies for a durable cure for those living with HIV is core to ending the epidemic. Cure research has entered a dynamic period, with new scientific discoveries advancing our understanding of immune control as well as potential pathways for eradication. Cure research, development and advocacy are integral to the HIV response, and a critical element of the HIV-prevention-and-treatment continuum. It’s vital for advocates to understand the science of cure and to champion equity in research, development and, ultimately, access to the cure interventions of the future.
AVAC’s Cure Initiatives
AVAC has supported HIV cure research and advocacy for 10 years, helping to shape a research agenda that centers the priorities of informed communities. AVAC’s investment in research translation and support for cure advocates reflects a commitment to advancing HIV cure research that is community-centered, ethically based and scientifically rigorous. AVAC has supported the advancement of cure science in three areas:
Creating new tools for science translation and cure literacy.
Supporting a cadre of informed cure science champions.
Providing an enabling environment for research.
Creating Tools for Cure Literacy
Understanding the basic science and strategies underpinning research for an HIV cure is both complex and essential. Accurate information on the promise and the challenges in cure research enables all stakeholders, including affected communities, to engage with critical questions facing the field. AVAC contributes literacy tools on the fundamentals of the science and challenges driving the field forward. A generation of community-based advocates who are focused on cure research rely on these tools to stay up-to-date and prepared.
Language for an HIV Cure — this document shares up-to-date, community-preferred terminology within cure research.
Sex & HIV Cure Research — a poster outlining how sex differences impact the possibility of an HIV cure
HIV Cure and the Environment — a webinar recording discussing how the environment may impact HIV cure strategies
Fostering Advocacy Champions for HIV Cure Research
Progress in HIV cure research must be supported and guided by an advocacy agenda that puts communities first. With a cadre of knowledgeable and passionate advocates engaged in cure research and development, trials can be designed to successfully test strategies that align with community needs. Cure advocates play a crucial role in ensuring the fruits of science will be understood and accepted by the communities most affected by HIV. AVAC’s investment in cure champions includes:
Advocacy-For-A-Cure Academy
Co-hosted by AVAC and the International AIDS Society, The Advocacy-For-Cure Academy identifies and nurtures advocates to fight effectively for the development of supportive research environments and the ethical involvement of impacted communities in clinical research. Leading cure researchers and academy attendees, explore current strategies under investigation, population specific considerations and effective strategies for translating the science to a variety of stakeholders. They consider the challenges in cure research, approaches to broad stakeholder engagement, and an advocacy agenda to accelerate the design, social acceptability, and rapid adoption of HIV-cure products. Learn more.
The Martin Delaney Collaboratories for HIV Cure Research (MDC)
The NIH’s Martin Delaney Collaboratories for HIV Cure Research foster dynamic, multidisciplinary collaborations among academic researchers, industry, government, and community partners to pursue cure strategies for HIV. AVAC leads community engagement for three of ten collaboratories, including the REACH, PAVE and I4C, supporting advocates and communities to play their part to ensure ethical cure research moves forward.
The African HIV Cure Consortia includes six partners (AVAC, African Alliance, HCAAP, GGTI, IAS, SANTHE) working together to accelerate HIV cure research in Africa.
Enabling Environment for Research
HIV cure research requires expensive laboratory equipment, policies that support collaboration between research facilities and industry, and accessible prevention & treatment programs. Advocates need to work with donors and policymakers to sustain funding and promote basic and translational science.
Advocates from The African HIV Cure Consortia, MDC and the Advocacy-For-A-Cure Academy— as well as other advocates who depend on AVAC’s cure resources to understand the issues— contribute time and expertise to influence policy and funding decisions that advance cure research.
Impacts
Doreen Moraa is leading efforts to combat misinformation around HIV cure. She is working with researchers to translate the science and share accurate and accessible information quickly. Visit her YouTube channel for several informative cure videos.
Elina Mwasinga and Lusungu Harawa worked with the National AIDS Commission and Ministry of Health to organize the first agenda setting workshop in Africa to understand the barriers and opportunities for cure research in Malawi.
The PAVE CAB has created an African wide storytelling campaign to share the importance of HIV cure research from the perspective of young people.
PrEP Power
Shaping the Future of HIV Prevention for Key Populations
Overview
Advances in long-acting PrEP represent unprecedented opportunities to bend the curve of the HIV epidemic, if unprecedented investment and coordination focus on reaching key populations (KPs). Key populations, including gay men and other men who have sex with men, trans and gender non-binary individuals, sex workers, and people who use drugs, are consistently marginalized from health services. While they account for 55% of people acquiring HIV globally, and 80% outside of sub-Saharan Africa, UNAIDS data show only 40% of men who have sex with men, 39% of transgender individuals, 39% of people who inject drugs, and 50% of sex workers who were at risk of HIV were accessing effective prevention. Reaching these communities is central to making a meaningful impact in the reduction of HIV incidence globally.
About this Project
PrEP Power, a project led by Global Black Gay Men Connect (GBGMC), supported by the Global Key Population Advisory Group (KPAG), and with technical support from AVAC, is spearheading efforts to ensure KPs have equitable and effective access to the full range of HIV prevention options, including long-acting PrEP.
PrEP Power will coordinate market assessments, demand forecasting, human centered design research, community education, and demand generation to address barriers to long-acting PrEP access by KPs.
AVAC’s support of this project will help uncover some of the major factors that support or obstruct PrEP access for KPs, help create accurate demand forecasts to support efficient production of long-acting PrEP, and ultimately, increase access to and uptake of long-acting PrEP.
Key Population Trans National Collaboration (KP-TNC)
A cross country collaboration strengthening advocacy for key populations
Civil Society for key populations (KPs) must overcome significant challenges in their advocacy. Stigma, discrimination, disinformation, repression, criminalization, violence, and economic inequities burden and marginalize LGBTQIA+ people, sex workers, people who use drugs and other key populations who are vulnerable to HIV exposure. The KP-TNC fosters a community of practice and builds coalitions to develop strategies and advance advocacy for global health equity at large, and for HIV prevention and treatment among key populations.
About This Project
The KP-TNC is made up of consortiums of KP-led organizations in eight countries: Ghana, Kenya, Malawi, Nigeria, South Sudan, Tanzania, Zambia and Zanzibar. It plays a crucial role in strengthening relationships between KP organizations and development partners, regional organizations, the African Union, PEPFAR, The Global Fund and country governments. The latter holds special importance for TNC members who operate in countries where discrimination and criminalization of key populations has posed a serious barrier to advocacy. These constraints have undermined the development of effective policy and programs, depriving policy makers of essential impute from key populations on the design and implementation of programs aimed at delivering health services to them. The work of the KP-TNC is shoring up these critical failings with deeply informed, well resourced KP-led organizations who bring innovation and solutions that work.
The KP-TNC provides members with strategic training & education, and offers a platform for developing best practices. Advocacy is focused on PEPFAR’s Country Operational Plans (COPs), the Key Population Investment Fund (KPIF), other global, regional or country process for health programming, and expanding KP leadership in the design, implementation and evaluation of programs that deliver healthcare services to key populations.
Advocacy for Pandemic Prevention, Preparedness and Response (PPPR)
Making the connections between HIV, Global Health, Pandemic Readiness and Equity
Efforts to prepare for the next pandemic are changing the trajectory of global health. Governments around the world are coordinating on a range of agreements to meet the challenge of future global health threats. For Pandemic Prevention, Preparedness and Response (PPPR) to succeed, it is imperative that lessons from the HIV response are integrated into the architecture being built for PPPR. This means principles of equity must be embedded at every level of these agreements, and governments and civil society must be empowered to hold each other accountable to their commitments. The HIV response is inextricably linked to the progress or failure of PPPR. If done correctly, engaged and supported civil society and an integrated, fully funded response to HIV and the globes other current pandemics become the foundation for PPPR to effectively respond to emerging threats.
About this Project
HIV advocates bring essential expertise to advocacy for PPPR. AVAC works in partnership to track the process and content of these agreements. Through collaboration, we identify gaps, develop an advocacy agenda and put forward concrete proposals. We champion key priorities aimed at ensuring principles of equity guide the structure and operation of the global architecture for PPPR that is being built in the aftermath of the COVID-19 pandemic.
In a reimagined vision for pandemic readiness and global health, each country contributes their fair share, based on resources available, to be distributed globally, with priority for serving those most in need and achieving global health equity. As we saw during the COVID-19 Pandemic, richer countries have long abandoned global public health concerns once they consider the situation to be under control in their own countries (as with HIV, TB, malaria, and other infectious diseases). This isolationist approach must end: until access to essential health services and biomedical interventions is equal for all, we are all vulnerable to new health threats.
There is a significant opportunity to harness new initiatives and reform existing infrastructure to better address health issues, recommitting the world to the primary health care (PHC) measures outlined in the Astana Declaration and prioritizing health systems strengthening. There is growing recognition of the interrelated nature of global health and the need to integrate health responses between disease areas and with trade, education, labor, and finance. Resources for PPPR have historically been too little and too focused on infrastructure (laboratory capacity, gene sequencing functionality, and surveillance) while donor countries typically see PHC and health systems strengthening as an in-country responsibility. Multilateral-driven policy initiatives and platforms such as the WHO Pandemic Accord, new Pandemic Fund, and UN PPPR High-Level Meeting (HLM) present a great opportunity to, for the first time, collectively fund and strengthen health systems and primary health care—if the decisions incorporate lower- and middle-income country (LMIC) and civil society priorities.
Partnerships to Promote Effective HIV Prevention Policy
Working with global partners to advance policy priorities
Overview
Ending the HIV epidemic depends on political will, committed resources and a policy environment that supports and adequately finances equitable access to HIV prevention research, services, interventions, and products with communities at the center. Nearly four decades of HIV advocacy has shown us the power and potential of a strong ecosystem of partners in creating and sustaining effective local, national and international policies.
About the Project
AVAC and partners founded the Global AIDS Policy Partnership (GAPP) and the Federal AIDS Policy Partnership (FAPP) to create diverse coalitions of organizations who are committed to maintaining and expanding well-resourced, evidence-based HIV treatment and prevention programming and funding at the US and international levels. Through these coalitions, AVAC brings diverse perspectives and expertise to identify policy priorities and support the creation of campaigns to advance them.
The Global AIDS Policy Partnership As a co-chair of the Global AIDS Policy Partnership (GAPP), AVAC helps the 70-member coalition expand and improve US global HIV/AIDS programming through PEPFAR and the Global Fund. The GAPP is comprised of more than 70 US organizations—including advocates, civil society and faith-based organizations, philanthropy, implementers, professional membership organizations, and NGOs.
Federal AIDS Policy Partnership AVAC is also a member and a co-convener of the Research Working Group of the Federal AIDS Policy Partnership (FAPP), a national coalition of more than 120+ local, regional, and national organizations advocating for federal funding, legislation and policy to end the HIV epidemic in the United States. Much of FAPP’s policy and advocacy work is accomplished through seven FAPP-affiliated working groups. The Research Working Group works to advance the HIV research agenda through relationship building with the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC) and other HIV research funders, identifying gaps in HIV research, educating policy makers on the value of HIV research (for the field, but also for the broader research enterprise), and increasing federal funding through advocacy and coalition building.
Global Health Technologies Coalition AVAC co-founded and participates in the Global Health Technologies Coalition (GHTC), a coalition of more than 40 organizations and institutions advocating for US and multilateral policymakers to enact policies and investments to accelerate development of health technologies that are affordable and accessible to the communities who need them.
AVAC Advocacy Fellows Program
Supporting emerging advocates and a generation of advocacy
Applications
AVAC is no longer accepting applications for 2024 Advocacy Fellows.
Well-supported advocates keep the global response to HIV on track. Effective HIV prevention depends on programs and research that are fundamentally grounded in the needs and priorities of people who need prevention most. Passionate, skilled community advocates are the lynchpin to this process. They explain the science, define priorities, hold stakeholders accountable and influence the field.
About AVAC Advocacy Fellows
More than 10 years ago, AVAC launched its first Advocacy Fellows program to identify emerging HIV prevention champions, support their efforts, help hone their skills, strengthen the capacity of civil society to shape the agenda for HIV prevention research and influence how fast new interventions move into policy and programs. Today, the Advocacy Fellows program continues, offering 12 – 18 months of intensive support to emerging and mid-career advocates to complete an advocacy project focused on HIV prevention and global health equity—from research to programs to structural interventions that address human rights.
AVAC provides technical and financial support to Fellows—both salary and project budget—for the duration of the Fellow’s year. The Fellows program is implemented through a close collaboration among the Advocacy Fellow, the Host Organisation and AVAC.
Advocacy Fellows are housed by “Host Organisations” who are the fiscal and administrative grant partners. Hosts provide daily supervision to Fellows, ensure their projects are aligned with the organization’s goals and ensure that their activities and strategies are contextualized in the country/community.
Impact
Since launching in 2009, nearly 100 alumni fellows from 70+ partner organizations across 15+ countries have participated in the program. They have gone on to change policy, champion community perspectives, help strengthen healthcare systems, demystify HIV prevention research, and insist on fairness and transparency locally, regionally and globally.
I had no knowledge about good planning, accountability and execution of a good project. But with the assistance of the fellowship team at AVAC, as I write now, I feel I am one of the most supersonic HIV cure advocates the world has ever seen!
Moses Supercharger
2017 AVAC Advocacy Fellow
The AVAC Fellowship turned a naive nurse to a robust advocate. Now I can advocate for anything that I believe is right, even if I may be the only man standing and be unpopular… South African’s U=U scale up would not be where it is now if it was not for what I started then [when I was an AVAC Fellow].
Mandisa Dukashe
2020 AVAC Advocacy Fellow
The Choice Agenda
The Choice Agenda is a global forum for advocacy on the latest in HIV prevention research
Overview
Discussion, debate, and information sharing has been core to HIV advocacy and activism for over four decades resulting in many hard fought global gains in HIV treatment and prevention.
Today, as we work to make complex science accessible, identify where advocacy and action are needed, and pursue bold national, regional, and international agendas that improve global responses to HIV and prepare to prevention future pandemics, we need a space to come together.
About the Project
The Choice Agenda provides such a space—it is a new global forum for advocacy on the latest in HIV prevention. With monthly webinars hosting highly-informed discussions with advocates and experts across the field and a moderated listserv of nearly 2000 subscribers from 40 countries, the Choice Agenda platform is serving as an essential space for the HIV prevention community to come together to discuss, debate and chart the way forward.
The Choice Agenda program, and all of its participants take on a wide range of topics. Together, the TCA community drills into critical choices, including the need for short acting, non-systemic, user-controlled options, and a wide range of tailored implementation strategies that must define advocacy, the HIV response, and global health equity at large. Participants are also provided with links to a curation of exceptional resources to support further education and advocacy.
Join the Listserv
Join in on agenda-setting conversations. Members are encouraged to share their opinions and concerns and contribute to discussions and debates in the space. They can also reach out with suggestions about webinar content and speakers. Reach out to Jim at [email protected] to be added to the list.
The Webinars
The Choice Agenda hosts monthly webinars and moderates passionate, highly-informed discussions with advocates and experts across the field. Upcoming events are above on this page. Recordings are available here. Materials from previous events will be posted soon.
Stay in Touch
Follow along on Twitter via #TheChoiceAgenda and email Jim to join the listserv.
So many interesting threads and important to have a platform where people can voice difficult issues in a frank and challenging way. I am learning so much.
Dr Rachel Baggaley
WHO
Thank you so much Jim for moderating this forum. I want to nominate Jim to be the next PM for Thailand.
Udom Likhitwonnawut
AVAC consultant
Maximizing Options to Advance Informed Choice for HIV Prevention (MOSAIC)
Launched in 2021, MOSAIC, short for Maximizing Options to Advance Informed Choice for HIV Prevention, is an $85 million five-year global project. It is funded through the generous support of the American people through the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the US Agency for International Development (USAID). The project focuses on HIV prevention for adolescent girls, young women, and other women by accelerating introduction and scale-up of new and emerging biomedical prevention products.
Choice Matters
Adolescent girls and young women (AGYW) and other women continue to account for more than half of the number of people living with HIV worldwide. As new PrEP options become available, women in all their diversity should be presented with their choice of methods to prevent HIV.
What MOSAIC Means for Women
MOSAIC works in Botswana, Eswatini, Kenya, Lesotho, Namibia, Nigeria, South Africa, Uganda, Zambia and Zimbabwe to support health systems to better provide adolescent girls and young women (AGYW) with access to multiple effective PrEP products that meet their changing needs and desires. MOSAIC initiatives advance and promote informed choice and its integration in policies and programs.
Project Objectives
Focus on the needs and preferences of women
Gather research and evidence on connecting people to products that work for them
Work closely with regulators and policymakers to expedite the rollout of products
Advocate for the rapid integration of products into national programs
Strengthen local partnerships to promote product introduction
The MOSAIC consortium is led by FHI 360 along with core partners Wits Reproductive Health and HIV Institute (Wits RHI), Pangaea Zimbabwe AIDS Trust (PZAT), LVCT Health, Jhpiego and AVAC. The work is also supported by technical partners from Afton Bloom, Avenir Health, Columbia University, Mann Global Health, RTI International, the University of Pittsburgh and the University of Washington.
PxROAR and CureROAR
Supporting Advocate Education and Campaigns
AVAC’s PxROAR (Prevention Research, Outreach, Advocacy and Representation) and CureROAR trains US, European and African partners in advocacy to advance research and ultimately rollout of interventions related to HIV cure and prevention. The program provides mentorship, peer support, networking opportunities, technical support and financial assistance.
Supporting Advocacy Where it’s Needed
The ROAR programs bring together advocates around regional or topic-based issues to support specialized advocacy. Each ROAR cadre develops expertise and an advocacy agenda to advance key priorities. Providing this support means critical issues, such as the inclusion of transgender people in research or investment in cure research or scrutinizing the role of FDA approval in global access to new prevention options will be doggedly advanced by informed and effective advocates.
About the Project
The ROAR programs educate its members on the science of HIV prevention and cure research. Additionally, they demystify and empower members to understand the process of then delivering proven interventions to the communities that need these options most.
The ROAR programs also provide a platform for specific advocacy campaigns. The five cadres of ROAR advocates are PxROAR US, PxROAR Europe, PxROAR Africa, PxROAR TG and CureROAR. Members are based in Africa, the US and Europe, and represent the range of HIV-affected communities.
PxROAR United States & PxROAR Europe: These programs expand members’ capacity to contribute to advocacy for research, development and implementation of new HIV prevention options. Members track FDA and EMA licensing processes and advocate for sustained funding to key research entities including the US National Institutes of Health and European-based research institutes funded through the EU’s Financial Framework 2014-2020 and Horizon 2020.
PxROAR Africa: Through dialogues, shared learning and strategic action, this ROAR team advances the human right to health, including comprehensive HIV prevention treatment and care. With extensive experience in advocacy and activism aimed at securing self-determination, free expression, and culturally competent health services, PxROAR AFRICA’s work focuses on agendas that will eventually end HIV epidemics in their communities. Members represent LGBTQI individuals, sex workers and other criminalized and marginalized populations.
PxROAR TG: PxROAR TG articulates an HIV prevention advocacy agenda specifically for trans people within the framework of key populations’ needs and programs. Members are based in Southern and Eastern Africa.
CureROAR: The HIV cure field is undergoing a period of robust scientific investigation. The CureROAR program supports members to understand the relevant science and prepare an advocacy agenda that will ensure cure research reflects the needs, priorities and experiences of all populations affected by HIV. CureROAR is made up of members from countries where cure research is taking place and CureROAR members represent communities affected by HIV.
Contact
For more information on the PxROAR program, please email [email protected].
