Innovations in GPP

This webinar on September 11 featured speakers from around the world with experience implementing GPP at research sites, within networks, and at the sponsorship level.

They illustrated how GPP can expand beyond the more familiar (but always reliable) CABs and town hall meetings to newer ideas like partnership-based approaches, the creation of a community scorecard, and more.

Moderator and Presenter:

  • Ntando Yola, Desmond Tutu Health Foundation

Presenters:

  • Sarah Read, National Institute of Allergy and Infectious Diseases
  • Clever Chilende, Treatment Advocacy & Literacy Campaign (TALC)

Recording / Clever Chilende Slides / Sarah Read Slides / Ntando Yola Slides

Avac Event

Breaking New Ground: Expanding Access to Lenacapavir—Lessons from Dolutegravir and the Future of HIV Prevention

This UAN Call, titled Breaking New Ground: Expanding Access to Lenacapavir—Lessons from Dolutegravir and the Future of HIV Prevention, brought together global health experts, community advocates, and civil society organizations to discuss the challenges and opportunities in ensuring equitable access to Lenacapavir.

This webinar was hosted by Unitaid.

Avac Event

Restrategizing Civil Society Engagement for Pandemic and Global Governance

As we are building back from the aftermath of the COVID-19 pandemic, current and future generations face multiple grand-scale challenges, including the climate crisis, related disasters, pollution, and biodiversity loss. These challenges also heighten the threat of future pandemics from emerging or re-emerging diseases. On the 14th of August 2024, the WHO has declared the Mpox outbreak as a public health emergency of international concern (PHEIC) under the International Health Regulations (2005) (IHR), which highlighted the growing concerns.

The recent amendments to the IHR (2005), agreed upon during the 77th World Health Assembly, are pivotal in enhancing global health regulations. These amendments aim to address the shortcomings revealed by the COVID-19 pandemic. Fundamental changes include a broadened definition of pandemic emergencies, principles of solidarity and equality, and reinforced WHO authority.

We aim to draw lessons from the successful experiences of diverse CSOs in enhancing inclusivity in multilateral discussions and implementation of agreements/treaties on topics such as one health, other health issues, climate, human rights, and more. For example, the processes leading to the Paris Agreement have set important precedents for integrating diverse voices and ensuring meaningful participation in global decision-making. Indigenous groups have also been involved in the inception to implementation processes of the Convention on Biological Diversity (CBD).

This side event aims to serve as a consolidation platform for civil society to share and find strategies that redefine civil society roles in global decision-making processes that address health threats such as future pandemics, climate crises, and others.

Objectives

The side event will reassess the strategies utilized to expand the role and involvement of civil society in global governance for health, climate, and other development sectors. The event’s objectives are further detailed in the following:

  • To explore and develop concrete strategies that enhance participatory, inclusive global governance for health, climate, human rights and other global challenges, starting from the Pandemic Agreement through meaningful civil society engagement, particularly in the face of shrinking civic spaces.
  • To foster collaborations among CSOs from multiple sectors to advance health and health-related development agendas.

Moderator:

  • Samantha Rick, Multilateral Engagement and Pandemic Preparedness Advocacy Specialist, AVAC

Speakers:

  • Eloise Todd, Co-Founder and Executive Director of Pandemic Action Network
  • Lawrence O. Gostin, Faculty Director O’Neill Institute for National and Global Health Law
  • Neil Vora, Executive Director of Preventing Pandemics at the Source
  • Olivia Herlinda, Chief Research and Policy at CISDI

Avac Event

Sustainability of the HIV/AIDS Response – Getting to 2030 & Beyond

The state of the HIV/AIDs endemic is reaching a critical point requiring evaluation of the current state of the global response, progress made thus far, and planning for post-2030 goals. The National Academy of Medicine is hosting a timely international meeting to facilitate discussion on these issues.

This one-day workshop is being held on September 18, 2024, from 9:00 AM – 5:00 PM US Eastern. Ambassador John N. Nkengasong, the Senior Bureau Official for Global Health Security and Diplomacy at the US State Department, will deliver the opening remarks. His address will set the stage for discussions across three subsequent panels.

Broadly, the goals of this workshop are to:

  • Explore how we can re-energize the global HIV response to reach the 2030 goals but also to look beyond.
  • Craft strategies to increase and sustain political commitment.
  • Highlight global accountability and domestic-donor financing.

AGENDA HIGHLIGHTS:

Introduction and Welcome

  • Victor Dzau, National Academy of Medicine
  • Carlos del Rio, Emory University and National Academy of Medicine

Opening Remarks

  • John N. Nkengasong, U.S. State Department

Post-2030 Strategy: Achieving 2025 Goals & Optimizing Future Response

  • A summary of response since the setting of the 2030 agenda – successes, shortfalls, areas to evolve – and discussion of how to build upon momentum to design impactful, sustained response post-2030.

Sustaining Political Commitment to Ending HIV as a Public Health Threat

  • Discussion of how to sustain and increase global political support for prioritizing the HIV response to end the epidemic and sustain support post 2030.

Global Accountability: Domestic and Donor Support

  • A conversation on strategies to garner joint accountability as well as domestic and donor support for current and future financing of the HIV response.

New Peer-Reviewed Articles, Upcoming Webinars & More!

Dear Advocate,  

AVAC and partners authored three new peer-reviewed articles this month on a range of HIV prevention issues. From the potential and challenges of long-acting formulations in HIV care, to the benefits of delivering family planning AND PrEP using pharmacies, e-pharmacies and private sector clinics, to the necessity for gender-transformative approaches to ensure effective and equitable participation of women in biomedical prevention trials, these are must-read pieces. Scroll down for more and mark your calendars for four webinars coming up, including this week!

The Long Wait for Long-Acting HIV Prevention and Treatment Formulations

This commentary in The Lancet HIV calls on WHO, financial donors, manufacturers, and governments to take coordinated action to make long-acting HIV prevention and treatment available at scale in lower- and middle-income countries.

Harnessing Private Sector Strategies for Family Planning to deliver the Dual Prevention Pill

The latest edition of the Journal of the International AIDS Society features newly published research by AVAC and partners on the benefits of delivering family planning and PrEP using pharmacies, e-pharmacies and telemedicine, in addition to private sector clinics. The research demonstrates why these delivery methods should be prioritized for rolling out the Dual Prevention Pill (DPP), a daily pill that combines oral PrEP with an oral contraceptive to prevent both unintended pregnancy and HIV. 

Meta-analysis of Pregnancy Events in Biomedical HIV Prevention Trials in Sub-Saharan Africa: Implications for Gender Transformative Trials

CASPR partners authored new research published in AIDS and Behaviorhighlighting the need for clinical trial teams to balance the goals of generating scientific evidence with participants’ fertility choices. The authors argue that to better support participants, trials should adopt strategies that accommodate changing fertility preferences, plan for pregnancies, and consider the ethical implications of allowing pregnant participants to continue in studies. This approach would contribute to a more gender-transformative approach to pregnancy in HIV prevention trials.

Mark Your Calendars: Upcoming Webinar

TOMORROW, August 27: Opportunities to Expand Equitable Access to HIV Prevention Services through Community Pharmacies 
Join The Choice Agenda and RxEACH, a national coalition effort working to expand and sustain access to HIV prevention and linkage to care services in community pharmacies for a webinar discussing the opportunity to expand equitable access to HIV prevention services, including PrEP, and what is needed to grow and sustain community-based HIV prevention service programs in pharmacies. 

August 29: Let’s Talk LEN: What global advances in HIV prevention mean for Black communities in the US
Join PrEP in Black America, Black Public Health, Federal AIDS Policy Partnership (FAPP), AVAC, and APHA, this webinar will explore the implications of the groundbreaking results from the PURPOSE 1 trial of Lenacapavir for US Black populations.
 
August 29: PrEP Your Booty
Join The Choice Agenda and HPTN 106 (REV UP), an innovative clinical trial from the HIV Prevention Trials Network that will investigate the safety and acceptability of a tenofovir-based rectal douche for HIV prevention, for a discussion with researchers leading the study.
 
September 11: Innovations in GPP
Join AVAC and champions of Good Participatory Practices (GPP) as they illustrate the evolution of GPPS from CABs and town hall meetings to more innovative and partnership-based approaches.

Avac Event

Innovations in GPP

This webinar featured speakers from around the world with experience implementing GPP at research sites, within networks, and at the sponsorship level.

They illustrated how GPP can expand beyond the more familiar (but always reliable) CABs and town hall meetings to newer ideas like partnership-based approaches, the creation of a community scorecard, and more.

Moderator and Presenter:

  • Ntando Yola, Desmond Tutu Health Foundation

Presenters:

  • Sarah Read, National Institute of Allergy and Infectious Diseases
  • Clever Chilende, Treatment Advocacy & Literacy Campaign (TALC)

Recording / Clever Chilende Slides / Sarah Read Slides / Ntando Yola Slides

Impact of the Anti-Homosexuality Act on PrEP Uptake Rates in Uganda Compared to Other Countries

Oral PrEP initiations in Uganda were among the highest in the region, with sizable increases each quarter, until the enactment of the Anti-Homosexuality Act (AHA) in March 2023. Since then, the number of new PrEP initiations plummeted, and have since struggled to sustain rates seen in 2023. Public policies clearly matter.

African Networks of People Living with HIV Seek Resource Commitments in the Fight to End HIV

A coalition of African People Living and Affected with HIV released a statement during the 25th International AIDS Conference to extend gratitude to the international community for their contributions in ending the epidemic globally, but also highlighted several concerns including the need for sustained investment, efforts to push for a 5-year PEPFAR reauthorization, and advocating for key populations as they face increased discrimination.

Read the full statement here.

Avac Event

2024 IUSTI World Congress

The International Union Against Sexually Transmitted Infections (IUSTI) and ASHM are pleased to invite you to the 25th IUSTI World Congress, which will this year incorporate the Australasian Sexual and Reproductive Health Conference.

Taking place 17-20 September 2024 at the International Convention Centre in Gadigal Country, Australia, this conference will provide an opportunity to meet, discuss and learn about the latest research and innovation in sexual and reproductive health. The program will incorporate a range of world leading speakers and presentations, providing an opportunity to expand your professional knowledge through local and international insight.

Click here for registration and more info.

Global HIV Prevention Advocates Call for Accelerated Timeline for Widespread Access to Injectable Lenacapavir for PrEP

A Joint Statement

Today a global cadre of HIV prevention advocates is calling for an accelerated timeline for access to the HIV prevention drug lenacapavir. Gilead, the developer of the drug, announced topline results from a large study among cisgender African women on 20 June, followed shortly thereafter with a statement about access. 

There is much to do before this twice-yearly HIV prevention option can be included in comprehensive prevention programs, and this coalition of civil society groups is calling for all stakeholders to urgently come together to apply lessons of past PrEP introduction to accelerate the timeline for this important new option to become widely available to those who need and want to use it.

“This is an incredibly important day for African women. Twice-yearly injectable lenacapavir will be an important addition to HIV prevention choices and has the potential to expand access to more women who need and want effective prevention options.”

Ntokozo Zakwe, Community Media Trust in South Africa and a member of the PURPOSE 1 Global Community Advisory Group (GCAG)

“African women need and want new HIV prevention options. We need everyone who has a role to play in bringing lenacapavir to our communities to prioritize the most progressive timeline the world has seen for rollout of a new prevention option, while collaborating with civil society and advocates to ensure introduction plans will result in uptake and impact.”

Chilufya Kasanda Hampongo of Treatment Advocacy and Literacy Campaign in Zambia and a co-leader of the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP

Leaders of the PURPOSE 1 Global Community Accountability Board (GCAG), the Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP, the African Women Prevention Community Accountability Board, and the Coalition to Accelerate and Support Prevention Research (CASPR) have partnered with AVAC to identify the following actions for Gilead, regulators, normative agencies, funders and national policymakers:

  • All stakeholders must prioritize and uplift community voices and community choices for including lenacapavir in the range of HIV prevention options that offer the widest choice to the most people.
  • Gilead should prioritize and quickly share analysis of the data from PURPOSE 1 and begin submission to multiple regulatory agencies on an accelerated and parallel schedule, with the potential to add data from PURPOSE 2 (among other studies) on a rolling basis to the regulatory portfolio. At the same time, national regulatory agencies need to be ready to review the data once submitted and act swiftly in making regulatory decisions.
  • WHO must begin preparations now for including lenacapavir, once approved, in HIV prevention guidelines as swiftly as possible, in time for regulatory approval.
  • Gilead should transparently share clear plans for pricing of lenacapavir and access for communities most in need, and commit to providing enough drug to support early launch and rollout.
  • Following Gilead’s announcement last week that they are developing a direct voluntary licensing program for lenacapavir, it is imperative that Gilead grants non-exclusive licenses to multiple generic manufacturers in multiple geographies before the end of the year; that license agreements are made publicly available; and that the licenses include access to finished product based on public health imperatives, and not on World Bank country classifications or geographical location. 
  • PEPFAR and the Global Fund should work urgently with other donors and Ministries of Health to negotiate price and volume guarantees with Gilead to ensure there is a sustainable supply for the initial introduction period until generics are registered and readily available.
  • Funders, Ministries of Health, implementers and civil society partners need to collaboratively ​​design a comprehensive introduction strategy that breaks the sequential nature of traditional approaches to scale and speed up introduction. Part of accelerating speed is moving toward a parallel approach where research, implementation science, and scale-up programs are designed, funded and implemented in parallel. All stakeholders, working through the Coalition to Accelerate Access to Long-Acting PrEP, should commit to developing a robust introduction strategy ahead of regulatory approvals and WHO guidelines to ensure time is not lost.
  • Ministries of Health and policymakers must work together and with donors to ensure lenacapavir is integrated swiftly into national guidelines and prevention programs and made available to all populations for which the drug is approved and recommended.
  • Ministries of Health, policy makers and donors must work to ensure strategic demand creation and health-systems strengthening to support robust HIV prevention programs that provide a full range of HIV prevention options that allow people to choose what works best for them.
  • All stakeholders must commit to speeding long-term access to lenacapavir to trial participants and to the women in the communities that hosted the study in parallel with increasing access to a full range of HIV prevention options to those who need and want them.

Advocates know that there are many more actions that will be needed to ensure lenacapavir and other HIV prevention options are widely available. Transparency, speed, scale and cooperation are essential as we work to end HIV as a public health threat.

“We have never seen such a good outcome from an HIV prevention trial, and to see such a result first among African women is groundbreaking. Gilead listened to advocates and followed Good Participatory Practice Guidelines to include two of the populations most in need of  HIV prevention – adolescent girls and pregnant women – in the study. National prevention programs must also prioritize these populations in PrEP programs that will provide lenacapavir.”

Lillian Mworeko, ICW East Africa and a leader of the African Women Prevention Community Accountability Board

“Results like this are what we’ve been waiting for throughout decades of HIV prevention research. We know what is needed now to move this drug swiftly to communities. Civil society stands ready as watchdogs of the process and as essential partners in a successful rollout.”

Stacey Hannah, director of the Coalition to Accelerate and Support Prevention Research (CASPR) and AVAC’s director of research engagement

Results from the ongoing PURPOSE 2 study among cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth are expected in late 2024 or early 2025. This second pivotal study will provide data, not just for gay men, but for trans and gender non-binary people, populations that have often been ignored by HIV prevention studies. Data for PURPOSE 2, along with PURPOSE 3, 4 and 5 studies, will provide the most comprehensive range of data across populations that has been seen to date. A schematic of the suite of studies is here.

“We eagerly await the PURPOSE 2 data and hope to see similar results for the populations represented in that study who also need new choices for HIV prevention. Lenacapavir has the possibility of transforming the HIV prevention landscape and changing the lives of millions of people around the world. There must be no delays in making it available globally. Now more than ever, we need speed, scale and equity to ensure we get impact.”

Mitchell Warren, AVAC’s executive director.

About

  • PURPOSE 1 Global Community Accountability Board (GCAG): The PURPOSE 1 and 2 efficacy trials each include Global Community Accountability Groups (GCAGs). Members of the GCAGs include leaders in HIV advocacy and experience with engagement in research and  development. Individual trial sites also have their own community-specific community advisory board, creating multiple layers of advocacy feedback.
  • Civil Society Caucus of the Coalition to Accelerate Access to Long-Acting PrEP: Established in 2022 to ensure civil society expertise influences the rollout of long-acting PrEP options, this Caucus includes representation from many civil society groups working on longer-acting PrEP introduction. These include, but are not exclusive to, the following: African Women Community Prevention Accountability Board; AfroCAB; APCOM; AVAC; Coalition to Accelerate and Support Prevention Research (CASPR); Frontline AIDS; Global Black Gay Men Connect (GBGMC); the Global Key Population Advisory Group; and ITPC.
  • African Women Prevention Community Accountability Board: The Accountability Board led the development of the Choice Manifesto and works ensure that the manifesto is translated into reality for all women, and is composed of 12 women from 7 countries representing East and Southern African nations.
  • Coalition to Accelerate and Support Prevention Research (CASPR): CASPR is an Africa-led coalition of 13 partners, funded by USAID and supported by AVAC, working together to change how HIV prevention is pursued and delivered. CASPR activities are focused primarily in key African countries with the highest burden of new HIV infections, and where biomedical HIV prevention research is ongoing or planned.
  • AVAC: AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity.