Late last month, we learned of the exciting interim result of the PURPOSE 1 HIV prevention studyof injectable lenacapavir (LEN) for HIV prevention among cisgender women and adolescent girls after an independent monitoring board found it to be safe and highly effective against HIV. AVAC issued a statement calling for early planning to accelerate its regulatory review and for ambitious introduction plans, and the PURPOSE 1 Global Community Accountability Group (GCAG) and the African Women’s Prevention Community Accountability Board also issued a statementcelebrating the crucial role of African women and communities in this study.
In addition, AVAC is releasing the Lens on LEN: The basics on injectable lenacapavir as PrEP. This Advocates’ Primer provides background on the product and trials; a summary of the early findings of PURPOSE 1; key remaining questions; and critical next steps.
Global HIV Prevention Advocates Call for Accelerated Timeline for Widespread Access to Twice-Yearly Injectable Lenacapavir for PrEP
In this call to action, the PURPOSE 1 Global Community Accountability Board (GCAG), the Civil Society Caucus of the long-acting PrEP Coalition, the African Women Community Prevention Accountability Board, and the Coalition to Accelerate and Support Prevention Research (CASPR) call on all stakeholders to urgently come together to learn the lessons of past PrEP product introduction and apply them to compress the timeline for making this important new option to become widely available to those who need and want to use it.
New Drug Provides Total Protection from HIV in Trial of African Women
This New York Times article provides terrific perspectives from AVAC partners Linda-Gail Bekker, Yvette Raphael and Lillian Mworeko. “For a young woman who can’t get to an appointment at a clinic in a town, a young woman who can’t keep pills without facing stigma or violence — an injection just twice a year is the option that could keep her free of HIV,” said Lillian Mworeko, who leads a group called the International Community of Women Living With HIV Eastern Africa.
We hope this new primer and our joint call to action are helpful in our collective advocacy to translate these exciting clinical trial results into actual public health impact with speed, scale and equity.
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.
A Ray of Hope for Uganda LGBTQ Community Amidst Anti-Homosexual Law
Written by Namiganda Jael, a journalist in Kampala, Uganda. She is a health reporter, writer and anchor at Metro 90.8 FM. She is also media coordinator at Health Journalist Network Uganda and a member of Tobacco Harm Reduction Uganda and the Uganda Parliamentary Press Association.
When she felt a bruise on her private parts, Ramzay, a transgender woman and a sex worker who prefers to be identified by only one name for fear of persecution, rushed to the nearest health center for treatment.
While there, Ramzay asked the doctor for an ointment cream. The doctor loudly wondered if she was gay because the ointment cream was for gay people.
“I felt embarrassed and stigmatized by the rudeness of the doctor and her coworkers,” she said, adding that the doctor’s response was a negative attitude she’d repeatedly experienced in other public hospitals whenever she visited to seek health services, including Human Immunodeficiency Virus (HIV) prevention.
When Ramzay tested HIV negative at the beginning of 2023, she decided to visit a local group, Justice and Economic Empowerment for Women and Girls Organization (JWEEG), for HIV preventive products, such as condoms, lubricants, Pre-exposure prophylaxis (PrEP), and post-exposure prophylaxis (PEP).
However, when the anti-homosexuality bill was signed into law by President Yoweri Museveni in May 2023, she became worried that access to HIV preventive treatment would be hampered. She was right.
PrEP and PEP are treatments for people at risk of HIV exposure. PEP is more commonly used and is given to people who have been raped and to medical professionals exposed to HIV while working. It’s only given to people who have tested HIV-negative.
JEEWG was founded in 2015 by Waseni Harriet, also known by her trade name Cindy. Her focus was to bring HIV preventive methods such as condoms to Kasensero village, where she saw her fellow sex workers washing and sharing condoms.
Harriet Wesani, founder JWEEG
It started with 25 members, but today, the organization has over 1,000 members who seek a wide range of services, including sexual and reproductive health, Waseni said.
To achieve her goal, Waseni looked for health service providers she could partner with to help bring HIV prevention and treatment measures to her community, including men who have sex with men and transsexual women.
But together with her partners, she did not give up. “So, we try to follow up on cases, especially those in the LGBT community affected by the law. At MARPI, we get all kinds of HIV medication; we collect ARVs for those who cannot pick it up from the facility because of fear or stigma,” she says, adding that for those who have relocated because of the law, HIV medication is taken to them or rendered to them in the nearest pick-up centers in the new areas.
In May 2023, Uganda passed a draconian and unconstitutional anti-homosexuality law. Sub-section two of Section Two of the Act states that a person who commits the offense of homosexuality is liable on conviction to life imprisonment.
In November 2023, human rights activists went to the constitutional court seeking nullification of the impugned law, arguing that it violated the human rights of homosexual people.
The decision came on April 3, 2024. Despite the court agreeing with the petitioners that some sections of the law infringed human rights as they were “…inconsistent with the right to health, privacy and freedom of religion”, in a ruling read by Deputy Chief Justice Richard Buteere, it upheld the law to the chagrin of many observers.
Article 27 of the Constitution states that no person shall be subjected to unlawful search of the body, home or other property or to unlawful entry of his or her premises. Article 24 on freedom from inhuman treatment states that a person shall not be subjected to any form of torture, cruel, inhuman, or degrading treatment or punishment or held in slavery.
With the constitutional court upholding the anti-homosexuality law despite such provisions, the petitioners filed an appeal at the Supreme Court in April, says Nicholas Opio, a human rights lawyer and one of the petitioners.
Opio says he was disappointed in the court’s ruling. “Striking section of the right to privacy and right to health was an attempt to appease donors to the health sector,” he says, adding the ruling didn’t help with safeguarding the rights of the LGBT community, whose existence is criminalized.
Genesis, a gay man who prefers to be identified by his first name only for fear of stigma and harm, says, “…nullifying some sections of the law seems to slightly calm the pressure on the health of the LGBT+ community, but the law in its entirety is ridiculous”.
“When the court nullified sections that obliged a medical practitioner or any other person to report suspected acts of homosexuality to police, I felt some slight relief because I am at least not worried about being reported by a doctor to authorities after learning that I am gay. “At least the patient-doctor confidentiality has been reinstated,” says Genesis.
Sharaim Ismael has been a sex worker since 2020 at the age of 18. As a transgender woman, she was assigned a male identity at birth but identified as a female. She has been moving from one place to another as a security precaution for her safety since the passage of the anti-homosexual law, she intimates.
“Because of my sexual identity and work, I left home because most people were threatening me, especially after the passing of the bill (Anti-homosexuality bill), so I ran away to northern Buganda,” she says.
Sharaim gets lubricants and HIV testing kits at JEEWG, which she uses to test her partners as she neither takes PrEP nor uses condoms as an HIV preventive measure.
PrEP is HIV medication administered to prevent people from contracting HIV from unprotected sex by 99%. With the Injectable drug, the risk is reduced by 74%, according to the United States Centers for Disease Control and Prevention (CDC).
According to the World Health Organization, HIV prevalence among transgender women is estimated to be 28.4 in eastern and southern Africa. As of 2023, Uganda’s national HIV prevalence stood at 5.8%, according to the 2020-2021 Uganda Population HIV Impact Assessment.
Uganda Population HIV Impact Assessment
In 2017, the Uganda Ministry of Health introduced PrEP and PEP into the country to fight against HIV infections. However, it has been mostly out of reach to gay people “because of the stigma in some health facilities where they don’t feel safe to seek health services,” Sharaim laments.
Ramzay and Sharaim are among the key populations (most at risk) in Uganda, a community of people at a higher risk of getting HIV.
Key populations in Uganda include sex workers, prisoners, men who have sex with men, truck drivers, fishermen, and bodaboda riders.
According to the Uganda Population-Based HIV Impact Assessment 2020-2021, the HIV rate in the key population is said to be at about 11%. This is almost twice the national adult prevalence rate of 5.8%.
Another organization helping LGBT+ people in Uganda access critical reproductive health services is the Children of the Sun Foundation (COSF). Thanks to donor funding, it operates a free clinic and shelter for LGBT+ people.
COSF Executive Director Henry Mukiibi says despite their constitutional protection, members of the LGBT+ community have been shamed and publicly castigated by health workers in some public and private health services.
Henry Mukiibi, founder of COSF
“One LGBT+ patient came here suffering from a hemorrhage and told us how a doctor shouted at him to get out of his clinic, accusing him of being gay and promoting bad sexual behavior,” Mukiibi narrates.
Even with the stringent law, Mukiibi says the COSF clinic has a permanent nurse and an on-call doctor to attend to the patients.
COSF premises
For HIV prevention, the clinic provides testing kits, condoms, and lubricants to the LGBT QI community. However, for HIV treatments, they are referred to licensed health centers that safely provide HIV treatment services to the community.
But COSF also does home delivery of drugs to members of the community who don’t feel safe going to health facilities to pick up their drugs for fear of stigma, discrimination, and even violence, Mukiibi reassures. To get the deliveries, patients in need call COSF or send a colleague to submit a request for them. Sometimes, through phone calls and home visits, the Foundation also follows up with the patients who fail to turn up for their medicine.
Sam, who prefers to be identified by his first name for fear of victimization, had his ARVs delivered to him for several weeks by COSF because he feared getting out of the house for several weeks. After the passage of the bad law, he was violently attacked and abused by some members of the village due to his sexual orientation.
“The home delivery of my HIV treatment drugs came in handy. It helped me adhere to treatment until I gained the confidence to get out and also shift to a new home,” says Sam.
“For PEP and PrEP, we refer members of the community to organizations such as The Aids Support Organisation (TASO), a local NGO that has been supporting people living with HIV and also involved in the fight against HIV spread for over 30 years and REACH OUT, a Community Health initiative NGO providing HIV services working mainly with urban and rural poor communities in Uganda where they get such services,” Mukiibi says.
He adds that for members who don’t feel safe moving to public spaces, the clinic partners with such organizations, which are then invited to provide outreach services to the community gathered at the clinic.
Dr. Nelson Musoba, Director General of Uganda Aids Commission, a government agency that coordinates the response to the country’s HIV/AIDS epidemic, rightly says preventive measures should be accessible to everyone who thinks they are at risk of contracting HIV.
“Everyone in Uganda should have access to all available HIV treatment services in Uganda without any kind of discrimination regardless of who they are,” he says, adding that the anti-homosexuality law doesn’t stop anyone from accessing HIV treatment.
However, Mukiibi disagrees. “When we have laws that discriminate against LBGT people, you increase the risk of violence and discrimination against them. We have seen them being stigmatized and discriminated against in health service centers because of their sexuality. The law increases and feeds the homophobia attitude even in the health practitioners,” he says.
The Situation in Kenya
In neighboring Kenya, although the situation isn’t better than in other countries where anti-homosexuality laws have been passed, the LGBT+ people are better off when it comes to access to health services, says Ishmael Bahati, the executive director of Persons Marginalised and Aggrieved Kenya (PEMA) and co-chair of Gay Bisexual Men (GBSM), network in Kenya that brings together all gay, bisexual men organizations working on health.
“In Mombasa County, for example, we have 14 government facilities which we have already sensitized the service providers to offer not only friendly services but also specific services needed for the gay and GBSMs.”
“PEMA does not have a distribution chain; we only do referrals. However, with our position on the national level, like at the coast, we do referrals and advocacy on health, mainly ensuring that the public/ government facilities can offer services to LGBTQI persons,” he emphasizes.
With the constitutional court having upheld the draconian anti-homosexuality law, eyes now turn to the Supreme Court to appeal, where the petitioners have filed an appeal to overturn the lower court’s impugned decision.
Landmark Trial in South Africa and Uganda Finds Twice Yearly HIV Prevention Injection Safe and Highly Effective
AVAC Calls for Accelerated Regulatory Review and Ambitious Introduction Plans
AVAC welcomes the groundbreaking results of the PURPOSE 1 HIV prevention study among adolescent girls and young women in South Africa and Uganda. Preliminary safety and efficacy results were reported today by Gilead Sciences, the developer of the lenacapavir, one of the HIV prevention drugs that was being studied in the trial. An independent data and safety monitoring board (DSMB), at a scheduled review of the trial data, found the regimen to be safe and highly effective, with no infections seen among trial participants who received injectable lenacapavir.
“This is one of the most important results we’ve seen to date in an HIV prevention study,” said Mitchell Warren, AVAC’s executive director. “Adding additional HIV prevention options means more people may find an option that is right for them. Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most – from an easier to follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit.”
“We are incredibly excited about this result, especially about what it can mean for women in Africa,” says Nandisile Sikwana, Regional Stakeholder Engagement Manager for AVAC, and a member of the PURPOSE 1 Global Community Advisory Group. “We applaud Gilead’s commitment to Good Participatory Practice in this and the other PURPOSE studies. While we wait for full data from the study, including adherence data of oral F/TAF, it is imperative that planning for rollout of lenacapavir be accelerated. We know that even with the most ambitious timeline, it will take time for lenacapavir to be rolled out,” says Sikwana.
The PURPOSE 1 study enrolled over 5,300 cisgender adolescent girls and young women ages 16-26 in South Africa and Uganda. The study is evaluating injectable lenacapavir for PrEP and daily oral emtricitabine/tenofovir alafenamide (F/TAF) for PrEP. A companion trial, PURPOSE 2, is underway in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the US, testing twice-yearly lenacapavir for PrEP among cisgender men who have sex with men, transgender women, transgender men, and gender non-binary people. Results from PURPOSE 2 are expected by early 2025. Additional studies in critical populations, including PURPOSE 3 among cisgender women in the US and PURPOSE 4 among people who use injection drugs, are also underway, and it will be imperative to understand how today’s results influence these trials. A schematic of the suite of studies is here.
Gilead’s plans for submission to regulatory agencies and future access, including the US Food and Drug Administration (FDA), are not yet clear. But the results reported today make this urgent. “We expect to see a timeline that takes into account a full analysis of PURPOSE 1 data and the coming data from PURPOSE 2 from Gilead as soon as possible, and we urge regulatory agencies to prepare to fast track regulatory review,” Warren said. “We also call on WHO to be prepared to quickly include lenacapavir, if approved by regulatory agencies, in HIV prevention guidelines. There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact and expand the toolbox of HIV prevention choices.”
“We now know that lenacapivir for PrEP is safe and highly effective among women,” Sikwana added. “Even as we await the results of the trial among other essential populations and for regulatory submission and review, there is urgent work to be done now by communities, policy makers, funders and program implementers to design and build HIV prevention programs and prepare health systems to deliver the growing array of biomedical PrEP options, including the addition of twice-yearly injectable lenacapavir. The full range of PrEP products – including oral PrEP – must be made feasible choices for all people who need and want HIV prevention options.”
Lessons learned from roll out of daily oral PrEP, and more recently the dapivirine vaginal ring and injectable cabotegravir, can help speed regulatory approval and guideline development in key countries, design of effective programs, and community understanding of and acceptance of lenacapavir for PrEP.
“AVAC and a cadre of international partners have been working together to plan for successful, accelerated introduction of lenacapavir. Since oral PrEP was first shown to be safe and effective 14 years ago, the global health community has failed in delivering PrEP at scale and with equity – and we have, therefore, not seen the impact that we need. The lessons from the past are clear, and we now must act on them and move with speed, scale and urgency. There can be no excuses and no delays,” said Warren. “We look forward to working with civil society partners, Gilead, international donors, normative agencies and national governments to ensure that this groundbreaking HIV prevention option is made available as quickly as possible and that we don’t squander this opportunity to drive down new HIV infections.”
Advocates’ Guide to DoxyPEP
Earlier this month, the US Centers for Disease Control and Prevention released much-needed clinical guidelines on how and when to prescribe an oral antibiotic, doxycycline, as post-exposure prophylaxis to prevent acquisition of some bacterial sexually transmitted infections (STIs) after sex, so called “DoxyPEP”.
Doxycycline is relatively inexpensive, easily tolerated, and widely available. It’s a promising tool to prevent bacterial STIs, including chlamydia and syphilis. However, many questions remain, including how DoxyPEP should be implemented equitably, if it is effective among cisgender women, and how it might impact the STI rates in low- and middle-income countries.
Read AVAC’s New Advocates’ Guide to DoxyPEP
AVAC’s new Advocates’ Guide to Doxycycline to Prevent Bacterial STIs (DoxyPEP) highlights the many DoxyPEP advocacy needs and considerations and covers an update on what the data do and don’t say, what we all need to know about this promising strategy for STI prevention and what critical questions remain that require advocacy and action.
DoxyPEP alone is not a complete solution to the escalating epidemic of STIs. But in a field with few recent innovations and limited investments in new prevention, detection, and treatment tools, DoxyPEP holds important potential. Today’s research, implementation, and policy decisions about DoxyPEP can shape the path for much-needed STI research and development in the future.
We hope this new guide is helpful in our collective advocacy to ensure promising science is translated into public health impact.
The Pandemic Accord
A Critical Fight in 2024
As the World Health Assembly concluded the 2024 session in Geneva last week, member states failed to reach an agreement on the Pandemic Accord. Aimed at formalizing global agreements that would improve pandemic preparedness, prevention and response (PPPR), negotiations for the Pandemic Accord faltered around commitments to key equity measures. Member States agreed to extend the negotiations through 2024.
These issues are explained in AVAC’s updated Advocates’ Guide for PPPR in 2024, which covers what you need to know about still unresolved, but critical questions, such as agreements on sharing data and vaccines, and offers timelines in 2024 for strategic advocacy.
“Without these commitments, we will fail to gain the necessary lead time to get ahead of rapidly spreading health emergencies and will have no chance of eliminating new viral threats once they emerge.”
Follow the work of the Coalition of Advocates for Global Health and Pandemic Preparedness and AVAC’s PPPR Work by contacting PPPR specialist Samantha Rick at [email protected].
The Pandemic Accord is a once-in-a-generation opportunity to strategize in ‘peace time’ before the next pandemic hits. Civil Society priorities can and must lead this effort.
Join Us for Our GPP Webinar Series
Good Participatory Practice Guidelines have been shaping and improving clinical research since 2007. They provide a global reference guide for ethical and effective stakeholder engagement, helping ensure the priorities of trial participants and their communities are centered in clinical trials and broader research agendas.
However, GPP implementation is far from easy—it looks different in every context, outcomes can be difficult to quantify, engagement work is often seen as secondary to clinical processes, and therefore, undervalued and under-resourced.
To help solve for this, last year AVAC introduced the GPP Body of Evidence, a new resource that brings together a set of tools highlighting the value of GPP, as well as the nuts and bolts of how to get it done.
Now join us for a series of webinars in collaboration with The Global Health Network, Wellcome Trust, and WHO, to analyze the current state of GPP and discuss areas of growth and further development as we chart the way forward.
Register for the GPP Body of Evidence Series
It’s Not Just About the Trial: GPP from discovery to delivery in TB research June 12, 2024 at 10am ET
GPP enhances every stage of the research lifecycle. In this webinar, our partners at TB Alliance and SMART4TB will share their experience, lessons learned, and innovative approaches in integrating GPP at the organizational, network and site level, from drug development through delivery.
More webinars coming soon, including Not Your Average GPP: Non-traditional approaches and A GPP Roadmap for the Future: Professionalizing, measuring and requiring!
Watch this space for more details.
It’s time for GPP to become an international standard for clinical research. Making that case and making it happen, using the GPP Body of Evidence, has never been easier.
Civil Society Voices at World Health Assembly
The annual World Health Assembly (WHA) is convening the last week of May in Geneva, Switzerland. As the decision-making body of the World Health Organization (WHO), amongst many other issues, the WHA will be attempting to finalize the Pandemic Accord after two years of ongoing negotiations.
The Pandemic Accord aims to strengthen pandemic prevention, preparedness and response (PPPR) by addressing coordination, equity principles, and financing expectations. The agreement will, hopefully, also take on a range of capacity issues, such as disease surveillance, support for healthcare workforces, lab facilities, and resources for non-pandemic related healthcare.
The Pandemic Accord is a once-in-a-generation opportunity to strategize in ‘peace time’ before the next pandemic hits. Civil Society priorities can and must lead this effort. Join us!
Upcoming Webinar
Join us on May 28 for a civil society and community perspective on the Pandemic Accord. Click below for more details and to register.
As we prepare to commemorate HIV Vaccine Awareness Day (HVAD) on May 18, the field continues to see some modest scientific breakthroughs, while still facing extraordinary challenges. Despite having an evolving toolbox of highly effective prevention options including new long-acting PrEP, we continue to see high HIV incidence in hard-hit corners of the world. Many advocates and researchers agree that ending the HIV epidemic globally without a vaccine will be extremely difficult—even with long-acting PrEP products on the market and more on the way.
“This toolbox of PrEP options will hopefully be transformative, but it is critically important that we still prioritize a vaccine.”
– Nina Russell, Director of TB and HIV R&D, the Bill & Melinda Gates Foundation on the new PxPulse podcast
Scroll through our list below for an exciting new podcast, HVAD webinars, and other key resources to mark HVAD 2024.
New PxPulse Podcast Episode!
Listen to the newest PxPulse podcast, “An HIV Vaccine: Looking into the future with Nina Russell with Nina Russell of the Bill & Melinda Gates Foundation who talks about where she sees promise in the science, the goals for an HIV vaccine, and why it has an essential role to play alongside the scale up of PrEP.
Join the Choice Agenda to gain a broad understanding of the current landscape for HIV vaccines and what discovery medicine means for HIV vaccine research and development moving forward, with a focus on community and advocacy priorities.
AVAC’s issue briefs, From the Lab to the Jab, cover the barriers to, and solutions for equitable access to vaccines in low- and middle-income countries. During this webinar, an expert panel will discuss lessons learned, an international initiative for vaccine development, and how research and access can be improved.
Partner Events
Communities across the globe are engaging in a wide array of events focused on HIV vaccine awareness. Watc this space for upcoming details on local and regional activities the Coalition to Accelerate & Support Prevention Research (CASPR) partners are leading.
Infographic
20 years and 12 efficacy trials have delivered two positive signals for vaccines and bNAbs, but unfortunately many more flat results. This infographic provides this historical timeline and key information about each trial.
And, on the heels of last week’s HIV Vaccine Trials Network (HVTN) annual meeting, where much discussion surrounded the potential of role of bNAbs in prevention (see AVAC’s 2023 HVAD spotlight on bNABs) be sure to watch this space for more resources that unpack it all.
AVAC Response to Uganda’s Constitutional Court Ruling on the Anti-Homosexuality Act
AVAC is gravely concerned with the Constitutional Court of Uganda’s recent decision to uphold the core provisions of the Anti-Homosexuality Act of 2023 (AHA) that was signed into law nearly one year ago. AVAC stands in solidarity with the LGBTQIA+ community in Uganda, and globally, in calling out this dangerous law.
“We had hoped that the AHA would be repealed in its entirety, as it is a clear violation of the health, rights and humanity of the LGBTQIA+ community, and will undermine and reverse Uganda’s progress in HIV prevention, destroying community wellbeing and taking lives along the way,” said Angelo Katumba, Senior Program Manager at AVAC. “We’ve seen the direct link between criminalization and stigma and the devastating impact both have on HIV incidence. Even with the partial repeal of four provisions within the law, the AHA remains in place and will continue to drive people underground, discouraging the most vulnerable populations from seeking testing, treatment and prevention, and they will setback the fight against HIV.”
The Anti-Homosexuality Act of 2023 (AHA) was brought to the Constitutional Court of Uganda for ruling on its legality late last year with advocates challenging the constitutionality of the law before the courts for months. Civil society advocates for LGBTQIA+ and HIV prevention have worked tirelessly over the years to change attitudes and policy in Uganda and around the world. The failure to nullify this law in full intensifies the threats faced by communities that have fought tirelessly for safety and recognition. Advocates are expected to repeal the ruling to the Supreme Court of Uganda.
Uganda’s Anti-Homosexuality Act is one of the world’s most extreme anti-gay laws, enacted at a time when several other countries, including the US, are seeing the right to health undermined through legal action and anti-LGBTQIA+ laws on the increase. Today, the Uganda’s Constitutional Court even referenced the 2022 United States’ Supreme Court opinion on Dobbs v. Jackson Women’s Health Organizationas part of its justification for the legality of the Uganda AHA.
“It is deeply disturbing to see how Uganda’s attack on human rights and evidence-based public health is influenced by and coordinated with extremist views in the US and on the US Supreme Court,” said Mitchell Warren, AVAC’s executive director. “This is a staggering message that a rights-based approach to healthcare is imperiled in many countries by reactionary movements that are gaining strength from each other.”
“We must stand up and fight back against these laws everywhere or we will never end any epidemic. We stand in solidarity with all allies and partners committed to turning the tide from hate and fear to global health equity for all,” Warren added.
Since the Ugandan law was passed last year, the number of clients attending drop-in centres providing HIV prevention and treatment services to key populations, including men who have sex with men, dropped from an average of 40 per week to two.
