STIWatch Newsletter, March 2024

The first quarter of 2024 ends with new research and questions on the future directions of STI vaccines and diagnostics. The Conference on Retroviruses and Opportunistic Infections (CROI) was the setting for positive news on the potential for early use of doxycycline to prevent STIs (DoxyPEP) in real-world settings and questions about its effectiveness in cisgender women given major evidence gaps. Important discussions and debates continued around the issue of antimicrobial resistance (AMR), as the field continues to grapple with the rollout of DoxyPEP. Presentations at CROI also highlighted the need for new diagnostics for syphilis as infections continue to increase globally and the need for STI advocacy efforts to ensure these infections get the attention and funding needed to develop vaccines and diagnostics that can prevent, detect, and treat these infections!    

In January, the US Centers for Disease Control and Prevention (CDC) released the STI surveillance data from 2022, which showed an increase in chlamydia and syphilis cases from 2021. Gonorrhea cases decreased between 2021 and 2022 by 9%. Alarmingly, 2022 congenital syphilis cases increased by 30% from 2021, signaling an urgent need for novel prevention, treatment, and testing methods.  

In Australia, a group of researchers published a response to the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine’s October 2023 statement on the use of DoxyPEP in Australia. The authors point to the potential threat of increasing AMR and the urgent need to implement measures to monitor DoxyPEP use and its impact.  

Read on for upcoming webinars, must-read resources supporting advocacy for improved funding and commitments for STI vaccines and diagnostics. Afterwards, test your knowledge with AVAC’s new STI Trivia quiz.  

New Report! STIs: A Review of the 2022 Vaccine and Diagnostic R&D Pipeline and Investments 

STI Vaccine and Diagnostic R&D Funding by Pathogen

new AVAC report tracks funding trends in vaccine and diagnostics R&D, and pipeline investments for some of the most common STIs, including chlamydia, genital herpes, gonorrhea, hepatitis B, human papillomavirus (HPV), syphilis, and trichomoniasis. The report finds that STI research remains underfunded and neglected compared to other infectious diseases. Read the report to learn more.


STI Advocacy Updates

AVAC spoke with two cervical cancer advocates, Tamika Felder and Karen Nakawala, in January as part of its cervical cancer webinar series. Felder and Nakawala are breaking taboos and saving lives by empowering people to share their stories of survivorship and senseless loss. 

Felder, founder of Cervivor, Inc., was diagnosed with cervical cancer at 25, and turned her struggle into a mission, providing resources and a platform for those affected by the disease. Her impactful work and advocacy inspired Nakawala to found the Teal Sisters Foundation in 2020, following her successful treatment for cervical cancer. To learn more about Tamika and Karen, watch AVACs cervical cancer webinar. Thank you, Tamika and Karen for all that you do!  

January 18 marked HPV Awareness Day. AVAC and TogetHER for Health released an updated call to action to improve HPV vaccination among people living with HIV. In total, 31 organizations signed on to this call, urging global leadership to increase access to lifesaving HPV vaccines for people living with HIV.


Upcoming Events

STI Awareness Week is April 14 – 20!

Join us for two webinars focused on syphilis and DoxyPEP. These webinars are intended for health care providers, civil society organizations, public health officials, and others working in the STI/HIV fields. 

September 2024 STI Conferences

Registration is now open for two important STI conferences in September – which unfortunately are running concurrently in different parts of the world!

The  2024 STI Prevention Conference will bring 1,200 conference attendees to Atlanta, Georgia, from September 16-19, 2024. Abstracts are being accepted until March 29. 

The  25th IUSTI World Congress  will take place September 17-20, 2024, in Sydney, Australia, and provide an opportunity to meet, discuss and learn about the latest research and innovation in sexual and reproductive health.  


What We’re Reading and Resources

  • Testing, testing: the advancing diagnostics for sexually transmitted infections. Diagnostics are urgently needed to detect STIs and this article examines several that are on the horizon. A US-Based company, Qvin is developing the Q-pad, a diagnostic menstrual pad with a removable strip to identify signs of diabetes and symptoms of high-risk human papillomavirus. Daye, a UK based gynecological start-up, launched a diagnostic product that is a tampon with the ability to screen for STIs. These advancements are exciting and serve as a reminder that advocacy is needed to ensure these products get to the people who need them. 
  • CARB-X Funds Visyby Medical to Develop a portable rapid diagnostic for Gonorrhea Including Antibiotic Susceptibility Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award up to US$1.8 million to biotechnology company, Visby Medical, to develop a portable rapid polymerase chain reaction (PCR) diagnostic to detect gonorrhea and its susceptibility to ciprofloxacin, a former frontline oral antibiotic that can no longer treat gonorrhea infections resistant to this medication. Funding will also support development of a test for gonorrhea, chlamydia, and trichomoniasis in men based on urine samples.
  • Syphilis Complicating Pregnancy and Congenital Syphilis. This manuscript provides a review of syphilis during pregnancy and congenital syphilis. As syphilis and congenital syphilis infections continue to rise, novel approaches are needed to detect, prevent, and treat infections. Because syphilis disproportionately affects populations with limited access to healthcare, new and improved diagnostics and therapeutics will need to be embedded within a health framework that prioritizes equity to improve the diagnosis and treatment of congenital syphilis, a preventable disease.  
  • Near-to-patient-testing to inform targeted antibiotic use for sexually transmitted infections in a public sexual health clinic: the NEPTUNE cohort study. This study examines the effectiveness of a novel lateral flow assay for point-of-care detection of gonorrhea among people with symptoms. Lateral flow assays are tests that can detect the presence of proteins or antigens for specific infections, like COVID-19 and HIV. This test had excellent clinical sensitivity and specificity in detecting gonorrhea among male and female patients with symptoms. A test like this could provide an important tool to better detect infections in settings without direct access to laboratory testing and reduce overtreatment.
  • Breaking Barriers in STI Clinical Management: Addressing Resistance Challenges and Incorporating New Diagnostic Approaches. This on-demand webinar features Dr. Van Der Pol and Dr. William Geisler who share their insights on crucial aspects of STI clinical management, focusing on resistance challenges and new diagnostic approaches. 

To learn more about AVAC’s STI Program, visit STIWatch.org and avac.org/sti. Email sti@avac.org for questions or additional information. And to sign up for specific updates on STIs, click here.

African Leadership and Global Health Advocacy

The Coalition to build Momentum, Power, Activism, Strategy & Solidarity in Africa (COMPASS) has finalized a transformative and power-sharing approach to the governance and leadership of South-North coalitions. This new approach represents innovation that harnesses the power of the coalition. It is redefining and strengthening South-North relationships, and it offers a model for a field seeking to decolonize global health. The effort was built on a founding principle of power-sharing, and a commitment that COMPASS would ultimately be led by an African-based organization. Pursuing this vision has involved a multi-year, member-led process for creating a participatory governance framework. And it has resulted in reimagining COMPASS leadership, with African organizations in control.  

This case study explores the COMPASS approach that made these changes possible, the growing pains that informed the process for instituting change, and what others can learn from this experience.

Tune in for a podcast from AVAC!

Hear from COMPASS partners on the pioneering approach to power sharing, and from Dr. Madhukar Pai on the global context.

Learn More

What is COMPASS?

COMPASS was founded in 2017 as a data and evidence-based South-North civil society coalition. The coalition from its beginnings has been dedicated to advancing strategic advocacy campaigns to influence policies, programs and funding for the HIV response in East and Southern Africa, with a particular focus in Malawi, Tanzania, and Zimbabwe, and at the global level. In December 2023, Pangaea Zimbabwe signed a new two-year, $4.9 million grant agreement with the Bill & Melinda Gates Foundation as the new secretariat of COMPASS Africa, a role previously served by AVAC. In recent years, AVAC was part of a coalition-wide effort to develop a clear transition plan for COMPASS to be led by African civil society organizations.

Since 2017, with a grant from the Bill & Melinda Gates Foundation, 29 COMPASS partner organizations have launched dozens of campaigns and logged 31 significant advocacy wins, with many multi-year campaigns still in progress. To name just a few of the wins from COMPASS campaigns:

  • Tanzania has changed the legal age of consent to access HIV services from age 18 to 15 and uptake has since seen a marked increase in testing, and increased awareness of HIV status among people 15 and older from approximately 60% to 82%.
  • Zimbabwe and Tanzania piloted community-led monitoring (CLM), which funds communities to track data on HIV services and report back on progress toward country targets, and whether services are meeting community needs. CLM was so successful, PEPFAR expanded the program in Zimbabwe and rolled it out globally.
  • Malawi’s once marginalized civil society now serves on technical working groups, influences the allocation of PEPFAR dollars and has become an essential partner to the national government in planning for HIV policies and programs. All three countries have secured funds for key population programs.

In the initial three years, results like these were delivered from a coalition with centralized leadership. Africa-based partners identified priorities, activated strategic relationships, navigated in-country challenges and executed co-created campaigns. US-based COMPASS partner organizations shared expertise on data and other technical assistance and leveraged access to global-level decision makers, with AVAC holding the primary grant and coordinating the coalition Secretariat. Coalition guidelines, partnership agreements and a robust process for co-developing strategy kept the coalition on track, but with success came challenges. 

Partners wanted more opportunities to share lessons learned from each other’s campaigns and to lend capacity to one another. Roles and responsibilities needed more clarity. Partners sought broader participation and transparency in coalition decision-making, in selecting new members, and having a more formalized governance. Partners also sought to improve the existing channels for sharing feedback and resolving conflicts transparently and equitably. 

Coalition members were ready to see power structures rearranged, redistributed, formalized and documented.

Ulanda Mtamba, a COMPASS member based in Malawi, put it this way: “For us partners in the South, it could feel like someone else is driving the vehicle from afar, while all the work is happening here.” 

These sentiments reinforced the founding plan to shift management of the primary grant to an African-based partner. Just as important, these considerations informed an effort to re-shape the coalition and create structures to support an African partner-led, multi-country, multi-continent coalition. 

Coalition Governance: Transparency, Participation and Trust

To create the needed structures and support for greater transparency and power-sharing among all partners in the coalition, COMPASS spent one year developing a governance manual that increases accountability and consistency, formulates the coalition structure, clarifies roles and responsibilities, and establishes a process for determining who holds the Secretariat. 

Thirty-six volunteers from across the COMPASS Africa responded to an open call to develop a comprehensive, participatory governance framework. The volunteers selected a two-chair leadership team and a steering committee to run the development process. 

“Partners were given a chance to select the leaders of the process. It was important that the process was community-led and participatory, so coalition members truly felt ownership of COMPASS. That itself was something very important,” said Francis Luwole, COMPASS country coordinator in Tanzania. 

As four working groups tackled issues such as sub-granting protocols, new membership and definition of roles and responsibilities, the steering committee focused on overall goals to be reflected in the governance manual: prioritize transparency; ensure accountability to COMPASS values; maximize opportunities for members to participate in decision-making; and ensure the country coalitions had ample opportunity to review, provide feedback and validate the manual. Through regular in-person and remote meetings, anonymous surveys and country visits, the co-chairs fostered a shared ownership of the coalition’s structure, purpose and future.

“Before now… there were no guidelines to answer questions such as ‘who we are, why we’re here, or who are we doing this for—there was no clarity in some of the roles and responsibilities of members in the coalition, especially for new members. The expectation now is for the governance manual to provide an outline of what the structure of the coalition is and the roles and responsibilities of all coalition members,” said Ulanda Mtamba.

The case study found that the participatory nature of the process ensured that diversity and inclusivity were at the forefront of the new COMPASS governance structure by allowing the opportunity for as many voices as possible to have their opinions and inputs considered. It also fostered a shared sense of ownership that empowered many coalition members to invest and believe in the change to create an African-led coalition. 

The 63-page governance manual now covers, among other things: member obligations and benefits; a protocol for conflict resolution; a selection process for new members; guidelines for meetings; sub-grant management; an M&E framework; a process for ending coalition membership and terminating the secretariat; and defined principles and core values. It also establishes a governance committee to serve as a decision-making and strategy-setting body with representatives from every COMPASS country, global partners, and key constituencies such as adolescent girls and young women, key populations and people living with HIV. The governance committee will be the primary leadership structure of COMPASS going forward, with coordination support from Pangaea Zimbabwe as the coalition secretariat.

“It speaks to inclusion. It speaks to equity. Our core values and principles have been reflected in the way we have structured the coalition. I’m very optimistic that, once we fully operationalize the governance manual, we are going to come up with something really beautiful, something that other partners or other coalitions may want to adapt,” said Maureen Luba, Malawi-based COMPASS member.

For more on the colonial legacy of global health, The Choice Agenda held a discussion examining the historical legacies and power dynamics that continue shaping global health. Watch the recording.

Shifting the Secretariat

As of December 2023, coalition member Pangaea Zimbabwe became the primary grant-holder and COMPASS Secretariat. In this role, Pangaea Zimbabwe will make sub-grants, convene the coalition, and be the primary point of contact for the coalition with its donors, support campaign tracking & evaluation, and administer the process that selects coalition leadership and new members. Dedicated teams comprised of in-country partners with expertise on data analysis and monitoring & evaluation will provide technical assistance across the coalition. AVAC is now a sub-grantee partner of COMPASS, continuing to coordinate the team that provides strategic and technical support to partner campaigns, provide status updates and background on the R&D pipeline for HIV prevention, support COMPASS partners in their engagement with PEPFAR and the Global Fund, and link the coalition to global platforms and advocacy initiatives. 

“From our earliest conception, we outlined a vision of collective power and shared decision-making that has been central to COMPASS’s success. For that success to be sustainable, AVAC and the COMPASS coalition at large pursued a future in which governance would be centered among African-based partners,” said Mitchell Warren. 

“Since 2017, we’ve been breaking new ground under COMPASS. We’ve expanded our networks and brought together the superpowers of seasoned advocates with diverse strengths to develop and share technical expertise and winning strategies,” said Imelda Mahaka, Executive Director of Pangaea Zimbabwe. “COMPASS has built a strong foundation based on collaboration, knowledge-exchange and trust that can and will accelerate innovative advocacy under African leadership.” 

Putting in the Time: Sustaining the partnerships 

The development of the manual and Pangaea Zimbabwe’s assumption of the Secretariat involved a phased, transparent multi-year transition plan to guide the handover of the secretariat and sub-grants management. AVAC and Pangaea Zimbabwe held weekly calls on the process, COMPASS partners contributed feedback to the plan, and the entire coalition was able to track milestones defined for the transition process.    

“Partners stressed to us repeatedly the importance of not rushing the process. All coalition partners needed time and opportunity to meaningfully participate in designing the new governance framework. Integrating this input into the governance manual was more important than finding quick solutions. We found the same was true in the process of transitioning the secretariat. Pangaea Zimbabwe wanted an appropriate on-ramp to get comfortable in their new role, with plenty of support and other partners also wanted to know how AVAC was supporting the relationship between Pangaea Zimbabwe and the project’s donor. We all invested time in building trust and confidence. For those in power who are now looking for a sustainable way to shift that power to others, my message to you is that you can’t just throw the bag and run,” said Justine MacWilliam, AVAC’s senior program manager. 

“This process has showed how to share power and take away the dominance of power. The desire for social justice has underpinned these values, the desire to equalize power, and the desire to contribute to something that is a legacy,” said David Kamkwamba of the Network of Journalists living with HIV (JONEHA) in Malawi. 

As COMPASS campaigns continue apace with a freshly inked grant from the Gates Foundation, coalition members, and Pangaea Zimbabwe are referencing the manual, testing its strength, making changes and sharing their insights. It is bold, careful and imperative work to build and use structures for collective power and effective action. 

“AVAC and COMPASS have set new benchmarks in effective civil society mobilization, advocacy and collaboration between global North and South. AVAC’s commitment to empowering African leadership within the coalition reflects a profound dedication to ensuring sustainability and maximizing impact. Coalition members are beginning a new chapter, founded on their inspired, tireless commitment to deepening the impact of COMPASS under African leadership,” said Uganda-based COMPASS member, Kenneth Mwehonge.

This is giving hope, especially to global south partners, especially in these times when we are talking about decolonizing global health. It’s timely and strategic. It’s proving to each other our readiness to say ‘This is possible. We can have leadership in the Global South where the work is happening, where the epidemic is being fought,” said Luba.  

The COMPASS Coalition understands that doing business as usual will not advance HIV prevention or global health equity. And this new power-sharing model cannot turn the tide all by itself. But COMPASS partners hope fellow travelers who see the necessity of decolonizing global health will be interested in this model and will follow its progress. The work will certainly change and evolve based on what is learned in the months and years ahead, but there’s no going back.

New Podcast Episode: Decolonizing Global Health

Dear Advocate,  

Investing in the long-term success of African leadership is essential to breaking cycles that perpetuate inequity and that stall progress in the HIV response. In our newest episode of PxPulse, we explore why and how the decisions that shape global health must be made by those facing the greatest risks. As the world evaluates the pandemic response and debates on decolonizing global health gain momentum, equity in global health has never been more urgent.   

For more than seven years, COMPASS Africa, a civil society coalition of 29 organizations working in three countries as well as regionally and globally, has used data-driven advocacy to improve the HIV response with high-impact campaigns. In January, the coalition underwent a major transition, with Pangaea Zimbabwe assuming the role of secretariat (previously held by AVAC), marking a historic milestone in the development of innovative models for power-sharing in coalition and an important step toward decolonizing global health. These changes in COMPASS come as other efforts, such as negotiations on the Pandemic Accord, are struggling to advance, uphold or safeguard equity. 

Now is the time to test new models. In Decolonizing Global Health: Dr. Madhukar Pai and COMPASS Africa Tell Us Why and How, we explore what it takes to invest in equity and power sharing.

New Episode of PxPulse!

This episode of PxPulse features global health leader, Dr. Madhukar Pai, along with two leaders of COMPASS AfricaFrancis Luwole and Barbra Ncube, talking about new models of power-sharing.

Listen now!

Tune in to Hear

Join the Conversation

To continue the conversation, register for the March 26 Choice Agenda webinar, Decolonizing Global Public Health: Exploring the how, from now, til as long as it takes.  

Celebrating Rep. Barbara Lee and the Black Women Who Helped Shape the AIDS Movement

Following Black History Month and during Women’s History Month, it is important to honor Black women who have championed efforts in ending the epidemic and have led the ongoing fight in ensuring healthcare equity and justice for all. Someone who has worn multiple hats both as an advocate and as a US policymaker is no other than Representative Barbara Lee.  

Throughout Rep. Lee’s close to three decades-long tenure as a member of the US House of Representatives, She has single-handedly created material change for people living with HIV and those at risk of infection, marginalization and stigmatization, both in the US and around the world. As AVAC’s executive director Mitchell Warren says, “when the definitive history of this pandemic is finally written, there is no greater shero in our collective story than Barbara Lee. The AIDS response wouldn’t be where it is today without her.” 

From co-authoring the Global AIDS and Tuberculosis Relief Act of 2000 and establishing the framework for the Global Fund to Fight AIDS, Tuberculosis and Malaria, to her instrumental work in drafting and passage of the President’s Emergency Plan for AIDS Relief (PEPFAR), to introducing legislation that would eventually lift the decades-old discriminatory HIV travel ban to the US, to her relentless efforts advocating to reform HIV/AIDS criminalization laws in the US, most recently with the Repeal Existing Policies that Encourage and Allow Legal (REPEAL) HIV Discrimination Act, Rep. Lee has walked the walk. She put grassroots-led efforts at the center of US and global policy in relation to those directly impacted by the HIV/AIDS epidemic. 

Thank you, Rep. Barbara Lee, for the legacy you have built in forging an AIDS-free generation and for centering impacted communities throughout your work. We look forward to your efforts as co-chair and co-founder of the bipartisan and bicameral Congressional HIV/AIDS Caucus and a member of the full appropriations committee in continuing to support HIV/AIDS prevention, education, research and access to treatment while combatting stigma.   

In addition to celebrating the tireless advocacy of Rep. Barbara Lee during Women’s History Month, it’s important to name the Black women who have changed the course of the AIDS epidemic including, but of course not limited to Raniyah CopelandDázon Dixon DialloLeisha McKinley-BeachYvette Raphael, and those we honor in our everyday actions, Hydeia BroadbentKatrina HaslipDawn Smith, and the recently passed, Joan Gibbs

HIV Cure Updates and Opportunities

Last week’s Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, Colorado, was full of new research, provocative discussion and debate on a wide range of issues from longer-acting injectable PrEP; the dapvirine vaginal ring (DVR) in pregnancy; doxycycline as post-exposure prophylaxis (DoxyPEP) to prevent sexually transmitted infections (STIs); and so much more. Check out our daily summaries of highlights from CROI and recordings and resources from the daily Community Breakfast Club sessions

It was also the setting for important updates on the HIV reservoir lending to new insights into potential HIV cure strategies. Progress in HIV cure research, as part of a pipeline of biomedical tools to help end the epidemic, must be supported and guided by an advocacy agenda that puts communities first. Read on for cure highlights from CROI, new opportunities for cure advocates, and an upcoming webinar on pediatric cure research with Deborah Persaud and Gabriela Cromhout.

Cure Highlights from CROI – Q&A with AVAC’s Jessica Salzwedel

AVAC’s Jessica Salzwedel who leads our advocacy for HIV cure research and serves as the community engagement coordinator for Research Enterprise to Advance a Cure for HIV (REACH), Immunotherapy for Cure (I4C), and Pediatric Adolescent Virus Elimination (PAVE) shares her highlights from the research presented at CROI and insights into what it means for advocacy in this Q&A.

Read the Q&A

“Four preclinical and clinical results stood out because they advanced how researchers might tailor cure strategies to optimize the impact for people with HIV. We heard more about the potential role of sex hormones in directing the immune system in a study looking at fetus acquisition of HIV. Another study showed that women may be better candidates for the so-called “block and lock” strategy. We also heard results from the IMPAACT P1115 trial, which showed that early HIV treatment can lead to control of the virus in children. And a nonhuman primate study of adeno-associated virus (AAV), which delivered broadly neutralizing antibodies (bNAbs) may offer a pathway to a scalable, durable control option for pediatric cure. In basic science new data suggests that autologous neutralizing antibodies in some people delay rebound. And finally, we heard about rare T-cells that seem to resist killing, which could be important in developing strategies that could lead to durable control and eradication of HIV. ” Read the Q&A to see what it all means.  

Join Us for the 2024 Cure Academy

The Advocacy-for-Cure Academy, organized in partnership with the International AIDS Society, awards fellowships to advocates or peer educators to take part in workshops on HIV cure advocacy with international experts. The academy develops fellows’ cure research literacy and reinforces their advocacy and engagement skills in line with recommendations from Research priorities for an HIV cure: International AIDS Society Global Scientific Strategy 2021Applications are now open. Deadline Monday, 25 March 2024. The next Cure Academy runs June 8 – 10, 2024 in eastern Africa. 

And check out what five alumni from the program are doing with their fellowships intended to create solutions that advance HIV cure research in their local context. 

Webinar

Updates on Pediatric HIV Cure Research From CROI

Thursday, March 2, 10:00-11:30 am EST

Researchers Deborah Persaud and Gabriele Cromhout join AVAC’s Jessica Salzwedel to discuss the latest from CROI on pediatric cure.

REGISTER NOW

Resources

Wednesday’s CROI Roundup

By Jeanne Baron, AVAC Senior Producer & Editor

The presentations on the last day of CROI 2024 highlighted yet again that research conducted in ethical partnership with communities is about developing products and delivering them with speed, scale, equity and impact. Advocacy to build better systems to support the health and wellbeing of people all over the globe is a form of optimism about the future. From cure research findings to racial disparities in health, to regional Mpox responses, to a hard look at rollout challenges with existing HIV prevention options, CROI ended on a provocative note—challenging researchers and advocates alike to leverage what we have while developing what we need.  

Please enjoy our roundup from the final day of CROI and check out our summaries from Monday and Tuesday. And stay tuned for a full update on all the cure research coming next week! 

Community Breakfast Club research roundup 

More than 100+ advocates joined the final Community Breakfast Club meeting. Advocates Natasha Mwila and Moses Supercharger and researchers Carlos del Rio and Christina Farr offered highlights from sessions on the links between HPV and HIV; the latest cure research showing the potential of early treatment in children to control HIV; the potential of injectables for both treatment and prevention; and the need to accelerate access, especially following Tuesday’s SEARCH results. As one advocate on the call said, “We need to demand that access provisions are spelled out by innovators, as early as possible in the product development. Yes, choice is about the options that best suit your needs at any given time. But we can’t have choices when the options are out of reach.” There was also a clarion call to ensure mentorship for the next generation of scientists and advocates. 

The promise and pitfalls of biomedical prevention 

CROI ended on a powerful call to action to better understand the options that exist today and solve the problems of access. At one of the final sessions, Promise and Pitfalls of Biomedical Prevention: Beyond Phase III, three presentations put a spotlight on the status of approved products and the need for choice.  

Rupa Patel from the CDC took attendees through a maze of access barriers facing injectable cabotegravir – from insurance to personnel issues – in the U.S.— the only country with a commercial market at this time. Rollout in other countries is just beginning with initial, limited supply (1.2 million doses for low- and middle-income countries through 2025). Still, it’s moving faster than oral PrEP, where it took more than three years after FDA approval before a single African country approval. In contrast, just two years post-FDA approval, seven African countries have approved injectable cabotegravir, with several others pending. (Check out AVAC’s PrEP tracker for details.) But these gains are still too slow. Patel concluded by offering future solutions, including accelerating the entry of generics in the market, pursuing scientific and regulatory efforts in parallel, and expanding models that build up community delivery of HIV services.  

Leila Mansoor laid out the complex journey of the dapivirine vaginal ring (DVR). Initial efficacy trials reported approximately 30% efficacy, but Mansoor presented additional exploratory analyses that estimated risk-reduction could actually be 75-91% with high adherence. In addition, the REACH study showed that when young women are offered high-quality counseling and choice, it results in high adherence; the young women in REACH preferred DVR to oral PrEP by 2 to 1. Data presented earlier this week expanded the evidence of the DVR’s safety for people who are pregnant and lactating. And 11 countries have approved it. Mansoor’s call to action: women need and want DVR as an option, and it is now being added to the SEARCH study.  

Jenelle Stewart then faced down the doubters of event-driven PrEP by marshalling evidence that the intervention works in men and may work in women. Stewart referenced a JAMA article by Jeanne Marrazzo just last week that high-but-imperfect adherence (4-6 pills per week) was protective for women. She followed with a clear call for event-driven PrEP for women without needing to go through another large, randomized trial. Stewart made several other provocative points, concluding that event-driven PrEP is desired by some, effective, and should be incorporated in public health guidelines.

Latest in Treatment

Wednesday’s news also included exciting late-breaking data about HIV treatment. An interim analysis of the LATITUDE Phase III trial of monthly injectable cabotegravir and rilpivirine showed superior efficacy of viral load suppression compared to daily oral ART in participants with adherence challenges. The Data Safety and Monitoring Board for this study, based on review of various endpoints, recommended that all eligible participants be offered the combination injectable.  

In addition, results of a Phase II study of weekly oral islatravir and lenacapavir showed safety and non-inferiority of viral suppression to daily ART. Take home message: this product has the potential to become the first weekly oral regimen for treatment.  

Race and HIV, STIs and Mpox 

Pandemic racial disparities were on full display during the session, Using Data to Inform Interventions: Epidemiology of HIV, STIs, Mpox, and COVID-19. While much of the research showed the potential to use epidemiological data to better address public health problems, it was clear that health systems and infrastructure aren’t keeping pace.  

Andre Dailey, from the U.S. Centers for Disease Control & Prevention (CDC), presented a study that observed an overall decrease in Black/White racial disparities in U.S. HIV diagnoses between 2017 and 2021, but showed that for some key populations, including Black/White MSM, people who inject drugs, and others, disparities in diagnoses either did not change or increased. This is not good news for health equity. Sonia Singh also from the CDC, presented data on the lifetime risk of HIV diagnosis among MSM in the U.S., 2017-2021. She found that overall lifetime risk of HIV diagnosis improved among MSM (1 in 7), but there are great racial disparities. That number is 1 in 15 among White and Asian MSM, 1 in 11 among Native Americans and Alaskan Native MSM, 1 in 7 among Native Hawaiian/Pacific Islanders, 1 in 5 among Hispanic/Latino MSM (of any race) and 1 in 3 among Black MSM.  

Mayara Secco Torres da Silva of the Instituto Nacional de Infectologia Evandro Chagas presented data on the two Mpox outbreaks in Rio de Janeiro, Brazil, pointing to the need for enhanced community surveillance, integration of HIV and STI services and access to preventive vaccines. Brazil had the second worst Mpox outbreak in the Western Hemisphere, after the U.S. In studying the two outbreaks from 2022 and 2023, several patterns emerged demonstrating several disparities in Mpox diagnoses. Those who were disproportionately diagnosed with Mpox were Black Brazilians, people having a secondary school or less education, and MSM. The second outbreak in 2023 saw a higher proportion of PLWP and PrEP users diagnosed with Mpox than in the first outbreak. Da Silva called for better Mpox surveillance systems. She said ensuring more people with HIV are sustained in care is necessary to prevent worsening Mpox outcomes, and reminded the audience that Brazil, and other low- and middle-income countries (LMICs) still have not had access to the smallpox vaccine that was a primary tool in virtually ending these outbreaks in the U.S. and Western Europe.  

HIV cure and upcoming webinars 

There was a wealth of news and updates on cure research at CROI 2024. Keep watch for the latest research on the HIV reservoir and cure strategies from AVAC next week. 

And mark your calendars for a host of webinars that will follow up on many of the questions raised at CROI 2024, avac.org/events-and-webinars/.

Tuesday’s CROI Roundup

By Jeanne Baron, AVAC Senior Producer & Editor

Yesterday’s second full day at CROI 2024 in Denver included several studies presented on biomedical prevention, and the sum total of the message is clear: PrEP works, and choice works! Advocates have long called for choice—and now the science shows it works for individuals and supports declines in population-level incidence. Whether we’re talking about a daily pill of PrEP, injectable cabotegravir, or the dapivirine vaginal ring (DVR), from the US to Kenya, Australia to Uganda, people deserve choice! 

There was also more conversation about DoxyPEP, and how researchers and public health programs are balancing the public health benefits of reduced syphilis and chlamydia rates, with the threat of antimicrobial resistance, especially for gonorrhea.  

Here are highlights of the research!  

Tuesday’s Community Breakfast Club message, Living with HIV for a Lifetime—It’s Complicated, rang loud and clear.  

Allison Agwu from Johns Hopkins and Judith Currier from UCLA, talked about strategies presented on cross cutting health issues from cardiovascular disease to HPV that are affecting quality of life for PLHIV. And they talked about advances in treatment, such as the progress of long acting injectables, combination therapy with broadly neutralizing antibodies (bNAbs), and a long-acting pill—all of which are in the pipeline. 

But the advocacy around these field-changing issues echoes the very same priorities for HIV prevention, and the same priorities needed for global heath equity at large. Once new products are approved, they simply don’t reach the people who need them most, and offering choice is the key to reaching impact.  

“We are learning we have to figure out access in parallel with delivery. Clinics just can’t operationalize these innovations; we have to focus on this more and fund implementation science,” said Currier.    

“We need the a la carte of options. Something that fits in someone’s life now may not fit later,” said Agwu. 

The Breakfast session moderator, Annette Sohn from amfAR, talked about the advocacy still needed to ensure research is inclusive and data is gathered for all the populations that carry a disproportionate burden of HIV — another issue of great importance in HIV prevention.  “We still routinely have to tell researchers to stop combining data on men who have sex with men and transgender women.” For more on inclusive research for transgender people check out the The Transgender Manifesto.  

Evidence for making the most of prevention tools and the power of choice! 

Studies from three different continents delivered the message: enriched programs that support coverage and choice of prevention options will yield dramatic results.  

PEPFAR representatives pledged to take the findings of the SEARCH Dynamic Choice study into their programming decisions. Why? Just look at these results: Conducted in Kenya and Uganda, the study offered oral PrEP, PEP or injectable cabotegravir to both men and women, and an option to switch products. Prevention services were person-centered, including access to a clinician by phone at any time, clinic and community access to services, and counseling to develop personalized adherence plans. Coverage among study participants increased to 69.7% compared to 13% in the standard of care. Among people who self-reported HIV risk, coverage was 76%. Of the 56% who chose injectable CAB, 42% were not on any prevention product in the prior month. And perhaps most intriguing of all, 28% of participants used two different products during the study and the study arm ended with zero incidence of HIV compared to 1.8% in the control group—these numbers show why adding to the method mix expands the number of people who continue with prevention, even as their needs change. “CAB-LA is not simply replacing oral PrEP. It’s expanding the pie,” said Moses Kamya of Kampala’s Makerere University, who presented these data.  

Data from the INSIGHT cohort looked at PrEP uptake and continued use among more than 3,000 adolescent girls and young women in six African countries over six months. Participants who were shown test results measuring protective levels of PrEP in their bodies had higher adherence. The results: uptake was greater than 90%, at least 64% showed evidence of recent use. Investigators reported that “real time feedback” from these tests motivated adherence. 

In the US, a study conducted by Emory University suggests a direct link between population PrEP coverage and decreased HIV incidence. Between 2012-2021, PrEP coverage in the US ranged from 3.8% in West Virginia to 22% in New York, and rates of new diagnoses fell in association with increased coverage by state.  

Data from Australia analyzed HIV incidence among all people prescribed PrEP in Australia’s national PrEP program by tracking government subsidized PrEP prescriptions and antiretroviral therapy (ART) between 2018 and 2023. ART was used as a proxy for HIV acquisition, because both testing and treatment among PLHIV are high across the country. The data showed that low PrEP usage among gay men and other men who have sex with men, along with younger age and hepatitis C treatment was predictive of HIV incidence. Nicholas Medland who presented the data said “the overall incidence rate is low. As long as you can get PrEP out the door, it works at the population level.” 

The Deliver Study investigating efficacy of the dapivirine vaginal ring (DVR) among pregnant and lactating people (PLP) provided data from people in the second trimester of pregnancy. Building on earlier findings in later stages of pregnancy, investigators reported no increased rate of adverse outcomes compared to pregnancy outcomes in the community, and that “data support using DVR” as an HIV prevention option for PLP.  At this time, 11 countries have approved DVR, but this data is needed for regulators to approve its use for people who are pregnant. See our PrEP tracker for the latest on DVR initiations, regulatory approvals and more.  

DoxyPEP rollout: Ready? Or not? 

Yesterday we reported on DoxyPEP research, which showed reduced syphilis and chlamydia rates among MSM and TGW (though limited reductions in gonorrhea). There’s cautious optimism among researchers and public health programs about DoxyPEP, but questions remain about antimicrobial resistance (AMR) and whether expanding this intervention to cisgender women (where more research is urgently needed!) would further increase AMR globally. A round table discussion featured many angles.  

Chase Cannon from the University of Washington started with a history lesson—prophylaxis for STIs isn’t new. It was a program of the military in the mid-20th century for American soldiers but ultimately ended. Current data shows the clinical benefits of DoxyPEP. It reduces STI incidence significantly, it’s cost-effective and well-tolerated.  While concerns about AMR are real, taking DoxyPEP is less exposure to doxycycline than taking a full course to treat an STI. Alongside the clinical benefits, Cannon made the case that the community interest and uptake is hard to ignore. He pointed to qualitative research that DoxyPEP has played a transformative role in reducing stigma, sexual stress and anxiety in MSM.  

Beatrice B.S.L. Bercot countered with a more sober look, warning that AMR is already a problem in many European and African countries, and she’s cautious about wider global rollout. Her solution? “The damage is done” with gonorrhea drug resistance, the world has an urgent need for a gonorrhea vaccine. She also noted that while DoxyPEP is promising for syphilis and chlamydia, we need more surveillance and monitoring to better understand AMR spread. 

Stephanie E. Cohen from San Francisco’s Department of Public Health focused on implementation questions. She said DoxyPEP research and implementation is making the same mistakes made with PrEP—a lack of research for cisgender women and people assigned female at birth, and similar racial disparities in DoxyPEP use as seen with PrEP. Cohen cautioned that focusing on “risk categories” in marketing DoxyPEP may exacerbate disparities just as it did with PrEP.  

Cohen urged training for providers, marketing strategies that are non-stigmatizing, and new surveillance tools to monitor AMR. She called for better clinical guidance on STI screenings of people using doxy-PEP to identify other STIs. 

The rich data presented on Tuesday made clear the connection between science and the real-world. But Sunday’s opening session reminded advocates that many researchers who lead the science fail to understand that fundamental truth. During the Martin Delaney Lecture given by Frank Mugisha of Sexual Minorities Uganda, those who listened learned about the impact of draconian homophobic and transphobic legislation that is imperiling the lives LGBTQI+ communities in countries across Africa and in the US. To our dismay, many researchers attending the opening plenary chose not to listen. To learn more, please read this statement from the CROI Community Educator Scholars and Mentors, advocates and others who stand in solidarity.  

CROI Roundup – Highlights from Monday

The highs and lows of great science but profound inequities were front and center on the first official day of CROI 2024. From increasing data on demonstrating the efficacy of DoxyPEP (doxycycline as post-exposure prophylaxis) against some sexually transmitted infections (STIs); and advances in the promise of long-acting PrEP; to data that reinforces the reliability of affordable rapid testing to screen for HIV— Monday showcased vitally important scientific insights.  

Sessions throughout the day, as well as at Sunday’s opening session, reminded all participants that every one of the scientic advances presented at CROI will fail, unless the voices of people who need solutions are heard, amplified and elevated and allowed to lead the discussions.  

Social and behavioral researchers discuss equity with R&D during CROI Community Breakfast Talk   

Monday’s Community Breakfast Club focused on social and behavioral science at CROI – disciplines that have often been marginalized. Speakers pointed out the ongoing need for more of this essential research at CROI. “As much as we try to discover new devices, they need to reach people to have impact. For example, long acting injectables have not worked in real life because we’ve neglected the complexity of rolling [them] out,” said LaRon Nelson, of the Yale School of Nursing. And Sari Reisner, an epidemiologist at the University of Michigan underscored that the outcomes of research are directly tied to the level of involvement from communities whom research is ultimately meant to serve. Don’t miss two more days of programming, sign up here

The HIV vaccine search continues 

Barney Graham and Julie McElrath both provided overviews of three decades of HIV vaccine research, and its current status. Graham explained in his opening session Fields Lecture how insights on HIV structure paved the way for rapid understanding of the SARS-COV-2 and resulting vaccines.  

And in her Monday plenary, McElrath summarized the collective knowledge gained from the ten vaccine efficacy trials that have been conducted over the past 20 years. (And check out our new summary graphic of the efficacy trials to date.) She then outlined the key strategies now moving forward–inducing broadly neutralizing antibodies (bNAbs), inducing supplementary CD8+ T-cell responses, and delivering bNAbs as passive protection while learning about vaccine design. Further sessions dug into finer details of early-stage investigations—updates on germline-targeting trials, which use a series of vaccines to prompt the body to develop precursors that lead to bNAbs; and newer adjuvants that enhance the germline targeting strategy 

Even longer long-acting PrEP products? 

A longer-acting injectable cabotegravir for prevention (injectable CAB) has made it through a phase 1 safety and tolerability study. ViiV, the maker of the currently approved injectable cabotegravir, presented findings on a new formulation that could double the time between intramuscular jabs, from two to four months, potentially making it a three-dose annual intervention, instead of six doses.  

Merck also presented data on the safety and pharmacokinetic profile of MK-8527, a product that they are hoping to develop as a monthly pill to prevent HIV. They reported the dose was safe, well-tolerated and sufficient to show anti-viral activity against HIV. The product is currently in a phase 2 trial in several countries globally; and later phase studies would be needed to demonstrate efficacy. Check out our prevention product timeline here

DoxyPEP brings down incidence of some STIs. But what else do we need to know? 

Studies corroborated the promise of DoxyPEP to bring down STIs. The DoxyVAC study showed reduced incidence of chlamydia and syphilis and some reduction of gonorrhea. But a vaccine against meningococcal disease (the 4CMenB vaccine) did not show a reduction in gonorrhea incidence, which was seen in an earlier phase of the research. Studies out of San Francisco of men who have sex with men and trans women showed a high demand for DoxyPEP among PrEP users and STI incidence decline. But there remain many questions on DoxyPEP. More data is needed for use among cisgender women, as well as research among communities in low-income countries. Many researchers and advocates are calling for more data on DoxyPEP’s potential to increase antimicrobial resistance (AMR)—which needs more attention as guidelines accelerate DoxyPEP use. Join us in April for an STI Awareness week webinar series where Fabian Kong, Annie Luetkemeyer, and Connie Celum will lead a discussion on AMR, DoxyPEP and more. Sign up here to receive updates, www.avac.org/signup

Can we eliminate HPV? 

In what proved to be one of the most elegant plenaries ever delivered, Nelly Mugo from the Kenya Medical Research Institute (KEMRI) provided a remarkable presentation on Shall We Reach Human Papillomavirus Elimination in the Face of Inequity? Her presentation reinforced the essential need to link the best possible science with deep and durable community engagement. And it was quite fitting that she delivered her talk on HPV Awareness Day, when AVAC, TogetHER for Health and partners launched a call to action for global leadership to increase access to lifesaving HPV vaccines for people living with HIV. 

Stay tuned for more updates from AVAC as we track the research and discussion at #CROI2024, and don’t forget to join us Tuesday and Wednesday for the Community Breakfast Clubs

Join us for CROI 2024!

The 31st annual Conference on Retroviruses and Opportunistic Infections (CROI) kicks off this weekend, and runs from March 3-6 in Denver, Colorado. CROI is the go-to forum for groundbreaking science in the HIV field, and this years’ program is full of exciting new research.

At AVAC, we’re tracking data and discussion on long-acting, injectable PrEP; the dapvirine vaginal ring (DVR) in pregnancy; doxycycline as post-exposure prophylaxis (DoxyPEP) to prevent sexually transmitted infections (STIs); and the latest in HIV cure and control. We’re also very excited for this year’s Martin Delaney Presentation—Unveiling the Power of Uganda’s LGBTIQ Advocacy in Shaping HIV Response and Health Care Access—that will be delivered by Frank Mugisha of Sexual Minorities Uganda (SMUG) in Uganda and couldn’t be more timely. Be sure to check out the conference program.  

AVAC and partners have worked to follow and explain the research presented at CROI for many years, making the science more accessible, connecting the findings to community priorities, and ensuring civil society and affected communities are represented within the program, and ultimately the research. For those attending or not, this email shares ways to follow along and join in the discussion and debate. 

Follow Along

Be part of the conversation by following AVAC on X (Twitter) at @hivpxresearch for real-time updates using the conference hashtag #CROI2024, and be sure to sign up and follow our partner, Aidsmap, who will be reporting from the conference.

Community Breakfast Clubs

Join the CROI Community Liaisons, AVAC, the European AIDS Treatment Group, and partners for daily Community Breakfast Clubs. These virtual webinars feature researchers and advocates discussing some of the most consequential science being presented at CROI. They are open to all, CROI registrants and non-registrants alike. CROI registration not required.

Monday, 4 March, 7:00am – 8:00am MT (Click here to determine the time in your location.)
Spotlight on Social and Behavioural Science at CROI 2024
 
Tuesday, 5 March, 7:00am – 8:00am MT (Click here to determine the time in your location.)
Living with HIV for a Lifetime – It’s Complicated
 
Wednesday, 6 March, 7:00am – 8:00am MT (Click here to determine the time in your location.)
Research Roundup: Scientists and Advocates Offer Fresh Perspectives and Seasoned Analyses of CROI 2024 Research
 
Looking forward to seeing you at the daily Breakfast Club sessions and to working together to unpack the research and be sure it is applied! 

AVAC Condemns Ghana’s Actions to Further Criminalize LGBTQ+ People

AVAC joins allies around the world to condemn in the strongest possible terms this week’s actions by Ghana’s lawmakers, who have passed legislation to further criminalize LGBTQ+ people.  

Homosexuality was illegal in Ghana before the passage of the so-called “Human Sexual Rights and Family Values Act”, which now furthers the criminalization of this community, making it a crime to identify as LGBTQ+, to form or fund LGBTQ+ groups, to advocate for LGBTQ+ rights or distribute advocacy materials, with multi-year jail terms attached. The new law also encourages communities to report LGBTQ+ people to authorities. Find more background on Ghana’s legislation here

“With these actions, Ghana is joining a hyper-fundamentalist global movement that uses anti-queer propaganda to strip away fundamental rights of citizens in a free society,” said Richard Muko, AVAC’s Senior Program Manager of Policy Advocacy, and member of the Key Populations Transnational Collaboration (KP-TNC).  

It is with grave alarm that AVAC re-states our concerns and demands from May 31, 2023—when Uganda’s President Yoweri Museveni signed into law the Anti-Homosexuality Act, a similar assault on citizens’ rights. 

“This is a growing, global tsunami. As with Uganda’s hateful AHA law, these anti-gay laws threaten lives and livelihoods, and the ability to connect key populations with the resources they need and deserve to prevent and treat HIV and to live their fullest lives. But the danger runs deeper than any one health threat. These actions represent a profound attack on free societies. We must unite to oppose these laws.  LGBTQ+ communities and other minorities must enjoy the full rights of citizenship, or these protections, which include access to healthcare, may well be imperiled for everyone,” said Mitchell Warren, AVAC’s executive director.  

Amnesty International has tracked a surge of intensifying hostility and discriminatory bills across 12 African countries in the last year, and in the US, 25 states passed anti-trans bills in 2023. Political leaders in the US and in countries across Africa are openly calling for LGBTQ+ people to be driven from public life, while US-based hate groups are providing support to proponents of this anti-civil rights agenda on the continent.  

“Singling out vulnerable communities as scapegoats, exposing them to violence and incarceration, is integral to instilling a climate of terror that enables divisive forces to consolidate power. It is imperative to stop these laws,” said Manju Chatani-Gada, Director of Partnerships & Capacity Strengthening  

AVAC urgently calls on Ghanaian President Nana Akufo-Addo to reject this bill. We are not alone. Here are statements from UNAIDS and The US Department of State. To add your voice, see guidelines here, prepared by LGBTQ+ activists working in Ghana.