As overall sexually transmitted infections (STI) rates continue to rise globally, STI diagnostic and vaccine research and development (R&D) investments remain underfunded and neglected compared to other infectious diseases, a new AVAC report finds.  

This report, Sexually Transmitted Infections: A Review of the 2022 Vaccine and Diagnostic Research and Development Pipeline and Investments, examines disbursements by the U.S. National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation—the largest investors across a vast range of global health R&D areas—and is one of few reports to track 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.  

It found that leading philanthropic and public funding for STI vaccine and diagnostic R&D totaled just US $103 million in 2022 with most of the funding coming from the NIH, at US $78 million, approximately 76 percent of total reported funding disbursements. 

“We’re seeing the gap widen—as the global burden of STIs continues to increase, funding for R&D tools to reduce this burden lags behind,” said Alison Footman, PhD, senior program manager for STIs at AVAC and lead author of the report. “If we’ve learned anything from the HIV and COVID-19 epidemics, it’s that we need to get ahead of transmission by prioritizing the health of people and communities and committing the resources needed to develop user-centered diagnostics, treatments and prevention methods. Point-of-care tests that are effective, affordable, and user-friendly, and vaccines to prevent and treat STIs are on the horizon but will only be developed and delivered if money is made available with urgency and scale.” 

Of the total US $103 million in STI vaccine and diagnostic R&D funding reported, only seven percent (US $6.8M) was dedicated to diagnostic research—a much lower amount than vaccine research, which was funded at US $93 million or 90 percent of the total funding. The remaining 3 percent was directed towards projects that examined both vaccine and diagnostic R&D. As with vaccine R&D, the NIH accounted for most of the diagnostic R&D investments (73 percent). 

“Many STI testing programs rely on patients to present with symptoms. But considering that most STIs are asymptomatic, this approach is missing the mark,” Footman added. “We need to be investing in tests for STIs that will improve detection, and therefore limit the time between test and treatment, and hopefully prevent transmission. The overall STI R&D investments are already too little overall, and just seven percent of total funding dedicated to diagnostics is not commensurate with the public health need.”  

Other Key Findings

• Six institutes and centers within the US NIH contributed the bulk of funding (US $78 million) toward STI diagnostic and vaccine R&D.
• 59 organizations were funded worldwide to conduct STI R&D; of those, 78 percent (n=46) were located in the US.
• Institutions in South Africa and Zambia were the only African countries where local organizations were funded to conduct STI vaccine and diagnostic research. In total, US $814,279 was provided directly to these two countries, representing less than 1 percent of total funding spent.
• By pathogen, most funding (51 percent) was dedicated to HPV R&D, with gonorrhea and syphilis rounding out the top three pathogens funded.
• US $50 million was spent on HPV vaccine R&D, $18 million on gonorrhea vaccine R&D, $9 million on syphilis vaccine R&D, $8 million on chlamydia vaccine R&D, $3.5 million on genital herpes vaccine R&D, and $2.8 million on Hepatitis B vaccine R&D.
• NIH spending accounted for most STI diagnostic R&D investments (73 percent).
• Of diagnostic funding available, 66 percent was dedicated to multi-pathogen research, 33 percent towards HPV, and 1 percent towards hepatitis B. (Multi-pathogen diagnostic projects included research on syphilis, gonorrhea, genital herpes, and chlamydia).

The report also includes spotlights on DoxyPEP; on WHO’s new reports and manuals that provide information on diagnostics currently available to guide development; and on seven AVAC partners in East and Southern Africa who received funding to conduct projects on community needs to prevent, detect, and treat STIs. These advocacy projects helped build a stronger advocacy movement to improve funding and commitments in and around STI vaccines and diagnostics.  

For years, AVAC has been tracking investments and funding trends in HIV prevention and cure R&D. 

HIV Prevention Research & Development Investments 2021: Shifting investment priorities fund innovation in a challenging global health landscape

Global Investment in HIV Cure Research & Development in 2021

This new report on STI vaccine and diagnostic R&D is intended to help decision-makers and advocates identify current funding investments, opportunities, and gaps. Tracking investments over time can also demonstrate the effects of public policies and guidelines, such as WHO’s STI Vaccine Roadmap, on funding decisions and inform research priorities. 

For more information on the state of STI vaccines and diagnostics R&D, visit STIWatch.org, or get in touch at avac@avac.org.

Last October when an unprecedented proposal to cut $767 million in federal funding for domestic US HIV programs was put forward in the Congress, AVAC joined PrEP4All, HIVMA, PrEP In Black America, NASTAD, the HIV+Hepatitis Policy Institute, The AIDS Institute, AIDS United, NMAC, and several members of the Federal AIDS Policy Partnership to launch the #SaveHIVFunding campaign. Since then, thousands of advocates and community members, along with over 100 organizations, joined the fight to demand Congress continue the bipartisan commitment to fund Ending the HIV Epidemic (EHE) efforts.

With key deadlines in the FY24 budget process quickly approaching, it is more important now than ever that you join us in telling Congress to reject cuts and #SaveHIVFunding by sending letters to your Congressional representatives.

The House bill also proposes to cut 53 percent of spending for the Minority HIV/AIDS Initiative, which seeks to eliminate racial and ethnic health disparities in HIV. The bill would also completely eliminate funding for the Minority AIDS Initiative within the Substance Abuse and Mental Health Administration.

Together, these funding cuts would eliminate all activities of the EHE, reverse recent progress in bringing down annual HIV rates, and leave state and local health departments and community-based organizations without critical funding to provide services to their communities. With 70 percent of the 1.2 million Americans living with HIV projected to be age 50 and older by 2030, the impact on the aging HIV community would be severe.

In contrast, the Senate bipartisan spending bill proposes to maintain HIV funding for Fiscal Year 2024 (FY24) and includes a proposed increase of $3 million dollars to continue the fight to end the epidemic and begin work toward a National PrEP Program. 

Please help us push Congress to pass a final FY24 spending bill that rejects cuts to HIV programs and instead would #SaveHIVFunding by sending letters to your Senators and Representative now! Please also review the #SaveHIVFunding social media toolkit that you and your organization can use to urge our leaders in Congress to #SaveHIVFunding.

In the year ahead, staking out a course that will advance the HIV response and global health equity faces serious headwinds.

Several African countries are seeing historic attacks on civil rights aimed at persecuting the LGBTQIA+ community, and most notably, Uganda is embroiled in crises with the enactment of Anti-Homosexuality Act. PEPFAR Re-authorization has been stalled by utter dysfunction in the US House of Representatives, the same body that has proposed massive cuts in domestic HIV funding. Negotiations on the WHO’s Pandemic Accord have so far failed to prioritize meaningful commitments to equity—jeopardizing global preparedness against future health threats. And at least 43 countries are holding elections in 2024, with several countries, including the US, facing serious threats from authoritarian candidates.  

But in HIV prevention, there’s also momentum. The scale-up of PrEP began accelerating in 2021 and has kept apace, with more than 6.2 million people initiated oral PrEP, and another approximately 4000 people have initiated either injectable cabotegravir or the dapivirine vaginal ring. If planning, policies and programs get it right and offer choices in programs that are co-designed by communities that need prevention most, modeling indicates the world could reach UN targets of 10 million PrEP users by 2025. But what does it take to ensure choice, what priorities will ensure policies, programs will serve the communities burdened by HIV? 

Decolonizing global health can and must be a guide star for these efforts. In 2024, it’s time to double down. Decolonizing global health is not a dream. It’s not an “extra” to reach for only when it’s easy. It’s not wishful thinking. Decolonizing global health is a cornerstone in reaching global targets, making prevention a reality, ending the epidemic, and preparing for the next one. 

It demands changes across the field, from research to rollout. AVAC is tracking this progress, developing strategic resources, and supporting the advocates who know that global health will advance or decline depending on progress in key areas:

Empowering Community Leaders & Following Community Priorities

Models of leadership that center communities necessarily involve money but must go beyond the size of the check and whose name is on it. New structures are needed, based on collaboration, transparency, and trust. The COMPASS coalition is pioneering a model to do just that. Read more about this exciting work here.

Pursuing a People’s Research Agenda

A community driven agenda is needed to define research questions and recommendations for HIV prevention research, rollout and investments. With an active HIV pipeline in research and development that is increasingly weighted toward early-phase science, a need for unstinting support for vaccine research, and momentum in cure research, it’s critical for informed and intensive community advocacy to shape the research enterprise. See the pipeline here. 

Program for Choice 

The promise of new options in HIV prevention must not be squandered in siloed programs, or by poorly planned supply chains, or because of disconnected policy decisions. People have diverse needs and face complex challenges; ending HIV depends on finding the option that works best for each individual. Read more about the choice initiatives and the Choice Manifesto and the Global HIV Prevention Roadmap for Key Populations.

Create a New Global Architecture Founded in Equity for Pandemic Readiness

When the next pandemic hits, allocating tools to the most vulnerable is the most effective and efficient way to fight it. County commitments, engagement with civil society, funding levels, and how well planning incorporates equity as a principle has yet to be secured in the Pandemic Accord or other agreements related pandemic planning. Advocates have a role to play in demanding engagement and ensuring equity. Find resources to keep you up to date on the issue here. 

Embrace the Role of Prevention in Global Targets

To end AIDS as a public health threat by 2030, prevention efforts must make dramatic strides to reach fewer than 370,000 new infections by 2025. As the UNAIDS HIV Prevention Roadmap documents, the most successful HIV responses have come from countries who “have directed resources towards high-impact combination HIV prevention programs and supported and worked with community-led responses that reach the populations and places most in need”. UNAIDS targets will continue to falter at the global level if the field fails to learn the lessons of countries such as El Salvador, Kenya or Thailand where incidence saw steep reductions by centering prevention programs around the needs of key populations.   

In the months to come, AVAC will be following progress toward these goals and reaching out to you to discuss, debate, collaborate and unite.

AVAC is thrilled to see the launch last week of injectable cabotegravir for PrEP (injectable CAB) in Zambia—the first program outside of the US to do so. And earlier this week the Desmond Tutu Health Foundation in South Africa also announced “the first jab” of injectable CAB administered in its FASTPrEP study. This news comes on the heels of another important gain—the announcement of a new licensing agreement that will double the supplies of the dapivirine vaginal ring (DVR) across Africa. 

All represent significant milestones that we hope will be the first of many in 2024. Leveraging these achievements so that people who need and want HIV prevention can access choice is the prevailing question on our minds at AVAC. Choice is the key: it requires robust investment in the policies, planning and programs that ensure every proven product—oral PrEP, injectable CAB and the DVR—are included in the package of HIV prevention options, along with sustained research and development of new interventions.

So what is the status of access among PrEP options as 2024 begins?

As it stands, oral PrEP is offered in 122 countries with cumulative initiations reaching more than 6 million (2012 – December 2023). (Check out the Global PrEP Tracker for details.) Trends in initiations saw great progress over the last two years, but to reach UNAIDS targets of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough. People will need to find an option they can use for as long as they need it. PrEP coverage, seeing the most people possible using an option that works as long as they need it, regardless of product type, is the goal—with programs and products to support them.  

Injectable CAB supplies are an important factor. Late in October 2023, Injectable CAB’s developer, ViiV, forecasted a 40% increase in available doses to low- and middle-income countries, reaching 1.2 million doses through 2025. These doses are headed to implementation science (IS) studies that are evaluating how to scale up delivery and to national programs supported by PEPFAR and Global Fund, including Zambia’s. 

Zambia is now the second country in the world, after the USA, to roll out injectable CAB outside the planned and ongoing IS studies. And more countries are expected to follow in Zambia’s path, including Malawi and Zimbabwe. Check out our Country Planning Matrix that tracks this progress of injectable CAB as well DVR. 

In addition, 11 countries have approved the DVR, and 38 implementation science studies are delivering or planning to deliver injectable CAB and/or the DVR. Check out our Integrated Study Tracker that catalogues these projects. 

As these products start arriving in country, key issues must be addressed:

• increasing supplies and obtaining lower prices for both products;
• ensuring the delivery mechanisms for rolling out injectable CAB and DVR are integrated into prevention programs that are well-designed to reach those who could benefit from PrEP products;
• establishing how to deliver acceptable HIV prevention services to a wide range of populations, including adolescents, pregnant and lactating people, sex workers, LGBTQ+ communities and people who inject drugs; and
• advancing a learning agenda across programs that are delivering HIV prevention—inclusive of injectable CAB and DVR—to ensure information, lessons and insights are shared.

But above all, effective delivery must be defined by delivering choice through programs where end-users are supported to select the option that best fits their lives. AVAC’s Wawira Nyagah and Mitchell Warren outlined these issues—and the lessons from oral PrEP that need to be leveraged—in a recent commentary in Bhekisisa: Bending the curve: What a decade-long roll-out of the anti-HIV pill can teach the world. 

As 2024 begins, at AVAC we see possibility. PrEP initiation trends, country approvals for new products, program launches, and efforts at transparency and coordination could pay enormous dividends. But fulfilling this promise is not certain. It depends on overcoming systemic challenges around access and choice.

Let’s not waste 2024.