Report Archives

There are an estimated 374 million new sexually transmitted infections (STIs) acquired per year. This equates to more than 1 million chlamydia, gonorrhea, syphilis, and trichomoniasis infections every day. These infections can lead to pelvic inflammatory disease, infertility, and increased transmission of HIV, when left untreated. The World Health Organization (WHO) publishes clinical guidelines to support STI testing for these infections, however, obtaining regulatory approvals for these diagnostics remains confusing. As the STI diagnostic landscape continues to evolve, it is imperative to review the processes that will help to promote access and uptake of new tests.

In September 2024, AVAC and WHO co-hosted a webinar to support researchers, product developers and the global advocacy community in identifying and discussing ways to bring new STI diagnostics to market with speed, equity and scale. Speakers have reviewed several pathways to create access to STI diagnostics, including:

WHO prequalification;
Expert Review Panel for Diagnostics; and
Collaborative Registration Procedure.

Speakers’ experiences related to promoting access through regulations. The South African Health Products Regulatory Authority discussed ways to leverage these pathways and. The Bill and Melinda Gates Foundation highlighted the importance of building on these regulatory pathways and processes in catalyzing the development of new STI diagnostics and ensuring greater access to STI testing services.

Additional details are below and the recording of the webinar along with slides are available online.

WHO Prequalification of Diagnostics

WHO prequalification (PQ) aims to promote and facilitate access to safe, appropriate, and affordable IVDs of good quality.

The PQ application process includes several steps pictured below.

In 2025, the WHO PQ application process will include STI diagnostics, both laboratory and point of care tests for chlamydia, gonorrhea, and trichomoniasis diagnosis using platforms (e.g. NAT; isothermal) for molecular detection and lateral flow and other technology for antigen testing.
Technical Specification Series (TSS) documents are tailored to specific pathogen or type of assay and include requirements that address the needs of Member States in LMICs and related to general performance characteristics.
The expert consultation to set the technical specifications for STI diagnostics was held in August 2024. The draft document will be available for public comment before the end of 2024. This is an important step which will advise developers on their PQ submissions for new products.

Expert Review Panel for Diagnostics

The purpose of the expert review panel for diagnostics (ERP-D) is to:

Assess the potential risks/benefits associated with the procurement of diagnostic products that may have a high public health impact, but have not yet undergone a stringent assessment, either by the WHO Prequalification or by a SRA.
Advise the Procurement Agencies (PA) and Technical Programs (TP) in their decision on whether to allow grant funds to be used for the time-limited procurement of the diagnostics reviewed by the ERPD.

The ERPD risk/benefit assessment does not replace WHO PQ/SRA assessment but should be seen as a step towards a WHO PQ or full regulatory review.
The ERPD mechanism should facilitate access to IVDs for neglected diseases, as well as innovative devices, if the associated risks are deemed to be lower than the potential benefits.
Eligible products include innovative IVDs or IVD technologies with substantial public health impact that are listed through an Invitation to Manufacturer (ItM) for an Expression of Interest (EoI) that is developed and published by a PA or TP with IVD specifications.

Facilitated Registration Pathways and Collaborative Registration Procedure

Facilitated Regulatory Pathways (FRP) are a type of regulatory pathway available to National Regulatory Agencies (NRAs), which are meant to facilitate and accelerate the regulatory decisions and the introduction of quality-assured products in countries, through the use of concepts of reliance and collaboration.
FRPs can help NRAs:
- Leverage on the work performed by others, improving efficiency of the regulatory systems by avoiding duplication of regulatory efforts and work.
- Optimize the use of human and financial resources and increase expertise and build capacities.
- Reduce the time needed to process a product application and reduce workload and backlog.
- Perform science-based and transparent regulatory decision-making, while maintaining national independence on their decisions.
- Ensure timely access to priority quality-assured products in countries.
- Collaborative Registration Procedure (CRP) facilitates the exchange of information to accelerate national registrations in countries through the provisions to NRAs of detailed assessment and inspection reports generated by reference NRAs/PQ

Perspectives from the South African Health Products Regulatory Authority (SAHPRA)

LMICs are in frequent demand of prequalified products for the diagnosis of disease.
More than 10 African NRAs participate in WHO PQ and all recognize WHO PQ for importation of IVDs into countries.
Many of the regulatory systems need assistance and guidance to better regulate IVDs, facilitate access to quality assured medical products, and build capacity.
Additionally, navigating some of the WHO processes can be confusing while balancing an evolving global regulatory space.

WHO PQ has helped in strengthening regulatory systems, promoting the concept of reliance to increase effectiveness of regulation and efficiency, and informed NRAs own regulatory decision-making.
WHO CRP has also led to shortening the approval time, i.e. the products are approved within 90 days from the day of submission in countries such Zambia, Tanzania, South Africa, and Kenya.
Challenges around navigating the WHO PQ process include:
- Information asymmetry: Coordination and communication ,namely the lack of clarity in the procedure on some steps (who should notify whom), the lack of user-friendly tools to exchange information and report progress of applications, the applicants’ low level of awareness about the process and the lack of more direct interactions
- Quality of Submission: Quality issues that are occasionally discovered at the verification stage before being distributed. For example, manufacturers have been found to supply oral fluid HIV rapid diagnostic tests whose specifications were different from what was prequalified. The submissions of incomplete dossiers or discrepancies between the information submitted by the applicant and the one assessed by SRAs, were considered as the main causes for delays during the procedure. NRAs also identified the need for further guidance, particularly on post-approval management of IVDS approved through PQ.
- Double standards” – local vs. international market: Manufactures need to consider the needs of African markets along with other countries when developing products they hope to introduce into these countries.
- Post Approval Changes Management- Process not well understood by Manufacturers especially those in LMIC’s
- Lack of secure information technology systems: lack of secure platforms and procedures for the exchange and management of nonpublic information
- Lack of an assessment strategy and metrics for measuring and documenting the success of an agreement
- Resources misfit: Zambia only has two registration officers and can experience difficulties in adhering to timelines when receiving multiple submissions.

Recommendations

Communicate about the added benefits-increased best practice sharing by WHO PQT
Promote work-sharing initiatives among NRAs in LMICs (e.g., SADC/ZAZIBONA, ECOWAS, AMDF)
Increase regular exchange of information and knowledge
Strengthen formal procedure to collect input from NRAs on local unmet needs.

Resources

Webinar Recording
Webinar Slides: Introduction to Regulatory Pathways to Promote Accessibility of STI Diagnostics, Introduction to Facilitated Registration Pathways and Collaborative Registration Procedure (CRP) Slides, Prequalification of In Vitro Diagnostics Slides, Experiences from the South African Health Products Regulatory Authority, Expert Review Panel for Diagnostics (ERPD)
Collaborative Procedure for Accelerated Registration: Includes information on the WHO collaborative procedure aims, principles, process, and impact.
WHO collaborative registration procedure using stringent regulatory authorities’ medicine evaluation: reliance in action by Alexandra Vaz and colleagues: This article reports on the outcomes and stakeholders’ experience of using medicines assessments performed by Stringent Regulatory Authorities (SRA) in the Collaborative Registration Procedures (CRP).

FAQ

Is there a full list of who the procurement agencies are who can make a request to ERPD?  And can any technical program at WHO make a request to ERPD?

Answer: Request for ERPD assessment is typically made by agencies that are either WHO partners or those involved in global health procurement, such as Global Fund and GAVI, for diagnostics of interest for their needs. For new programmes or partners, WHO PQ team in charge of the ERPD program discuss the feasibility and funding source in consultation with procurement agencies and relevant WHO disease programmes. We also take into consideration our resources which are limited also.

Is ERPD limited to tests for which the PQ team has already prepared a TSS?

Answer: ERPD is not limited to just IVDs that have a TSS in preparation and are in the PQ pipeline. ERPD has recently expanded to NTDs which may not necessarily enter the PQ pipeline. The decision of a round of ERPD and eligibility of a range of IVDs with substantial public health impact is determined in coordination with PQ team. But ultimately the Invitation for submitting an Expression of Interest is decided by the partner (procurement agency or WHO disease programme) who is the owner of the call.

For TSS 24, will manufactures be able to submit for 1, 2 or 3 of the disease targets? I.e., can they submit for CT/NG as well as for CT/NG/TV, or must they include all 3?

Answer: For TSS 24 you can apply with tests that have any combination of the three disease targets, including just one.

In what ways is STI regulatory different from other diagnostics?

Answer: The regulation of STI diagnostics does not differ to other IVDs. However, IVD regulations are changing in Europe which may have an impact on jurisdictions that rely on EU CE-Marking. Until recently manufacturers of STI diagnostics (chlamydia, gonorrhea and trichomoniasis) have been able to place their product in the market without having to submit their technical file for premarket approval in Europe. This is changing in Europe as new regulations are implemented. When diagnostics for STIs, including, chlamydia, gonorrhea, and trichomoniasis, become eligible for prequalification, they will undergo prequalification assessment applicable for a risk class C device (see our guidance on the prequalification assessment based on risk classification here)

Is there a country list to facilitate registration through this procedure (CRP)?

Answer: List of countries that are currently participating in the CRP IVDS are found at Collaborative Procedure for Accelerated Registration | WHO – Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control). Additionally, other countries publish the WHO CRP process on their respective websites with processes to be followed, such as the Tanzania Medicines & Medical Devices Authority.

What is the added value for manufacturers to go through WHO PQ (as opposed to regional bodies) considering timelines and cost?

Answer: WHO Prequalification aims to have a transparent review process, which clearly outlines the dossier, inspection, and laboratory evaluation requirements. If a product is prequalified, manufacturers also can leverage the collaborative registration procedure to facilitate registration in all interested countries. The list of countries who are participating is expanding with the aim of encompassing different regions. Prequalification assessment team is currently implementing efficiencies in the process, including recently applying recognition of MDSAP inspections.

Which African countries do not require WHO PQ for public procurement? And if not, what regulatory authority do they recognize?

Answer: NRAs have several pathways to authorize use of IVDs in their countries, either though market authorization or special authorization. WHO PQ facilitates assessment of information during market authorization process and fastens regulatory decision. For many African countries including South Africa, Botswana, and Rwanda, approval from one of the stringent regulatory authorities is required. These regulatory authorities include the founding members of the International Medical Device Regulators Forum (IMDRF), such as the US Food and Drug Administration (United States), European Commission Directorate-General for Health and Food Safety (European Union), Therapeutic Goods Administration, Health Canada (Canada), and Pharmaceutical and Medical Devices Agency (Japan).

Which STI diagnostics undergo the ERPD pathway?

Answer: Currently there is no invitation for expression of interest for chlamydia, gonorrhea or trichomoniasis IVDs. Through the Global Fund ERPD, EOIs are accepted for syphilis RDTs.

What diagnostics are WHO pre-qualified?

Answer: The list of WHO prequalified IVDs, including diagnostics, can be downloaded from the WHO Prequalified In Vitro Diagnostics website.

Is there a PQ process for STIs? Which ones?

Answer: IVD products currently eligible for submission for PQ include syphilis, hepatitis B, and human papillomavirus. In 2025, the WHO PQ assessment process plans to include STI diagnostics, both laboratory and point of care diagnostics to detection chlamydia, gonorrhea, and trichomoniasis nucleic acid and rapid diagnostic tests (lateral flow assays) for chlamydia or gonorrhea antigens.

Led by AVAC alongside a network of partners, the People’s Research Agenda puts forward recommendations to diversify and strengthen the HIV prevention pipeline, enhance investment and financial support for HIV prevention research and development, and guide an advocacy strategy that truly addresses the needs of communities across the prevention pipeline.

The PRA is a living document developed through intentional consultative processes that used multiple modalities, including surveys, focus groups, convenings, to gather insights about the processes and products needed to actualize HIV prevention justice.

In this summary of the People’s Research Agenda, you’ll find the PRA’s core insights into the processes involved in HIV prevention research and implementation, and the types of products that should be developed through these processes.

Download the Report

This plan provides a broad view of all the moving parts and identifies actions and actors responsible for ensuring time is not wasted and opportunity not squandered.

In 2024, Gilead Sciences released findings from the PURPOSE 1 and PURPOSE 2 trials testing lenacapavir (LEN) as HIV prevention. The PURPOSE 1 trial found 100% efficacy in preventing HIV in 5,300 cisgender women in Uganda and South Africa, and the PURPOSE 2 trial showed a 96% reduction in HIV incidence among cisgender men, trans, and non-binary individuals across multiple countries. Both trials demonstrated LEN’s safety and effectiveness in reducing HIV transmission. This advocates’ primer provides background on the product and trials; a summary of the early findings of PURPOSE 1 & 2; key questions and next steps.

Download the report.

This roadmap addresses the critical need for integrated sexual and reproductive health (SRH) and HIV services. This integration is essential for enhancing public health outcomes, socio-economic benefits, and individual health and rights. The Roadmap aims to revitalize and sustain advocacy efforts for SRH and HIV integration, empower communities to hold stakeholders accountable for implementation, increase political and program support to enable the shift from policy to practice, and foster dynamic partnerships across research, advocacy, implementation, and policy sectors.

It was developed by Copper Rose Zambia (CRZ) as part of the Coalition to Accelerate and Support Prevention Research (CASPR). It draws on extensive input, including desk reviews, interviews, focus group discussions, and a specialized workshop held at the 2023 International Conference on AIDS and STIs in Africa (ICASA).

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes updates, emerging issues and upcoming events. A PDF version of this report is also available.

Progress in PrEP Uptake

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

Among 134 countries reviewed, 42 have comprehensive anti-discrimination policies covering a broad range of populations, while 24 lack any such policies. The remaining countries have adopted partial measures. Nations with comprehensive anti-discrimination policies, document significantly higher rates of PrEP initiation compared to those without such protections. Key studies show a strong link between supportive policies (which can enable PrEP eligibility, HIV self-testing, and lower age of consent for treatment, for example) and higher PrEP initiations.

An analysis presented at AIDS 2024, HIV Pre-Exposure Prophylaxis Policies Worldwide, by the Georgetown University Center for Global Health Policy & Politics and AVAC found that 69% of the 194 countries reviewed have approved at least one PrEP product. However, only 52% of these countries adhere to WHO guidance on PrEP eligibility, with regulatory approvals and national policies that support PrEP use for all populations or people at risk. This data reinforces the critical need for policies that support PrEP uptake.

PrEParing for New Products

Advocacy to accelerate licensing for new products can speed the process of generics manufacturing.

Three generic manufacturers—Aurobindo, Cipla, and Viatris—have licenses via the Medicinces Patent Pool to develop generic versions of injectable cabotegravir (CAB) for PrEP. These generic products are currently in development and expected to be submitted to regulatory authorities in the second half of 2026, with possible approval in 2027.

Does the Timeline Have to be this Long?

As CAB for PrEP is a long-acting, extended-release injection, bioequivalence (BE) testing takes time to determine whether the generic drug functions in the body similarly to the original drug. As shown on the timeline graphic below, the BE study (as determined by WHO guidance) is the longest part of the development process for generic CAB. But other steps, such as selecting and licensing generic manufacturers and technology transfer could be done faster. It is critical that generic manufacturers for new PrEP products, such as lenacapavir, star as soon as possible. This requires Gilead to pursue licensing even before regulatory submission, and to accelerate technology transfer and API development.

Product Updates

Data from HPTN 084 show that CAB for PrEP was generally well tolerated and safe for both pregnant cisgender women and their babies.
China has approved CAB for PrEP.
With PEPFAR support, Eswatini, Nigeria, and Ukraine are poised to introduce CAB for PrEP into their national PrEP programmes this quarter, and the South African government announced CAB supplies from PEPFAR will be launched in Q1/Q2 2025.

See AVAC’s Planning Matrix for more!

The Latest R&D in the Prevention Pipeline

Results from the PURPOSE 1 trial of injectable lenacapavir showing 100% efficacy in preventing HIV among cisgender women and adolescent girls dominated headlines at the AIDS 2024 conference. This Phase 3 trial, conducted by Gilead Sciences, involved over 5,000 participants from South Africa and Uganda and demonstrated superior results compared to daily oral PrEP options. See the New England Journal of Medicine publication, accompanying Editorial and our advocates’ primer to learn more about the results and what needs to happen next: Lens on LEN: The basics on injectable lenacapavir as PrEP.

Gilead’s PURPOSE 2 Phase 3 trial is ongoing and testing injectable lenacapavir as PrEP in the US, South Africa, Peru, Brazil, Mexico, Argentina, and Thailand, among cisgender men who have sex with men, transgender women, transgender men, and gender non-binary individuals. With 3,000 participants enrolled, initial results are anticipated in late 2024 or early 2025. Two other trials (PURPOSE 3 & 4) are currently recruiting in the United States, enrolling cisgender women and people who inject drugs, respectively. Enrollment for PURPOSE 5 in France and the UK is expected to commence in the latter half of this year. For more information about the lenacapavir trials, visit: An Overview of Lenacapavir for PrEP Trials.

Meanwhile, the bioequivalence study for the Dual Prevention Pill (DPP), designed to prevent both HIV and pregnancy, has concluded successfully, with each of the drugs functioning together in the body in a similar way to how they function alone. The promising results pave the way for regulatory submission and potential large-scale adoption, offering another significant tool in the fight against HIV and unintended pregnancies. Learn more about the DPP and find resources for your advocacy.

Prevention Playlist

AVAC develops a wide range of resources to inform decision making and action. Check out the latest:

Join

Read

Watch and Listen

Where’s the Equity? Including People with Disabilities in HIV Prevention Programming and Research
PxPulse: The Advocacy Chronicles with Ruth Akulu who shares advocacy wins around the Dual Prevention Pill
PxPulse: The Advocacy Chronicles with SMUG’s Allan Mwasa who discusses Uganda’s anti- homosexuality legislation
You Get What You Measure: Why Monitoring for PrEP Choice Helps Tell Our Story
PrEP Justice: Updates on the US v. Gilead case and the fight for equitable PrEP access
AIDS 2024: New Ways for the Next Wave: Innovative R&D for the future of Women’s prevention
Responding to Project 2025’s Threats to Science, Rights and Resources
Illinois PrEP Summit 2024: Disrupting Disparities and Advancing Access
It’s Not Just about the Trial: GPP from discovery to delivery in TB research
From the Lab to the Jab: Lessons learned and what’s next in HIV vaccine research
What’s Next for the Pandemic Accord? A civil society and communities perspective
PrEP and the Role of HIV Self-Testing

Use

In the second quarter of this year, there have been exciting new reports and updates on guidelines that could help better inform our efforts and ultimately reduce STIs. In May, the World Health Organization (WHO) released a new report highlighting increasing STI incidence rates globally. This report notes that syphilis, gonorrhea, chlamydia, and trichomoniasis account for more than one million infections daily. It also showed an increase in multi-drug resistant gonorrhea, highlighting the need for diagnostics to properly detect and treat infections. Two weeks later, the U.S. Centers for Disease Control and Prevention (CDC) released much-needed clinical guidelines on the use of doxycycline postexposure prophylaxis (DoxyPEP) for STI prevention—and AVAC launched the Advocates’ Guide to DoxyPEP, a helpful tool in understanding the science to date and considerations for future research and implementation. While STI prevention and treatment options remain limited, these updates represent progress in understanding who is impacted by STIs and developing interventions to meet their needs.

STI Advocacy Updates

In October, AVAC awarded funding to seven advocacy partners in Southern and East Africa to identify and share needs for STI prevention in their communities. Partners presented this work to a global audience, which is helping to build an advocacy agenda to accelerate development of new STI vaccines, diagnostics, and other prevention tools and strategies. In June, AVAC provided additional funding to support the ongoing STI work of these partners. Lookout for additional details about their progress in the coming months.

With syphilis and congenital syphilis rising in many countries, AVAC is following the work of Healthy Futures Global, a non-profit focused on the prevention of vertical transmission of syphilis. They are partnering with the Philippine Department of Health to understand how best to implement testing for HIV and syphilis in pregnancy with the ultimate goal of testing all pregnant Filipinas for HIV and syphilis. Subscribe to their newsletter here.

Upcoming Events

STI International Exchange (STIIX) Virtual Conference Series
July 12, 2024
In this virtual conference series STIIX will explore inequalities in sexual health and HIV across the United States and how to improve access to services for vulnerable communities. Registration is free and open to all.
AIDS 2024 Preconference: Mobilize for Action on Sexually Transmitted Infections!
July 21, 2024
The WHO, International AIDS Society (IAS), and International Union Against STIs (IUSTI) will host a pre-conference session during AIDS 2024 to explore pressing issues in STI prevention, testing, and treatment options. AVAC Senior Program Manager for STIs, Dr. Alison Footman, and AVAC Executive Director, Mitchell Warren, will speak at the pre-conference. In person and virtual participation are available if you are registered for AIDS 2024.
National Sexual Health Conference
July 30-31, 2024
This virtual conference creates opportunities to share information, efforts, research, and best practices related to sexual health across the lifespan.
IUSTI + STI Prevention
September 16-20, 2024 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.
National Coalition for Sexual Health (NCSH) Annual Meeting
September 26, 2024
The virtual NCSH Annual Meeting will include two panels: 1. Overcoming Obstacles: Sexual Health Censorship and Misinformation on Social Media and 2. Increasing the Appeal of STI Prevention Tools: Both Old and the New, and a Q&A session with a leader from the Division of STD Prevention, CDC.

New Resources

Doxycycline, an oral antibiotic, can be used as a post-exposure prophylaxis, commonly referred to as DoxyPEP, when used to prevent the acquisition of some bacterial STIs after sex. Doxycycline is inexpensive, easily tolerated, and widely available. However, questions remain regarding who will benefit most from DoxyPEP and how to implement this strategy broadly to ensure equitable access and minimize antimicrobial resistance. This guide seeks to explore and address these critical questions.

Webinar & Event Recordings

Syphilis in the U.S.: The current state of the epidemic and how it’s being addressed. This webinar focused on Syphilis and the National Syphilis and Congenital Syphilis Syndemic Federal Task Force.
DoxyPEP: Prevention, effectiveness, and AMR. This webinar focused on the latest scientific insights on DoxyPEP, its effectiveness in preventing STIs, and considerations around AMR.
Sexually Transmitted Infections: What You Should Know about STIs and Testing. This webinar focused on basic information on STIs and testing, including when you should get tested and the types of tests available for different infections.
Advancing Global Health Equity: Investing in Integrated HIV, HPV, and Cervical Cancer Initiatives. amfAR, Funders Concerned About AIDS (FCAA), and Funders For Reproductive Equity (FRE) brought donors together to explore the pivotal role philanthropy can play in advancing integrated solutions for HIV, HPV, and cervical cancer.
STI Engage
Plenary sessions from STI Engage are available. The meeting hosted five plenaries, more than 40 sessions, and nearly 200 presenters this year!

What We’re Reading

Dual Epidemics: Leveraging HIV Infrastructure to Support HPV prevention, Testing, and Cervical Cancer Elimination Goals. This policy brief explores the challenges in treatment, prevention and care of those affected by HIV and human papilloma virus (HPV), and the opportunities for integrated funding and service delivery to galvanize the attention and support needed to improve lives.
Syphilis Has Surged for Reasons That Go Beyond the Pathogen That Causes It. This perspectives piece highlights the rising rates of syphilis and congenital syphilis cases. Data from 2022 showed that lack of timely testing and adequate treatment contributed to 88% of congenital syphilis cases in the U.S. Additionally, fewer people have a primary care clinician and are seeking care in emergency departments, where syphilis testing capabilities are limited. There is need for a more comprehensive, syndemic-based, and strategic approach that includes addressing social determinants of health to help better detect and treat syphilis cases.
Gaps in the prevention of mother-to-child transmission of syphilis: a review of reported cases, South Africa, January 2020–June 2022. Within this study, authors found that syphilis testing and treatment among pregnant women in South Africa fell short of WHO’s congenital syphilis elimination goal where more than 95% of pregnant women receive at least one antenatal visit, more than 95% of pregnant women are tested for syphilis, and more than 95% of pregnant women with syphilis receive treatment. Barriers to syphilis treatment included presenting late to antenatal care and delays in receiving syphilis test results. On-site, rapid syphilis testing has shown to decrease treatment delays, especially in settings with limited laboratory facilities.
Millions of Girls in Africa Will Miss HPV Shots After Merck Production Problem. Merck will deliver only 18.8 million of the 29.6 million doses it was contracted to deliver in 2024 to low- and middle-income countries (LMICs) after a manufacturing disruption. While Merck plans to deliver delayed doses in 2025, this continues to delay implementation of HPV vaccines in LMICs that have waited years to begin vaccinating adolescent girls against HPV, the leading cause of cervical cancer.

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

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research and development, implementation and advocacy. Each issue includes updates, emerging issues and upcoming events. A PDF version of this report is also available.

Progress in PrEP Uptake

New research provides reassuring evidence that oral PrEP can reliably prevent HIV infection in cisgender women even with non-perfect adherence. Prior to becoming the director of NIAID, Dr. Jeanne Marrazzo led a team in a study assessing the effectiveness of F/TDF for PrEP (brand name Truvada) among cisgender women across a wide range (11) of studies. This paper—HIV Preexposure Prophylaxis with Emtricitabine and Tenofovir Disoproxil Fumarate Among Cisgender Women, which she also presented on a recent Choice Agenda webinar—dramatically shifts the conversation away from the need for women to be “super-adherers” to oral PrEP. The data also reinforce the need to support an array of options for women.

These graphics show the very high effectiveness of oral F/TDF for women with daily adherence and also for those who had consistently high adherence. Data comes from 11 demonstration projects of 2,954 cisgender women across six countries (Botswana, India, Kenya, South Africa, Uganda, USA) over eight years (2012-2020).

The data also demonstrates comparable effectiveness of F/TDF found in cisgender men who have sex with men (MSM).

Global and Country Milestones

January-March 2024

Global cumulative PrEP initiations surpassed 6.7 million, which includes CAB initiations (12,075) and DVR initiations (1,797).
Mexico and the United Arab Emirates approved oral F/TAF (or Descovy) in April.

For more comprehensive PrEP initiation data, see our tracker, data.prepwatch.org.

PrEParing for New Products

It has taken over a decade from positive efficacy results for daily oral TDF/ FTC to reach scale globally—and six years post-efficacy just to become available, in limited quantities, in lower-and middle-income countries (LMIC). During this time, nearly 20 million people acquired HIV. How many of those infections would have been prevented with faster, more efficient rollout of PrEP?

The rollout of oral PrEP demonstrates that people don’t take PrEP simply because it’s available—there needs to be a demand for it, and it needs to be accessible, acceptable and used effectively by those who need and want it. These are the lessons the field is applying to the rollout of the dapivirine vaginal ring (DVR) and injectable cabotegravir for PrEP. To reach the UNAIDS target of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough—and the graphic at right does show that the field is beginning to apply past lessons to accelerate introduction of injectable cabotegravir.

Having multiple options for users to choose from is critical to increasing PrEP coverage, as seen from the early results of the SEARCH dynamic choice study, where coverage among participants featured a choice of products and settings for receiving oral PrEP, PEP, or injectable cabotegravir. The study showed 70% PrEP coverage in contrast with 13% coverage among those only offered oral PrEP or PEP from standard programs.