Addressing Transgender Erasure in HIV Clinical Trials

The scorecard for transgender and gender-diverse inclusion

Scorecard indicators reveal a dearth of HIV research responsive to the needs of transgender and gender-diverse (TGD) communities. The lack of TGD representation in HIV clinical trials indicates a historical erasure of TGD communities with potential public health consequences. The scorecard might guide future HIV research to be more responsive to the needs of TGD people. Published in the American Journal of Public Health.

HIV Prevention Product Overview

The graphic provides an overview of PrEP products currently available and in late-stage clinical trials. 

This file is also available to download as a PowerPoint file.

STIWatch Quarterly Newsletter

Issue 7: August 2025

As many global health fields reassess their reliance on US government funding for research and development, the STI field—already underfunded and reliant on alternate donors—now faces even greater uncertainty. In this newsletter, we share a new STI resource for advocates and highlight the top issues we’re monitoring as events continue to unfold. 

Read for more.

EXPrESSIVE Phase 3 Trials

Seventeen countries are hosting sites for Merck’s trials of a monthly pill for PrEP. Launch is expected in Q3 2025. This graphic shows where these trials are taking place.

This file is also available to download as a PowerPoint file.

Lenacapavir Regulatory Approval

Regulatory approvals, pending decisions, and appeals as of July 2025, including US Food and Drug Administration approval. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.

This graphic is also available for download as a PowerPoint file.

Moving a Product to the Real World

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 (CAB) and lenacapavir (LEN) for PrEP. To reach the UNAIDS target of 10 million PrEP users by 2025, initiations of oral PrEP alone will not be enough—and this graphic shows that the field is beginning to apply past lessons to accelerate introduction of injectable PrEP options.

Download this as a PowerPoint file. And for the latest on lenacapavir, visit here.

Where We Are Now with LEN for PrEP

The chaos in foreign assistance programs (including discontinuation of major PrEP programs), cuts in staffing and new demands on donor commitments will make decisions on the procurement of LEN for PrEP more complex and uncertain.

In December 2024, the Global Fund and PEPFAR announced a plan to reach 2 million people with LEN for PrEP over three years. Exactly how funding to support this unprecedented introduction program will move forward, in the absence of significant US investment, is far from certain. The other stakeholders, including Global Fund, Gilead, CIFF and the Gates Foundation expressed commitments to the deal, but major questions remain.

This graphic is also available for download as a PowerPoint file.

Years Ahead in HIV Prevention Research: Time to Market

This timeline shows the potential time points when the next-generation of HIV prevention options might find their way into new programs.

This file is also available to download as a PowerPoint file.

Enhancing Community Engagement in HIV Prevention Clinical Trial Design

Insights from AVAC's clinical trial design academy

Presented at IAS 2025, this poster discusses the goals and lessons learned from the Clinical Trial Design Academy.

The Global Need for Long-Acting PrEP Among Key Populations

Forecasts of Global Demand 2025–2030

The introduction of long-acting PrEP represents a turning point in the global HIV response, especially for key populations who have historically faced persistent barriers to HIV prevention. Despite oral PrEP being introduced more than a decade ago, global uptake remains well below targets. New HIV infections are declining in some regions but are stagnating or rising in others, particularly where key populations are
underserved.

Also available on the GBGMC website.