Regulatory approvals, pending decisions, and appeals as of October 2025. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Dapivirine Vaginal Ring Regulatory Approval
AVAC Input for Recompetition of the NIAID HIV/AIDS Clinical Trials Networks
AVAC’s formal input submitted on the re-competition of the NIAID HIV/AIDS Clinical Trials Networks. The recommendations were informed by the People’s Research Agenda (PRA), a comprehensive framework developed through consultations with over 130 community representatives across 23 countries.
HIV Prevention Product Overview
The graphic provides an overview of PrEP products currently available and in late-stage clinical trials.
Manifestations and Lived Experiences of Structural Racism for Racial and Ethnic Minority Communities Affected by HIV Across the United States
Structural racism shapes the lived experiences of racial and ethnic minority communities through political disempowerment, inequitable access to resources, and intergenerational trauma. This study provides support for the argument that the HIV and COVID-19 epidemics will not be adequately addressed without urgent action on the various ways in which structural racism manifests in the US. Given the troubling trend toward stifling discussions on race and racism, now is the time to accelerate, not subdue, national, state, and local discourse on structural racism and intersectional oppression. Now is time for bold, transformative actions.
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 Research on Pause
Impacts of US government cuts on HIV R&D
This presentation, delivered by AVAC’s Executive Director, Mitchell Warren at IAS 2025, shares a sobering picture of the sweeping changes to science, global health and particularly, HIV R&D since January 20, 2025. It outlines the impact of foreign aid cuts, NIH grant terminations, and policy shifts and shares a vision for the future.
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.
Designing for the Future
Community perspectives for HIV prevention trials
Presented by AVAC’s Regional Program Manager for Research Engagement Grace Kumwenda at IAS 2025, this presentation summarizes community demands that future HIV prevention trials be ethical, acceptable, inclusive, feasible, and efficient.
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.
Now What with Injectable LEN for PrEP?
How to Translate Ambition into Accelerated Delivery and Impact
The announcements on 9 July 2025 from Global Fund and Gilead about their next steps for injectable lenacapavir (LEN) for PrEP are welcome, as one more part of the process. But they raise as many questions as they answer. This brief summary is intended to help outline what is actually known – and not – and what needs to happen next.