Presented at IAS 2025, this poster discusses the goals and lessons learned from the Clinical Trial Design Academy.
Enhancing Community Engagement in HIV Prevention Clinical Trial Design
Insights from AVAC's clinical trial design academy
Impact of US Funding Cuts on Services for Key Populations
Percentage of key population-serving implementing partners that have reported full or partial termination of the provision of KP services due to US funding cuts (as of April 2025).
Impact of Cuts to the Consortia for HIV/AIDS Vaccine Development (CHAVD)
HIV Vaccine Funding
In May 2025, NIH’s National Institute of Allergy and Infectious Diseases (NIAID) announced that funding for the Consortia for HIV/AIDS Vaccine Development (CHAVD) would end after the current grant cycle in June 2026. With only one more year of funding before the grants end, current plans for research, clinical trials and progress toward a vaccine are all at risk.
The annual funding for the consortia—approximately $67M—represents a significant chunk of the NIH’s funding for HIV vaccine development, and also approximately 10% of all funding for HIV vaccine research globally each year.
Excerpted from PxWire.
Potential Demand for LEN for PrEP
The top 16 PrEP markets, based on 2024 oral PrEP initiations and the possible 2026 injectable market, assuming 60% of new PrEP users choose an injectable, as seen in implementation studies.
LEN Generics — Can we go faster?
The timeline for generic LEN for PrEP to come to market is expected to be significantly shorter than for CAB for PrEP. Bioequivalence (BE) testing for LEN, which demonstrates a generic product works in the body in the same way as the originator product, is likely to be six months, vs. the 18 months for CAB for PrEP, because of differences in the drug formulation. The rapid granting of voluntary licensing by Gilead also contributes to this shorter timeline. For the latest on LEN, visit here.
Modelling Shows the Potential of LA-PrEP
Modelling data from South Africa demonstrate the potential of injectable PrEP to dramatically reduce HIV incidence by up to 90% by 2044, and potentially even sooner with more aggressive uptake. This potential goes beyond South Africa, lighting the way toward epidemic control the world over. Excerpted from PxWire.
PrEP Delivery Imperiled
Programs for delivering PrEP have been shuttered all over the world by the withdrawal of the US government from global health. This graphic illustrates some of the severe measurable impacts of these cuts. Excerpted from PxWire.
An “Innovation Pile-Up” in Next-Generation LA-PrEP is Possible
The HIV prevention market is headed toward a period of significant opportunity—and possible congestion—as a slate of new products are on track for continued development and potential introduction to the market in 2027 and 2028. Markets and policies must be built to support the products in the market already, so that new options can be rapidly deployed and deliver impact. Otherwise, the field will squander time and money, with epidemic control slipping further out of reach. Excerpted from PxWire.
Trials & Projects Halted by USAID Funding Suspension
The stop-work orders have disrupted USAID-supported HIV prevention research, halting critical investigations in vaccine and next-generation PrEP strategies.
The abrupt suspension of these trials also raises serious ethical concerns. Stopping trials mid-course undermines trust in research, jeopardizes community engagement, and abandons participants who volunteer their bodies for scientific discovery. It will take years to build back this critical infrastructure—for HIV research and beyond—as well as the community partnership and trust needed to ensure smooth and ethical research.
HIV Incidence, Age 15-49
Looking backward and then into the future, this chart shows actual HIV rates alongside projected rates with and without current prevention strategies (PrEP, VMMC, and free condoms).