A Billion-Dollar Question: Will Investments in Implementation Science Accelerate Lenacapavir’s Impact?



Sep 22, 2025

Rose Wilcher
The recent announcement that NIH may devote up to $1 billion – one-third of its HIV budget – to implementation science (IS) has put a spotlight on the field. The announcement is driven by a desire to optimize the impact of lenacapavir (LEN), a new pre-exposure prophylaxis (PrEP) product that was approved by the FDA in June and endorsed by the World Health Organization a month later. LEN, a subcutaneous injection given every six months, has shown remarkable efficacy in two Phase III trials and is widely seen as a breakthrough for HIV prevention.
But scientific breakthroughs do not implement themselves. It often takes years – sometimes decades – for scientific discoveries to translate into widespread practice and improve public health outcomes. That gap is precisely what implementation science aims to close, by studying how to move evidence-based practices, products, and innovations into routine use.
Implementation Science Alone Is Not Enough
The promise of large-scale IS investment is exciting, especially to accelerate LEN access. Yet what’s missing from the current conversation is a parallel investment in research translation. Generating rigorous evidence on how to deliver LEN in real-world contexts is critical. But unless IS is paired with deliberate strategies for translating findings into policy and practice, LEN’s potential will remain trapped in publications rather than transforming the epidemic.
Major funders – including the Global Fund, PEPFAR, and Unitaid – are already committing resources to LEN rollout in low-income countries as early as 2026. Ministries of Health are drafting national implementation plans now. Policymakers, providers, and communities cannot afford to wait several years for new studies to conclude before insights inform rollout. IS must be designed with real-time translation pathways that feed evidence directly into policy and program decisions as they unfold.
Research Translation in Action
During my time as Director of Research Utilization at FHI 360, we developed a framework to accelerate the uptake of study findings in policy and practice. The CATALYST study – a multi-country implementation study of informed PrEP choice – adapted this framework and put it into action.
CATALYST was designed to generate evidence on scalable and sustainable strategies for providing informed choice of multiple PrEP products in public health facilities in Africa. Notably, the study was conceived and launched just as two new PrEP products – the dapivirine vaginal ring and injectable cabotegravir (CAB) – were beginning to move from trials into programmatic rollout. That timing meant CATALYST could not wait for its final results to be useful; evidence needed to inform programming in real time. To meet this need, each study country developed a tailored research translation plan, with focal points on both the global and country teams responsible for ensuring translation activities were implemented from the start and sustained throughout the study.
Illustrative translation activities included:
Co-creation with stakeholders: We engaged policymakers, implementers, civil society, and young people during study design and throughout implementation to shape priorities, review progress, and interpret findings so evidence would be relevant and responsive to local needs.
Practical tools and training: We developed training materials and job aids to equip providers in study sites to offer PrEP choice counseling and made these technical resources publicly available for use in programmatic rollout beyond the study.
Learning platforms: We convened virtual and in-person learning sessions with stakeholders at national, subnational, facility, and community levels to enable rapid sharing of experiences and adaptations delivering PrEP choice across country and facility contexts.
Timely evidence sharing: We conducted interim analyses and aligned them with critical policy windows and knowledge exchange forums so data could inform decisions while rollout was underway.
Visibility and uptake: We presented interim findings and lessons at key global, regional, and national conferences, shared them through targeted discussions with funding agencies and ministries of health, and published them in peer-reviewed journals. We provided technical assistance to directly incorporate results into national PrEP policies and planning.
Although CATALYST was ultimately cut short by U.S. foreign aid reductions, the research translation approach was working. Even mid-way through the study, it was already influencing national rollout of the PrEP ring and CAB PrEP. Ministries of Health were updating clinical guidelines and implementation plans, refining product forecasting, and adopting CATALYST-generated tools and training materials in programmatic rollout sites.
The Way Forward
If NIH and other donors want IS investments to truly change the trajectory of the HIV epidemic, research translation must be treated as integral to those efforts, not optional. LEN’s rollout is already moving. We need IS that not only generates knowledge but also ensures that knowledge is mobilized and applied at scale to impact policies, programs, and lives.

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