By Karin Hatzold, Senior Advisor II, Infectious Diseases
Lenacapavir (LEN) represents one of the most significant advances in HIV prevention in recent years. A twice-yearly injectable PrEP option has the potential to transform prevention choice, especially for people who face challenges with daily pills, frequent clinic visits, stigma, disclosure concerns, or competing life priorities. But successful LEN introduction requires more than product availability. It depends on health systems, communities, providers, and supply chains being ready to support high-quality delivery, informed choice, sustained demand, and equitable access.
Last month in Cape Town, we convened the Regional LEN Learning Exchange as part of the LEN Technical Assistance Consortium, together with PSI, Wits RHI and CHAI, with the support of CIFF and Unitaid. The meeting brought together Ministries of Health, implementing partners, researchers, community leaders and technical partners from across Africa who are already advancing LEN introduction.
The workshop was an important moment for collective reflection, alignment, and problem-solving. It allowed us to take stock of early implementation experience, identify emerging policy and delivery gaps, and sharpen our shared understanding of what it will take to move from early introduction to sustainable, equitable scale.
The discussions reinforced a central lesson from our collective work: LEN introduction is not only about making a new product available. It is about shaping the future of HIV prevention delivery.
We focused on the systems that need to be in place for innovation to translate into impact: policy readiness, reliable supply, provider confidence, community trust, demand generation, differentiated delivery models, and the data systems needed to guide scale-up. The learning from countries already introducing LEN showed that success will depend not only on scientific innovation, but on how well we prepare health systems to deliver that innovation equitably and sustainably.
Across the exchange, four lessons from our shared implementation experience came into sharp focus.
LEN demand is real, but supply and readiness must keep pace
Across early-adopter countries, demand for LEN has been strong, with uptake moving quickly and, in some settings, faster than anticipated. Several countries reported that demand outpaced available supply, with stock-outs occurring within weeks of launch. This is encouraging because it shows that many people are interested in a prevention option that may better fit their lives. But it is also sobering.
Strong demand must be matched by careful planning: supply availability, site readiness, provider preparedness, demand generation, and clear client communication all need to be sequenced carefully so that early enthusiasm translates into equitable, sustained access.
Scale depends on making prevention simpler
If LEN is to reach people at scale, HIV testing pathways must be feasible, client-centered, and safe. Countries are actively exploring how to simplify testing requirements, including the role of HIV self-testing in supporting PrEPinitiation and continuation. The discussion was nuanced: we need to maintain safety and avoid missed acute HIV infections, but we must also avoid overly complex algorithms that make access difficult, especially outside traditional facility settings.
Scaling also requires a differentiated service delivery approach. No single model will be enough. Facility-based services remain essential, particularly for pregnant and breastfeeding women and clients needing integrated clinical care. But pharmacy delivery, community platforms, mobile outreach, peer-led models and digital entry points are all critical if we want LEN to reach those who are not well served by conventional systems. Zimbabwe’s pharmacy PrEPexperience, Uganda’s private-sector models, South Africa’s integrated digital systems, and community-based approaches across the region all point in the same direction: prevention must fit people’s lives, not the other way around.
Digital and AI-enabled tools showed up strongly in our discussions as another opportunity to address delivery challenges. Across South Africa, Zimbabwe and Mozambique, AI health companions, chatbots, digital referral tools and WhatsApp-based support systems are being used to answer sensitive questions, support service navigation, generate reminders and connect people to care. These tools are not a replacement for healthcare workers. Their value lies in preparing, guiding and supporting clients, while keeping human escalation and clinical oversight central. As countries introduce LEN and other prevention options, digital tools can help sustain engagement across the six-month dosing interval, but they must be safe, locally adapted, evidence-based, and connected to real services.
Whether we’re talking about testing algorithms, pharmacies or AI-powered support, the underlying question is the same: how do we make prevention easier to access while maintaining quality and safety?
LEN is part of a broader prevention choice agenda
LEN is exciting, but it should not crowd out other prevention options or lead to provider bias. Clients need clear, balanced counselling on PrEP, PEP options, and other prevention tools. Expanding choice means helping people choose the method that best fits their lives and allowing them to switch as their needs change.
We heard repeatedly that person-centered demand generation is key. The workshop challenged us to think beyond campaigns and slogans. Demand generation is not just communication; it is the deliberate process of building prevention literacy, trust, motivation, social support, and access. Human-centered design work from Zimbabwe showed that people respond best when they are approached not as “risk groups” but as whole human beings: parents, partners, workers, friends, people with hopes, responsibilities and choices. The emerging message was powerful: prevention should be framed around choice, confidence, freedom, and life.
We also discussed how different populations need different delivery models. Incident HIV infection during pregnancy and breastfeeding continues to contribute to vertical transmission in several countries. Long-acting PrEP could be game changing in this context, particularly where daily oral PrEP continuation is difficult during the postpartum period. Yet implementation remains uneven. Provider confidence, consistent safety messaging, integration into antenatal care and postnatal care platforms, and strong pharmacovigilance systems will be essential.
Innovation only succeeds when systems succeed
The countries leading LEN introduction aren’t simply rolling out a new medicine. They’re building the systems that will determine whether long-acting HIV prevention succeeds over the next decade. We also heard important lessons on monitoring, pharmacovigilance, and quality assurance. LEN requires a different M&E architecture from oral PrEP. Countries need client-level, longitudinal systems that can track initiation, persistence, next injection dates, missed visits, switching and adverse events monitoring. Early adverse event data are reassuring, with most events being mild and manageable injection-site reactions, but under-reporting remains a concern. Active pharmacovigilance, provider mentorship and supportive supervision will be essential as programs scale.
As we look ahead to AIDS 2026 in Rio de Janeiro, these early lessons are timely and important. The LEN TA Consortium will share this implementation learning through two satellite sessions focused on early country experience, demand generation, differentiated delivery, and the next phase of LEN scale-up. These sessions will provide an opportunity to bring regional learning to a global audience and to continue the conversation on how to translate scientific innovation into public health impact.
As we continue to build on these learnings, this workshop reinforced that introducing LEN isn’t the finish line. It’s the beginning of a new chapter in HIV prevention, one that puts choice, equity, and people at the center of how we deliver care. It asks us to rethink service models, rebuild systems around people’s realities, and rise to the challenge of equitable access.
The countries leading this work are generating the evidence the world needs. The next step is to ensure that this learning is shared, adapted, and acted upon, so that long-acting prevention becomes not a privilege for a few, but a real choice for all who need it.