South African Universities at the Forefront of Lenacapavir's Game-Changing HIV Prevention Trials
South Africa's battle against HIV has entered a transformative phase with lenacapavir, a revolutionary long-acting injectable pre-exposure prophylaxis (PrEP) administered just twice a year. Developed by Gilead Sciences, this subcutaneous injection has demonstrated near-perfect efficacy in clinical trials, particularly among high-risk groups like adolescent girls and young women (AGYW). What makes this breakthrough especially poignant for South Africa—the country with the world's largest HIV epidemic—is the pivotal role played by local universities in validating and now implementing the drug. Institutions such as the University of the Witwatersrand (Wits) and the University of Cape Town (UCT) led key PURPOSE trials, paving the way for national rollout amid mounting challenges.
The PURPOSE 1 trial, co-led by Professor Linda-Gail Bekker from UCT's Desmond Tutu Health Foundation, enrolled over 5,300 AGYW in South Africa and Uganda, showing zero HIV infections among lenacapavir recipients compared to daily oral PrEP. This 100% efficacy rate underscores its potential to disrupt transmission patterns where daily pills falter due to adherence issues. Wits Reproductive Health and HIV Institute (RHI) has since spearheaded real-world studies, marking the first lenacapavir administrations outside trials in December 2025.
First Shipments Arrive: Rollout Timeline and Initial Targets
In early April 2026, South Africa's first consignment of 37,920 doses arrived, funded by the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Health Minister Dr. Aaron Motsoaledi announced phased rollout beginning late May or early June 2026, starting in select public clinics across high-burden districts. Priority groups include AGYW—who account for 30% of new infections despite being 8% of the population—sex workers, men who have sex with men (MSM), transgender individuals, and pregnant or breastfeeding women.
These doses cover roughly 456,000 people over two years, a fraction of the 1.7-2.9 million annual recipients needed to slash new infections from 180,000 in 2024 to under 65,000 by 2043, per modeling from local researchers. Universities are integral, with Wits RHI's Unitaid-funded study embedding lenacapavir into Department of Health services via clinics and mobile units at schools and hotspots, gathering data on delivery models and adherence.
Wits RHI's Implementation Research: Bridging Trials to Real-World Delivery
The University of the Witwatersrand's RHI is leading a landmark Unitaid-backed study, the first to test lenacapavir in routine care. Partnering with the National Department of Health and Gilead, researchers deploy peer educators, digital platforms reaching 200,000+ monthly, and mobile clinics to tailor services. Early findings inform training for health workers and strategies for sustained use, crucial as adherence drops sharply after six months for daily PrEP.
"To make long-acting PrEP like lenacapavir successful, we must meet people where they are with flexible services," notes Professor Saiqa Mullick of Wits RHI. This university-driven effort addresses gaps in user preferences, stigma reduction, and integration into primary care, positioning Wits as a global leader in HIV innovation.
UCT's Legacy in PURPOSE Trials: From Cape Town Sites to Global Breakthrough
At UCT, the Desmond Tutu Health Foundation's Masiphumelele Research Site in Cape Town hosted PURPOSE 1 participants, contributing vital data on lenacapavir's superiority over emtricitabine/tenofovir alafenamide (F/TAF). Professor Bekker's leadership highlighted the drug's promise for AGYW, where HIV incidence remains alarmingly high at 4-5% annually in some areas.
UCT researchers continue advocating for equitable access, emphasizing combination prevention—lenacapavir alongside condoms, testing, and treatment. Their work underscores South African academia's capacity to drive evidence-based policy, even as rollout pressures mount.
US Funding Cuts: A Blow to University-Led Prevention Research
The Trump administration's 2025 PEPFAR cuts—ending USAID and CDC bridge funding—have ravaged community services in 27 of SA's 52 highest-HIV districts. PrEP uptake plummeted 25% in early 2025, HIV testing declined, and programs like DREAMS (which boosted AGYW PrEP starts 1.4-fold) collapsed. Universities feel the strain: Wits and UCT projects lost NGO partners for peer navigation, forcing reliance on overburdened clinics with 7am-4pm queues and stigmatizing staff.
"We're building lenacapavir programmes on a foundation of sand," warns Emily Bass of Physicians for Human Rights. Academic teams now pivot to digital tools and mobile outreach, but scaled research requires restored funding to avert resurgence.
Photo by Jolame Chirwa on Unsplash
Manufacturing Capacity Constraints: Universities Push for Local Production
Global supply lags demand; initial branded doses are pricier, with generics at $40/person/year slated for 2027 via Gilead licenses to six manufacturers. SA's March 2026 Expression of Interest seeks local producers, supported by Unitaid and USP technical aid. Wits researchers model that without rapid scale-up, infections won't drop sufficiently.
University labs contribute by validating quality and optimizing formulations, but capacity cuts exacerbate shortages. SA's local production bid could empower academia-industry ties for self-reliance.
Clinic Overload and Stigma: Research Insights from SA Campuses
Government facilities prioritize acute care, sidelining prevention amid PEPFAR voids. Wits studies reveal users abandoning services due to waits and insensitivity. UCT data stresses peer-led models, proven to boost retention 70% in past trials.
Emerging solutions include university-backed apps for reminders and telehealth, tested in ongoing pilots. These innovations could reclaim lost ground, ensuring lenacapavir reaches those needing it most.
Modeling the Impact: University Projections for Ending AIDS by 2043
Collaborative modeling by Wits and partners forecasts 75% infection reduction if 1.7M receive lenacapavir yearly, averting 840,000 cases over 20 years at R64bn—cost-effective vs. alternatives. Optimistic 2.9M coverage hits 47,000 annual infections by 2045.
Combined with 95% treatment coverage, universities project sub-0.1% incidence by 2039. These projections guide policy, highlighting academia's forecasting role.
Stakeholder Perspectives: Voices from SA's Academic Frontlines
"Lenacapavir isn't just a drug; it's a turning point, but systems must evolve," says Wits' Mullick. UCT's Bekker echoes: "Our trials prove its power; now implementation research ensures equity." Experts urge pharma funding for Zazi clubs and warn against delays, as every missed dose risks resurgence.
Government, Global Fund, and universities collaborate on training 300+ facilities in 24 districts, blending fixed and mobile delivery.
Future Outlook: How Universities Can Overcome Rollout Barriers
SA universities stand ready to innovate: Wits' digital platforms, UCT's community models, and joint bids for manufacturing. Boosting health budget to 20%+ and pharma partnerships could fill gaps. By 2030, lenacapavir—bolstered by academic rigor—could bend the epidemic curve, ending AIDS as a public threat.
This moment tests higher education's public health mandate, promising legacy if challenges are met head-on. Wits RHI's ongoing work exemplifies this, training next-gen researchers for sustainable impact.
Photo by Jolame Chirwa on Unsplash
Broader Implications for South African Higher Education
HIV research elevates SA universities globally, attracting funding and talent. Wits and UCT's leadership fosters interdisciplinary hubs blending epidemiology, pharma, and policy. Amid capacity strains, they advocate resilient systems, positioning academia as rollout architects.
Success here could model for Africa, where 25M live with HIV, amplifying universities' continental influence.
