The LEN4PrEP study: protocol for a phase 3B, non-randomised clinical trial integrating lenacapavir PrEP within multi-product HIV prevention services in primary care clinics in South Africa

Introduction

Despite the scale-up of HIV pre-exposure prophylaxis (PrEP), HIV incidence remains high. The highly effective, twice-yearly subcutaneous injectable lenacapavir for PrEP (L4P) has provided a potential breakthrough for HIV prevention, but there is limited real-world data on uptake, patterns of use and service delivery requirements when offered in public health settings. The LEN4PrEP study will evaluate the integration of L4P within existing multi-product HIV prevention services in real-world settings in South Africa.