The Malawi Ministry of Health (MoH)’s Department of HIV/AIDS and Viral Hepatitis (DHA) and National AIDS Commission (NAC), in partnership with Georgetown University’s Center for Innovation in Global Health (CIGH), launched the PathToScale implementation science initiative in Malawi on September 1, 2023. PathToScale aims to enroll up to 9,900 individuals onto long-acting injectable cabotegravir (CAB-LA) for HIV pre-exposure prophylaxis (PrEP) across populations at 36 existing service delivery sites in Blantyre and Lilongwe. The programmatic introduction of CAB-LA PrEP is being conducted through four main implementation science objectives: formative work to lay the groundwork for implementation and understand patient and provider preferences; implementation through diverse PrEP delivery channels; evaluation of an intensive continuation support intervention; and addressing systems barriers on the path to scale of PrEP services.

 

During the formative work, three core Blantyre Prevention Strategy (BPS) program elements (data access and use, the community lab model, and the QI collaborative) were adapted to Lilongwe to strengthen the district-level health system and support the introduction of new biomedical HIV prevention products, including CAB-LA. PathToScale has linked the early introduction of scientific activities and learnings to a systematic health systems-focused implementation approach to drive accelerated policy development and sustainable product adoption of injectable PrEP. See the HIVR4P conference satellite for a presentation of the data collected during the formative phase and early outcomes. Since its official launch in September 2023, PathToScale has supported the update of national PrEP guidelines, training of trainers and providers, and district and facility-level sensitization for CAB-LA rollout for the 36 PathToScale facilities. Building on the formative work, PathToScale utilized human-centered design (HCD) methods to co-design a PrEP continuation support package with providers, current and previous PrEP clients, and district and national-level colleague. The continuation support package includes three intervention components and will be tested at half of the facilities providing CAB-LA through PathToScale across both districts. 

 

The first dose of CAB-LA offered as part of the PathToScale study was provided in March 2024. A “lead-in” phase tested delivery in each of the 36 facilities with a small number of clients to address any concerns prior to scale up. The PathToScale scaled-up enrollment phase began September 1, 2025, with plans to enroll all CAB-LA clients for six months, with a five-month follow-up period.

 

The PathToScale Initiative co-principal investigators, co-investigators, and implementing and research partners include the Malawi MoH and NAC, Blantyre and Lilongwe Districts, CIGH, Johns Hopkins University, University of North Carolina-Malawi Project (Lilongwe), Johns Hopkins Research Project (Blantyre), QED, UCSF-HEALTHQUAL, the Clinton Health Access Initiative (CHAI), the Elizabeth Glazer Pediatric AIDS Foundation (EGPAF), MACRO, Partners in Hope (PIH), Lighthouse Trust, the Pakachere Institute of Health and Development Communication, and the Centre for the Development of People (CEDEP). Implementation is supported by the Bill & Melinda Gates Foundation. CAB-LA utilized in support of PathToScale was provided by the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund.