IMPALA seeks to test the effectiveness of long-acting (LA) 2-monthly injectable cabotegravir LA plus rilpivirine LA compared to continuation of daily oral dolutegravir-based treatment in adults with a history of sub-optimal HIV control in sub-Saharan Africa. The study hopes to generate data that will support improved access long-acting antiretrovirals with a view to reducing HIV transmission, morbidity and mortality from HIV/AIDS.
IMPALA is a phase 3, open-label, randomised clinical trial that will be conducted across 7 sites in 3 countries: Uganda, Kenya and South Africa. The trial will include 540 virologically suppressed adults who have had a detectable HIV viral load in prior 2 years of taking first-line ART or who have disengaged from HIV care. Qualitative work will be conducted with participants, healthcare workers and with key stakeholders in the HIV treatment field. We will also determine the cost-effectiveness of the LA treatment regimen is in a population at high risk of HIV-related illness and onwards transmission of HIV.