Effect of door-to-door distribution of HIV self-testing kits on HIV testing and antiretroviral therapy initiation: a cluster randomised trial in Malawi

Abstract Introduction: Reaching high coverage of HIV testing remains essential for HIV diagnosis, treatment and prevention. We evaluated the effectiveness and safety of door-to-door distribution of HIV self-testing (HIVST) kits in rural Malawi. Methods: This cluster randomised trial, conducted between September 2016 and January 2018, used restricted 1:1 randomisation to allocate 22 health facilities and their defined areas to door-to-door HIVST alongside the standard of care (SOC) or the SOC alone. The study population included residents (≥16 years). HIVST kits