This controlled before-and-after trial assessed the effectiveness of a district-level Community-led Total Sanitation (CLTS) intervention with and without locally managed Care Groups (CG) on observed sanitation and hygiene behaviours in rural Chiradzulu District, Malawi. The study was implemented in three sub-districts (also known as Traditional Authorities [TAs]). Two TAs received CLTS, which included an additional low-intensity government-led hygiene promotion campaign. One TA received the standard CLTS intervention (CLTS group), and one received the same intervention but with additional sanitation and hygiene promotion delivered through local Care Groups (CLTS+CG group). The third TA served as the control group. Hygiene and child faeces disposal outcomes were measured by fieldworker direct observation at baseline (April 2023) and endline (March 2024).