Community health worker-led hypertension management with independent prescribing in rural Lesotho: a cluster-randomised non-inferiority trial

Background: Hypertension is the leading global cause of premature mortality, yet treatment coverage and control remain poor. Whether community health workers (CHWs) can safely manage hypertension, including independent prescribing and titrating of antihypertensive therapy, remains unknown. Methods: We conducted a pragmatic, cluster-randomised, open-label, non-inferiority trial in 103 villages in rural Lesotho. Adults with treated, controlled hypertension (<140/90 mmHg) were eligible. Villages were randomised 1:1 to CHW-led hypertension care, including independent prescribing and titrating of antihypertensive therapy (amlodipine-hydrochlorothiazide combination pill at 5/12·5mg or 10/25mg) with clinical decision support, or to usual nurse-led, facility-based care. The primary endpoint was blood pressure control at 12 months among all randomised participants except those who became pregnant during follow-up, with a non-inferiority margin of –10% absolute risk difference. The study is completed and registered with ClinicalTrials.gov (NCT05684055). Findings: Between September 08, 2023, and January 31, 2024, we enrolled 807 participants (417 in 51 control villages, 390 in 50 intervention villages; 2 empty clusters; mean age 64.4 years; 82·3% women). At 12 months, blood pressure was controlled in 300 of 386 (77·7%) participants in the intervention group and 303 of 412 (73·5%) participants in the control group; 9 participants were excluded due to pregnancy. The absolute risk difference was 5·1% (95% CI, –0·9 to 11·2), meeting the criterion for non-inferiority. Mean 12-month systolic and diastolic blood pressures were 122·5 and 78·7 mmHg in the intervention group and 123·6 and 79·4 mmHg in the control group. Serious adverse events were similar in the two groups, with no excess events attributed to the intervention. Interpretation: These findings support decentralised, community-based hypertension care with task-sharing to trained CHWs as a scalable strategy to expand access to long-term chronic disease management in resource-limited settings.