Abstract
Access to hypertension care remains insufficient, particularly in remote rural areas in resource-limited settings. Community health workers (CHWs), lay providers living in the communities they serve, may help close this gap, but the effectiveness and safety of lay CHW-led hypertension care—including independent initiation and titration of medication—remain uncertain. We conducted a 1:1 cluster-randomized trial nested within the Community-Based Chronic Care Lesotho (ComBaCaL) cohort study in 103 rural villages in Lesotho. Following community-based hypertension screening, 547 nonpregnant adults with blood pressure (BP) ≥140/90 mm Hg were enrolled (274 control and 273 intervention). In intervention clusters, lay CHWs independently prescribed and titrated a fixed-dose combination of amlodipine and hydrochlorothiazide, guided by a mobile clinical decision support system. In control clusters, participants were referred to health facilities for standard care. The primary objective was to assess the effectiveness and safety of lay CHW-led care, with the primary outcome defined as BP <140/90 mm Hg at 12 months. In the intention-to-treat analysis (543 participants with 4 exclusions owing to intercurrent pregnancy), BP control was achieved by 156/271 (58%) versus 130/272 (48%) in intervention and control arms, respectively (adjusted odds ratio 1.52, 95% confidence interval 1.01 to 2.29, P = 0.046). A predefined complete case analysis yielded consistent results. No relevant differences in safety outcomes were observed. Among people with uncontrolled hypertension, lay CHW-led, CDSS-supported care was safe and more effective than referral to facility-based professional care. These findings support expanding first-line hypertension management by lay CHWs in remote, resource-limited settings. Clinicaltrials.gov registration: NCT05684055.
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Data availability
A de-identified individual-level key dataset alongside the statistical code for reproducing the primary and secondary endpoints is openly available from publication until at least 25 years thereafter via Zenodo at https://doi.org/10.5281/zenodo.16903262 (ref. 73). The trial was registered with ClinicalTrials.gov (NCT05684055), where a full protocol and statistical analysis plan are available. A study protocol manuscript has been published previously36. Requests for access to more detailed data may be made to the corresponding author by submitting a proposal. The proposal will be reviewed by the corresponding author and access granted if deemed reasonable within 4 weeks.
Code availability
The code for the CDSS application used by CHWs for data collection and service delivery is available via GitHub at https://github.com/clinepi-usb/cht-combacal. Access to the test environment of the CDSS application is available from the corresponding author upon written request. The request will be reviewed by the corresponding author and credentials for the test environment shared if deemed reasonable within 4 weeks.
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Acknowledgements
We acknowledge the SolidarMed team in Lesotho and Switzerland, the involved CHWs and the participants for their essential contributions. This study was part of the ComBaCaL project funded by the TRANSFORM grant of the Swiss Agency for Development and Cooperation (project no. 7F-10345.01.01) and a grant by the World Diabetes Foundation (WDF-1778). F.G.’s salary was funded through a personal MD/PhD grant by the Swiss National Science Foundation (grant no. 323530_207035). A.A.’s salary was funded through a grant of the Swiss National Science Foundation (Postdoc mobility no. P500PM_221961). The funders had no role in the study design, data collection, analysis, data interpretation or writing of the publication.
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A.A. and N.D.L. were the principal investigators; they acquired the funding, led the project and conceptualized the study together with F.G. F.G. drafted the study protocol and the final paper and led the clinical development of the CDSS application together with T.T. and F.R., and the local implementation together with R.G., I.A. and P.G. T.I.L., M.C., T.K., M. Mathulise, M. Maphenchane, M. Mokaeane, M. Mota, M. Mofokeng, M. Molulela, M.K., M.P.S., M.B. and R.M. were responsible for the local implementation through training and supervision of CHWs and local data monitoring. G.S.-S. was responsible for central data management and S.M. for the local data management. M. Mphunyane, L.S., M.T. and M.L. were involved in the conceptualization of the study and ensured alignment with local guidelines and practices. D.B.B. and K.K. led the technical development of the CDSS application. T.B. reviewed and approved the clinical algorithms. F.C. wrote the statistical analysis plan and conducted sample size calculations and all analyses. All authors read and approved the final paper.
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Extended data
Extended Data Fig. 1 Predefined subgroup analyses for blood pressure control rates ( < 140/90 mmHg) at 12 months in intervention versus control.
Adjusted odds ratio and its 95% CI were obtained by mixed-effect regression models adjusted for clustering and covariates (sex, age, district, facility access and baseline values when appropriate). The p value was two-sided and was not adjusted for multiple comparison. Hard health facility access defined as needing to cross a mountain or river or travel >10 km to the nearest health facility.
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Gerber, F., Sanchez-Samaniego, G., Gupta, R. et al. Lay community health worker-led care with mobile decision support for uncontrolled hypertension: a cluster-randomized trial. Nat Med 32, 915–923 (2026). https://doi.org/10.1038/s41591-026-04208-w
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DOI: https://doi.org/10.1038/s41591-026-04208-w
