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<p>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 &lt;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, <i>P</i> = 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: <a href="http://clinicaltrials.gov/ct2/show/NCT05684055">NCT05684055</a>.</p>

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Lay community health worker-led care with mobile decision support for uncontrolled hypertension: a cluster-randomized trial

  • 期刊论文

  • 发表日期：

    2026年2月12日

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  • Felix Gerber,
  • Giuliana Sanchez-Samaniego,
  • Ravi Gupta,
  • Thabo Ishmael Lejone,
  • Thesar Tahirsylaj,
  • Fabian Raeber,
  • Mamakhala Chitja,
  • Malebona Mathulise,
  • Thuso Kabi,
  • Mosoetsi Mokaeane,
  • Malehloa Maphenchane,
  • Manthabiseng Molulela,
  • Makhebe Khomolishoele,
  • Mota Mota,
  • Sesale Masike,
  • Matumaole Bane,
  • Manthati Mofokeng,
  • Mamoronts’ane Pauline Sematle,
  • Retselisitsoe Makabateng,
  • Madavida Mphunyane,
  • Lebohang Sao,
  • Mosa Tlahali,
  • Malitaba Litaba,
  • Dave Brian Basler,
  • Kevin Kindler,
  • Irene Ayakaka,
  • Pauline Grimm,
  • Thilo Burkard,
  • Frédérique Chammartin,
  • Alain Amstutz,
  • Niklaus Daniel Labhardt

摘要

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.