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Improving access to essential health services requires the development of innovative health service delivery models and their scientific assessment in often large-scale pragmatic trials. In many low- and middle-income countries, lay Community Health Workers (CHWs) play an important role in delivering essential health services. As trusted members of their communities with basic medical training, they may also contribute to health data collection. Digital clinical decision support applications may facilitate the involvement of CHWs in service delivery and data collection. Electronic consent (eConsent) can streamline the consent process that is required if the collected data is used for the scientific purposes. Here, we describe the experiences of using eConsent in the Community-Based chronic Care Lesotho (ComBaCaL) cohort study and multiple nested pragmatic cluster-randomized trials assessing CHW-led care delivery models for type 2 diabetes and arterial hypertension using the Trials within Cohorts (TwiCs) design. More than a hundred CHWs, acting both as service providers and data collectors in remote villages of Lesotho utilize an eConsent application that is linked to a tailored clinical decision support and data collection application. The eConsent application presents simplified consent information and generates personalized consent forms that are signed electronically on a tablet and then uploaded to the database of the clinical decision support application. This significantly streamlines the consent process and allows for quality consent documentation through timely central monitoring, facilitating the CHW-led management of a large-scale population-based cohort in a remote low-resource area with continuous enrollment-currently at more than 16,000 participants., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article., (© The Author(s) 2024.)

In Lesotho, the hypertension and diabetes care cascades are unknown. We measured awareness, treatment, and control of hypertension and diabetes among adults ≥18 years and identified factors associated with each step of the cascade, based on data from a population-based, cross-sectional survey in 120 randomly sampled clusters in the districts of Butha-Buthe and Mokhotlong from 1st November 2021 to 31st August 2022. We used multivariable logistic regression to assess associations. Among participants with hypertension, 69.7% (95%CI, 67.2-72.2%, 909/1305) were aware of their condition, 67.3% (95%CI 64.8-69.9%, 878/1305) took treatment, and 49.0% (95%CI 46.3-51.7%, 640/1305) were controlled. Among participants with diabetes, 48.4% (95%CI 42.0-55.0%, 111/229) were aware of their condition, 55.8% (95%CI 49.5-62.3%, 128/229) took treatment, and 41.5% (95%CI 35.1-47.9%, 95/229) were controlled. For hypertension, women had higher odds of being on treatment (adjusted odds ratio (aOR) 2.54, 95% CI 1.78-3.61) and controlled (aOR 2.44, 95%CI 1.76-3.37) than men. Participants from urban areas had lower odds of being on treatment (aOR 0.63, 95% CI 0.44-0.90) or being controlled (aOR 0.63, 95% CI 0.46-0.85). Considerable gaps along the hypertension and diabetes care cascades in Lesotho indicate that access and quality of care for these conditions are insufficient to ensure adequate long-term health outcomes., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Fernández et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Arterial hypertension (aHT) is a major cause for premature morbidity and mortality. Control rates remain poor, especially in low- and middle-income countries. Task-shifting to lay village health workers (VHWs) and the use of digital clinical decision support systems may help to overcome the current aHT care cascade gaps. However, evidence on the effectiveness of comprehensive VHW-led aHT care models, in which VHWs provide antihypertensive drug treatment and manage cardiovascular risk factors is scarce., Methods: Using the trials within the cohort (TwiCs) design, we are assessing the effectiveness of VHW-led aHT and cardiovascular risk management in two 1:1 cluster-randomized trials nested within the Community-Based chronic disease Care Lesotho (ComBaCaL) cohort study (NCT05596773). The ComBaCaL cohort study is maintained by trained VHWs and includes the consenting inhabitants of 103 randomly selected villages in rural Lesotho. After community-based aHT screening, adult, non-pregnant ComBaCaL cohort participants with uncontrolled aHT (blood pressure (BP) ≥ 140/90 mmHg) are enrolled in the aHT TwiC 1 and those with controlled aHT (BP < 140/90 mmHg) in the aHT TwiC 2. In intervention villages, VHWs offer lifestyle counseling, basic guideline-directed antihypertensive, lipid-lowering, and antiplatelet treatment supported by a tablet-based decision support application to eligible participants. In control villages, participants are referred to a health facility for therapeutic management. The primary endpoint for both TwiCs is the proportion of participants with controlled BP levels (< 140/90 mmHg) 12 months after enrolment. We hypothesize that the intervention is superior regarding BP control rates in participants with uncontrolled BP (aHT TwiC 1) and non-inferior in participants with controlled BP at baseline (aHT TwiC 2)., Discussion: The TwiCs were launched on September 08, 2023. On May 20, 2024, 697 and 750 participants were enrolled in TwiC 1 and TwiC 2. To our knowledge, these TwiCs are the first trials to assess task-shifting of aHT care to VHWs at the community level, including the prescription of basic antihypertensive, lipid-lowering, and antiplatelet medication in Africa. The ComBaCaL cohort and nested TwiCs are operating within the routine VHW program and countries with similar community health worker programs may benefit from the findings., Trial Registration: ClinicalTrials.gov NCT05684055. Registered on January 04, 2023., (© 2024. The Author(s).)

Background: There are no recent data on the prevalence of cardiovascular risk factors (CVDRFs) in Lesotho. This study aims to assess the prevalence of CVDRFs and their determinants., Methods: We conducted a household-based, cross-sectional survey among adults ≥18 y of age in 120 randomly sampled clusters in two districts., Results: Among 6061 participants, 52.2% were female and their median age was 39 y (interquartile range 27-58). The overall prevalence of overweight, diabetes, elevated blood pressure (BP) and tobacco use was 39.9%, 5.3%, 21.6% and 24.9%, respectively. Among participants, 34.6% had none, 45.2% had one and 20.2% had two or more CVDRFs. Women were more likely to have two or more CVDRFs (20.7% vs 12.3%). Overall, 7.5% of participants had elevated total cholesterol, 52.7% had low high-density lipoprotein cholesterol and 1.6% had elevated low-density lipoprotein cholesterol. Among younger participants (18-29 y), 16.1% reported tobacco use, 28.6% were overweight, 1.5% had diabetes and 3.5% had elevated BP. Household wealth positively correlated with the prevalence of elevated BP, overweight and diabetes, whereas tobacco use was higher among people in the lowest three wealth quintiles., Conclusions: CVDRFs are highly prevalent in Lesotho across age and sex groups, underlining the importance of strengthening prevention and care programs in Lesotho and similar settings in southern Africa., (© The Author(s) 2023. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene.)

Introduction: Prevalence of elevated blood pressure (BP) and diabetes mellitus (DM) is increasing in sub-Saharan Africa. Data on target organ damage such as retinopathy, left ventricular hypertrophy (LVH), renal impairment and peripheral neuropathy (PN) among persons with elevated BP and/or DM in sub-Saharan Africa remain scarce., Aim: To determine at community-level the prevalence of retinopathy, LVH, renal impairment, and PN among adults with elevated BP and/or DM, and assess the association of elevated BP and/or DM with target organ damage in Lesotho., Methods: During a household-based survey, a sub-sample of adults with elevated BP (≥ 140/90 mmHg) and/or DM (glycosylated hemoglobin ≥ 6.5%), as well as comparators (BP < 140/90 mmHg, HbA1c < 6.5%) were screened for retinopathy, LVH, renal impairment, and PN. We used multivariable logistic regression for inferential analysis., Results: Out of 6108 participants screened during the survey, 420 with elevated BP only, 80 with DM only, 61 with elevated BP and DM, and 360 comparators were assessed for target organ damage. Among those with elevated BP, and among those with DM with or without elevated BP, prevalence of retinopathy was 34.6% (89/257) and 14.4% (15/104); renal impairment was 45.0% (156/347) and 42.4% (56/132), respectively. Among those with elevated BP, 2.3% (7/300) and 65.7% (224/341) had LVH and left ventricular concentric remodeling, respectively. PN, only assessed among those with DM, was present in 32.6% (42/129). Elevated BP was associated with increased odds of retinopathy (aOR, 19.13; 95% CI, 8.52-42.94; P < 0.001) and renal impairment (aOR, 1.80; 95% CI, 1.27-2.55; P = 0.001). Presence of both elevated BP and DM was associated with an increased odds of retinopathy (aOR, 16.30; 95%CI, 5.69-46.68; P < 0.001), renal impairment (aOR, 2.55; 95% CI, 1.35-4.81; P = 0.004), and PN (aOR, 2.13; 95% CI, 1.04-4.38; P = 0.040)., Conclusion: We found a high prevalence of undiagnosed target organ damage among adults with elevated BP and/or DM during community-based screening. These findings emphasize the importance of regular prevention and screening activities in this setting., (© 2023. The Author(s).)

Background: WHO introduced the STEPwise approach to surveillance (STEPS) to monitor trends in non-communicable diseases. For arterial hypertension, the STEPS protocol takes the average of the last two out of three standard blood pressure measurements (SBPM). This study assesses the diagnostic accuracy of SBPM, same-day and next-day unattended automated measurement (uABP), with 24 h ambulatory measurement (24 h-ABPM) as reference., Methods: This diagnostic accuracy study was done within a population-based household survey on cardiovascular risk factors in two districts in Northern Lesotho. Adults (aged ≥ 18 years) with elevated SBPM (defined as ≥140/90 mmHg), and 2:1 age- and sex-matched participants with normal SBPM during the survey were recruited. Following SBPM, first uABP readings were obtained on survey day. Afterwards, participants received a 24 h-ABPM device. Second uABP readings were taken 24 h later, after retrieval of the 24 h-ABPM. The main outcome was overall diagnostic accuracy of all screening measurements (SBPM, first uABP, and second uABP), determined using area under the receiver operating characteristic curve (AUROC), with 24 h-ABPM as a reference., Findings: Between November 2, 2021 and August 31, 2022, 275 participants (mean age 58 years (SD: 16 years), 163 (59%) female) were enrolled, 183 of whom had elevated and 92 had normal SBPM. Mean difference between systolic daytime 24 h-ABPM and screening measurements was highest for SBPM (mean difference: -13 mmHg; 95% CI: -14 to -11). Mean difference between diastolic daytime 24 h-ABPM and diastolic SBPM was -2 mmHg (95% CI: -4 to -1), whereas no difference was found for mean diastolic first uABP (mean difference: -1 mmHg; 95% CI: -2.0 to 0.3); and mean diastolic second uABP (mean difference: 1.0 mmHg; 95% CI: -0.4 to 2.3). White coat hypertension was highest with SBPM (55 [20%]), followed by first uABP (27 [9.8%]), and second uABP (18 [6.5%]). Using systolic daytime 24 h-ABPM as a reference, the uABPs had higher AUROC (first uABP: 87% [95% CI: 83-91]; second uABP: 88% [95% CI: 84-92]); SBPM: (79% [95% CI: 74-85]). This difference was significant between first uABP and SBPM ( P  = 0.0024), and between second uABP and SBPM ( P  = 0.0017)., Interpretation: uABP had better diagnostic performance than SBPM. Integration of uABP into STEPS protocol should be considered., Funding: Swiss Agency for Development and Cooperation under the ComBaCaL project, and the World Diabetes Foundation., Competing Interests: NDL reports grants from the 10.13039/100000001Swiss National Science Foundation (Eccellenza Professorship and project grant), 10.13039/501100011318Botnar Foundation, Botnar Center for Child Health, 10.13039/100009131Swiss Agency for Development and Cooperation, and Moritz Straus Stiftung; consulting fees from 10.13039/100010877ViiV Healthcare, the 10.13039/501100005416Research Council of Norway, and the 10.13039/100000001Swiss National Science Foundation (all paid to his division); honoraria for lectures from ETHZ and Swiss TPH (paid to his division); travel grants from 10.13039/100005564Gilead Sciences and 10.13039/100010877ViiV Healthcare; participation on a Data Safety Monitoring Board for Pharming (payments made to his division). EF received travel support from the European Union’s Horizon 2020 research and innovation programme under Marie Skłodowska-Curie grant agreement (No 801076), through SSPH+ Global PhD Fellowship Programme in Public Health Sciences (GlobalP3HS). All other authors declare no competing interests., (© 2023 The Author(s).)