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Purpose: The open, prospective Community-Based chronic Care Lesotho (ComBaCaL) cohort is the first study to comprehensively investigate socioeconomic indicators, common chronic diseases and their risk factors in a remote rural setting in Lesotho. It serves as a platform for implementing nested trials using the Trials within Cohorts (TwiCs) design to assess community-based chronic care interventions. Here, we present the cohorts sociodemographic and chronic disease risk factor profile, including self-reported HIV prevalence and hypertension and diabetes care cascades. Participants: Since February 2023, Community Health Worker (CHWs) supported by a clinical decision support and data collection application, have enrolled inhabitants from 103 randomly selected rural villages in Butha-Buthe and Mokhotlong districts in North-East Lesotho. As of May 31, 2024, the cohort includes 5008 households with 14735 participants (55% female, median age 19 years). The cohorts socioeconomic status is low with an International Wealth Index of 26, a monthly household income of 42.4 USD and low levels of formal education. Among the 7917 adult participants, 42.5% are overweight or obese, with higher rates among women, and 33.1% smoke tobacco, with higher rates among men. Self-reported HIV prevalence is 15.1% with a 98.4% treatment rate. Hypertension prevalence is 17% with a 56% control rate and diabetes prevalence is 4% with a 39% control rate. Findings to date: The cohorts low socioeconomic status is linked to multiple health risks including insufficient access to clean energy, essential healthcare services, adequate sanitary facilities and secure food supply. Besides the expected high HIV prevalence, we found significant hypertension, diabetes and cardiovascular risk factor prevalences. While treatment and control rates for diabetes and hypertension are higher than in similar settings, they remain below global targets. Future plans: Ongoing cluster-randomized TwiCs, which will be completed in 2025, are assessing the effectiveness of community-based, CHW-led care interventions for diabetes and hypertension. CHWs will continue to closely monitor the cohort and integrate additional measurements such as HIV testing. This will provide further insights into the dynamics and interactions of chronic diseases and inform the development of future nested trials on innovative community-based prevention and care interventions. Registration:NCT05596773
Purpose: The open, prospective Community-Based chronic Care Lesotho (ComBaCaL) cohort is the first study to comprehensively investigate socioeconomic indicators, common chronic diseases and their risk factors in a remote rural setting in Lesotho. It serves as a platform for implementing nested trials using the Trials within Cohorts (TwiCs) design to assess community-based chronic care interventions. Here, we present the cohorts sociodemographic and chronic disease risk factor profile, including self-reported HIV prevalence and hypertension and diabetes care cascades. Participants: Since February 2023, Community Health Worker (CHWs) supported by a clinical decision support and data collection application, have enrolled inhabitants from 103 randomly selected rural villages in Butha-Buthe and Mokhotlong districts in North-East Lesotho. As of May 31, 2024, the cohort includes 5008 households with 14735 participants (55% female, median age 19 years). The cohorts socioeconomic status is low with an International Wealth Index of 26, a monthly household income of 42.4 USD and low levels of formal education. Among the 7917 adult participants, 42.5% are overweight or obese, with higher rates among women, and 33.1% smoke tobacco, with higher rates among men. Self-reported HIV prevalence is 15.1% with a 98.4% treatment rate. Hypertension prevalence is 17% with a 56% control rate and diabetes prevalence is 4% with a 39% control rate. Findings to date: The cohorts low socioeconomic status is linked to multiple health risks including insufficient access to clean energy, essential healthcare services, adequate sanitary facilities and secure food supply. Besides the expected high HIV prevalence, we found significant hypertension, diabetes and cardiovascular risk factor prevalences. While treatment and control rates for diabetes and hypertension are higher than in similar settings, they remain below global targets. Future plans: Ongoing cluster-randomized TwiCs, which will be completed in 2025, are assessing the effectiveness of community-based, CHW-led care interventions for diabetes and hypertension. CHWs will continue to closely monitor the cohort and integrate additional measurements such as HIV testing. This will provide further insights into the dynamics and interactions of chronic diseases and inform the development of future nested trials on innovative community-based prevention and care interventions. Registration:NCT05596773
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.
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 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 counselling, basic guideline-directed antihypertensive, lipid-lowering, and antiplatelet treatment supported by a tablet-based decision support application to eligible participants. In control clusters, 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 with regard to 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 December 11, 2023, 371 and 673 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 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 The trial is registered on clinicaltrials.gov (NCT05684055; January 04, 2023).
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