An interventional study of First-line antihypertensive single-pill combination (SPC) and Standardized counselling and referral to the closest health facility in Arterial Hypertension, sponsored by University Hospital, Basel, Switzerland. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Health services research
ComBaCaL aHT TwiC 1 and aHT TwiC 2 are two cluster-randomized controlled trials that are identical in intervention, design and endpoints. TwiC 1 enrols individuals with uncomplicated aHT with baseline BP values above treatment targets and the hypothesis is that in intervention clusters where community-based treatment is offered, a higher proportion will have controlled aHT at twelve months' follow-up as compared to control clusters where participants are referred to the facility for further care after diagnosis.
TwiC 2 enrols individuals with uncomplicated pharmacologically controlled aHT with the hypothesis that the offer of community-based antihypertensive treatment is non-inferior to facility-based care with regard to BP control rates at twelve months. The trials are nested within the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID 2022-00058, clinicaltrials.gov ID NCT05596773), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local chronic care village health workers (CC-VHWs). 50% of the villages being part of the overarching ComBaCaL cohort will be randomly allocated to receive the TwiC intervention. The non-selected villages will serve as comparators and follow the regular ComBaCaL cohort activities conducted by CC-VHWs, including screening, diagnosis, standardized counselling and referral to a health facility for further therapeutic management. The TwiC intervention will be offered to all eligible people living with aHT in the sampled intervention villages. Individuals with uncomplicated uncontrolled and uncomplicated controlled aHT at baseline will be enrolled in aHT TwiC 1 and aHT 2 respectively. In case of complicated disease, unclear diagnosis, or presence of clinical alarm signs or symptoms, participants will be referred to the closest health facility for further investigation.
Globally, arterial hypertension (aHT) is the single most important risk factor for early mortality. The task-shifting from facility-based healthcare professionals to lay healthcare workers (LHWs) at community-level has been identified as a promising solution to increase access to aHT treatment in low- and middle-income countries (LMICs). A cluster-randomized intervention is planned within the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID 2022-00058, clinicaltrials.gov ID NCT05596773), a platform for the investigation of chronic diseases and their management in rural Lesotho that is maintained by local chronic care village health workers (CC-VHWs). CC-VHWs are lay healthcare workers operating within the Lesotho Ministry of Health (MoH) Village Health Worker Program who receive a specific training to deliver chronic care services.
In the intervention clusters, CC-VHWs operating within the existing healthcare system will be capacitated to screen for and diagnose aHT, to prescribe first-line antihypertensive single-pill combinations (SPCs) and to monitor the treatment supported by a tailored clinical decision support application (ComBaCaL app) in their villages. The control group consists of people diagnosed with aHT living in villages that are also part of the ComBaCaL cohort but not sampled for the intervention (control villages), where CC-VHWs will only screen for and diagnose aHT with subsequent standardized counselling and referral to the closest health facility if aHT is present, but no village-based prescriptions.
The effectiveness of this intervention in two different trial populations is assessed:
Randomization for the two TwiCs will be done at cluster level, meaning that all people with aHT in one village will be offered the same care package from their local CC-VHW. It is planned to recruit 100 clusters (50 per study arm) for a total of 800 participants with uncontrolled aHT (TwiC 1) and 1000 participants with controlled aHT (TwiC2). 50% of the villages being part of the overarching ComBaCaL cohort will be randomly allocated to receive the TwiC intervention. The non-selected villages will serve as comparators and follow the regular ComBaCaL cohort activities conducted by CC-VHWs, including screening, diagnosis, standardized counselling and referral to a health facility for further therapeutic management. The TwiC intervention will be offered to all eligible people living with aHT in the sampled intervention villages. Individuals with uncomplicated uncontrolled and uncomplicated controlled aHT at baseline will be enrolled in aHT TwiC 1 and aHT 2 respectively. In case of complicated disease, unclear diagnosis, or presence of clinical alarm signs or symptoms, participants will be referred to the closest health facility for further investigation.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 1,354 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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Inclusion Criteria ComBaCaL-TwiC 1:
Inclusion criteria ComBaCaL-TwiC 2
Exclusion Criteria for both ComBaCaL-TwiC 1\&2:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CC-VHWs do screen, diagnosis, first-line aHT treatment for eligible participants, treatment monitoring at community-level (ComBaCaL app guides them to provide first-line antihypertensive SPCs to eligible individuals and treatment monitoring/ support to all individuals with aHT). CC- VHW offers lifestyle counselling, lipid -lowering treatment to participants with high CVD risk and antiplatelet treatment to participants with history of stroke/ myocardial infarction. Trained, supervised, mentored by chronic care nurses (CC nurses) and guided by the ComBaCaL app they follow-up persons with aHT to monitor adherence, life-style changes, treatment response, side-effects. TwiC 1: individuals with uncomplicated aHT (baseline BP above treatment targets) TwiC 2: individuals with uncomplicated pharmacologically controlled aHT. In case of complicated disease or presence of clinical alarm signs/ symptoms, participants are referred to the closest health facility for further investigation.
Drug: First-line antihypertensive single-pill combination (SPC)
Control villages will follow the standard of care in the ComBaCaL cohort study. CC-VHWs will also receive tablets with the ComBaCaL app installed. They are trained, supervised and equipped to screen and diagnose aHT with subsequent referral to facility-based follow-up and care. In control villages the ComBaCaL app supports clinical decision making and documentation for screening, diagnosis and referral, but not prescription/ provision of antihypertensive or lipid-lowering medication. TwiC 1: enrols individuals with uncomplicated aHT with baseline BP values above treatment targets. TwiC 2: enrols individuals with uncomplicated pharmacologically controlled aHT. In case of complicated hypertension or presence of clinical alarm signs or symptoms, participants will be immediately referred to the closest health facility for further investigation.
Other: Standardized counselling and referral to the closest health facility
In intervention villages, participants diagnosed with aHT are offered pharmacological treatment (eHealth supported prescription of first-line antihypertensive single-pill combination (SPC)) and treatment monitoring in the villages by CC-VHWs guided by the ComBaCaL app.
In control villages, participants diagnosed with aHT receive a standardized counselling by the CC-VHW and are referred to the closest health facility for initiation or continuation of antihypertensive treatment.
Blood pressure (BP) within target (<140/90 mmHg)
Proportion of participants whose blood pressure (BP) is within target (\<140/90 mmHg)
Time frame: 12 months after enrolment
Change in 10-year risk for a fatal or non-fatal CVD event estimated using the World Health Organization (WHO) CVD risk prediction tool
The colour of the CVD risk prediction tool cell indicates the 10-year risk of a fatal or non-fatal CVD event. The value within the cell is the risk percentage. Colour coding is based on the grouping (Green\<5%; Yellow5% to \<10%; Red20% to \<30%; Deep red≥30%)
Time frame: 6 and 12 months after enrolment
Change in dietary habits
Change in dietary habits using a shortened unquantified food frequency questionnaire adapted from an assessment tool for obesity used in South Africa
Time frame: 6 and 12 months after enrolment
Change in International Physical Activity (PA) Questionnaire Short Form (IPAQ-SF)
The IPAQ-SF addresses the number of days and time spent on PA in moderate intensity, vigorous intensity and walking of at least 10-min duration the last 7 days, and also includes time spent sitting on weekdays the last 7 days
Time frame: 6 and 12 months after enrolment
Change in total cholesterol
Change in total cholesterol
Time frame: 6 and 12 months after enrolment
Change in abdominal circumference
Change in abdominal circumference
Time frame: 6 and 12 months after enrolment
Change in Body mass index (BMI)
Change in Body mass index (BMI)
Time frame: 6 and 12 months after enrolment
Blood pressure (BP) within target (<140/90 mmHg)
Proportion of participants whose BP is within target (\<140/90mmHg)
Time frame: 6 months after enrolment
Change in mean systolic blood pressure (SBP)
Mean systolic blood pressure (SBP)
Time frame: 6 and 12 months after enrolment
Change in mean diastolic blood pressure (DBP)
Mean diastolic blood pressure (DBP)
Time frame: 6 and 12 months after enrolment
Change in occurrence of Serious Adverse Events (SAEs)
Change in occurrence of Serious Adverse Events (SAEs)
Time frame: 6 and 12 months after enrolment
Change in occurrence of Adverse Events of Special Interest (AESIs)
Change in occurrence of Adverse Events of Special Interest (AESIs)
Time frame: 6 and 12 months after enrolment
Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antihypertensive treatment
Change in proportion of participants not taking treatment at enrolment who have initiated pharmacological antihypertensive treatment
Time frame: 6 and 12 months after enrolment
Change in proportion of participants who are engaged in care
Change in proportion of participants who are engaged in care (defined as reporting intake of antihypertensive medication as per prescription of a healthcare provider within the two weeks prior to assessment six and twelve months after enrolment or reaching treatment targets without intake of medication)
Time frame: 6 and 12 months after enrolment
Change in self-reported adherence to treatment
Change in self-reported adherence to treatment
Time frame: 6 and 12 months after enrolment
Change in Quality of life (using EQ-5D-5L questionnaire)
Change in Quality of life (using EQ-5D-5L questionnaire). The scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.
Time frame: 6 and 12 months after enrolment
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — An anonymized key dataset necessary for reproducing the primary and key secondary endpoints will be made freely available in an appropriate repository, such as zenodo.org, alongside the publication of the study results. Besides removal of variables not required for key analysis, we will remove participant identifier, study site and exact date information. Requests for access to more detailed data may be made to the corresponding author by submitting a proposal, which will be reviewed by the trial consortium. The statistical report for the primary and key secondary endpoints and the code to produce it will be published together with the data set.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Within 3 months after publication of primary results
Access criteria: Open access
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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