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Arterial HypertensionNCT05684055

"Community-based, eHealth Supported Management of Cardiovascular Risk Factors by Lay Village Health Workers (ComBaCaL aHT TwiC 1 & ComBaCaL aHT TwiC 2)

A study testing First-line antihypertensive single-pill combination (SPC) and Standardized counselling and referral to the closest health facility in people with Arterial Hypertension, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arterial Hypertension
What is being tested?
First-line antihypertensive single-pill combination (SPC) and Standardized counselling and referral to the closest health facility
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,354 participants
Where
2 sitesin 2 countries
Study dates
9 Sep 2023to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant of the ComBaCaL cohort study (signed informed consent available)
  • Living with aHT, defined as reporting intake of antihypertensive medication or being newly diagnosed during screening via standard diagnostic algorithm
  • BP ≥140/90 mmHg at baseline
  • Participant of the ComBaCaL cohort study (signed informed consent available)
  • Reporting intake of antihypertensive medication
  • BP<140/90 mmHg at baseline

Who cannot join

  • Reported pregnancy (at baseline or during follow-up)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Lesotho1 site

  • SolidarMed Lesotho

    Maseru

Other trials in Lesotho

Switzerland1 site

  • University Hospital Basel, Division of Clinical Epidemiology

    Basel, 4051

Other trials in Switzerland

About this study

Official title: Community-based, eHealth Supported Management of Cardiovascular Risk Factors by Lay Village Health Workers for People With Controlled and Uncontrolled Arterial Hypertension in Rural Lesotho: Joint Protocol for Two Cluster-randomized Trials Within the ComBaCaL Cohort Study (ComBaCaL aHT TwiC 1 & ComBaCaL aHT TwiC 2)

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.

Read the detailed description

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:

  • in people with uncomplicated aHT and blood pressure (BP) values above treatment target (≥ 140/90 mmHg) at baseline (aHT TwiC 1) and
  • in people with uncomplicated aHT and BP values below treatment target at baseline (aHT TwiC 2).

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.

Being tested
First-line antihypertensive single-pill combination (SPC), Standardized counselling and referral to the closest health facility
Keywords
Community-Based Chronic Disease Care Lesotho (ComBaCaL) cohort study, low- and middle-income countries (LMICs), facility-based healthcare professionals, lay healthcare workers (LHWs), community-based aHT care models, chronic care village health workers (CC-VHWs), Lesotho Ministry of Health (MoH) Village Health Worker Program, village-based prescription, chronic care nurses (CC nurses), non-communicable diseases (NCDs), cardiovascular disease (CVD)
Medical subject headings
Hypertension, Noncommunicable Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • First-line antihypertensive single-pill combination (SPC)Drug

    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.

  • Standardized counselling and referral to the closest health facilityOther

    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.

Study groups in NCT05684055
Study groupRoleWhat they receive
Intervention villagesActive comparatorCC-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.
Receives: Drug: First-line antihypertensive single-pill combination (SPC)
Control villagesActive comparatorControl 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.
Receives: Other: Standardized counselling and referral to the closest health facility

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood pressure (BP) within target (<140/90 mmHg)

    Proportion of participants whose blood pressure (BP) is within target (<140/90 mmHg)

    Measured: 12 months after enrolment

Secondary outcomes (15)

  1. 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%)

    Measured: 6 and 12 months after enrolment

  2. 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

    Measured: 6 and 12 months after enrolment

  3. 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

    Measured: 6 and 12 months after enrolment

  4. Change in total cholesterol

    Change in total cholesterol

    Measured: 6 and 12 months after enrolment

  5. Change in abdominal circumference

    Change in abdominal circumference

    Measured: 6 and 12 months after enrolment

  6. Change in Body mass index (BMI)

    Change in Body mass index (BMI)

    Measured: 6 and 12 months after enrolment

  7. Blood pressure (BP) within target (<140/90 mmHg)

    Proportion of participants whose BP is within target (<140/90mmHg)

    Measured: 6 months after enrolment

  8. Change in mean systolic blood pressure (SBP)

    Mean systolic blood pressure (SBP)

    Measured: 6 and 12 months after enrolment

  9. Change in mean diastolic blood pressure (DBP)

    Mean diastolic blood pressure (DBP)

    Measured: 6 and 12 months after enrolment

  10. Change in occurrence of Serious Adverse Events (SAEs)

    Change in occurrence of Serious Adverse Events (SAEs)

    Measured: 6 and 12 months after enrolment

  11. Change in occurrence of Adverse Events of Special Interest (AESIs)

    Change in occurrence of Adverse Events of Special Interest (AESIs)

    Measured: 6 and 12 months after enrolment

  12. 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

    Measured: 6 and 12 months after enrolment

  13. 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)

    Measured: 6 and 12 months after enrolment

  14. Change in self-reported adherence to treatment

    Change in self-reported adherence to treatment

    Measured: 6 and 12 months after enrolment

  15. 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.

    Measured: 6 and 12 months after enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2023
  2. Study start9 Sep 2023
  3. Primary completion4 May 2025
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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. ComBaCaL aHT TwiC 1 and aHT TwiC 2 are two cluster-randomized controlled trials that are identical in intervention, design and endpoints. They only differ in the trial population and trial hypothesis. TwiC 1 enrols individuals with uncomplicated aHT with baseline BP values above treatment targets. TwiC 2 enrols individuals with uncomplicated pharmacologically controlled aHT. In the intervention clusters community-based treatment is offered. In the control clusters participants are referred to the facility for further care after diagnosis.
Masking
None (open label)
Enrolment
1,354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05684055
Sponsor's protocol ID
AO_2022-00074; am22Labhardt2
Status last verified
Feb 2026
First submitted
2 Jan 2023
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Gerber F, Gupta R, Lejone TI, Tahirsylaj T, Lee T, Sanchez-Samaniego G, Kohler M, Haldemann MI, Raeber F, Chitja M, Mathulise M, Kabi T, Mokaeane M, Maphenchane M, Molulela M, Khomolishoele M, Mota M, Masike S, Bane M, Sematle MP, Makabateng R, Mphunyane M, Phaaroe S, Basler DB, Kindler K, Burkard T, Briel M, Chammartin F, Labhardt ND, Amstutz A. Community-based management of arterial hypertension and cardiovascular risk factors by lay village health workers for people with controlled and uncontrolled blood pressure in rural Lesotho: joint protocol for two cluster-randomized trials within the ComBaCaL cohort study (ComBaCaL aHT Twic 1 and ComBaCaL aHT TwiC 2). Trials. 2024 Jun 6;25(1):365. doi: 10.1186/s13063-024-08226-2.

    PubMed 38845045

  • Gerber F, Sanchez-Samaniego G, Gupta R, Lejone TI, Tahirsylaj T, Raeber F, Chitja M, Mathulise M, Kabi T, Mokaeane M, Maphenchane M, Molulela M, Khomolishoele M, Mota M, Masike S, Bane M, Mofokeng M, Sematle MP, Makabateng R, Mphunyane M, Sao L, Tlahali M, Litaba M, Basler DB, Kindler K, Ayakaka I, Grimm P, Burkard T, Chammartin F, Amstutz A, Labhardt ND. Lay community health worker-led care with mobile decision support for uncontrolled hypertension: a cluster-randomized trial. Nat Med. 2026 Mar;32(3):915-923. doi: 10.1038/s41591-026-04208-w. Epub 2026 Feb 12.

    PubMed 41680483

Questions about this trial

What is this clinical trial studying?

A study testing First-line antihypertensive single-pill combination (SPC) and Standardized counselling and referral to the closest health facility in people with Arterial Hypertension, run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Lesotho, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure (BP) within target (<140/90 mmHg) (time frame: 12 months after enrolment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05684055, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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