Non-communicable Diseases (NCDs)ComBaCaLNCT05596773
Community-Based Chronic Disease Care in Rural Lesotho
An observational study of Non-communicable Diseases (NCDs), run by University Hospital, Basel, Switzerland at 2 sites in 2 countries.
Trial summary
This ComBaCaL cohort study is to assess the impact of community-based, lay-led chronic disease screening and care interventions in rural Lesotho. It aims to establish a prospective research and service delivery platform in rural Lesotho that is managed by eHealth-supported Chronic Care Village Health Worker (CC-VHWs)… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non-communicable Diseases (NCDs)
- How many people
- 17,500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Feb 2023to 31 Dec 2027
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Inhabitants of around 100 (range 90-110) randomly selected villages in rural Lesotho. The estimated mean number of inhabitants per village is 200. All inhabitants will be approached for consent and all consenting individuals (assent plus guardian consent for adolescents (10-17 years), guardian consent for children <10 years) will be enrolled into the ComBaCaL cohort.
Who may be able to join
- Village size of 40 to 100 households
- Village consent obtained from village chief
- Possibility to identify or recruit a CC-VHW from the village population meeting the following requirements which are largely in line with the criteria of the Lesotho VHW Program Policy:
- o Criteria of the Lesotho Village Health Program Policy:
- Having primary residence in the village (according to village chief)
- Having a proven record of trustworthiness in the resident village
Show all 18Show fewer
- Having proven ability to maintain confidentiality on public matters
- Being aged between 20 and 50 years
- Being able to provide written reports and being able to do basic mathematical calculations
- Having at least educational level equivalent to high school leaving certificate (Junior Certificate)
- o Additional ComBaCaL criteria:
- Having the ability and willingness to work with a tablet-based eHealth tool
- Having good social and communication skills
- Having the ability and willingness to interact with health professionals and the village population
- Being able to speak, understand and write in English-
- Having successfully completed the ComBaCaL CC-VHW training including final assessment
- Having primary residence in the village (self-reported at time of enrolment)
- Being able and willing to consent to participation or in case of individuals aged below 18
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Lesotho1 site, 1 recruiting
- Recruiting
Solidarmed Lesotho
Maseru
Irene Ayakaka, MD PhD, +266 28325172
Irene Ayakaka, MD PhD
Switzerland1 site, 1 recruiting
- Recruiting
Division of Clinical Epidemiology, University Hospital Basel, University of Basel
Basel, 4001
Niklaus Labhardt, Prof. Dr. med., +41 79 870 18 59, niklaus.labhardt@usb.ch
Felix Gerber, +41 76 720 82 49, Felix.Gerber@usb.ch
About this study
Official title: Community-Based Chronic Disease Care in Rural Lesotho: The ComBaCaL Cohort Study
This ComBaCaL cohort study is to assess the impact of community-based, lay-led chronic disease screening and care interventions in rural Lesotho. It aims to establish a prospective research and service delivery platform in rural Lesotho that is managed by eHealth-supported Chronic Care Village Health Worker (CC-VHWs) providing regular chronic disease screening, monitoring and referral services. The implementation outcomes of the cohort as well as the effect of the cohort activities on disease-specific care cascades will be assessed. Subsequently, nested trials to assess the effectiveness of specific chronic disease control interventions will be developed. Measurements and data entry will be conducted by CC-VHWs. The CC-VHWs will be equipped with the essential tools required for chronic disease monitoring in the community (i.e. BP machines, scales, measuring band, glucometers, and urine dipsticks). They will undergo a theoretical and practical training covering all aspects required for correct data collection and chronic disease screening, diagnosing, referral and counselling services. At every visit, the CC-VHW will screen participants for warning signs and symptoms (i.e. shortness of breath, severe headache, chest pain, new-onset confusion, impaired consciousness, severely impaired general state of health) and refer participants to the closest health centre in case of any danger-sign. The CC-VHWs will be continuously monitored and supervised by health centre nurses of the respective village's catchment area, mainly through direct interaction during monthly VHW meetings and by CC nurses through field visits, remote interaction via phone calls or messages sent via the ComBaCaL app and through direct contact during the monthly VHW meetings at the health centre. The CC-VHWs are embedded within the Lesotho MoH VHW program and may during the project period be trained and equipped to provide further routine services in their communities.
Read the detailed description
Globally, non-communicable diseases (NCDs) are the leading cause of death and disability with a particularly high burden in Low- and middle-income countries (LMICs), where more than 75% of all premature NCD deaths occur. Lesotho is a typical example of an African LMIC where NCDs are overtaking Human immunodeficiency virus (HIV)/AIDS and other infectious diseases as major cause of disability, morbidity and early death. HIV and NCDs are chronic diseases and share several characteristics such as the asymptomatic initial phase, progression to complications with disability and early death, and need for life-long treatment. The Ministry of Health (MoH) of Lesotho has therefore proposed in its NCD strategic plan that lessons learnt from the HIV program should be taken up to similarly reduce the existing access barriers to NCD care. Two scoping reviews have shown that the evidence on how and to what extent task shifting to lay workers can successfully be implemented for NCDs in sub-Sahara Africa is very limited. This open, prospective cohort study aims at generating evidence on community-based screening, diagnosis and management of uncomplicated arterial hypertension (aHT), Diabetes mellitus (DM) and other chronic diseases by lay Village health worker (VHWs) in a rural sub-Saharan African setting. It is to establish an observational cohort (ComBaCaL cohort) with regular monitoring of chronic disease indicators and risk factors in Butha-Buthe and Mokhothlong districts in Lesotho that will be managed by lay Chronic Care Village Health Workers (CC-VHWs), supported by a dedicated tablet-based eHealth application. The prevalence of common chronic diseases and associated risk factors in the cohort population and will be assessed and their development over time will be monitored. Initial focus will be on aHT, DM, cardiovascular disease risk factors (CVDRFs) and HIV. Other conditions may be included at a later stage. The effect of the ComBaCaL activities on condition- specific care cascade outcomes, such as screening coverage, disease awareness, linkage to care, engagement in care and disease control rates will be analyzed. Cohort variables will be assessed at baseline and pre-specified analyses to assess the effect of the ComBaCaL on chronic disease care cascades will be conducted at six months (range 150-240 days) and twelve months (range 300-480 days) after enrolment. Variables which may change over time will be reassessed during follow-up visits at intervals of around six months.
The ComBaCaL cohort will be a platform for nested pragmatic trials (Trials within a Cohort, TwiCs) assessing chronic disease care interventions.
- Conditions
- Non-communicable Diseases (NCDs)
- Keywords
- Community-Based Chronic Disease Care Lesotho (ComBaCaL), Chronic Care Village Health Worker (CC-VHWs), eHealth application (ComBaCaL app), Lesotho, low- and middle-income countries (LMICs), Arterial hypertension (aHT), Diabetes mellitus (DM)
- Medical subject headings
- Noncommunicable Diseases, Hypertension, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening coverage
Screening coverage for aHT and (pre)DM, defined as the proportion of screening-eligible participants that have been screened for the respective disease within the previous 3 years
Measured: At baseline
Disease awareness
Disease awareness for aHT and (pre)DM, defined as the proportion of participants diagnosed with aHT or (pre)DM that are aware of their condition
Measured: At baseline
Linkage to care
Linkage to care for aHT and DM, defined as the number of participants with aHT or (pre)DM who (re)started drug treatment for their respective condition since enrolment
Measured: Up to 3 years after enrolment
Engagement in care
Engagement in care for aHT and DM, defined as the number of participants with aHT or (pre)DM who had a check-up measurement (BG or HbA1C for (pre)DM, BP for aHT) or drug refill within the last 180 days for their condition
Measured: Up to 3 years after enrolment
Disease control level
Disease control level for aHT and DM, defined as the number of participants with aHT or DM who are reaching disease-specific treatment targets (BP <140/90 mmHg for aHT, fasting blood glucose (FBG) < 7mmol/l and/or HbA1C <7.0% for DM)
Measured: Up to 3 years after enrolment
Occurrence of clinically relevant events (number)
Occurrence of clinically relevant events (Clinical event of special interest (CESI), Serious clinical event (SCE), Serious clinical event of special interest (SCESI), as defined by the protocol
Measured: Up to 3 years after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start22 Feb 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-communicable Diseases (NCDs)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Agency for Development and Cooperation, The World Diabetes Foundation, SolidarMed
- Responsible party
- Sponsor
- Investigators
- Niklaus Labhardt, Prof. Dr. med., Principal investigator, Division of Clinical Epidemiology, University Hospital Basel, University of BaselAlain Amstutz, MD, Principal investigator, Division of Clinical Epidemiology, University Hospital Basel, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596773
- Sponsor's protocol ID
- AO_2022-00058; ex21Labhardt
- Acronym
- ComBaCaL
- Status last verified
- Feb 2026
- First submitted
- 12 Oct 2022
- Last updated
- 13 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 will be made freely available in an appropriate repository, such as zenodo.org, alongside the publication of 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.
Publications
Gerber F, Sanchez-Samaniego G, Tahirsylaj T, Lejone TI, Lee T, Raeber F, Chitja M, Mathulise M, Kabi T, Mokaeane M, Maphenchane M, Molulela M, Mota M, Masike S, Bane M, Makabateng R, Khomolishoele M, Sematle M, Gupta R, Ayakaka I, Sao L, Tlahali M, Phaaroe S, Litaba M, Mphunyane M, Basler DB, Kindler K, Grimm P, Seelig E, Burkard T, Briel M, Chammartin F, Amstutz A, Labhardt ND. Cohort profile: the open, prospective Community-Based chronic Care Lesotho (ComBaCaL) cohort - design, baseline chronic disease risk factors and hypertension and diabetes care cascades. BMJ Open. 2025 Jul 25;15(7):e093852. doi: 10.1136/bmjopen-2024-093852.
PubMed 40713039
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Chronic Disease Care in Rural Lesotho: The ComBaCaL Cohort Study
- ClinicalTrials.gov ID
- NCT05596773
- Acronym / sponsor ID
- ComBaCaL / AO_2022-00058; ex21Labhardt
- Conditions
- Non-communicable Diseases (NCDs)
- Keywords
- Community-Based Chronic Disease Care Lesotho (ComBaCaL), Chronic Care Village Health Worker (CC-VHWs), eHealth application (ComBaCaL app), Lesotho, low- and middle-income countries (LMICs), Arterial hypertension (aHT), Diabetes mellitus (DM)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 17,500 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss Agency for Development and Cooperation, The World Diabetes Foundation, SolidarMed
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This ComBaCaL cohort study is to assess the impact of community-based, lay-led chronic disease screening and care interventions in rural Lesotho. It aims to establish a prospective research and service delivery platform in rural Lesotho that is managed by eHealth-supported Chronic Care Village Health Worker (CC-VHWs) providing regular chronic disease screening, monitoring and referral services. The implementation outcomes of the cohort as well as the effect of the cohort activities on disease-specific care cascades will be assessed. Subsequently, nested trials to assess the effectiveness of specific chronic disease control interventions will be developed. Measurements and data entry will be conducted by CC-VHWs. The CC-VHWs will be equipped with the essential tools required for chronic disease monitoring in the community (i.e. BP machines, scales, measuring band, glucometers, and urine dipsticks). They will undergo a theoretical and practical training covering all aspects required for correct data collection and chronic disease screening, diagnosing, referral and counselling services. At every visit, the CC-VHW will screen participants for warning signs and symptoms (i.e. shortness of breath, severe headache, chest pain, new-onset confusion, impaired consciousness, severely impaired general state of health) and refer participants to the closest health centre in case of any danger-sign. The CC-VHWs will be continuously monitored and supervised by health centre nurses of the respective village's catchment area, mainly through direct interaction during monthly VHW meetings and by CC nurses through field visits, remote interaction via phone calls or messages sent via the ComBaCaL app and through direct contact during the monthly VHW meetings at the health centre. The CC-VHWs are embedded within the Lesotho MoH VHW program and may during the project period be trained and equipped to provide further routine services in their communities.
Detailed description
Globally, non-communicable diseases (NCDs) are the leading cause of death and disability with a particularly high burden in Low- and middle-income countries (LMICs), where more than 75% of all premature NCD deaths occur. Lesotho is a typical example of an African LMIC where NCDs are overtaking Human immunodeficiency virus (HIV)/AIDS and other infectious diseases as major cause of disability, morbidity and early death. HIV and NCDs are chronic diseases and share several characteristics such as the asymptomatic initial phase, progression to complications with disability and early death, and need for life-long treatment. The Ministry of Health (MoH) of Lesotho has therefore proposed in its NCD strategic plan that lessons learnt from the HIV program should be taken up to similarly reduce the existing access barriers to NCD care. Two scoping reviews have shown that the evidence on how and to what extent task shifting to lay workers can successfully be implemented for NCDs in sub-Sahara Africa is very limited. This open, prospective cohort study aims at generating evidence on community-based screening, diagnosis and management of uncomplicated arterial hypertension (aHT), Diabetes mellitus (DM) and other chronic diseases by lay Village health worker (VHWs) in a rural sub-Saharan African setting. It is to establish an observational cohort (ComBaCaL cohort) with regular monitoring of chronic disease indicators and risk factors in Butha-Buthe and Mokhothlong districts in Lesotho that will be managed by lay Chronic Care Village Health Workers (CC-VHWs), supported by a dedicated tablet-based eHealth application. The prevalence of common chronic diseases and associated risk factors in the cohort population and will be assessed and their development over time will be monitored. Initial focus will be on aHT, DM, cardiovascular disease risk factors (CVDRFs) and HIV. Other conditions may be included at a later stage. The effect of the ComBaCaL activities on condition- specific care cascade outcomes, such as screening coverage, disease awareness, linkage to care, engagement in care and disease control rates will be analyzed. Cohort variables will be assessed at baseline and pre-specified analyses to assess the effect of the ComBaCaL on chronic disease care cascades will be conducted at six months (range 150-240 days) and twelve months (range 300-480 days) after enrolment. Variables which may change over time will be reassessed during follow-up visits at intervals of around six months.
The ComBaCaL cohort will be a platform for nested pragmatic trials (Trials within a Cohort, TwiCs) assessing chronic disease care interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inhabitants of around 100 (range 90-110) randomly selected villages in rural Lesotho. The estimated mean number of inhabitants per village is 200. All inhabitants will be approached for consent and all consenting individuals (assent plus guardian consent for adolescents (10-17 years), guardian consent for children <10 years) will be enrolled into the ComBaCaL cohort.
Key inclusion criteria (18 listed)
- Village size of 40 to 100 households
- Village consent obtained from village chief
- Possibility to identify or recruit a CC-VHW from the village population meeting the following requirements which are largely in line with the criteria of the Lesotho VHW Program Policy:
- Having primary residence in the village (according to village chief)
- Having a proven record of trustworthiness in the resident village
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Screening coverage
Time frame: At baseline
Screening coverage for aHT and (pre)DM, defined as the proportion of screening-eligible participants that have been screened for the respective disease within the previous 3 years
Disease awareness
Time frame: At baseline
Disease awareness for aHT and (pre)DM, defined as the proportion of participants diagnosed with aHT or (pre)DM that are aware of their condition
Linkage to care
Time frame: Up to 3 years after enrolment
Linkage to care for aHT and DM, defined as the number of participants with aHT or (pre)DM who (re)started drug treatment for their respective condition since enrolment
Engagement in care
Time frame: Up to 3 years after enrolment
Engagement in care for aHT and DM, defined as the number of participants with aHT or (pre)DM who had a check-up measurement (BG or HbA1C for (pre)DM, BP for aHT) or drug refill within the last 180 days for their condition
Disease control level
Time frame: Up to 3 years after enrolment
Disease control level for aHT and DM, defined as the number of participants with aHT or DM who are reaching disease-specific treatment targets (BP <140/90 mmHg for aHT, fasting blood glucose (FBG) < 7mmol/l and/or HbA1C <7.0% for DM)
Occurrence of clinically relevant events (number)
Time frame: Up to 3 years after enrolment
Occurrence of clinically relevant events (Clinical event of special interest (CESI), Serious clinical event (SCE), Serious clinical event of special interest (SCESI), as defined by the protocol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Derived from this study: PubMed 40713039Gerber F, Sanchez-Samaniego G, Tahirsylaj T, Lejone TI, Lee T, Raeber F, Chitja M, Mathulise M, Kabi T, Mokaeane M, Maphenchane M, Molulela M, Mota M, Masike S, Bane M, Makabateng R, Khomolishoele M, Sematle M, Gupta R, Ayakaka I, Sao L, Tlahali M, Phaaroe S, Litaba M, Mphunyane M, Basler DB, Kindler K, Grimm P, Seelig E, Burkard T, Briel M, Chammartin F, Amstutz A, Labhardt ND. Cohort profile: the open, prospective Community-Based chronic Care Lesotho (ComBaCaL) cohort - design, baseline chronic disease risk factors and hypertension and diabetes care cascades. BMJ Open. 2025 Jul 25;15(7):e093852. doi: 10.1136/bmjopen-2024-093852.
- Individual participant dataSharing planned: Yes. • An anonymized key dataset will be made freely available in an appropriate repository, such as zenodo.org, alongside the publication of 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Niklaus Labhardt, Prof. Dr. med. principal investigator
Division of Clinical Epidemiology, University Hospital Basel, University of Basel
Alain Amstutz, MD principal investigator
Division of Clinical Epidemiology, University Hospital Basel, University of Basel
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-communicable Diseases (NCDs), 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 18 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 13 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?
Contact Niklaus Labhardt, Prof. Dr. med. (+41 79 870 18 59, niklaus.labhardt@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening coverage (time frame: At baseline). The study lists 6 primary outcomes in all. 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 NCT05596773, which also lists 1 linked publication.
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 13 Feb 2026.