Clinical trial Recruiting at 2 sites Observational

Community-based care for chronic diseases in rural Lesotho

Official title: Community-Based Chronic Disease Care in Rural Lesotho: The ComBaCaL Cohort Study

Run by University Hospital, Basel, Switzerland · NCT05596773 · Data updated 2026-11-12

This study tests if community health workers in rural Lesotho can effectively help manage chronic diseases like diabetes and hypertension using new technology and regular check-ups.

Quick facts

Study typeObservational
SexAll
Enrollment17500 (estimated)
SponsorUniversity Hospital, Basel, Switzerland
Academic / other
Locations2 sites (Maseru and 1 other locations)
StatusRecruiting
StartedFebruary 22, 2023
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedFebruary 13, 2026
Trial IDNCT05596773 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are residents of rural villages in Lesotho with a population of 40 to 100 households who are affected by non-communicable diseases.

Probably not a fit

Patients living in urban areas or those with complex chronic conditions requiring specialized medical care may not benefit from this community-based intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to evaluate the effectiveness of community-based interventions led by lay health workers for managing non-communicable diseases (NCDs) in rural Lesotho. The study will utilize eHealth tools to support Chronic Care Village Health Workers (CC-VHWs) in conducting regular screenings, monitoring, and referrals for conditions such as hypertension and diabetes. By establishing a research and service delivery platform, the study seeks to generate evidence on the impact of these interventions on chronic disease management in low-resource settings. Data will be collected by CC-VHWs who will be trained to use essential monitoring tools and eHealth applications.

Why it matters

Potential benefit: If successful, this approach could significantly improve access to chronic disease care and management in rural communities, leading to better health outcomes.

How similar studies have gone: While there is limited evidence on the effectiveness of task shifting to lay workers for NCDs in sub-Saharan Africa, similar approaches in HIV care have shown promise.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria village level:

* 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
* 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

Inclusion criteria individual level:

* 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

Where it's running

  • Solidarmed Lesotho
    Maseru, Lesotho
    Recruiting
  • Division of Clinical Epidemiology, University Hospital Basel, University of Basel
    Basel, Switzerland
    Recruiting

Study contacts

  • Principal investigator: Niklaus Labhardt, Prof. Dr. med. — Division of Clinical Epidemiology, University Hospital Basel, University of Basel
  • Study coordinator: Niklaus Labhardt, Prof. Dr. med.
  • Email: niklaus.labhardt@usb.ch
  • Phone: +41 79 870 18 59

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.