Tuberculosis ActiveNCT06574529
Video-observed Therapy for Active Tuberculosis: a Feasibility Study
A study testing Video-observed therapy (vDOT) in people with Tuberculosis Active, run by Ligue Pulmonaire Genevoise at 1 site in Switzerland.
Trial summary
Tuberculosis (TB) is still present in Switzerland, and concerns mainly foreign-born subjects. Monitoring compliance to treatment by Directly Observed Therapy (DOT) is strongly encouraged by the World Health Organization (WHO). It is however time-consuming, costly and stigmatising. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Tuberculosis Active
- What is being tested?
- Video-observed therapy (vDOT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Nov 2021to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age above 16 years of age; providing informed consent (translators were used whenever necessary to ensure understanding of study and vDOT procedure); having a diagnosis of untreated active tuberculosis, irrespective of site of infection, confirmed by culture and/or Polymerase chain reaction test (PCR) and follow-up ensured by Geneva University Hospital.
Who cannot join
- refusal to participate, not fulfilling inclusion criteria
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva University Hospital
Geneva, Canton of Geneva, 1205
About this study
Official title: Video-observed Therapy (vDOT) as a Surrogate to Directly Observed Therapy (DOT) for Active Tuberculosis: a Feasibility Study in a Low Incidence High-income Area
Tuberculosis (TB) is still present in Switzerland, and concerns mainly foreign-born subjects. Monitoring compliance to treatment by Directly Observed Therapy (DOT) is strongly encouraged by the World Health Organization (WHO). It is however time-consuming, costly and stigmatising. This study aims to examine the feasibility of monitoring compliance through a secured web platform and videos sent via an application on a cellphone, a concept known as vDOT (Video-observed therapy). The study aims to include all patients treated for tuberculosis is on our area during an 18 month period and monitor acceptance, compliance, and technical issues related to vDOT.
Read the detailed description
The study aims to include all patients who are treated de novo for active tuberculosis is our area. The aim of this study, was to show that vDOT was feasible in a low-incidence high income area, that it had a high acceptance rate among patients and health-care professionals, with a low rate of technical difficulties or pitfalls.
All patients with a diagnosis of tuberculosis irrespective of site(s) of infection, were invited to participate in this study. The Division of Pulmonology of Geneva University Hospital diagnoses and follows virtually all cases of tuberculosis in the Canton of Geneva. Annual number of cases in Geneva between 2020 and 2023 was on average 43/year (range: 36-53). Incidence was 7-10.3/105 inhabitants compared to a national incidence of 3.99-4.72 /105 inhabitants during the same period.
Specialized TB nurses were trained to use the vDOT platform and provided the training with the help of translators whenever required. The application (APP) was installed with the patient, and a test video was sent to the platform. The APP uses simple understandable pictograms and is thus not per se language-dependent . vDOT was started as soon as possible after initiation of TB treatment, either during a hospital stay or during the first outpatient follow-up visit at our centre. Whenever necessary, a portable cell phone was provided for the patient, for the duration of the treatment.
The SureAdhere platform was used for vDOT (https://dimagi.com/sureadhere/). Once the videos have been recorded, they are sent automatically as soon as the patients' cell phone has access to internet.
For each patient, the number of videos to be sent each week was specified (5 as default option).
- Conditions
- Tuberculosis Active
- Being tested
- Video-observed therapy (vDOT)
- Keywords
- Compliance, Directly observed therapy, Video-observed therapy
- Medical subject headings
- Tuberculosis, Patient Compliance, Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-observed therapy (vDOT)Device
All participants are required to send 5 times per week a short video showing they are actually taking their treatment for tuberculosis via a dedicated application on their cellphone
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The study is not randomised; all subjects included are submitted to the VOT Receives: Device: Video-observed therapy (vDOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance rate
Number of patients accepting to install the application on their cellphone and send videos of their treatment until treatment completion, among all patients initiating a treatment for active tuberculosis in our center
Measured: Two weeks after starting TB treatment
Effective implementation rate
Number of patients for whom installing the application, and learning how to use it was possible among all patients with active TB during study period
Measured: Two weeks after starting TB treatment
Secondary outcomes (3)
Ratio of number of videos sent to number of videos expected
Number of videos recorded on the secured platform compared with number expected(% x number of weeks of treatment)
Measured: Duration of treatment (max 12 months)
Quality of videos sent
Proportion of videos with technical problems (sound, lighting, framing) was recorded
Measured: Duration of treatment (max 12 months)
Evaluation of video-observed therapy by specialized nurses following the patients
Questionnaire with Likert scales submitted to all nurses at the end of the study
Measured: End of study (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start26 Nov 2021
- Primary completion18 Jul 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis ActiveStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients with active tuberculosis were invited to participate in the study and followed during the duration of their treatment until treatment completion
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligue Pulmonaire Genevoise
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Jean-Paul Janssens, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574529
- Sponsor's protocol ID
- CCER 2021-01713
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-observed Therapy (vDOT) as a Surrogate to Directly Observed Therapy (DOT) for Active Tuberculosis: a Feasibility Study in a Low Incidence High-income Area
- ClinicalTrials.gov ID
- NCT06574529
- Acronym / sponsor ID
- CCER 2021-01713
- Conditions
- Tuberculosis Active
- Keywords
- Compliance, Directly observed therapy, Video-observed therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ligue Pulmonaire GenevoiseUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 28 Aug 2024 (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.
Tuberculosis (TB) is still present in Switzerland, and concerns mainly foreign-born subjects. Monitoring compliance to treatment by Directly Observed Therapy (DOT) is strongly encouraged by the World Health Organization (WHO). It is however time-consuming, costly and stigmatising. This study aims to examine the feasibility of monitoring compliance through a secured web platform and videos sent via an application on a cellphone, a concept known as vDOT (Video-observed therapy). The study aims to include all patients treated for tuberculosis is on our area during an 18 month period and monitor acceptance, compliance, and technical issues related to vDOT.
Detailed description
The study aims to include all patients who are treated de novo for active tuberculosis is our area. The aim of this study, was to show that vDOT was feasible in a low-incidence high income area, that it had a high acceptance rate among patients and health-care professionals, with a low rate of technical difficulties or pitfalls.
All patients with a diagnosis of tuberculosis irrespective of site(s) of infection, were invited to participate in this study. The Division of Pulmonology of Geneva University Hospital diagnoses and follows virtually all cases of tuberculosis in the Canton of Geneva. Annual number of cases in Geneva between 2020 and 2023 was on average 43/year (range: 36-53). Incidence was 7-10.3/105 inhabitants compared to a national incidence of 3.99-4.72 /105 inhabitants during the same period.
Specialized TB nurses were trained to use the vDOT platform and provided the training with the help of translators whenever required. The application (APP) was installed with the patient, and a test video was sent to the platform. The APP uses simple understandable pictograms and is thus not per se language-dependent . vDOT was started as soon as possible after initiation of TB treatment, either during a hospital stay or during the first outpatient follow-up visit at our centre. Whenever necessary, a portable cell phone was provided for the patient, for the duration of the treatment.
The SureAdhere platform was used for vDOT (https://dimagi.com/sureadhere/). Once the videos have been recorded, they are sent automatically as soon as the patients' cell phone has access to internet.
For each patient, the number of videos to be sent each week was specified (5 as default option).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients with active tuberculosis were invited to participate in the study and followed during the duration of their treatment until treatment completion
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Video-observed therapy (vDOT)The study is not randomised; all subjects included are submitted to the VOT |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- age above 16 years of age; providing informed consent (translators were used whenever necessary to ensure understanding of study and vDOT procedure); having a diagnosis of untreated active tuberculosis, irrespective of site of infection, confirmed by culture and/or Polymerase chain reaction test (PCR) and follow-up ensured by Geneva University Hospital.
Key exclusion criteria (1 listed)
- refusal to participate, not fulfilling inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-observed therapy (vDOT)All participants are required to send 5 times per week a short video showing they are actually taking their treatment for tuberculosis via a dedicated application on their cellphone | Device | Study group |
Primary outcome
Acceptance rate
Time frame: Two weeks after starting TB treatment
Number of patients accepting to install the application on their cellphone and send videos of their treatment until treatment completion, among all patients initiating a treatment for active tuberculosis in our center
Effective implementation rate
Time frame: Two weeks after starting TB treatment
Number of patients for whom installing the application, and learning how to use it was possible among all patients with active TB during study period
3 secondary outcomes
Ratio of number of videos sent to number of videos expected
Time frame: Duration of treatment (max 12 months)
Quality of videos sent
Time frame: Duration of treatment (max 12 months)
Evaluation of video-observed therapy by specialized nurses following the patients
Time frame: End of study (18 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jean-Paul Janssens, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-observed therapy (vDOT) in people with Tuberculosis Active, run by Ligue Pulmonaire Genevoise at 1 site in Switzerland.
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 1 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: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptance rate (time frame: Two weeks after starting TB treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.