Clinical trial NCT05865626: Evaluation of the VOT Among Tuberculosis Patients From Lambaréné
Official title: A Pilot Study to Evaluate Video Observed Treatment Among Tuberculosis Patients From Lambaréné Using an Instant Messenger Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Lead sponsor: Centre de Recherche Médicale de Lambaréné
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In the intervention group, 20 subjects will receive a smartphone and one of the two incentives (close-follow-up or a financial incentive) over a 12 weeks period. After this period, the participant will receive the second incentive. The order is determined randomly with 10 participants receiving the incentives. Participants may receive a third incentive (social feedback) the earliest 6 weeks after the beginning of the treatment, in addition to the basic incentive. The 10 participants in the control group will not receive a smartphone but will be followed-up monthly.
Primary purpose: OTHER

Brief summary: This pilot study aimed to assess the feasibility of using an instant messenger to monitor drug intake in tuberculosis patients and to assess cash incentive to improve adherence to drug intake

Detailed description: At the initial visit, the inclusion criteria are cross-checked, the subject is informed of the study procedures, and an informed consent form is signed by subjects willing to participate.

For the participants from the intervention group, the research team will provide a smartphone with the WhatsApp application to each participant. At the initial visit, the research team will explain to the participants how to use the phone and the instant messenger application for the study. Briefly, the subject is filmed while taking the drug. This can be via a "selfie" or by a family member. The video is then sent to the study phone contact.

Once the video is received by an investigator, a message will be sent back to the participant's mobile phone acknowledging receipt of the video. An investigator trained on the DOT protocol, will review the video clips to assess if the drug was taken correctly or not. A daily log is filled in to keep track of drug intake for each participant.

Participants from both the control and intervention group are seen once per month in person for follow-ups and getting new drugs. At these time points information on drug intake is gathered.

Eligibility criteria: Inclusion Criteria:

Older than 18 years

* Signed informed consent form
* Living in an area with mobile phone coverage
* Have at least 3 months of treatment remaining

Exclusion Criteria:

• Not being able to use a smartphone and unlikely to learn how to

Primary outcomes:
measure: feasibility assessment
timeFrame: at the end of study (2 years)
Secondary outcomes:
measure: adherence to the VOT
timeFrame: at the end of study (2 years)
measure: effect of cash incentives on adherence to the VOT
timeFrame: at the end of study (2 years)
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Centre de recherches médicales de Lambaréné
Study officials:
affiliation: Centre de Recherche Médicale de Lambaréné
name: Bertarnd Lell, prof.
role: STUDY_DIRECTOR
References:
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