Evaluation of the VOT Among Tuberculosis Patients From Lambaréné

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Study to Evaluate Video Observed Treatment Among Tuberculosis Patients From Lambaréné Using an Instant Messenger Application

Conditions
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Tuberculosis

Intervention / Treatment
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* Other: VOT with and without cash incentive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VOT without cash incentive at the begining<br>Participants in this group start VOT without financial motivation. In the second part of their follow-up, VOT is combined with financial motivation. | Other: VOT with and without cash incentive<br>* Here we are interested in the remote monitoring of TB treatment, and the impact that financial motivation can have on compliance with this monitoring. the cross-over here means that participants in each intervention group will at some point receive VOT without motivation and then VOT with motivation, depending on whether they start with one or the other combination<br>* Other names: VOT;|
| Experimental: VOT with cash incentive at the begining<br>The participants in this group start the VOT with the financial motivation. In the second part of their follow-up, VOT is no longer associated with financial motivation | Other: VOT with and without cash incentive<br>* Here we are interested in the remote monitoring of TB treatment, and the impact that financial motivation can have on compliance with this monitoring. the cross-over here means that participants in each intervention group will at some point receive VOT without motivation and then VOT with motivation, depending on whether they start with one or the other combination<br>* Other names: VOT;|
| No Intervention: Standard care<br>The participants in this group self-administer the anti-tuberculosis treatment as is done routinely. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility assessment | proportion of participants in the intervention groups who regularly send the videos throughout the follow-up. | at the end of study (2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to the VOT | number of videos received compared to the expected number of videos | at the end of study (2 years) | 
| effect of cash incentives on adherence to the VOT | comparison of the proportion of videos received during the follow-up phase without financial motivation and the proportion of videos received during the follow-up phase with financial motivation. | at the end of study (2 years) |