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Evaluation of the VOT Among Tuberculosis Patients From Lambaréné

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05865626
Acronym
dotsapp
Enrollment
30
Registered
2023-05-19
Start date
2018-10-10
Completion date
2022-06-30
Last updated
2023-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

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.

Interventions

OTHERVOT with and without cash incentive

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

Sponsors

Centre de Recherche Médicale de Lambaréné
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
feasibility assessmentat the end of study (2 years)proportion of participants in the intervention groups who regularly send the videos throughout the follow-up.

Secondary

MeasureTime frameDescription
adherence to the VOTat the end of study (2 years)number of videos received compared to the expected number of videos
effect of cash incentives on adherence to the VOTat the end of study (2 years)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.

Countries

Gabon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026