Evaluation of the VOT Among Tuberculosis Patients From Lambaréné

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Other: VOT with and without cash incentive

• Registration Number: NCT05865626
• Lead Sponsor: Centre de Recherche Médicale de Lambaréné

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.

Study Timeline

• Study Start: 2018-10-10
• Primary Completion: 2020-06-30
• Study Completion: 2022-06-30
• Study First Submitted: 2023-04-29
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-09
• Last Update Submitted: 2023-05-09
• Study First Posted: 2023-05-19
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VOT without cash incentive at the begining	VOT with and without cash incentive	Participants in this group start VOT without financial motivation. In the second part of their follow-up, VOT is combined with financial motivation.
VOT with cash incentive at the begining	VOT with and without cash incentive	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

Primary Outcome Measures

Name	Time	Method
feasibility assessment	at the end of study (2 years)	proportion of participants in the intervention groups who regularly send the videos throughout the follow-up.

Secondary Outcome Measures

Name	Time	Method
adherence to the VOT	at 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 VOT	at 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.

Trial Locations

Locations (1)

Centre de recherches médicales de Lambaréné; 🇬🇦 Lambaréné, Gabon