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Evaluation of the VOT Among Tuberculosis Patients From Lambaréné (dotsapp)

Primary Purpose

Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Gabon
Study Type
Interventional
Intervention
VOT with and without cash incentive
Sponsored by
Centre de Recherche Médicale de Lambaréné
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tuberculosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de recherches médicales de Lambaréné

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

VOT without cash incentive at the begining

VOT with cash incentive at the begining

Standard care

Arm Description

Participants in this group start VOT without financial motivation. In the second part of their follow-up, VOT is combined with financial motivation.

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

The participants in this group self-administer the anti-tuberculosis treatment as is done routinely.

Outcomes

Primary Outcome Measures

feasibility assessment
proportion of participants in the intervention groups who regularly send the videos throughout the follow-up.

Secondary Outcome Measures

adherence to the VOT
number of videos received compared to the expected number of videos
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.

Full Information

First Posted
April 29, 2023
Last Updated
May 9, 2023
Sponsor
Centre de Recherche Médicale de Lambaréné
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1. Study Identification

Unique Protocol Identification Number
NCT05865626
Brief Title
Evaluation of the VOT Among Tuberculosis Patients From Lambaréné
Acronym
dotsapp
Official Title
A Pilot Study to Evaluate Video Observed Treatment Among Tuberculosis Patients From Lambaréné Using an Instant Messenger Application
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche Médicale de Lambaréné

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VOT without cash incentive at the begining
Arm Type
Experimental
Arm Description
Participants in this group start VOT without financial motivation. In the second part of their follow-up, VOT is combined with financial motivation.
Arm Title
VOT with cash incentive at the begining
Arm Type
Experimental
Arm Description
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
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
The participants in this group self-administer the anti-tuberculosis treatment as is done routinely.
Intervention Type
Other
Intervention Name(s)
VOT with and without cash incentive
Other Intervention Name(s)
VOT
Intervention Description
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
Primary Outcome Measure Information:
Title
feasibility assessment
Description
proportion of participants in the intervention groups who regularly send the videos throughout the follow-up.
Time Frame
at the end of study (2 years)
Secondary Outcome Measure Information:
Title
adherence to the VOT
Description
number of videos received compared to the expected number of videos
Time Frame
at the end of study (2 years)
Title
effect of cash incentives on adherence to the VOT
Description
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.
Time Frame
at the end of study (2 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertarnd Lell, prof.
Organizational Affiliation
Centre de Recherche Médicale de Lambaréné
Official's Role
Study Director
Facility Information:
Facility Name
Centre de recherches médicales de Lambaréné
City
Lambaréné
ZIP/Postal Code
242
Country
Gabon

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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27352879
Citation
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Results Reference
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Evaluation of the VOT Among Tuberculosis Patients From Lambaréné

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