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dotsapp: Evaluation of the VOT Among Tuberculosis Patients From Lambaréné

Sponsor
Centre de Recherche Médicale de Lambaréné (Other)
Overall Status
Completed
CT.gov ID
NCT05865626
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
44.6
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Other: VOT with and without cash incentive
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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)
Primary Purpose:
Other
Official Title:
A Pilot Study to Evaluate Video Observed Treatment Among Tuberculosis Patients From Lambaréné Using an Instant Messenger Application
Actual Study Start Date :
Oct 10, 2018
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: VOT without cash incentive at the begining

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
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
Other Names:
  • VOT

    		•
    Experimental: VOT with cash incentive at the begining

    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
    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
    Other Names:
  • VOT

    		•
    No Intervention: Standard care

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. adherence to the VOT [at the end of study (2 years)]

      number of videos received compared to the expected number of videos

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre de recherches médicales de Lambaréné Lambaréné Gabon 242

    Sponsors and Collaborators

    • Centre de Recherche Médicale de Lambaréné

    Investigators

    • Study Director: Bertarnd Lell, prof., Centre de Recherche Médicale de Lambaréné

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    EDOA Jean Ronald, Dr, Centre de Recherche Médicale de Lambaréné
    ClinicalTrials.gov Identifier:
    NCT05865626
    Other Study ID Numbers:
    • dotsapp1
    First Posted:
    May 19, 2023
    Last Update Posted:
    May 19, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tuberculosis

    Study Results

    No Results Posted as of May 19, 2023