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TuberculosisdotsappNCT05865626

Evaluation of the VOT Among Tuberculosis Patients From Lambaréné

A study testing VOT with and without cash incentive in people with Tuberculosis, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tuberculosis
What is being tested?
VOT with and without cash incentive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGabon
Study dates
10 Oct 2018to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Older than 18 years
  • Signed informed consent form
  • Living in an area with mobile phone coverage
  • Have at least 3 months of treatment remaining

Who cannot join

  • Not being able to use a smartphone and unlikely to learn how to

Trial locations and contacts

1 site in 1 country.

Gabon1 site

  • Centre de recherches médicales de Lambaréné

    Lambaréné, 242

Other trials in Gabon

About this study

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

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

Read the 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.

Conditions
Tuberculosis
Being tested
VOT with and without cash incentive
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VOT with and without cash incentiveOther

    Also called VOT

    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

Study groups in NCT05865626
Study groupRoleWhat they receive
VOT without cash incentive at the beginingExperimentalParticipants in this group start VOT without financial motivation. In the second part of their follow-up, VOT is combined with financial motivation.
Receives: Other: VOT with and without cash incentive
VOT with cash incentive at the beginingExperimentalThe 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
Receives: Other: VOT with and without cash incentive
Standard careNo interventionThe participants in this group self-administer the anti-tuberculosis treatment as is done routinely.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. feasibility assessment

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

    Measured: at the end of study (2 years)

Secondary outcomes (2)

  1. adherence to the VOT

    number of videos received compared to the expected number of videos

    Measured: at the end of study (2 years)

  2. 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.

    Measured: at the end of study (2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2023
  2. Study start10 Oct 2018
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05865626
Sponsor's protocol ID
dotsapp1
Acronym
dotsapp
Status last verified
May 2023
First submitted
29 Apr 2023
Last updated
19 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Belard S, Remppis J, Bootsma S, Janssen S, Kombila DU, Beyeme JO, Rossatanga EG, Kokou C, Osbak KK, Obiang Mba RM, Kaba HM, Traore AN, Ehrhardt J, Bache EB, Flamen A, Rusch-Gerdes S, Frank M, Adegnika AA, Lell B, Niemann S, Kremsner PG, Loembe MM, Alabi AS, Grobusch MP. Tuberculosis Treatment Outcome and Drug Resistance in Lambarene, Gabon: A Prospective Cohort Study. Am J Trop Med Hyg. 2016 Aug 3;95(2):472-80. doi: 10.4269/ajtmh.15-0668. Epub 2016 Jun 27.

    PubMed 27352879

  • Elangovan R, Arulchelvan S. A Study on the Role of Mobile Phone Communication in Tuberculosis DOTS Treatment. Indian J Community Med. 2013 Oct;38(4):229-33. doi: 10.4103/0970-0218.120158.

    PubMed 24302824

  • Sinkou H, Hurevich H, Rusovich V, Zhylevich L, Falzon D, de Colombani P, Dadu A, Dara M, Story A, Skrahina A. Video-observed treatment for tuberculosis patients in Belarus: findings from the first programmatic experience. Eur Respir J. 2017 Mar 22;49(3):1602049. doi: 10.1183/13993003.02049-2016. Print 2017 Mar.

    PubMed 28331042

  • Garfein RS, Collins K, Munoz F, Moser K, Cerecer-Callu P, Raab F, Rios P, Flick A, Zuniga ML, Cuevas-Mota J, Liang K, Rangel G, Burgos JL, Rodwell TC, Patrick K. Feasibility of tuberculosis treatment monitoring by video directly observed therapy: a binational pilot study. Int J Tuberc Lung Dis. 2015 Sep;19(9):1057-64. doi: 10.5588/ijtld.14.0923.

    PubMed 26260824

  • Handbook for the use of digital technologies to support tuberculosis medication adherence. Geneva: World Health Organization; 2017.

  • Iribarren SJ, Schnall R, Stone PW, Carballo-Dieguez A. Smartphone Applications to Support Tuberculosis Prevention and Treatment: Review and Evaluation. JMIR Mhealth Uhealth. 2016 May 13;4(2):e25. doi: 10.2196/mhealth.5022.

    PubMed 27177591

  • Giordano V, Koch H, Godoy-Santos A, Dias Belangero W, Esteves Santos Pires R, Labronici P. WhatsApp Messenger as an Adjunctive Tool for Telemedicine: An Overview. Interact J Med Res. 2017 Jul 21;6(2):e11. doi: 10.2196/ijmr.6214.

    PubMed 28733273

  • Seewoodharry MD, Maconachie GDE, Gillies CL, Gottlob I, McLean RJ. The Effects of Feedback on Adherence to Treatment: A Systematic Review and Meta-analysis of RCTs. Am J Prev Med. 2017 Aug;53(2):232-240. doi: 10.1016/j.amepre.2017.03.005. Epub 2017 Apr 26.

    PubMed 28456347

  • Lutge EE, Wiysonge CS, Knight SE, Sinclair D, Volmink J. Incentives and enablers to improve adherence in tuberculosis. Cochrane Database Syst Rev. 2015 Sep 3;2015(9):CD007952. doi: 10.1002/14651858.CD007952.pub3.

    PubMed 26333525

  • Stuurman AL, Vonk Noordegraaf-Schouten M, van Kessel F, Oordt-Speets AM, Sandgren A, van der Werf MJ. Interventions for improving adherence to treatment for latent tuberculosis infection: a systematic review. BMC Infect Dis. 2016 Jun 8;16:257. doi: 10.1186/s12879-016-1549-4.

    PubMed 27268103

Questions about this trial

What is this clinical trial studying?

A study testing VOT with and without cash incentive in people with Tuberculosis, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

feasibility assessment (time frame: at the end of study (2 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05865626, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.

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