Evaluation of the VOT Among Tuberculosis Patients From Lambaréné
NCT ID: NCT05865626
Last Updated: 2023-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-10-10
2022-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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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.
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
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
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
Standard care
The participants in this group self-administer the anti-tuberculosis treatment as is done routinely.
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent form
* Living in an area with mobile phone coverage
* Have at least 3 months of treatment remaining
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Centre de Recherche Médicale de Lambaréné
OTHER
Responsible Party
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EDOA Jean Ronald
Dr
Principal Investigators
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Bertarnd Lell, prof.
Role: STUDY_DIRECTOR
Centre de Recherche Médicale de Lambaréné
Locations
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Centre de recherches médicales de Lambaréné
Lambaréné, , Gabon
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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dotsapp1
Identifier Type: -
Identifier Source: org_study_id
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