Evaluation of the VOT Among Tuberculosis Patients From Lambaréné

NCT05865626 | Completed

• 1 other identifier: dotsapp1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• feasibility assessment

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

  at the end of study (2 years)

Secondary Outcomes (2)

• adherence to the VOT

  at the end of study (2 years)

• effect of cash incentives on adherence to the VOT

  at the end of study (2 years)

Study Arms (3)

VOT without cash incentive at the begining

EXPERIMENTAL

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

VOT with cash incentive at the begining

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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

Interventions

VOT with and without cash incentive OTHER

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

Also known as: VOT

VOT with cash incentive at the begining; VOT without cash incentive at the begining

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre de Recherche Médicale de Lambaréné: lead

Study Sites (1)

Centre de recherches médicales de Lambaréné

Lambaréné, 242, Gabon

Location

Related Publications (10)

• 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.

  PMID: 27352879 BACKGROUND

• 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.

  PMID: 24302824 BACKGROUND

• 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.

  PMID: 28331042 BACKGROUND

• 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.

  PMID: 26260824 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 27177591 BACKGROUND

• 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.

  PMID: 28733273 BACKGROUND

• 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.

  PMID: 28456347 BACKGROUND

• 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.

  PMID: 26333525 BACKGROUND

• 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.

  PMID: 27268103 BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Bertarnd Lell, prof.

  Centre de Recherche Médicale de Lambaréné

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: May 19, 2023
• Study Start: October 10, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2022
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GA (1)