Evaluation of the VOT Among Tuberculosis Patients From Lambaréné

Tuberculosis Clinical Trial

— dotsapp  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05865626
• Other study ID #: dotsapp1
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2023
• Source: Centre de Recherche Médicale de Lambaréné
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Gabon	Centre de recherches médicales de Lambaréné	Lambaréné

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche Médicale de Lambaréné

Country where clinical trial is conducted

Gabon, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	adherence to the VOT	number of videos received compared to the expected number of videos	at the end of study (2 years)
Secondary	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.	at the end of study (2 years)