Abstract
Introduction The effectiveness of video-observed therapy (VOT) for treating tuberculosis (TB) has not been measured in low- and middle-income countries (LMICs), where >95% of TB cases and deaths occur. In this study, we analyse the effectiveness and patient cost-difference of VOT compared to clinic-based directly observed therapy (DOT) in improving medication adherence in Moldova, a LMIC in Eastern Europe.
Methods The study was a two-arm individually randomised trial with 197 TB patients (n=99 DOT control group; n=98 VOT treatment group; multidrug-resistant TB cases were excluded). The primary outcome was observed medication adherence, measured by the number of days that a patient failed to be observed adhering to medication for every 2-week period during the course of their treatment.
Results VOT significantly decreased nonadherence by 4 days (95% CI 3.35–4.67 days, p<0.01) per 2-week period: 5.24 days missed per 2-week period for DOT and 1.29 days for VOT. VOT patients spent MDL 504 (∼EUR 25) (95% CI MDL 277–730, p<0.01) and 58 h (95% CI 48–68 h, p<0.01) less on their treatment. In addition, VOT increased self-reported satisfaction with treatment. We found no significant results pertaining to treatment success, patient wellbeing or patient employment status and some evidence of an increase in side-effects.
Discussion In this trial, VOT increased observed medication adherence for TB patients in Moldova, a LMIC, when compared to clinic-based DOT. Additionally, VOT significantly reduced the time and money patients spent on their treatment.
Abstract
In this RCT, patients were assigned to either in-person observed treatment (as normal) or asynchronous video-observation. Observed medication adherence and satisfaction were improved and loss in patient time and costs during treatment were reduced. https://bit.ly/2Klmf18
Footnotes
This article has an editorial commentary: https://doi.org/10.1183/13993003.01998-2020
This article has supplementary material available from erj.ersjournals.com
This study was registered at ClinicalTrials.gov with identifier NCT02331732. The study protocol, informed consent and statistical analysis plan can be shared. Data can be provided to researchers that provide a methodologically sound proposal. Aggregate data for all of the outcomes we collected in our trial can also be shared. For individual de-identified participant data, we will need to seek permission from our Moldovan partners. The data can be made available for sharing beginning 3 months and ending 36 months following journal publication.
Conflict of interest: L. Ravenscroft reports consultancy fees from United Nations Development Programme (UNDP), during the conduct of the study.
Conflict of interest: S. Kettle reports consultancy fees from United Nations Development Programme (UNDP), during the conduct of the study.
Conflict of interest: R. Persian reports consultancy fees from United Nations Development Programme (UNDP), during the conduct of the study.
Conflict of interest: S. Ruda reports consultancy fees from United Nations Development Programme (UNDP), during the conduct of the study.
Conflict of interest: L. Severin reports personal fees from UNDP Moldova, grants from PAS Center, non-financial support from Moldcell Company, during the conduct of the study; personal fees from UNDP Moldova, outside the submitted work.
Conflict of interest: S. Doltu reports personal fees from UNDP Moldova, grants from PAS Center, non-financial support from Moldcell Company, during the conduct of the study; personal fees from UNDP Moldova, outside the submitted work.
Conflict of interest: B. Schenck has nothing to disclose.
Conflict of interest: G. Loewenstein has nothing to disclose.
Support statement: The Behavioural Insights Team received funding for their time spent on the project from the United Nations Development Programme. In addition, Moldcell provided unlimited internet traffic for patients in the VOT arm free of charge. No financial support was provided to any individuals for the project. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received September 12, 2019.
- Accepted April 13, 2020.
- Copyright ©ERS 2020