JMIR Publications

ABSTRACT

Background:

The End TB Strategy envisions a world free of tuberculosis (TB)-zero deaths, disease and suffering due to TB by 2035. Non-adherence reduces cure rates, prolongs infectiousness, and contributes to emergence of multi-drug resistant TB (MDR-TB). Moreover, MDR-TB is a growing, complex and costly problem that presents a major obstacle to TB control. Directly observed therapy (DOT) for treatment adherence monitoring is the recommended standard however it is challenging to implement at scale because it is labor-intensive. Mobile health interventions can facilitate remote adherence monitoring and minimize the costs and inconveniences associated with standard DOT.

Objective:

The DOT Selfie study aims to evaluate the effectiveness of using Video Directly Observed Treatment (VDOT) to improve medication adherence in TB treatment versus usual care DOT in an African context.

Methods:

The DOT Selfie study is an open-label, randomized controlled trial (RCT) with two parallel groups, in which 144 adult TB patients aged 18-65 years will be randomly assigned to receive the usual care DOT monitoring or VDOT as the intervention. The intervention will consist of a smart phone App, a prepaid weekly internet, translated text message reminders and an incentive for those who adhere. The participant will use a smartphone to record and send time-stamped encrypted videos showing his/her daily medication ingestion. This video component will directly substitute the need for daily face-to-face meetings between the health provider and patient. We hypothesize that the VDOT intervention will be more effective because it allows patients to swallow their pills anywhere, anytime. Moreover, patients will receive mobile-phone based ‘social bundle’ incentives to motivate adherence to continued daily submission of videos to the health system. The health providers will log into a secured computer system to verify treatment adherence, document missed doses, investigate the reasons for missed doses, and follow pre-specified protocol measures to reestablish medication adherence. The primary endpoint is adherence level as measured by the fraction of expected doses observed over the treatment period. The main secondary outcome will be time-to-treatment completion in both groups.

Results:

This RCT will be among the first to evaluate the effectiveness of VDOT within an African setting. The results will provide robust scientific evidence on the implementation and adoption of mobile Health (mHealth) tools coupled with incentives to motivate TB medication adherence. If successful, VDOT will be applicable to other low-income settings and to a range of chronic diseases with lifelong treatment such as HIV/AIDs.

Conclusions:

This RCT will be the first to evaluate the effectiveness of VDOT within an African setting. The results will provide insights regarding the usage of mobile Health (mHealth) tools and social bundle incentives to motivate TB medication adherence. If successful, VDOT will be applicable to other African settings and to a range of chronic diseases with lifelong treatment, such as HIV/AIDs. Clinical Trial: ClinicalTrials.gov NCT04134689; http://clinicaltrials.gov/ct2/show/NCT04134689