VDOT 2

The effect of digital dosing monitoring and mobile phone reminders upon the adherence of patients treated for tuberculosis in Vietnam.

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STUDY SITES: Thanh Hoa province

TIMELINE: April 2017 – June 2019

PROJECT IMPLEMENTER: National Lung Hospital / National TB Program

FUNDED BY: Woolcock Institute of Medical Research

CORE STAKEHOLDER: Thanh Hoa Lung Hospital

PRIMARY OBJECTIVE: To evaluate the feasibility and effectiveness of digital adherence support, among outpatients with newly diagnosed smear positive pulmonary tuberculosis treated in Vietnam.

RESEARCH METHOD:

A parallel arm randomised controlled study to compare digital adherence monitoring and automated reminders, with scheduled history review, with a control group receiving standard self-administered therapy.

Eligible patients will be invited to enrol through a District TB Clinic or outpatient clinic at the Thanh Hoa Lung Hospital by staff working for the National TB Program. A pill count will be performed by health workers at the time of enrolment, evaluating the number of daily doses remaining and the number that was prescribed during the preceding month. This will be the baseline against which adherence during the next month will be assessed.

Once enrolled, individuals will be followed up until the completion of therapy, or until loss to follow-up, transfer out or treatment failure is documented by the  National TB Program staff. In the intervention arm, patients will be provided an adherence monitoring box to record daily adherence.

The proportion of individuals missing at least 3/15 doses (80%) per month on average will be the primary outcome measure.