Trial Information

A Randomized Controlled Trial to Examine the Effectiveness of Use of Mobile Phones and Text Messaging to Improve Adherence to Treatment of Latent TB

1. Purpose

The purpose of this study is to compare the proportion of patients who are adherent to
their TB medications among those receiving weekly text messages plus standard of care
and those who receive standard of care only.

2. Justification:

Previous research has shown that weekly text messages from a health care provider
increases medication adherence for HIV patients. The investigators would like to
determine if a similar effect in terms of adherence can be seen in patients receiving
medication for latent tuberculosis infection

3. Objectives

Primary Objective:

1) To compare successful treatment completion rates for patients treated with either 9
months of INH or 4 months of RIF between those receiving weekly SMS text messages via mobile
phone plus standard of care to those receiving standard care. The standard of care at the TB
clinics for all LTBI patients includes provision of a 30 day supply of medications - either
isoniazid 300mg daily for 9 months or rifampin 600mg daily for 4 months - at a time, monthly
blood-work and monthly clinic visits. Successful treatment completion is defined as taking
at least 80% of the doses of INH prescribed within 12 months or at least 80% of the disease
of RIF prescribed within 6 months.

Secondary Objectives:

1. To compare the proportion of prescribed doses taken on schedule (daily adherence) prior
to medication discontinuation or interruption on medical advice between those receiving
weekly SMS text messages via mobile phone to those receiving standard care;

2. To measure patient satisfaction with the SMS intervention using a provider administered
questionnaire including a series of Likert questions.

4) Research Method

This study is a prospective open-label multicentre randomized controlled trial of a clinical
intervention. It is estimated that 486 study participants will be required to have 80% power
to detect a 15% difference in adherence at a .05 level of significance. In addition to
recruiting English-speaking participants, the investigators will also be recruiting
participants that have Chinese and Punjabi as their first language.

Upon consent, participants will be randomly assigned to receive either 1) standard of care
(9 months of INH or 4 months of RIF) and weekly SMS text messages via mobile phone or 2)
standard of care (9 months of INH or 4 months of RIF) without weekly SMS text messages via
mobile phone.

The clinicians, pharmacists and researchers involved in evaluating compliance will not be
blinded to the allocation of the intervention and control groups, as they will be required
to review patients charts periodically, respond to patients text messages when they are
experiencing difficulty in taking medications or side effects, as well as to ensure the
successful operation of the SMS technology platform.