Table 4 Characteristics of ongoing studies

Trial name or title

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

Monitoring Patient Compliance with Tuberculosis Treatment Regimens

Cluster randomized trial of using mobile text messaging and a medication monitor in tuberculosis (TB) case management

Methods

Open-label multicenter randomized controlled trial

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care.

Cluster Randomized Controlled Trial

Participants

Subjects initiating treatment for latent TB infection who are aged above 18 years, who own a mobile phone or share mobile phone access with a household member who consents to participate. In addition, the subject should be able to read text-messages in English or has a family member or friend that can provide translation and assistance with text-messages during the duration of the study

Inclusion criteria:

Inclusion criteria:

• New, spear-positive drug susceptible TB patients who have been on treatment for less than two weeks

• TB patients, smear-positive or smear-negative, recruited from the study clusters (county/district)

• 15 years and older

• Willing to participate in the study

• Conscious without any mental disease

• Access to a mobile phone (self-report)

• Conscious without any visual, auditory or language impairment

• At least 18 years old

• Intending to reside in Karachi for the duration of treatment

• Patient or family member is able to read a short message service (SMS)/ text and use medication monitor after training

Exclusion criteria:

Exclusion criteria:

• Does not meet inclusion criteria

• Patients who do not have regular access to a mobile phone

• Patients with tuberculosis pleurisy

• Patients with no sputum smear data at tuberculosis diagnosis

• Patients who have previously received treatment

Patients who have another member in their household who is already a part of the study

Interventions

Weekly text messages will be sent to the participants in the intervention arm asking them how they are

Other: Interactive Reminders

This is a cluster randomized non blinded trial. Clusters are defined as a county or district. This is a four armed trial, three intervention arms and one control arm:

Daily SMS reminders sent to TB patients at a pre-specified time. They are asked to respond to the reminders. If a response is not received within two hours, they are sent another reminder for up to three hours per day

1. Mobile phone

Patients are provided with mobile phones as a reminding tool to take their tuberculosis medication. On medication intake days patients are sent a SMS to remind them to take their medication. They respond with a brief message when medication is taken. Doctors in TB dispensary collect the SMS feedback from patients to assess how many doses are missed in a month. Based on the missed doses, additional intervention and incentive mechanisms are implemented such as visits from the township/village doctor and incentives per visit given to the township/village doctor.

2. Medication monitor

Patients are provided with a medication monitor box with reminding functions. This tool is used to remind patients to their tuberculosis medication and also records drug intake. Doctors at the TB dispensary collect the drug intake record from medication monitor monthly to assess that how many doses are missed in a month. Based on the missed doses, additional intervention and incentive mechanism are implemented as described in the mobile phone intervention (1)

3. Mobile phone and medication monitor

Patients are provided with both the mobile phone and medication monitor box with reminding function for as tools for communication, reminding and recording drug intake. The drugs intake record from medication monitor and SMS from patients are collected monthly, and the number of doses missed in a month is calculated using the drug intake record of the medication monitor. Based on the missed doses, additional intervention and incentive mechanism are implemented as described in the mobile phone intervention (1)

4. Control

Patients are managed based on the current standard of care.

All patients will be followed up to the end of tuberculosis treatment.

Outcomes

Primary outcome: Successful completion of LTBI treatment regimens. [Time Frame: 4 or 9 months]. 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

Primary outcomes:

Primary outcome:

• Treatment Outcomes [Time Frame: After 6 to 8 months of treatment] [Designated as safety issue: No]. The investigators will compare clinically reported treatment outcomes between the intervention and control groups.

• The mean proportion of months on TB treatment where at least 3 doses were missed in a month (this is based on pill count data from the medication monitoring box)

• Sputum conversion [ Time Frame: At 2, 5, and 6/7 months of treatment ] [ Designated as safety issue: No ]The investigators will look at sputum test results for patients at months 2, 5, and 6/7 of their treatment to compare when sputum conversion occurs between the intervention and control group at these three periods during their treatment.

Secondary outcomes:

• The mean proportion of months a patient has at least 7 doses missed

• The mean proportion of overall missed doses

• Treatment compliance [Time Frame: Monthly visits for 6 to 8 months of treatment ] [ Designated as safety issue: No ]The regularity of treatment will be measured using urinalysis tests that detect the presence of isoniazid or rifampicin, a first line drug for TB treatment, in patients' urine. These results will be collected through monthly "surprise" visits to the participants' houses. The number of negative results will be compared between treatment and control groups.

• Proportion of patients defined as non-adherent (at least 10% of doses missed)

• Proportion of patients defaulting during TB treatment

• Proportion of smear positive TB cases who become smear negative at 2 months

Secondary outcomes:

• Physical fitness and mobility [Time Frame: Monthly visits for 6 to 8 months of treatment] [Designated as safety issue: No].The investigators will measure physical fitness and mobility through questionnaires conducted with patients during household visits each month that they are on treatment. The investigators are using two indices. The physical fitness index will record respondents’ ability to perform certain tasks. The mobility index will record the mobility of participants.

• The proportion of patients with treatment outcome of cure or completed treatment

• Psychological Impacts [ Time Frame: Monthly visits for 6 to 8 months of treatment ] [ Designated as safety issue: No ]In order to gauge the psychological impacts of the system, the investigators will be looking at participants' perceptions on the likelihood of being cured, how they feel on a given day using the pain scale, and how supported they feel. This data will be collected through questionnaires conducted at each monthly mid-line visit.

Starting date

April 2012

2011

2011

Estimated study completion date

December 2014

November 2014

August 2012

Contact information

Richard Lester: richard.lester@bccdc.ca Natasha Van Borek: natasha.vanborek@bccdc.ca

Shama Mohammed: shama.mohammed@irdresearch.org

Professor Shiwen Jiang: jiangsw@chinatb.org

Notes

ClinicalTrials.gov identifier: NCT01549457

ClinicalTrials.gov identifier: NCT01690754

Current Controlled Trials identifier: ISRCTN46846388