ImportanceThe rapid uptake of mobile phones in low and middle-income countries over the past decade has provided public health programs unprecedented access to patients. While programs have used text messages to improve medication adherence, there have been no high-powered trials evaluating their impact on tuberculosis treatment outcomes.ObjectiveTo measure the impact of Zindagi SMS, a two-way SMS reminder system, on treatment success of people with drug-sensitive tuberculosis.DesignWe conducted a two-arm, parallel design, effectiveness randomized controlled trial in Karachi, Pakistan. Individual participants were randomized to either Zindagi SMS or the control group. Zindagi SMS sent daily SMS reminders to participants and asked them to respond through SMS or missed (unbilled) calls after taking their medication. Non-respondents were sent up to three reminders a day.SettingPublic and private sector tuberculosis clinics in Karachi, Pakistan.ParticipantsNewly-diagnosed patients with smear or bacteriologically positive pulmonary tuberculosis who were on treatment for less than two weeks; 15 years of age or older; reported having access to a mobile phone; and intended to live in Karachi throughout treatment were eligible to participate. We enrolled 2,207 participants, with 1,110 randomized to Zindagi SMS and 1,097 to the control group.Main OutcomeThe primary outcome was clinically recorded treatment success based upon intention-to-treat.ResultsWe found no significant difference between the Zindagi SMS or control groups for treatment success (719 or 83% vs. 903 or 83%, respectively, p = 0·782). There was no significant program effect on self-reported medication adherence reported during unannounced visits during treatment.ConclusionIn this large-scale randomized controlled effectiveness trial of SMS medication reminders for tuberculosis treatment, we found no significant impact.Trial RegistrationThe trial was registered with ClinicalTrials.gov, NCT01690754.

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PurposeNon-adherence to tuberculosis therapy can lead to drug resistance, prolonged infectiousness, and death; therefore, understanding what causes treatment default is important. Pakistan has one of the highest burdens of tuberculosis in the world, yet there have been no qualitative studies in Pakistan that have specifically examined why default occurs. We conducted a mixed methods study at a tuberculosis clinic in Karachi to understand why patients with drug-susceptible tuberculosis default from treatment, and to identify factors associated with default. Patients attending this clinic pick up medications weekly and undergo family-supported directly observed therapy.MethodsIn-depth interviews were administered to 21 patients who had defaulted. We also compared patients who defaulted with those who were cured, had completed, or had failed treatment in 2013.ResultsQualitative analyses showed the most common reasons for default were the financial burden of treatment, and medication side effects and beliefs. The influence of finances on other causes of default was also prominent, as was concern about the effect of treatment on family members. In quantitative analysis, of 2120 patients, 301 (14.2%) defaulted. Univariate analysis found that male gender (OR: 1.34, 95% CI: 1.04–1.71), being 35–59 years of age (OR: 1.54, 95% CI: 1.14–2.08), or being 60 years of age or older (OR: 1.84, 95% CI: 1.17–2.88) were associated with default. After adjusting for gender, disease site, and patient category, being 35–59 years of age (aOR: 1.49, 95% CI: 1.10–2.03) or 60 years of age or older (aOR: 1.76, 95% CI: 1.12–2.77) were associated with default.ConclusionsIn multivariate analysis age was the only variable associated with default. This lack of identifiable risk factors and our qualitative findings imply that default is complex and often due to extrinsic and medication-related factors. More tolerable medications, improved side effect management, and innovative cost-reduction measures are needed to reduce default from tuberculosis treatment.

We conducted a qualitative study to understand user perceptions, acceptability and engagement with an interactive SMS reminder system designed to improve treatment adherence for patients with tuberculosis (TB). Patients received daily reminders and were asked to respond after taking their medication. Non-responsive patients were sent up to three reminders a day. We enrolled 30 patients with TB who had access to a mobile phone and observed their engagement with the system for a one-month period. We also conducted semi-structured interviews with 24 patients to understand their experience with the system. Most patients found the reminders helpful and encouraging. The average response rate over the study period was 57%. However, it fell from a mean response rate of 62% during the first ten days to 49% during the last ten days. Response rates were higher amongst females, participants with some schooling, and participants who had sent an SMS message the week prior to enrolment. Non-responsiveness was associated with a lack of access to the owner of the mobile phone, problems with the mobile phone itself and literacy. Our pilot study suggests that interactive SMS reminders are an acceptable and appreciated method of supporting patients with TB in taking their medication.