Impact of a Daily SMS Medication Reminder System on Tuberculosis Treatment Outcomes: A Randomized Controlled Trial.

IMPORTANCE: The 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. OBJECTIVE: To measure the impact of Zindagi SMS, a two-way SMS reminder system, on treatment success of people with drug-sensitive tuberculosis. DESIGN: We 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. SETTING: Public and private sector tuberculosis clinics in Karachi, Pakistan. PARTICIPANTS: Newly-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 OUTCOME: The primary outcome was clinically recorded treatment success based upon intention-to-treat. RESULTS: We 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. CONCLUSION: In this large-scale randomized controlled effectiveness trial of SMS medication reminders for tuberculosis treatment, we found no significant impact. TRIAL REGISTRATION: The trial was registered with ClinicalTrials.gov, NCT01690754.

Determinants of Default from Tuberculosis Treatment among Patients with Drug-Susceptible Tuberculosis in Karachi, Pakistan: A Mixed Methods Study.

PURPOSE: Non-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. METHODS: In-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. RESULTS: Qualitative 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. CONCLUSIONS: In 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.

Harnessing Photovoice for tuberculosis advocacy in Karachi, Pakistan.

In Pakistan, despite publically available free testing and treatment throughout the country, there were an estimated 58,000 deaths due to tuberculosis in 2010. Understanding the experiences of people affected by TB is essential in addressing barriers to effective treatment. The Indus Hospital used Photovoice to understand the experiences of people affected by TB in Karachi. Two hundred and thirty photographs and stories were collected from 55 people affected by TB. Five major themes and 12 sub-themes emerged from the data: the physical aspects of TB (weakness and the side effects of the medication), the social aspects of TB (loneliness, stigma, and the fear/guilt of infecting family members), the socio-economic aspects of TB (financial difficulties/poverty and poor living conditions), supportive factors during treatment (support from family and friends, support from welfare organizations, prayer, visiting peaceful places), and recovery (happiness about getting better). The photographs, stories, and a Call for Action were shared at a Gallery event with patients, practitioners, and policy-makers. This study provides a look at the complexities surrounding TB and emphasizes the need for holistic interventions for TB that address all aspects of the disease, including its social determinants. It also highlights the potential of Photovoice as an effective means to bring much-needed attention to this disease.

Understanding the knowledge and perceptions about clubfoot in Karachi, Pakistan: a qualitative exploration.

This paper explores local knowledge and perceptions about clubfoot in the Indus Hospital's catchment population in Karachi, Pakistan. Data was collected through seven focus group discussions with community members and Lady Health Workers, nine in-depth interviews with parents of children with treated or untreated clubfoot, and one interview with an adult with untreated clubfoot. We found that participants were unable to distinguish clubfoot from other disabilities. Moreover, participants had a number of beliefs about the causes of clubfoot, which included lunar and solar eclipses, religious explanations, the health status and behaviours of parents, and genetics. While participants were aware of surgery and other allopathic treatments for clubfoot, many also believed in traditional and religious treatments or were unaware that clubfoot is a treatable condition. This study is the first of its kind in Pakistan and provides important insights that clubfoot programs need comprehensive strategies to raise awareness about clubfoot amongst community members, health providers, and religious leaders in order to be successful.

User engagement with and attitudes towards an interactive SMS reminder system for patients with tuberculosis.

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.

Engaging the private sector to increase tuberculosis case detection: an impact evaluation study.

BACKGROUND: In many countries with a high burden of tuberculosis, most patients receive treatment in the private sector. We evaluated a multifaceted case-detection strategy in Karachi, Pakistan, targeting the private sector. METHODS: A year-long communications campaign advised people with 2 weeks or more of productive cough to seek care at one of 54 private family medical clinics or a private hospital that was also a national tuberculosis programme (NTP) reporting centre. Community laypeople participated as screeners, using an interactive algorithm on mobile phones to assess patients and visitors in family-clinic waiting areas and the hospital's outpatient department. Screeners received cash incentives for case detection. Patients with suspected tuberculosis also came directly to the hospital's tuberculosis clinic (self-referrals) or were referred there (referrals). The primary outcome was the change (from 2010 to 2011) in tuberculosis notifications to the NTP in the intervention area compared with that in an adjacent control area. FINDINGS: Screeners assessed 388,196 individuals at family clinics and 81,700 at Indus Hospital's outpatient department from January-December, 2011. A total of 2416 tuberculosis cases were detected and notified via the NTP reporting centre at Indus Hospital: 603 through family clinics, 273 through the outpatient department, 1020 from self-referrals, and 520 from referrals. In the intervention area overall, tuberculosis case notification to the NTP increased two times (from 1569 to 3140 cases) from 2010 to 2011--a 2·21 times increase (95% CI 1·93-2·53) relative to the change in number of case notifications in the control area. From 2010 to 2011, pulmonary tuberculosis notifications at Indus Hospital increased by 3·77 times for adults and 7·32 times for children. INTERPRETATION: Novel approaches to tuberculosis case-finding involving the private sector and using laypeople, mobile phone software and incentives, and communication campaigns can substantially increase case notification in dense urban settings. FUNDING: TB REACH, Stop TB Partnership.