The effect of weekly text-message communication on treatment completion among patients with latent tuberculosis infection: study protocol for a randomised controlled trial (WelTel LTBI)

Mia L van der Kop, Jasmina Memetovic, Anik Patel, Fawziah Marra, Mohsen Sadatsafavi, Jan Hajek, Kirsten Smillie, Lehana Thabane, Darlene Taylor, James Johnston, Richard T Lester, Mia L van der Kop, Jasmina Memetovic, Anik Patel, Fawziah Marra, Mohsen Sadatsafavi, Jan Hajek, Kirsten Smillie, Lehana Thabane, Darlene Taylor, James Johnston, Richard T Lester

Abstract

Introduction: Interventions to improve adherence to treatment for latent tuberculosis infection (LTBI) are necessary to improve treatment completion rates and optimise tuberculosis (TB) control efforts. The high prevalence of cell phone use presents opportunities to develop innovative ways to engage patients in care. A randomised controlled trial (RCT), WelTel Kenya1, demonstrated that weekly text messages improved antiretroviral adherence and clinical outcomes among patients initiating HIV treatment. The aim of this study is to determine whether the WelTel intervention can improve treatment completion among patients with LTBI and to evaluate the intervention's cost-effectiveness.

Methods and analysis: This open, two-site, parallel RCT (WelTel LTBI) will be conducted at TB clinics in Vancouver and New Westminster, British Columbia, Canada. Over 2 years, we aim to recruit 350 individuals initiating a 9-month isoniazid regimen. Participants will be randomly allocated to an intervention or control (standard care) arm in a 1:1 ratio. Intervention arm participants will receive a weekly text-message 'check-in' to which they will be asked to respond within 48 h. A TB clinician will follow-up instances of non-response and problems that are identified. Participants will be followed until treatment completion (up to 12 months) or discontinuation. The primary outcome is self-reported treatment completion (taking ≥80% of doses within 12 months). Secondary outcomes include daily adherence (percentage of days participants used medication as prescribed) and time to treatment completion. Patient satisfaction with the intervention will be evaluated, and the intervention's cost-effectiveness will be analysed through decision-analytic modelling.

Ethics and dissemination: Ethical approval has been obtained from the University of British Columbia. This trial will test the efficacy and cost-effectiveness of the WelTel intervention to improve treatment completion among patients with LTBI. Trial results and economic evaluation will help inform policy and practice on the use of WelTel in this population.

Trial registration number: ClinicalTrials.gov NCT01549457.

Figures

Figure 1
Figure 1
The WelTel intervention illustrating how the patients and clinicians communicate on a weekly basis through the WelTel intervention.
Figure 2
Figure 2
The flow of participants through the WelTel LTBI study. LTBI, latent tuberculosis infection; TB, tuberculosis.
Figure 3
Figure 3
A decision tree that will be used in the economic analysis of the trial. INH, isoniazid.

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Source: PubMed

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