Promoting adherence to treatment for latent TB infection through mobile phone text messaging: study protocol for a pilot randomized controlled trial

Eyal Oren, Melanie L Bell, Francisco Garcia, Carlos Perez-Velez, Lynn B Gerald, Eyal Oren, Melanie L Bell, Francisco Garcia, Carlos Perez-Velez, Lynn B Gerald

Abstract

Background: An estimated two billion people, over one third of the world's population, have latent infection with Mycobacterium tuberculosis (LTBI). Patient adherence to LTBI treatment is currently poor given that individuals show no symptoms of illness and may not feel that they are at risk of developing active tuberculosis (TB). Short text messages can serve as a simple reminder to take medications and address barriers to adherence such as forgetfulness and lack of social support.

Methods/design: We aim to determine the feasibility and acceptability of text reminders for improving adherence in latent TB patients using a randomized controlled single-blinded trial, measuring adherence through an increase in treatment completion rates. Forty adult LTBI participants will be randomized to either text messages plus phone call reminders or phone call reminders only (usual care). Recruitment, retention, and study acceptability will be assessed as primary outcomes.

Discussion: This pilot study will examine the feasibility of using text messaging for increasing adherence to treatment for latent tuberculosis infection. The study will allow for evaluation of process measures and challenges and development of a model for scaling up an effectiveness trial for increasing treatment adherence.

Trial registration: NCT02690818 (Clinical Trials.gov).

Keywords: Latent tuberculosis infection; Text messages; Treatment adherence.

Figures

Fig. 1
Fig. 1
Schedule of enrolment, interventions, and assessments
Fig. 2
Fig. 2
Sample visit protocol, 4-month regimen

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