Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging

Overview

The purpose of this pilot study is to determine whether regularly scheduled medication reminder text messages (SMS) are effective in increasing latent tuberculosis infection (LTBI) treatment completion.

Full Title of Study: “Promoting Adherence to Treatment for Latent TB Infection Through Mobile Phone Text Messaging”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Investigator)
  • Study Primary Completion Date: September 26, 2018

Detailed Description

We aim to determine the feasibility and acceptability of text reminders for improving adherence in latent TB patients. Specific objectives of the current study are to: 1) Assess the feasibility of the intervention as indicated by participant recruitment and retention and; 2) Evaluate the acceptability of the intervention, as indicated by intervention adherence, outcome measurement rates, and feedback from participants. Data will be used to design a definitive trial which will test the hypothesis that the intervention will improve medication adherence, as measured through an increase in treatment completion rates, and result in higher self-reported medication adherence, fewer missed appointments and doses, and a shorter course of treatment.

Interventions

  • Behavioral: Regularly scheduled LTBI medication reminder text messages
    • Regularly scheduled medication reminder text messages Daily LTBI text messages without the option to text back. The messages will read, “This is a reminder to take your medication.”

Arms, Groups and Cohorts

  • Experimental: Behavioral intervention arm
    • Regularly scheduled medication reminder text messages Daily LTBI text messages without the option to text back. The messages will read, “This is a reminder to take your medication.” Standard of care: Monthly reminder call and clinic visit
  • No Intervention: Control group receiving standard care
    • Standard of care: Monthly reminder call and clinic visit

Clinical Trial Outcome Measures

Primary Measures

  • Recruitment
    • Time Frame: Ongoing
    • How many approached by clinic, how many referred, how many study eligible, how many consented; why ineligible or refused; how long to recruit each patient

Secondary Measures

  • Retention
    • Time Frame: Ongoing
    • How many drop out at each monthly time point, who and why
  • Perceptions of Intervention through a questionnaire
    • Time Frame: Once, up to 12 months post-treatment
    • Perceptions and opinions (if the intervention was helpful, non-helpful, effectiveness) in the intervention arm will be assessed after the study follow-up through a questionnaire of a subset of enrolled individuals at the completion of the participant’s treatment (up to 12 months post-treatment initiation).

Participating in This Clinical Trial

Inclusion Criteria

  • Consent to the study – Own a mobile phone which operates on a telecom provider supported by our SMS platform – Initiating or actively receiving treatment for LTBI at the Pima County TB Clinic in Tucson, AZ – Prescribed self-administered therapy – Report not having prior or current active TB disease – Know how to and are able to receive SMS messages – At least 18 years of age Exclusion Criteria:

  • Do not meet inclusion criteria – Do not consent to study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Arizona
  • Collaborator
    • Pima County Health Department
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eyal Oren, PhD, Principal Investigator, University of Arizona

References

Oren E, Bell ML, Garcia F, Perez-Velez C, Gerald LB. Promoting adherence to treatment for latent TB infection through mobile phone text messaging: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2017 Mar 13;3:15. doi: 10.1186/s40814-017-0128-9. eCollection 2017.

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