Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Promoting Adherence to Treatment for Latent TB Infection Through Mobile Phone Text Messaging

Conditions
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Latent Tuberculosis

Intervention / Treatment
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* Behavioral: Regularly scheduled LTBI medication reminder text messages


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral intervention arm<br>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 | Behavioral: Regularly scheduled LTBI medication reminder text messages<br>* 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.<br>|
| No Intervention: Control group receiving standard care<br>Standard of care: Monthly reminder call and clinic visit | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | 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 | Ongoing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | How many drop out at each monthly time point, who and why | Ongoing | 
| Perceptions of Intervention through a questionnaire | 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). | Once, up to 12 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculosis, Latent Tuberculosis, Texting, Adherence, Medication