Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging

Not Applicable

Completed

• Conditions: Latent Tuberculosis
• Interventions: Behavioral: Regularly scheduled LTBI medication reminder text messages

• Registration Number: NCT02690818
• Lead Sponsor: University of Arizona

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-24
• Study Start: 2016-04
• Primary Completion: 2018-09-26
• Study Completion: 2018-09-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-22
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral intervention arm	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." Standard of care: Monthly reminder call and clinic visit

Primary Outcome Measures

Name	Time	Method
Recruitment	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 Outcome Measures

Name	Time	Method
Retention	Ongoing	How many drop out at each monthly time point, who and why
Perceptions of Intervention through a questionnaire	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).

Trial Locations

Locations (1)

Pima County Health Department; 🇺🇸 Tucson, Arizona, United States