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CompletedNCT02690818TXT4MEDUpdated Apr 23, 2019

Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging

An interventional study of Regularly scheduled LTBI medication reminder text messages in Latent Tuberculosis, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-23.

Sponsored by University of Arizona · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Latent Tuberculosis

Keywords

  • Tuberculosis
  • Latent Tuberculosis
  • Texting
  • Adherence
  • Medication
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In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's enrollment of 30 is below the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.

Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Do not meet inclusion criteria
  • Do not consent to study
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • 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

    Behavioral: Regularly scheduled LTBI medication reminder text messages

  • No intervention
    Control group receiving standard care

    Standard of care: Monthly reminder call and clinic visit

Interventions

  • BehavioralRegularly 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."

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Ongoing

Secondary outcomes

  1. Retention

    How many drop out at each monthly time point, who and why

    Time frame: Ongoing

  2. 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).

    Time frame: Once, up to 12 months post-treatment

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Study locations

1 site
  • Pima County Health Department
    Tucson, Arizona 85714, United States
08

References and documents

Publications

  • 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. PubMed 28293431 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02690818
Lead sponsor
University of Arizona
Collaborators
Pima County Health Department, American Lung Association
Responsible party
Sponsor
First posted
Feb 24, 2016
Start date
Apr 2016
Primary completion
Sep 26, 2018
Completion
Sep 26, 2018
Last update
Apr 23, 2019

Study contacts

Eyal Oren, PhD
principal investigator · University of Arizona

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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