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Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging (TXT4MED)

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ClinicalTrials.gov Identifier: NCT02690818
Recruitment Status : Recruiting
First Posted : February 24, 2016
Last Update Posted : October 27, 2017
Sponsor:
Collaborators:
Pima County Health Department
American Lung Association
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Latent Tuberculosis Behavioral: Regularly scheduled LTBI medication reminder text messages Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Promoting Adherence to Treatment for Latent TB Infection Through Mobile Phone Text Messaging
Study Start Date : April 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Arm Intervention/treatment
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
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."
No Intervention: Control group receiving standard care
Standard of care: Monthly reminder call and clinic visit



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Retention [ Time Frame: Ongoing ]
    How many drop out at each monthly time point, who and why

  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02690818


Contacts
Contact: Eyal Oren, PhD (520) 626-7008 eoren@email.arizona.edu
Contact: Erika Barrett, MPH barrette@email.arizona.edu

Locations
United States, Arizona
Pima County Health Department Recruiting
Tucson, Arizona, United States, 85714
Contact: Eyal Oren, PhD         
Sponsors and Collaborators
University of Arizona
Pima County Health Department
American Lung Association
Investigators
Principal Investigator: Eyal Oren, PhD University of Arizona

Publications:
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT02690818     History of Changes
Other Study ID Numbers: TXT4MED
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Arizona:
Tuberculosis
Latent Tuberculosis
Texting
Adherence
Medication

Additional relevant MeSH terms:
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections