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

This study is currently recruiting participants.
Verified October 2017 by University of Arizona
Sponsor:
ClinicalTrials.gov Identifier:
NCT02690818
First Posted: February 24, 2016
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Pima County Health Department
American Lung Association
Information provided by (Responsible Party):
University of Arizona
  Purpose
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 Intervention
Latent Tuberculosis Behavioral: Regularly scheduled LTBI medication reminder text messages

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome 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 Outcome 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).


Estimated Enrollment: 40
Study Start Date: April 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Publications:
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT02690818     History of Changes
Other Study ID Numbers: TXT4MED
First Submitted: January 5, 2016
First Posted: February 24, 2016
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