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

Primary Purpose

Latent Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regularly scheduled LTBI medication reminder text messages
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Latent Tuberculosis focused on measuring Tuberculosis, Latent Tuberculosis, Texting, Adherence, Medication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pima County Health Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral intervention arm

Control group receiving standard care

Arm Description

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

Standard of care: Monthly reminder call and clinic visit

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2016
Last Updated
April 22, 2019
Sponsor
University of Arizona
Collaborators
Pima County Health Department, American Lung Association
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1. Study Identification

Unique Protocol Identification Number
NCT02690818
Brief Title
Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging
Acronym
TXT4MED
Official Title
Promoting Adherence to Treatment for Latent TB Infection Through Mobile Phone Text Messaging
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
September 26, 2018 (Actual)
Study Completion Date
September 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
Pima County Health Department, American Lung Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis
Keywords
Tuberculosis, Latent Tuberculosis, Texting, Adherence, Medication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral intervention arm
Arm Type
Experimental
Arm Description
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
Arm Title
Control group receiving standard care
Arm Type
No Intervention
Arm Description
Standard of care: Monthly reminder call and clinic visit
Intervention Type
Behavioral
Intervention Name(s)
Regularly scheduled LTBI medication reminder text messages
Intervention Description
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."
Primary Outcome Measure Information:
Title
Recruitment
Description
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 Outcome Measure Information:
Title
Retention
Description
How many drop out at each monthly time point, who and why
Time Frame
Ongoing
Title
Perceptions of Intervention through a questionnaire
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Oren, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pima County Health Department
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85714
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28293431
Citation
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.
Results Reference
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Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging

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