Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging

Latent Tuberculosis Clinical Trial

— TXT4MED  

Official title:

Promoting Adherence to Treatment for Latent TB Infection Through Mobile Phone Text Messaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690818
• Other study ID #: TXT4MED
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: September 26, 2018

Study information

• Verified date: April 2019
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 26, 2018
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Intervention

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."

Locations

Country	Name	City	State
United States	Pima County Health Department	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
University of Arizona	American Lung Association, Pima County Health Department

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ongoing
Secondary	Retention	How many drop out at each monthly time point, who and why	Ongoing
Secondary	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).	Once, up to 12 months post-treatment