Clinical Trial: Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Arizona

Current Primary Outcome: 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


Original Primary Outcome: Completion of LTBI Treatment [ Time Frame: Once, up to 12 months post-treatment ]

The primary outcome, Completion of LTBI treatment, will be compared between the two study arms at the end of the study follow-up, up to 12 months post-treatment initiation (depending on study regimen, 9 month INH or 4 month RIF). Treatment completion is defined by at least 6 months treatment of daily INH (within 9 months, 180 dose minimum) or 4 months treatment of daily RIF (120 dose minimum).


Current Secondary Outcome:

  • 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).


Original Secondary Outcome:

  • Costs of Intervention [ Time Frame: Once, at the end of 2 Years ]
    Site-specific cost profile of the intervention for the PCHD site will be collected once, at the end of the study (e.g. number of diagnostic tests, number of treatment profiles, personnel hours in FTE, text messaging costs of UA and the clinic if any)
  • 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).


Information By: University of Arizona

Dates:
Date Received: January 5, 2016
Date Started: April 2016
Date Completion: December 2017
Last Updated: August 2, 2016
Last Verified: July 2016