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Completed

NCT Number: NCT02690818

Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging

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.

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Key information

Conditions

Latent Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pima County Health Department

Tucson, Arizona, 85714, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regularly scheduled LTBI medication reminder text messages

Behavioral

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • American Lung Association
  • Pima County Health Department

Registry information

Official study title

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

Acronym: TXT4MED

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 24, 2016
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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