Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging

NCT ID: NCT02690818

Last Updated: 2019-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-09-26

Brief Summary

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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

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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.

Conditions

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Latent Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Regularly scheduled LTBI medication reminder text messages

Intervention Type 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."

Control group receiving standard care

Standard of care: Monthly reminder call and clinic visit

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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."

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* Do not consent to study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pima County Health Department

UNKNOWN

Sponsor Role collaborator

American Lung Association

OTHER

Sponsor Role collaborator

University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eyal Oren, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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Pima County Health Department

Tucson, Arizona, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28293431 (View on PubMed)

Other Identifiers

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TXT4MED

Identifier Type: -

Identifier Source: org_study_id

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