NCT02690818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2018

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2.5 years

First QC Date

January 5, 2016

Last Update Submit

April 22, 2019

Conditions

Keywords

TuberculosisLatent TuberculosisTextingAdherenceMedication

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Retention

    Ongoing

  • Perceptions of Intervention through a questionnaire

    Once, up to 12 months post-treatment

Study Arms (2)

Behavioral intervention arm

EXPERIMENTAL

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

Behavioral: Regularly scheduled LTBI medication reminder text messages

Control group receiving standard care

NO INTERVENTION

Standard of care: Monthly reminder call and clinic visit

Interventions

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."

Behavioral intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Do not consent to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pima County Health Department

Tucson, Arizona, 85714, United States

Location

Related 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.

    PMID: 28293431BACKGROUND

MeSH Terms

Conditions

Latent TuberculosisTuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Study Officials

  • Eyal Oren, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

February 24, 2016

Study Start

April 1, 2016

Primary Completion

September 26, 2018

Study Completion

September 26, 2018

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations