Latent TuberculosisTXT4MEDNCT02690818
Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging
A study testing Regularly scheduled LTBI medication reminder text messages in people with Latent Tuberculosis, run by University of Arizona at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis
- What is being tested?
- Regularly scheduled LTBI medication reminder text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 26 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Do not meet inclusion criteria
- Do not consent to study
Trial locations and contacts
1 site in 1 country.
United States1 site
Pima County Health Department
Tucson, Arizona, 85714
About this study
Official title: Promoting Adherence to Treatment for Latent TB Infection Through Mobile Phone 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.
Read the detailed 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.
- Conditions
- Latent Tuberculosis
- Being tested
- Regularly scheduled LTBI medication reminder text messages
- Keywords
- Tuberculosis, Latent Tuberculosis, Texting, Adherence, Medication
- Medical subject headings
- Latent Tuberculosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regularly scheduled LTBI medication reminder text messagesBehavioural
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."
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Regularly scheduled LTBI medication reminder text messages |
| Control group receiving standard care | No intervention | Standard of care: Monthly reminder call and clinic visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Ongoing
Secondary outcomes (2)
Retention
How many drop out at each monthly time point, who and why
Measured: Ongoing
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).
Measured: Once, up to 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startApr 2016
- Primary completion26 Sep 2018
- Study completion26 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Pima County Health Department, American Lung Association
- Responsible party
- Sponsor
- Investigators
- Eyal Oren, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690818
- Sponsor's protocol ID
- TXT4MED
- Acronym
- TXT4MED
- Status last verified
- Apr 2019
- First submitted
- 5 Jan 2016
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28293431
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adherence to Treatment for Latent TB Infection Through Mobile Phone Text Messaging
- ClinicalTrials.gov ID
- NCT02690818
- Acronym / sponsor ID
- TXT4MED / TXT4MED
- Conditions
- Latent Tuberculosis
- Keywords
- Tuberculosis, Latent Tuberculosis, Texting, Adherence, Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Pima County Health Department, American Lung Association
- Study start
- Apr 2016
- Primary completion
- 26 Sep 2018 (actual)
- Study completion
- 26 Sep 2018 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention arm | Experimental | Behavioral: Regularly scheduled LTBI medication reminder text messagesRegularly 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 |
| Control group receiving standard care | No intervention | –Standard of care: Monthly reminder call and clinic visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Do not meet inclusion criteria
- Do not consent to study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regularly scheduled LTBI medication reminder text messagesRegularly 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." | Behavioural | Behavioral intervention arm |
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
2 secondary outcomes
Retention
Time frame: Ongoing
Perceptions of Intervention through a questionnaire
Time frame: Once, up to 12 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Background: PubMed 28293431Oren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Oren, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regularly scheduled LTBI medication reminder text messages in people with Latent Tuberculosis, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02690818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.