Latent TuberculosisNCT05412212
Brief Educational Video for Patients Prescribed LTBI Treatment
A study testing LTBI video intervention in people with Latent Tuberculosis, run by Kaiser Permanente at 1 site in United States.
Trial summary
Many patients who are prescribed treatment for latent tuberculosis (LTBI) do not complete treatment. Effective interventions that are low-cost and feasible for large-scale implementation are needed to support efforts to eliminate TB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Latent Tuberculosis
- What is being tested?
- LTBI video intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,894 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2022to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active KSPC member
- Age ≥18 years
- Receipt of an LTBI treatment prescription order (medication ID codes listed below)
- Isoniazid: 12199066, 1214000023, 1216000272, 12022505, 12035328, 12035329, 12035330, 12035331, 12035332, 12035333, 12035334, 12035335, 12035336, 12035337, 12015833, 12032230, 12035338, 12035339, 12035340, 12035341, 12035342, 12035343, 12035344, 12035345, 12024985, 12035346, 12181973
- Rifampin: 12199042, 121103412, 1214000029, 1214000030, 1214000340, 1214000565, 1215200240, 1206096, 12017860, 1209060, 12011205, 12015920, 190716, 1902899, 190207268, 190210700, 12189972, 12189977, 12189987
- Isoniazid (see codes above) + Rifampin (see codes above), also: 12032976, 12199041, 12029484, 12189973, 12168828
- Isoniazid (see codes above) + Rifapentine (121100982, 1206442, 12025808, 12188784, 12189978)
- LTBI ICD-10 diagnosis code prior to prescription order: R76.11, R76.12, Z22.7
Who cannot join
- Active TB ICD-10 diagnosis code prior to prescription order: A15, A17, A18, A19
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Southern California Department of Research and Evaluation
Pasadena, California, 91103
About this study
Official title: A Brief Educational Video for Patients Prescribed Latent Tuberculosis Treatment: A Randomized Trial in an Integrated Healthcare Organization in the United States
Many patients who are prescribed treatment for latent tuberculosis (LTBI) do not complete treatment. Effective interventions that are low-cost and feasible for large-scale implementation are needed to support efforts to eliminate TB. The investigators hypothesize that a 3-minute educational LTBI video intervention will improve treatment completion compared to standard care (no intervention).
A randomized trial will be conducted at Kaiser Permanente Southern California, including adults who are prescribed treatment for LTBI, identified using an electronic health record algorithm. At the time of treatment prescription, patients will be randomized to receive the LTBI video intervention or standard care at a ratio of 2 to 1. Those in the intervention group will be sent a secure text message or e-mail with a link to the video. Individuals who watch the LTBI video will be invited to respond to 4 short questions about their perceptions of the video accessibility and content.
Read more
The primary outcome is LTBI treatment completion (dispensation of the required number of doses) in the year following prescription order. Secondary outcomes are LTBI treatment initiation (at least one dispensation) in the year following prescription order; initiation and completion within the year following prescription order stratified by LTBI treatment regimen (if feasible); the proportion of individuals randomized to the intervention group who watched the LTBI video; and the perceptions of those who watched the video.
The primary analysis will be based on intention-to-treat. Characteristics of individuals in the intervention and standard care groups will be described, and rates of LTBI treatment completion will be calculated. To assess the effect of the intervention, Poisson regression with robust standard errors will be used to estimate unadjusted and adjusted rate ratios and 95% confidence intervals. Per-protocol analyses will also be conducted, comparing those in the intervention group who watched the LTBI video to those in the standard care group. Similar methods will be used for secondary analyses.
Assuming the completion rate in the standard care group is 0.5 (based on recent KPSC data), approximately 918 patients will be needed to achieve 80% power with type one error 0.05 to detect an intervention effect of 0.10 in the completion rate between groups. This sample size will be feasible to achieve over the 1 year trial duration.
Read the detailed description
Please see the full protocol for details of the study.
- Conditions
- Latent Tuberculosis
- Being tested
- LTBI video intervention
- Keywords
- adherence, digital health intervention
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTBI video interventionOther
3-minute educational video about latent tuberculosis and importance of taking and completing treatment
| Study group | Role | What they receive |
|---|---|---|
| LTBI video intervention | Experimental | Patients randomized to the intervention group will be sent an invitation with a link to watch a brief (~3 minute video) about the importance of taking and completing LTBI treatment. Receives: Other: LTBI video intervention |
| Standard care | No intervention | Patients who are randomized to receive standard of care will not receive any messages or have any contact with the research team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Completion
Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription
Measured: 1 year after treatment prescription
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start3 Jun 2022
- Primary completion29 Dec 2024
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,894 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412212
- Sponsor's protocol ID
- 12324
- Status last verified
- Mar 2026
- First submitted
- 6 Jun 2022
- Last updated
- 9 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Educational Video for Patients Prescribed Latent Tuberculosis Treatment: A Randomized Trial in an Integrated Healthcare Organization in the United States
- ClinicalTrials.gov ID
- NCT05412212
- Acronym / sponsor ID
- 12324
- Conditions
- Latent Tuberculosis
- Keywords
- adherence, digital health intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,894 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 29 Dec 2024 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Posted 9 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many patients who are prescribed treatment for latent tuberculosis (LTBI) do not complete treatment. Effective interventions that are low-cost and feasible for large-scale implementation are needed to support efforts to eliminate TB. The investigators hypothesize that a 3-minute educational LTBI video intervention will improve treatment completion compared to standard care (no intervention).
A randomized trial will be conducted at Kaiser Permanente Southern California, including adults who are prescribed treatment for LTBI, identified using an electronic health record algorithm. At the time of treatment prescription, patients will be randomized to receive the LTBI video intervention or standard care at a ratio of 2 to 1. Those in the intervention group will be sent a secure text message or e-mail with a link to the video. Individuals who watch the LTBI video will be invited to respond to 4 short questions about their perceptions of the video accessibility and content.
The primary outcome is LTBI treatment completion (dispensation of the required number of doses) in the year following prescription order. Secondary outcomes are LTBI treatment initiation (at least one dispensation) in the year following prescription order; initiation and completion within the year following prescription order stratified by LTBI treatment regimen (if feasible); the proportion of individuals randomized to the intervention group who watched the LTBI video; and the perceptions of those who watched the video.
The primary analysis will be based on intention-to-treat. Characteristics of individuals in the intervention and standard care groups will be described, and rates of LTBI treatment completion will be calculated. To assess the effect of the intervention, Poisson regression with robust standard errors will be used to estimate unadjusted and adjusted rate ratios and 95% confidence intervals. Per-protocol analyses will also be conducted, comparing those in the intervention group who watched the LTBI video to those in the standard care group. Similar methods will be used for secondary analyses.
Assuming the completion rate in the standard care group is 0.5 (based on recent KPSC data), approximately 918 patients will be needed to achieve 80% power with type one error 0.05 to detect an intervention effect of 0.10 in the completion rate between groups. This sample size will be feasible to achieve over the 1 year trial duration.
Detailed description
Please see the full protocol for details of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LTBI video intervention | Experimental | Other: LTBI video interventionPatients randomized to the intervention group will be sent an invitation with a link to watch a brief (~3 minute video) about the importance of taking and completing LTBI treatment. |
| Standard care | No intervention | –Patients who are randomized to receive standard of care will not receive any messages or have any contact with the research team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Active KSPC member
- Age ≥18 years
- Receipt of an LTBI treatment prescription order (medication ID codes listed below)
- LTBI ICD-10 diagnosis code prior to prescription order: R76.11, R76.12, Z22.7
Key exclusion criteria (1 listed)
- Active TB ICD-10 diagnosis code prior to prescription order: A15, A17, A18, A19
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 |
|---|---|---|
| LTBI video intervention3-minute educational video about latent tuberculosis and importance of taking and completing treatment | Other | LTBI video intervention |
Primary outcome
Treatment Completion
Time frame: 1 year after treatment prescription
Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LTBI video intervention in people with Latent Tuberculosis, run by Kaiser Permanente 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 8 inclusion and 1 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 9 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Completion (time frame: 1 year after treatment prescription). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.