Brief Educational Video for Patients Prescribed LTBI Treatment

NCT05412212 | Active Not Recruiting

• 1 other identifier: 12324
• Study Type: interventional
• Target: 1,898
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Latent Tuberculosis

Keywords

adherence; digital health intervention

Outcome Measures

Primary Outcomes (1)

• Treatment completion

  Proportion of patients prescribed LTBI treatment who complete the treatment within one year of treatment prescription

  1 year after treatment prescription

Secondary Outcomes (6)

• Treatment initiation

  1 year after treatment prescription

• Treatment initiation by treatment regimen

  1 year after treatment prescription

• Treatment completion by treatment regimen

  1 year after treatment prescription

• Video Watch Completion

  1 year after treatment prescription

• Video Accessibility

  1 year after treatment prescription

Study Arms (2)

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.

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.

Interventions

LTBI video intervention OTHER

3-minute educational video about latent tuberculosis and importance of taking and completing treatment

LTBI video intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active TB ICD-10 diagnosis code prior to prescription order: A15, A17, A18, A19

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Southern California Department of Research and Evaluation

Pasadena, California, 91103, United States

Location

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: June 3, 2022
• Primary Completion: December 29, 2024
• Study Completion: December 31, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)