VDOT for LTBI
Trial question
What is the role of video directly observed therapy to monitor short-course treatment of latent tuberculosis infection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
61.0% female
39.0% male
N = 130
130 patients (79 female, 51 male).
Inclusion criteria: patients with newly diagnosed latent tuberculosis infection agreed to a 3-month treatment regimen with once-weekly isoniazid and rifapentine.
Key exclusion criteria: unwilling to allow access to medical records; incarceration; enrollment in a court-ordered alcohol/drug treatment program; physical or cognitive incapability to use video directly observed therapy.
Interventions
N=68 VDOT (video directly observed therapy).
N=62 DOT (in-person directly observed therapy).
Primary outcome
Treatment completion at 16 weeks
73.5%
69.4%
73.5 %
55.1 %
36.8 %
18.4 %
0.0 %
VDOT
DOT
No significant
difference ↔
No significant difference in treatment completion at 16 weeks (73.5% vs. 69.4%; OR 1.23, 95% CI 0.57 to 2.63).
Secondary outcomes
No significant difference in the rate of completion of 11 doses within 16 weeks (73.5% vs. 72.6%; OR 1.05, 95% CI 0.48 to 2.28).
No significant difference in the rate of completion of 12 doses within 11 weeks (51.5% vs. 43.5%; OR 1.38, 95% CI 0.69 to 2.75).
No significant difference in satisfaction with treatment monitoring (92.1% vs. 86.7%; RR 1.06, 95% CI -1.32 to 3.44).
Conclusion
In patients with newly diagnosed latent tuberculosis infection agreed to a 3-month treatment regimen with once-weekly isoniazid and rifapentine, VDOT was not superior to DOT with respect to treatment completion at 16 weeks.
Reference
Richard S Garfein, Lin Liu, Javier Cepeda et al. Asynchronous Video Directly Observed Therapy to Monitor Short-Course Latent Tuberculosis Infection Treatment: Results of a Randomized Controlled Trial. Open Forum Infect Dis. 2024 Mar 26;11(4):ofae180.
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