Characterizing Tuberculosis Medication Side Effects Using Video Directly Observed Therapy Monitoring in Uganda: Opportunities for Digital Pharmacovigilance
Abstract
Abstract Background Monitoring medication-related side effects is essential to tuberculosis (TB) pharmacovigilance, yet remains challenging in resource-limited settings. Video directly observed therapy (VDOT) offers an opportunity to capture patient-reported side effects in real time. This study characterized TB medication side effects reported through VDOT. Methods We conducted a secondary analysis of 68 adults treated for drug-susceptible TB in a randomized VDOT trial in Kampala, Uganda, during 2020–2021. Side effects were recorded longitudinally through the VDOT platform. A severity-weighted burden score was developed from reporting frequency and severity, and latent class analysis identified burden subgroups. Results Median age was 30 years; 50% were female and 31% were living with HIV. The most frequent side effects were joint/body pain (84%), body weakness (79%), and red/discolored urine (68%). Higher burden scores were observed among participants aged > 30 years (p = 0.030), people living with HIV (p = 0.023), smokers (p = 0.023), and those with lower TB knowledge (p = 0.033). Two subgroups emerged: High (66.2%) and Low Burden (33.8%). Conclusions VDOT enabled longitudinal monitoring of medication-related side effects and revealed substantial variation in burden, along with associated factors. VDOT shows promise as a digital pharmacovigilance tool supporting patient-centered TB care. Future studies should evaluate its integration into routine TB programs.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 68 participants or records.
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