An exploratory, qualitative study of treatment preferences among participants in a TB therapeutic trial

Background: TB is a leading cause of morbidity and mortality, and TB treatment shortening is a focus of TB therapeutic trials. Clofazimine (CFZ) has been proposed as part of a shorter TB regimen but the drug causes skin hyperpigmentation. Patient preferences around shorter regimens with CFZ should be documented.

Methods: We performed an exploratory, qualitative sub-study using in-depth interviews among purposively selected participants in the CLO-FAST trial (NCT04311502). Participants were asked about their experience with their assigned treatment regimen and about preferences for treatment. Data were analysed by trained qualitative researchers using the theoretical framework of acceptability.

Results: Twenty-three participants from India, Malawi, and Zimbabwe were selected from 89 participants randomised to two study arms in the parent trial. Most participants expressed preference for shorter regimen even if it led to skin hyperpigmentation. Preferences for a longer regimen may have been influenced by anticipated concerns around inadvertent disclosure and by a belief that longer regimens were more potent.

Conclusion: Preference assessment can be successfully built into therapeutic TB trials. Most participants preferred shorter treatment but concerns about potency and skin discolouration were expressed. Additional work is needed to describe therapeutic preferences among people with TB.