"Six months is a lot of time to lie": Anticipated stigma, disclosure and treatment preferences among participants in a tuberculosis therapeutic trial.

BACKGROUND

Tuberculosis (TB) is a leading cause of morbidity and mortality around the world. TB treatment is complex and clinical research has focused on shortening duration. Understanding patient preferences around treatment shortening is an important field of study, especially is shorter regimens contain drugs that have side effects that are challenging for people receiving treatment. Clofazimine, a drug that can cause skin hyperpigmentation has been proposed as a component of shorter TB treatment regimens. Concerns about hyperpigmentation and its impact on disclosure have been raised as issues that could make such treatment unacceptable.

METHODS

This was an exploratory, qualitative sub-study using in-depth interviews (IDIs) among purposively selected participants in the CLO-FAST trial (NCT04311502). CLO-FAST randomized participants to receive a standard, 6-month TB treatment regimen or a 3-month regimen containing clofazimine. A qualitative, exploratory sub-study of participants in the trial was undertaken to explore treatment preferences. Participants were asked about their experience with their assigned treatment regimen with a focus on disclosure of TB status and preferences for treatment. Data were analyzed by trained qualitative researchers using the theoretical framework of acceptability and the disclosure decision model.

RESULTS

Twenty-three participants from India, Malawi and Zimbabwe were selected from the 89 participants in the parent trial. The major themes that were generated were: 1) decisions around deliberate disclosure; 2) experiences with inadvertent disclosure; 3) consequences of inadvertent disclosure; and 4) the impact of inadvertent disclosure on regimen preferences. Most participants expressed a preference for shorter regimen even if it led to skin color changes. Preferences for a longer regimen seemed to be driven by anticipated concerns around inadvertent disclosure and by a belief that longer regimens were more potent.

CONCLUSIONS

Preference assessment can be successfully built into therapeutic TB trials. Most participants prefer shorter treatment but concerns about potency and skin discoloration were expressed. Additional work is needed to delineate drivers of therapeutic preferences among people with TB.

TRIAL REGISTRATION: NCT04311502, registered November 5, 2021.