Six months is a lot of time to lie - Anticipated stigma, disclosure and treatment preferences among people with tuberculosis

Sep 30, 2026

Uploaded by Bintang

Exploratory qualitative sub-study within the CLO-FAST trial examined treatment preferences and how disclosure of tuberculosis status influenced acceptability of shorter therapy. Twenty-three participants from India, Malawi, and Zimbabwe completed in-depth interviews after receiving either standard 6-month treatment or a 3-month clofazimine-containing regimen. Themes covered deliberate disclosure, inadvertent disclosure experiences and consequences, and preference impacts. Most favored shorter regimens despite potential skin color change, while anticipated stigma and concerns about potency shaped longer-regimen preference.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages20

Reading Time50 min

AccessFree to download

Study overview

CLO-FAST trial and qualitative methods

Participant themes and findings

University of Zimbabwe-Clinical Trials Research Centre (UZ-CTRC) University of North Carolina Project Johns Hopkins Project, Blantyre Clinical Research Site University of California, San Francisco (UCSF) University of North Carolina Project University of Nebraska Medical Center Harvard T. H. Chan School of Public Health Harvard Medical School Tuberculosis, clofazimine, disclosure, stigma, hyperpigmentation, preferences December 22nd, 2025 [https://doi.org/10.21203/rs.3.rs-8277920/v1](https://doi.org/10.21203/rs.3.rs-8277920/v1) 􀁱 􀅏 This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License No competing interests reported. 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 «eld 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. 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. 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. 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. NCT04311502, registered November 5, 2021. Systematically documenting the preferences of people receiving therapy for TB is an important but overlooked area of TB therapeutic trials. By embedding a qualitative preference study within a trial of TB treatment shortening, we found that: Systematic preference work can be included in large, multi-centered clinical trials for TB; Preferences about treatment duration varied, with up to one in four participants preferring to take a longer regimen that did not cause changes in skin color; Disclosure was an important reason for regimen preference, but it appeared anticipated stigma was a strong preference driver compared with actual experiences of stigma. Every year, ten million people around the world become newly sick with tuberculosis (TB), including 400,000 individuals with drug-resistant forms of disease (DR-TB)1. Treating TB is challenging, as multimonth courses of four to seven medications must be taken daily to achieve non-relapsing cure2. Despite being a treatable and prev

FAQs

What is the purpose of this study?

The study explores acceptability and treatment preferences for shorter tuberculosis regimens, focusing on how anticipated stigma and disclosure of TB status shape participants’ decisions.

How were participants and regimens assigned in the CLO-FAST qualitative sub-study?

Participants selected from the parent CLO-FAST trial were interviewed after receiving either a standard 6-month TB regimen or a 3-month regimen containing clofazimine.

What key themes were identified about disclosure and preferences?

Themes included decisions around deliberate disclosure, experiences with inadvertent disclosure, consequences of inadvertent disclosure, and how inadvertent disclosure affected regimen preferences.

Sep 30, 2026

Uploaded by Bintang