Evidence map›Paper›PMID 42445209›Full record

ArticleIJTLD open2026

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

F Mugodhi, C Kanyama, F Makiya, J Metcalfe, C Potani, K K Scarsi, I Weir, J Furin, A5362/CLO-FAST study team

Registry-linked trialAbstract read
In one paragraph

Article in IJTLD open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04311502 (A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04311502 phase2terminatednot on this map

A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2021 to 2025Enrolled104ConditionsHIV, TuberculosisArmsRifapentine, Rifampicin, Isoniazid, Pyrazinamide, Ethambutol
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

F MugodhiUniversity of Zimbabwe-Clinical Trials Research Centre (UZ-CTRC), Harare, Zimbabwe.
C KanyamaUniversity of North Carolina Project, Lilongwe, Malawi.
F MakiyaJohns Hopkins Project, Blantyre Clinical Research Site, Blantyre, Malawi.
J MetcalfeDivision of Pulmonary and Critical Care Medicine, San Francisco General Hospital and Trauma Center, University of California, San Francisco (UCSF), CA, USA.
C PotaniUniversity of North Carolina Project, Lilongwe, Malawi.
K K ScarsiCollege of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA.
I WeirCenter for Biostatistics in AIDS Research in the Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
J FurinDepartment of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.
A5362/CLO-FAST study team

Funding

Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Northwestern University Clinical Trial UnitUM1AI069471 · NIAID · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Chad J Achenbach · 2012 to 2026
$24.6M
NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI069471
6 · The paper itself

Abstract

backgroundTB 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.

methodsWe 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.

resultsTwenty-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.

conclusionPreference 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.

Indexed as

clinical trialclofaziminehyperpigmentationNCT04311502preferencesstigmatuberculosis

Identifiers

PMID42445209
PMCPMC13362207

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.