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Study identifier: NCT05633056 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

An Adaptive Randomized Controlled Trial

Condition: Multi Drug Resistant Tuberculosis · HIV Infections  ·  Sponsor: Columbia University

PhaseNA
Planned participants360
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersYes

About this study

This is a prospective, adaptive, randomized controlled trial comparing the effectiveness of 4 intervention arms on a combined endpoint in adults with confirmed MDR-TB HIV initiating Bedaquiline-containing MDR-TB treatment regimens and on ART (integrase strand transfer inhibitor (INSTI)-based fixed dose combination therapy) in KwaZulu-Natal, South Africa. Interventions arms include: enhanced standard of care; psychosocial support; mHealth using cellular-enabled electronic dose monitoring; combined mHealth psychosocial support. Level of support will be adjusted using a differentiated service delivery (DSD)- informed assessment of treatment support needs.

This description comes directly from the study's public registry record.

Talk to the study team

Kogieleum Naidoo  ·  +27 31 260 4687  ·  Kogie.Naidoo@caprisa.org

Max O'Donnell, MD, MPH  ·  mo2130@columbia.edu

Always discuss trial participation with your own doctor first.

Locations (1)

King DinuZulu HospitalDurban, KwaZulu-Natal, South AfricaRecruiting

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Source record: clinicaltrials.gov/study/NCT05633056