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An Adaptive Randomized Controlled Trial
Sponsor: Columbia University
Summary
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.
Official title: Adaptive Evaluation of mHealth and Conventional Adherence Support Interventions to Optimize Outcome With New Treatment Regimens for Drug-resistant Tuberculosis and HIV in South Africa
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2023-03-07
Completion Date
2029-04
Last Updated
2025-05-04
Healthy Volunteers
Yes
Interventions
Adherence support intevention
Compare the effects of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform.
Locations (1)
King DinuZulu Hospital
Durban, KwaZulu-Natal, South Africa