RecruitingNot ApplicableNCT05633056

An Adaptive Randomized Controlled Trial

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

Sponsor

Columbia University

Enrollment

360 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

HIV Infections Multi Drug Resistant Tuberculosis

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests new treatment combinations for people who have both tuberculosis (TB) that is resistant to standard antibiotics and HIV. It aims to find faster, more effective ways to treat drug-resistant TB in HIV-positive patients. **You may be eligible if...** - You have tested positive for TB (confirmed by culture or molecular test) - You are HIV-positive - Your TB strain is resistant to at least rifampicin (a key TB antibiotic), confirmed by testing - You are about to start treatment for drug-resistant TB **You may NOT be eligible if...** - You do not have drug-resistant TB - You are not HIV-positive - You have already started treatment for this current episode of TB Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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