Actively Recruiting
An Adaptive Randomized Controlled Trial
Led by Columbia University · Updated on 2025-05-04
360
Participants Needed
1
Research Sites
316 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
C
Centre for the AIDS Programme of Research in South Africa
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Adaptive Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Culture or molecular test positive for Mycobacterium tuberculosis (MTB)
- Molecular test positive for HIV or documented HIV positive history
- Drug-susceptibility testing showing at least rifampicin-resistant tuberculosis
- Starting Bedaquiline-containing TB treatment within 4 weeks of enrollment and first-time treated with Bedaquiline
- On or starting antiretroviral therapy (ART) including dolutegravir-containing combination regimen within 4 weeks of enrollment
- Able to provide informed consent in isiZulu or English
You will not qualify if you...
- Pregnancy
- Prisoner status
- Excluded at discretion of Investigator or clinician
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
King DinuZulu Hospital
Durban, KwaZulu-Natal, South Africa, 4001
Actively Recruiting
Research Team
K
Kogieleum Naidoo, Prof
CONTACT
M
Max O'Donnell, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
4
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