An Adaptive Randomized Controlled Trial (NCT05633056) | Clinical Trial Compass
RecruitingNot Applicable
An Adaptive Randomized Controlled Trial
South Africa360 participantsStarted 2023-03-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Culture or molecular test positive for MTB
. Molecular test positive for HIV or a documented HIV positive history
. Drug-susceptibility testing by molecular (i.e. GeneXpert MTB/RIF) or conventional testing consistent with at least rifampicin-resistant TB,
. Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ
. On treatment with Antiretroviral Therapy (ART) regimen, including dolutegravir-containing combination Antiretroviral Therapy regimen (i.e. Tenofovir-Lamivudine-Dolutergravir), or starting within 4 weeks of enrollment,
. Capacity for informed consent in either isiZulu or English
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'Phase NA' — can you help me understand what that means for how much is already known about the safety and effectiveness of the treatments being tested, and how that affects whether this might be right for me?
2Since this trial is studying both multi-drug resistant tuberculosis and HIV together, and I may have one or both of these conditions, can you walk me through how my specific situation fits with what this study is actually looking at?
3The trial is measuring both biological outcomes — like lab results — and clinical outcomes, such as how I'm feeling or recovering — so what does that mean in practice for how closely I'd be monitored, and how often would I need to come in?
4Because this is an adaptive randomized controlled trial, the treatment I receive could change as the study progresses — can you explain how that works and what it would mean for my care if I were assigned to a different treatment arm mid-study?
5Before we talk about enrolling in this trial, is there a standard treatment option for drug-resistant TB or HIV that I should consider first, and how does that compare to what this study is testing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.