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
Columbia University
360 participants
Mar 7, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria3
- Pregnancy
- Prisoners
- Discretion of IOR or clinician
Interventions
Compare the effects of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform.
Locations(1)
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NCT05633056