An Adaptive Randomized Controlled Trial

Launched by COLUMBIA UNIVERSITY · Nov 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how effective different types of support can be for adults with both multi-drug resistant tuberculosis (MDR-TB) and HIV. Participants will be given a treatment that includes Bedaquiline, a medication for MDR-TB, while also receiving antiretroviral therapy (ART) for HIV. The trial will compare four different approaches: standard medical care, psychosocial support (which helps with emotional and social aspects), mobile health technology that tracks medication use, and a combination of mobile health and psychosocial support. The goal is to find out which method helps patients the most during their treatment.

To participate in this trial, individuals must be adults aged 18 and older who have tested positive for both MDR-TB and HIV, and who are starting treatment soon. They should be able to give informed consent and will be excluded if they are pregnant or incarcerated. Participants can expect to receive support tailored to their needs, and their level of help may be adjusted based on what they require throughout the study. This trial is currently recruiting participants in KwaZulu-Natal, South Africa.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Culture or molecular test positive for MTB
• • 2. Molecular test positive for HIV or a documented HIV positive history
• • 3. Drug-susceptibility testing by molecular (i.e. GeneXpert MTB/RIF) or conventional testing consistent with at least rifampicin-resistant TB,
• • 4. Initiating treatment with a Bedaquiline -containing TB regimen within 4 weeks of enrollment and first-time being treated with BDQ
• • 5. 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,
• • 6. Capacity for informed consent in either isiZulu or English
• Exclusion Criteria:
• • 1. Pregnancy
• • 2. Prisoners
• • 3. Discretion of IOR or clinician