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
Trial Details
| Condition | Multi Drug Resistant Tuberculosis, HIV Infections |
| Intervention | Adherence support intevention |
| Phase | NA |
| Status | Recruiting |
| Participants | 360 |
| Est. Completion | 1 Apr 2027 |
| Last Updated | 28 May 2026 |
Primary Outcome
Biological outcome; Clinical outcome; Biological outcome; Clinical outcome; Biological outcome
Eligibility Criteria
Inclusion 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
Trial Sites
Countries
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