RecruitingNANCT05633056

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

ConditionMulti Drug Resistant Tuberculosis, HIV Infections
InterventionAdherence support intevention
PhaseNA
StatusRecruiting
Participants360
Est. Completion1 Apr 2027
Last Updated28 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

South Africa
View Registry Entry

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