Comparing different support methods for treating drug-resistant tuberculosis and HIV in South Africa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a prospective, adaptive, randomized controlled trial designed to evaluate the effectiveness of four different intervention arms aimed at improving treatment adherence in adults with multi-drug resistant tuberculosis (MDR-TB) and HIV. Participants will be randomized into one of the four arms, which include enhanced standard care, psychosocial support, mHealth with electronic dose monitoring, and a combination of mHealth and psychosocial support. The study will utilize a Bayesian adaptive design, allowing for adjustments based on ongoing assessments of treatment support needs. Participants will be followed for six months during the intervention and monitored telephonically until the end of treatment, with a primary outcome assessed at 12 months.

Why it matters

Who can join: the full rules

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

Where it's running

• King DinuZulu Hospital
  Durban, KwaZulu-Natal, South Africa Recruiting

Study contacts

• Principal investigator: Max O'Donnell, MD, MPH — Columbia University
• Study coordinator: Kogieleum Naidoo
• Email: Kogie.Naidoo@caprisa.org
• Phone: +27 31 260 4687

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.