NCT05633056Recruiting
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
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 21 Nov 2022
- Start date
- 7 Mar 2023
- Primary completion date
- Apr 2027
- Lead sponsor
- Columbia University
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT05633056
What you commit to
- Study type: Interventional
- Planned participants: 360
- From 7 Mar 2023 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Pregnancy
- Prisoners
- Discretion of IOR or clinician
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King DinuZulu Hospital Coordinator of this site? Confirm its status | Durban | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.