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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 (ADAP-TIV)
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.
Details
| Lead sponsor | Columbia University |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 360 |
| Start date | 2023-03-07 |
| Completion | 2029-04 |
Conditions
- Multi Drug Resistant Tuberculosis
- HIV Infections
Interventions
- Adherence support intevention
Primary outcomes
- Biological outcome — 06 months
TB culture conversion - Clinical outcome — 12 months
Survival - Biological outcome — 12 months
HIV viral load - Clinical outcome — 12 months
Retention in care - Biological outcome — 12 months
TB culture conversion
Countries
South Africa