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An Adaptive Randomized Controlled Trial

NCT05633056 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-05-04

No results posted yet for this study

Summary

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.

Conditions

  • Multi Drug Resistant Tuberculosis
  • HIV Infections

Interventions

BEHAVIORAL

Adherence support intevention

Compare the effects of adherence support interventions on clinical and biological endpoints using an adaptive randomized platform.

Sponsors & Collaborators

  • Centre for the AIDS Programme of Research in South Africa

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Max O'Donnell, Prof · University of Columbia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-07
Primary Completion
2027-04-30
Completion
2029-04-30

Countries

  • South Africa

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05633056 on ClinicalTrials.gov