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An Adaptive Randomized Controlled Trial

ConditionsMulti Drug Resistant TuberculosisHIV Infections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Prisoners

Discretion of IOR or clinician

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adherence support intevention

    Behavioral

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

Treatment groups

360 Participants
are divided into 4 treatment groups
Group A: Enhanced standard of careNo intervention 0 interventions
Group B: Psychosocial supportOther 1 intervention
Group C: mHealthOther 1 intervention
Group D: mHealth and Psychosocial supportOther 1 intervention

Trial outcomes

Primary outcomes

1

Biological outcome

TB culture conversion

Time frame
06 months
2

Clinical outcome

Survival

Time frame
12 months
3

Biological outcome

HIV viral load

Time frame
12 months
4

Clinical outcome

Retention in care

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Columbia University

Lead sponsor

Centre for the AIDS Programme of Research in South Africa

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov
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