Status:
COMPLETED
Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study
Lead Sponsor:
Centre for the AIDS Programme of Research in South Africa
Collaborating Sponsors:
Columbia University
Conditions:
Adherence, Patient
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The goal of the proposed study is to enhance adherence and retention in care for M/XDR-TB HIV patients through enhanced standard of care, targeted transition to outpatient medication self-administrati...
Detailed Description
Tuberculosis (TB) remains the leading cause of morbidity and mortality worldwide among people living with HIV (1). Globally, the incidence of multidrug-resistant tuberculosis (MDR-TB) and extensively ...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- MTB culture positive with at least isoniazid and rifampicin resistance OR Molecular drug susceptibility test confirming resistance to at least isoniazid and rifampicin OR Polymerase chain reaction test (Xpert MTB/RIF) result showing MTB positive and RIF resistance. OR MTB positive with Rifampicin monoresistance
- Initiating treatment for M/XDR-TB which includes Bedaquiline (BDQ) or Moxifloxacin/Levaquin
- Have capacity for informed consent
- HIV Positive Patients: on ART or initiating ART within the following 4 weeks as per clinician recommendation
Exclusion
- Pregnancy
- Prisoners
- Discretion of IOR or clinician
Key Trial Info
Start Date :
April 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2022
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT04032730
Start Date
April 29 2018
End Date
December 5 2022
Last Update
February 8 2023
Active Locations (1)
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1
King Dinuzulu Hospital
Durban, KwaZulu-Natal, South Africa