NCT03162107|Completed
Promoting Engagement in the Drug Resistant TB/HIV Care Continuum in South Africa
PRAXIS
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PRAXIS
Sponsor study identifier
observational
199
1 country
1
Study Start
December 2016
Actual (reported)Primary Completion
January 10, 2020
Actual (reported)Study Completion
August 16, 2021
Actual (reported)The goals of this research are to understand adherence and retention in care for multi-and extensively drug-resistant tuberculosis (M/XDR-TB) patients using a mixed methods approach.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 16, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2016
Actual (reported)March 24, 2017
Actual (reported)May 22, 2017
Actual (reported)January 10, 2020
Actual (reported)August 16, 2021
Actual (reported)Medication adherence based on electronic monitoring
An electronic monitoring system (e.g., Wisepill technologies) will be used to measure adherence to antiretroviral therapy and treatment of multi- and extremely-drug resistant tuberculosis.
6 months
Medication adherence based on self-report
6 months
Sociomedical risk factors associated with six-month adherence to ART or TB medications
6 months
Adult patients with newly diagnosed active pulmonary multi- and extremely-drug resistance tuberculosis (M/XDR-TB) (≥ 18 years old), admitted for routine care at King DinuZulu Hospital in Durban, South Africa will be approached for enrollment. Only patients with capacity for consent will be included in the study. Healthcare workers will be approached for participation in focus group discussions.
King Dinuzulu Hospital
Durban, KwaZulu-Natal, South Africa
Bateman M, Wolf A, Chimukangara B, Brust JCM, Lessells R, Amico R, Boodhram R, Singh N, Orrell C, Friedland G, Naidoo K, Padayatchi N, O'Donnell MR. Adherence Measured Using Electronic Dose Monitoring is Associated with Emergent Antiretroviral Resistance and Poor Outcomes in People with Human Immunodeficiency Virus/AIDS and Multidrug-Resistant Tuberculosis. Clin Infect Dis. 2022 Oct 29;75(9):1489-1496. doi: 10.1093/cid/ciac232.
Hair samples PBMCs TB Isolates
Nesri Padayatchi, MBChB
Centre for the AIDS Programme of Research in South Africa
199 participants (actual enrollment reported by the registry).
First Submitted
March 24, 2017
First Posted
May 22, 2017
Study Start
December 2016
Actual (reported)Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia
Contact the study team to confirm eligibility.
Primary Completion
January 10, 2020
Actual (reported)Study Completion
August 16, 2021
Actual (reported)Last Updated
July 20, 2022
Record last verified: 2022-07
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Source: ClinicalTrials.gov.
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