Ignite Creation Date:
2024-05-06 @ 1:29 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04032730
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2018-08-29
Brief Title:
Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study
Sponsor:
Centre for the AIDS Programme of Research in South Africa
Organization:
Centre for the AIDS Programme of Research in South Africa
Study Overview
Official Title:
Promoting Engagement in the Drug Resistant TB-HIV Care Continuum in South Africa PRAXIS Study PRospective Study of Adherence in MXDR-TB Implementation Science Aim 2
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRAXIS
Brief Summary:
The goal of the proposed study is to enhance adherence and retention in care for MXDR-TB HIV patients through enhanced standard of care targeted transition to outpatient medication self-administration prior to hospital discharge and use of community adherence groups with an overarching goal of promoting patient engagement in a care continuum
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 drug resistant tuberculosis XDR-TB the most drug-resistant forms of TB has approximately doubled over the past fifteen years 1-3 Nowhere has this increased incidence generated more concern than in South Africa where interactions between TB and generalized HIV epidemics are causing explosive TB incidence 4-6 and case-fatality are threatening to undermine the progress reached with antiretroviral therapy ART 7 8
Medication adherence a key predictor of outcomes in MXDR-TB and HIV treatment is understudied in high burden TB-HIV settings 9-11 Patient losses during transitions in the care continuum are frequent 12 increase mortality and limit control of the linked epidemics Demands of MXDR-TB HIV treatment are severe including extraordinary pill burden severe adverse effects lengthy treatment isolation and stigma with few parallels in modern medicine 13-15
Medication adherence a key predictor of outcomes in MXDR-TB and HIV treatment is understudied in high burden TB-HIV settings 9-11 Patient losses during transitions in the care continuum are frequent 12 increase mortality and limit control of the linked epidemics Demands of MXDR-TB HIV treatment are severe including extraordinary pill burden severe adverse effects lengthy treatment isolation and stigma with few parallels in modern medicine 13-15
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None