Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197613
Status:
COMPLETED
Last Update Posted:
2012-09-17
First Post:
2005-09-12
Brief Title:
The Adult Antiretroviral Treatment and Resistance Study Tshepo
Sponsor:
Harvard School of Public Health HSPH
Organization:
Harvard School of Public Health HSPH
Study Overview
Official Title:
The Adult Antiretroviral Treatment and Resistance Study Tshepo
Status:
COMPLETED
Status Verified Date:
2012-09
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:
None
Brief Summary:
The Adult Antiretroviral Treatment and Resistance Study hereafter referred to as The Tshepo Study is the first large-scale research study of antiretroviral therapy to treat AIDS and HIV infection in Botswana The Tshepo Study is an open-label randomized study comparing 1 the rate of development and specific types of drug resistance mutations with various antiretroviral combination therapies to HIV-1C the subtype of HIV found in southern Africa and 2 the short and long-term effectiveness of two operational modifications of Directly Observed Therapy DOT medication adherence strategies for antiretroviral therapy Specifically treatment follow-up via the Standard of Care the national standard of care as it evolves in Botswana with intensive clinic-based follow up including regular adherence education sessions will be compared to Community-Based Directly Observed Therapy Com-DOT Com-DOT involves the SOC with added community or family-based DOT This Com-DOT component would involve a trained community or family-based Medication Partner mopati who observes the patient take his or medications daily
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None