The Adult Antiretroviral Treatment and Resistance Study (Tshepo)
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Harvard School of Public Health Harvard School of Public Health (HSPH)
Collaborators:
Botswana Ministry of Health Bristol-Myers Squibb McGill University Health Center McGill University Health Centre/Research Institute of the McGill University Health Centre Princess Marina Hospital, Botswana