The Adult Antiretroviral Treatment and Resistance Study (Tshepo)

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.

Conditions

• AIDS
• HIV Infection

Interventions

DRUG

(A) zidovudine, lamivudine and nevirapine

DRUG

(B) zidovudine, lamivudine and efavirenz

DRUG

(C) zidovudine, didanosine, and nevirapine

DRUG

(D) zidovudine, didanosine, and efavirenz

DRUG

(E) stavudine, lamivudine, and nevirapine

DRUG

(F) stavudine, lamivudine and efavirenz

PROCEDURE

Adherence Strategy Standard of Care (SOC)

PROCEDURE

Adherence Strategy Community-Based DOT

Sponsors & Collaborators

• Princess Marina Hospital, Botswana

  collaborator UNKNOWN

• Botswana Ministry of Health

  collaborator OTHER_GOV

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  collaborator OTHER

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Harvard School of Public Health (HSPH)

  lead OTHER

Principal Investigators

• Richard Marlink, MD · Harvard School of Public Health AIDS Initiative

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-12-31

Completion

2007-12-31

Countries

• Botswana

Study Locations