Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

Study Overview
=================
Brief Summary
-----------------
Three or more anti-HIV drugs are taken in combination as part of a treatment regimen. These drug regimens must be closely followed in order to be successful. Having a support person watch a patient take his or her anti-HIV drugs each day may help a patient follow his or her regimen. This study will see if patient-chosen treatment supporters help patients take HIV medicines correctly and improve their health. Study hypothesis: The mean change in CD4 count at 12 and 24 months will be significantly higher in the directly observed therapy-highly active antiretroviral therapy (DOT-HAART) arm as compared to the self-administered arm.

Detailed Description
-----------------
South Africa has one of the worst and fastest growing HIV epidemics in the world. Highly active antiretroviral therapy (HAART) has been shown both at the individual and public health levels to reduce morbidity, mortality, and vertical and possibly horizontal HIV transmission. However, expenses, feasibility, long-term adherence, and effective delivery of HAART remain formidable barriers, particularly in developing nations. Recently, international initiatives have provided hope for widespread use of HAART at affordable cost in sub-Saharan Africa. Simplified, once-daily HAART regimens with directly observed therapy (DOT) may help to achieve high levels of treatment adherence, a key component for long-term viral suppression and treatment success. Peer advocates have been used to improve adherence with medical therapies in a variety of settings. This study will evaluate the effectiveness and feasibility of DOT using patient-nominated peer supervisors to improve adherence to HAART in HIV infected adults in South Africa. Participants will be randomly assigned to either Peer-DOT-HAART or self-administration of a once-daily combination of the Western Cape Province ART program medications for 24 months. Study measures will include CD4 cell count and HIV viral load, adherence questionnaires, genotypic HAART resistance testing, and incidence of new or recurrent opportunistic infections.

Official Title
-----------------
DOT-HAART for HIV-Infected South African Adults

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: Directly Observed Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected Viral load greater than 1000 copies/ml CD4 count of 200 cells/mm3 or less, or World Health Organization Stage 4 disease Living in the area of the study site Had a known address for more than 3 months Willing to nominate a treatment supervisor (a close family member, sexual partner, friend, or community volunteer) to observe daily ingestion of tablets Willing to disclose HIV status to a treatment supervisor and ready to commit to long-term antiretroviral therapy Acceptable methods of contraception Exclusion Criteria: Pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Use of a patient nominated peer supporter who will observe the morning dose of ARVs | Behavioral: Directly Observed Therapy<br>* Use of a patient nominated peer supporter who will observe the morning dose of ARVs<br>|
| No Intervention: 2<br>Self administration of ARVs | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment | Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat | at 12 and 24 months of treatment | 
| Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment | Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT) | 24 months | 
| Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm |  | 12 months | 
| Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Directly Observed Therapy, DOT