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Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

This study has been terminated.
(DSMB stopped trial for futility)
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
Dr. Richard Chaisson, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00076804
First received: February 3, 2004
Last updated: March 10, 2014
Last verified: March 2014
Results First Received: June 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Behavioral: Directly Observed Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study site was a public sector ART clinic at the GF Jooste Hospital, a secondary level facility in Cape Town, Western Cape province of South Africa, serving several peri-urban townships. Enrollment began February 13, 2005, and ended on July 7, 2007, with the last follow-up occurring on July 25, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Peer Supporter Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
Self Administration Self administration of ARVs

Participant Flow:   Overall Study
    Peer Supporter     Self Administration  
STARTED     137     137  
COMPLETED     77 [1]   68 [2]
NOT COMPLETED     60     69  
Death                 9                 20  
Lost to Follow-up                 9                 9  
Withdrawal by Subject                 10                 8  
Early study Closure                 32                 32  
[1] 111 completed week 48, 77 completed week 96.
[2] 102 completed week 48, 68 completed week 96



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Peer Supporter Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
Self Administration Self administration of ARVs
Total Total of all reporting groups

Baseline Measures
    Peer Supporter     Self Administration     Total  
Number of Participants  
[units: participants]
  137     137     274  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     134     136     270  
>=65 years     3     1     4  
Age  
[units: years]
Mean ± Standard Deviation
  35.7  ± 9.7     36.7  ± 9.2     36.2  ± 9.1  
Gender  
[units: participants]
     
Female     79     79     158  
Male     58     58     116  
Region of Enrollment  
[units: participants]
     
South Africa     137     137     274  



  Outcome Measures
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1.  Primary:   Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment   [ Time Frame: at 12 and 24 months of treatment ]

2.  Primary:   Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment   [ Time Frame: 24 months ]

3.  Primary:   Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm   [ Time Frame: 12 months ]

4.  Primary:   Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm   [ Time Frame: 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  More Information