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
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Time Frame Adverse Event data was collected throughout the duration of the study. It was assessed at each clinic visit and if the subject presented between visits.
Additional Description 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

Serious Adverse Events
    Peer Supporter     Self Administration  
Total, serious adverse events      
# participants affected / at risk     19/137 (13.87%)     29/137 (21.17%)  
General disorders      
Death    
# participants affected / at risk     9/137 (6.57%)     20/137 (14.60%)  
# events     9     20  
DAIDS Grade IV AE    
# participants affected / at risk     5/137 (3.65%)     2/137 (1.46%)  
# events     5     2  
Hospitalization    
# participants affected / at risk     5/137 (3.65%)     7/137 (5.11%)  
# events     5     7  
Events were collected by systematic assessment




  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Intervention was stopped at 12 months, transition phase did not ensure that participants developed a set of adherence strategies to replace DOT-ART. Low incidence of AIDS-defining illness and death limit our ability to make final conclusions  


Results Point of Contact:  
Name/Title: Richard E. Chaisson
Organization: Johns Hopkins University Center for TB Research
phone: 4109551755
e-mail: rchaiss@jhmi.edu


Publications of Results:

Responsible Party: Dr. Richard Chaisson, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00076804     History of Changes
Other Study ID Numbers: 1R01AI055359-01A1, 1 R01 AI055359-01A1
Study First Received: February 3, 2004
Results First Received: June 1, 2010
Last Updated: March 10, 2014
Health Authority: United States: Federal Government