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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 9, 2015
Last verified: March 2015
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 
Overall Participants Analyzed 
[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
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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.

Frequency Threshold
Threshold above which other adverse events are reported   5  

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

Other Adverse Events
    Peer Supporter   Self Administration
Total, other (not including serious) adverse events     
# participants affected / at risk   71/137 (51.82%)   89/137 (64.96%) 
General disorders     
AIDS-Defining Illness †     
# participants affected / at risk   22/137 (16.06%)   31/137 (22.63%) 
# events   28   35 
DAIDS Grade III Event †     
# participants affected / at risk   17/137 (12.41%)   21/137 (15.33%) 
# events   22   25 
New Diagnosis/Worsening Medical Condition †     
# participants affected / at risk   32/137 (23.36%)   37/137 (27.01%) 
# events   39   52 
Events were collected by systematic assessment



  Limitations and Caveats
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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


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