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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: April 23, 2012
Last verified: April 2012
History of Changes
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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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 ]
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Measure Type Primary
Measure Title Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment
Measure Description Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat
Time Frame at 12 and 24 months of treatment  
Safety Issue No  

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

Measured Values
    Peer Supporter     Self Administration  
Number of Participants Analyzed  
[units: participants]
 		  136     136  
Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment  
[units: participants]
 		  99     93  


Statistical Analysis 1 for Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.42
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Unadjusted endpoint analyses were conducted on an intention-to-treat basis using all patients enrolled to compare outcomes in the DOT vs. Self-ART arm. For viral load analyses, missing values were considered detectable (missing¼failure analysis). As-treated analyses were also conducted using patients remaining in the study with available data.Crosssectional comparisons between study groups were conducted using two sample t-test,Wilcoxon rank-sum test,chi-squared orFisher’s exact and Kaplan–Meier
[2] Other relevant information, such as adjustments or degrees of freedom:
  one degree of freedom
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Logistic regression analysis & Cox proportional hazards regression analyses were performed to compare outcomes after adjusting for the relevant covariates,including study arm, age, sex, baseline CD4 cell counts and viral load and pill count adherence



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 ]
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3.  Primary:   Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm   [ Time Frame: 12 months ]
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4.  Primary:   Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm   [ Time Frame: 24 months ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  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: April 23, 2012
Health Authority: United States: Federal Government