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Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

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ClinicalTrials.gov Identifier: NCT00076804
Recruitment Status : Terminated (DSMB stopped trial for futility)
First Posted : February 6, 2004
Results First Posted : July 2, 2010
Last Update Posted : March 27, 2015
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
Dr. Richard Chaisson, Johns Hopkins University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Behavioral: Directly Observed Therapy

  Participant Flow

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

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

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 ]
  Hide Outcome Measure 1

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  

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 
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
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Chi-squared
P Value [4] 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] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  one degree of freedom
[4] 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 ]
  Show Outcome Measure 2

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

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


  Other Adverse Events


  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


  More Information