Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
This study has been terminated.
(DSMB stopped trial for futility)
Sponsor:
Johns Hopkins University
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
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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
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 | |
|---|---|---|---|
|
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
Show All 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 |
| 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 method 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 ] |
| 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 ] |
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 |