Helping HIV Infected Patients in South Africa Adhere to Drug Regimens

This study has been terminated.

( DSMB stopped trial for futility )

Study NCT00076804 Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

First Received on February 3, 2004. Last Updated on June 1, 2010 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
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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

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

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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2. Primary:

Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load and at 12 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 ]

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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

No publications provided

Responsible Party:	Dr. Richard E. 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:	June 1, 2010
Health Authority:	United States: Federal Government