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The "START" (a Streamlined ART Initiation Strategy) Study (START-ART)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01810289
First Posted: March 13, 2013
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
Results First Submitted: January 9, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV
Intervention: Behavioral: START

  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
No text entered.

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
Pre-intervention This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
Post-intervention This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.

Participant Flow:   Overall Study
    Pre-intervention   Post-intervention
STARTED   7277   4747 
COMPLETED   7277   4747 
NOT COMPLETED   0   0 



  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.
A patient is considered in pre-intervention group (control) if becoming eligible for ART initiation during a time period prior to the roll out of the intervention at the clinic. A patient is grouped into the intervention if becoming eligible for ART initiation during a time period after the roll out of the intervention at the clinic.

Reporting Groups
  Description
Pre-intervention This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
Post-intervention This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
Total Total of all reporting groups

Baseline Measures
   Pre-intervention   Post-intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 7277   4747   12024 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 31 
 (26 to 38) 
 30 
 (25 to 37) 
 31 
 (26 to 38) 
Gender 
[Units: Participants]
Count of Participants
     
Female      4715  64.8%      2830  59.6%      7545  62.7% 
Male      2562  35.2%      1917  40.4%      4479  37.3% 


  Outcome Measures

1.  Primary:   Evaluate Programmatic Change of START on Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients   [ Time Frame: 3 years ]

2.  Secondary:   Evaluate the Effect of START on the Incidence of Mortality in Treatment-eligible, HIV-infected Patients.   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Evaluate the Effect of START on Retention in HIV Care Among Treatment-eligible, HIV-infected Patients.   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Evaluate the Effect of START on HIV RNA Levels Among Treatment-eligible, HIV-infected Patients   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Evaluate the Effect of START on the Incidence of Vertical Transmission in All HIV-infected Women Who Are Treatment-eligible During the Study Period.   [ Time Frame: 3 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  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
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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.


Results Point of Contact:  
Name/Title: Dr. Elvin Geng
Organization: University of California at San Francisco
phone: 415-476-4082 ext 409
e-mail: elvin.geng@ucsf.edu


Publications of Results:

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01810289     History of Changes
Other Study ID Numbers: START-ART
First Submitted: March 11, 2013
First Posted: March 13, 2013
Results First Submitted: January 9, 2017
Results First Posted: February 27, 2017
Last Update Posted: February 27, 2017