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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
  Purpose
START is clinic-level (not individual-patient) intervention to catalyze the process of ART initiation among HIV-infected adults who meet CD4-based criteria for combination ART (e.g., adults with a CD4 T cell level < 350/ul). The three START components are: (1) real-time point-of-care CD4 testing using the Alere PIMA platform to ascertain treatment eligibility in real time at first presentation to care, (2) targeted knowledge transfer (i.e., dissemination) of recent scientific evidence regarding effects rapid ART initiation on survival to front line health care workers; and 3) feedback and reporting to clinic and providers. There three components represent empirically validated steps in the PRECEED implementation model.

Condition Intervention
HIV Behavioral: START

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The "START" (a Streamlined ART Initiation Strategy) Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Evaluate the Effect of START on the Incidence of Mortality in Treatment-eligible, HIV-infected Patients. [ Time Frame: 3 years ]
  • Evaluate the Effect of START on Retention in HIV Care Among Treatment-eligible, HIV-infected Patients. [ Time Frame: 3 years ]
  • Evaluate the Effect of START on HIV RNA Levels Among Treatment-eligible, HIV-infected Patients [ Time Frame: 3 years ]
  • 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 ]

Enrollment: 12024
Study Start Date: April 2013
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MJAP Clinics
START
Behavioral: START

INTERVENTION: START is clinic-level (not individual-patient) intervention to catalyze the process of ART initiation among HIV-infected adults who meet CD4-based criteria for combination ART (e.g., adults with a CD4 T cell level < 350/ul). The three START components are: (1) real-time point-of-care CD4 testing using the Alere PIMA platform to ascertain treatment eligibility in real time at first presentation to care, (2)targeted knowledge transfer(i.e., dissemination) of recent scientific evidence regarding effects rapid ART initiation on survival to front line health care workers; and 3)feedback and reporting to clinic and providers. There three components represent empirically validated steps in the PRECEED implementation model.

This intervention will be implemented at all Makerere Joint AIDS Program (MJAP) clinics in Kampala and Mbarara districts in a step-wedge design.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All MJAP-supported clinics in Kampala and Mbarara Districts

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810289


Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Diane V Havlir, MD University of California, San Francisco
Principal Investigator: Moses Kamya, MB.Ch.B Makerere University
Principal Investigator: Elvin Geng, MD, MPH University of California, San Francisco
  More Information

Publications:
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
Last Verified: January 2017

Keywords provided by University of California, San Francisco:
HIV, ART, CD4