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

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.
 
ClinicalTrials.gov Identifier: NCT01810289
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : February 27, 2017
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Behavioral: START Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12024 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Clinic level stepped wedge design where each clinic has an amount of time in the pre-intervention or standard of care condition and then crosses over in the intervention condition
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The "START" (a Streamlined ART Initiation Strategy) Study
Study Start Date : April 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: MJAP Clinics Intervention
START intervention. This is a stepped wedge design so each clinic will experience both conditions.
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.


No Intervention: MJAP Clinics Pre-Intervention
Standard of care. This is a stepped wedge design so each clinic will experience both conditions.



Primary Outcome Measures :
  1. Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients [ Time Frame: 14 days ]
    Patients may be ART eligible at the start of the study or become ART eligible for the first time in the 3 year time frame.


Secondary Outcome Measures :
  1. Incidence of Mortality in Treatment-eligible, HIV-infected Patients. [ Time Frame: 1 years ]
    We ascertained mortality in the subgroup of those selected for HIV RNA assessment. Vital status is not reliably reported in program data. Assessment was 1 year after ART eligibility.

  2. Retention in HIV Care Among Treatment-eligible, HIV-infected Patients. [ Time Frame: 1 years ]
    Retention was operationalized as the proportion of appointments made within 7 days within one year after ART eligibility.

  3. HIV RNA Levels Among Treatment-eligible, HIV-infected Patients One Year Following ART Eligibility [ Time Frame: 1 year ]
    Due to financial constraints, HIV RNA was measured in a random sample of patients to asses virologic suppression.

  4. Incidence of Vertical Transmission in All HIV-infected Women Who Are Treatment-eligible During the Study Period. [ Time Frame: 3 years ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • All MJAP-supported clinics in Kampala and Mbarara Districts

Exclusion Criteria:

  • None.

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
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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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01810289    
Other Study ID Numbers: START-ART
First Posted: March 13, 2013    Key Record Dates
Results First Posted: February 27, 2017
Last Update Posted: November 7, 2018
Last Verified: November 2018
Keywords provided by University of California, San Francisco:
HIV, ART, CD4