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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01810289
First received: March 11, 2013
Last updated: October 10, 2013
Last verified: October 2013
  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: 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 the programmatic change of START on the cumulative incidence of ART initiation in newly treatment eligible HIV-infected patients receiving care under routine program conditions in a large, multi-site, HIV care program in Uganda [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the effect of START on the incidence of mortality in treatment-eligible, HIV-infected patients. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: June 2013
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All MJAP-supported clinics in Kampala and Mbarara Districts

Exclusion Criteria:

  • None.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01810289     History of Changes
Other Study ID Numbers: START-ART
Study First Received: March 11, 2013
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 14, 2014