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

March 11, 2013
October 10, 2013
June 2013
May 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01810289 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
The "START" (a Streamlined ART Initiation Strategy) Study
The "START" (a Streamlined ART Initiation Strategy) Study

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.

RATIONALE: In Africa, up to a 50-75% of HIV-infected, adults fail to initiate (FTI) ART or encounter delays of months even after eligibility through CD4+ T-cell testing or clinical criteria are established. Recent randomized trials including ACTG Protocol 5164, ACTG 5221, CAMELIA and SAPIT have demonstrated that delays of even weeks in ART initiation increases mortality among patients presenting with active opportunistic infections. Even among those without active infections, mortality among untreated persons with a CD4 < 350 approaches 15/100 person-years - a large proportion of which should be avoidable in patients who have presented to care. New dissemination and implementation strategies that are generalizable across resource-limited settings are needed to address FTI and make the public health approach more effective. The overall goal of the multi-component START strategy is to initiate the greatest number of eligible patients in the shortest amount of time possible, while maintaining safety, efficacy and cost effectiveness.

HYPOTHESIS: The START intervention, a combined intervention using provider education, novel technology and reinforcing feedback, will increase the rapidity and completeness of ART initiation.

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.

STUDY DESIGN: A cluster-randomized, step-wedge trail of 24 clinics operated by the Makerere Joint AIDS Program. Four clinic sites will be randomly assigned to the START at 6-month intervals between month six and 24 during the three-year trial.

PRIMARY OBJECTIVE

1. 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.

SECONDARY OBJECTIVES

  1. Evaluate the effect of START on the incidence of mortality in treatment-eligible, HIV-infected patients.
  2. Evaluate the effect of START on plasma HIV RNA levels one year after treatment eligibility in HIV-infected patients presenting to care in a multi-site, HIV care program.
  3. Evaluate the effect of START on the incidence of vertical transmission in all HIV-infected women who are pregnant at the time they present to care.
  4. To assess the cost-effectiveness of the START intervention.
  5. To evaluate adaptation of START intervention into clinical care through qualitative analysis of counseling interactions and limited interviews with counselors and patients regarding their experience of counseling and identification of content of current counseling activities and how this changes over time.

OUTCOMES: The primary outcome of the study is ART initiation. Secondary outcomes are all-cause mortality, plasma HIV RNA at one year after clinic presentation, vertical transmission events and cost-effectiveness measures.

ANALYTIC PLAN: The analytic approach for the primary outcome consists of estimate of a given HIV-infected individual's probability of initiating ART on a given calendar day conditional on a subject being eligible to initiate on that day (i.e., in the corresponding risk set) and the intervention status of the subject's site on the day of enrollment through Cox proportional hazard models. Analogous approaches will be used to evaluate the effect of the intervention on the cumulative incidence of death one year after eligibility and the fraction of patients with undetectable plasma HIV RNA one year after treatment eligibility (irrespective of whether or when ART was initiated) as well as vertical transmission events among pregnant women.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
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.

Experimental: MJAP Clinics
START
Intervention: Behavioral: START
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
3000
May 2016
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All MJAP-supported clinics in Kampala and Mbarara Districts

Exclusion Criteria:

  • None.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01810289
START-ART
No
University of California, San Francisco
University of California, San Francisco
Not Provided
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
University of California, San Francisco
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP