The "START" (a Streamlined ART Initiation Strategy) Study (START-ART)
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|ClinicalTrials.gov Identifier: NCT01810289|
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : February 27, 2017
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: START||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12024 participants|
|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)|
|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|
Experimental: MJAP Clinics Intervention
START intervention. This is a stepped wedge design so each clinic will experience both conditions.
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.
- 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.
- 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.
- 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.
- 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.
- Incidence of Vertical Transmission in All HIV-infected Women Who Are Treatment-eligible During the Study Period. [ Time Frame: 3 years ]
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
|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|