N/A Completed N=12,024 Randomized Treatment

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

HIV

Source: ClinicalTrials.gov NCT01810289 ↗

Enrolled (actual)

12,024

Serious AEs

0.0%

Results posted

Feb 2017

Primary outcomePrimary: Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients — 2585; 3753 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients	2585; 3753	—
SECONDARY Incidence of Mortality in Treatment-eligible, HIV-infected Patients.	3; 2	—
SECONDARY Retention in HIV Care Among Treatment-eligible, HIV-infected Patients.	84; 84	—
SECONDARY HIV RNA Levels Among Treatment-eligible, HIV-infected Patients One Year Following ART Eligibility	58; 66	—
SECONDARY Incidence of Vertical Transmission in All HIV-infected Women Who Are Treatment-eligible During the Study Period.	—	—

Eligibility Criteria

Inclusion Criteria

All MJAP-supported clinics in Kampala and Mbarara Districts

Exclusion Criteria

None.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01810289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.