N/A
N=12,024
The "START" (a Streamlined ART Initiation Strategy) Study
HIV
Bottom Line
View on ClinicalTrials.gov: NCT01810289 ↗Enrolled (actual)
12,024
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients — 2585; 3753 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- START (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Aug 2016
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. |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- All MJAP-supported clinics in Kampala and Mbarara Districts
Exclusion Criteria
- None.
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.