CCTG 593

Design

CCTG 593 is a project to evaluate the uptake and effectiveness of an Active Linkage, Engagement, and Retention to Treatment (ALERT) specialist serving to 1) link newly diagnosed, HIV infected persons from HIV testing sites to HIV specialist providers, and 2) link confirmed HIV antibody negative persons with continued high risk behavior to pre-exposure prophylaxis (PrEP) centers.


Duration

Each subject who agrees to linkage received ALERT follow-up until successful linkage or 60 days following enrollment for linkage to care or 90 days following enrollment for linkage to PrEP, whichever comes first. The duration of the 593 project was for 3.5 years or until all subjects had been enrolled and either successfully linked, or 60 days pass for linkage to care or 90 days pass for linkage to PrEP.


Sample Size

Up to 600 subjects were tested and offered linkage across all CCTG sites:  LA County-USC Medical Center (LAC+USC), Harbor-UCLA/Long Beach Health Department (LB), UCSD/San Diego County Health Department (SD). 


Eligibility Criteria

Eligible subjects included any persons 18 years of age or older who have been tested for HIV at one of the CCTG testing sites (LAC+USC, LB, SD). 


Stratification

The randomization was stratified based on clinic site.


Intervention

The intervention consists of the ALERT specialist facilitating linkage of 1) newly diagnosed HIV+ individuals and 2) HIV antibody negative individuals with high-risk behaviors to the appropriate care site. The ALERT specialist established a relationship with the patient, scheduled follow up appointments with the appropriate linkage facility, shared important health system information, instituted phone calls on a scheduled basis, and tracked and provided consented feedback between the health care provider and the original referring testing site.


Outcomes

The CCTG 593 primary outcome will measure the effectiveness of the linkage program, which is defined as the proportion of individuals who, after either testing a) HIV positive will successfully be linked to care, or b) HIV antibody negative will successfully be linked to PrEP services by the ALERT specialist within 90 days of enrollment. Secondary outcomes will be performed at participating sites only and will measure the acceptance of the linkage program, which is defined as those individuals who, after testing either HIV positive or HIV antibody negative, will agree to be contacted by the ALERT specialist.