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ADAP Trofile Assay Access Program

Upated May 2009

Program Overview
	VA’s ADAP program offers Trofile tropism testing services to uninsured ADAP clients that meet the exception criteria for Trofile testing, and are being considered for use of the CCR5 entry inhibitor drug maraviroc (Selzentry). Maraviroc is a treatment option for experienced clients experiencing virological failure. The Trofile tropism assay determines if the client’s HIV-1 virus uses the CCR5 receptor to enter the CD4 cell. ADAP clients with Medicare, Medicaid, or private insurance must use that coverage to obtain a Trofile test.
VA ADAP has established Trofile assay sample collection sites in two health districts, see Program Structure and Process section below for list of sample collection sites. Expansion plans include the addition of several independent laboratory collection sites as well as several local health district sites. As additional sites are added to the program, VDH will post that information on the VDH ADAP Trofile website.

Program Overview

VA’s ADAP program offers Trofile tropism testing services to uninsured ADAP clients that meet the exception criteria for Trofile testing, and are being considered for use of the CCR5 entry inhibitor drug maraviroc (Selzentry). Maraviroc is a treatment option for experienced clients experiencing virological failure. The Trofile tropism assay determines if the client’s HIV-1 virus uses the CCR5 receptor to enter the CD4 cell. ADAP clients with Medicare, Medicaid, or private insurance must use that coverage to obtain a Trofile test.

VA ADAP has established Trofile assay sample collection sites in two health districts, see Program Structure and Process section below for list of sample collection sites. Expansion plans include the addition of several independent laboratory collection sites as well as several local health district sites. As additional sites are added to the program, VDH will post that information on the VDH ADAP Trofile website.

Structure & Process
	Please click here for a detailed overview of VA ADAP Trofile program. VDH ADAP Trofile assay access program involves coordination of multiple requirements, including: (1) pre-authorization procedure, (2) selection of collection site and scheduling draw appointment, (3) laboratory collection and initial sample processing, (4) final result reporting, and (5) prescription authorization. Please note: three forms are required: (1) client consent form , (2) ADAP medication/lab exception form. (3) Monogram Test Request form.
	Collection Sites & Procedures:
	Listing of health department collection sites. Listing of LabCorp Patient Service Center Sites (PSC) Please contact Monogram Biosciences at 1-800-777-0177 or the Monogram Biosciences Virology Clinical Consultant, at 1-703-624-8889, for information regarding locations of additional Trofile sample collection site.
	Local Health Department Procedures for LabCorp
	Sample to be drawn at Labcorp Sample collected at local health department to be sent to LabCorp

Educational Materials

Additional Resource

Trofile Assay

Food and Drug Administration announcement: maraviroc (Selzentry)

Questions or comments?

Contact HIV/STD/Viral Hepatitis Hotline

Last Updated: 05-22-2009

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ADAP Trofile Assay Access Program

Upated May 2009

Program Overview

Structure & Process

Collection Sites & Procedures:

Local Health Department Procedures for LabCorp

Educational Materials

Additional Resource