primary hiv infection: the cdc study pragna patel, md mph medical epidemiologist behavioral and...
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Primary HIV Infection: the CDC study
Pragna Patel, MD MPHMedical Epidemiologist
Behavioral and Clinical Surveillance BranchDHAP, CDC
February 28, 2005
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Background
• Primary HIV infection (PHI)– HIV viral replication and shedding occurs before
detectable antibody appears– Viremia peaks in blood and genital fluid– Contributes to the spread of HIV because
individuals are:• unaware of infection • highly infectious
• Important opportunity for HIV prevention• Studies have used nucleic acid amplification testing
(NAAT) to diagnose PHI
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Background• Quinn et al. [AIDS 2000] - multistage pooling cost-saving
method for HIV RNA detection
• Pilcher et al. [JAMA 2002] – pooled NAAT for PHI diagnosis feasible in a routine testing population and increased sensitivity of HIV detection
• Pilcher et al. – pooled NAAT detects PHI in high-risk populations even relative to more sensitive antibody assays
• Liska et al. – pooled NAAT feasible for PHI diagnosis in high risk populations
• Busch et al. – cost-effectiveness of pooled NAAT in donor screening is low
• Fiscus et al. – pooled NAAT feasible in Africa, however, parallel rapid and p24 antigen testing may detect 80% of PHI cases
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Unanswered questions
• Cost-effectiveness analysis of pooled NAAT relative to 2nd and 3rd generation HIV antibody testing
• Type of specimen: serum vs. plasma
• Size of pools: effect on sensitivity
• Evaluation of pooled NAAT relative to rapid tests in United States
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CDC study: Objectives
Primary objectives:• To assess the feasibility and cost-effectiveness
of pooled NAAT relative to 2nd and 3rd generation HIV antibody assays, rapid tests, and p24 antigen
• To identify PHI and other HIV infections that would otherwise be missed by current testing
• To evaluate the effect of pool size and HIV prevalence on sensitivity of pooled NAAT
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CDC study: ObjectivesSecondary objectives:• To describe the epidemiology of PHI
• To study PHI using epidemiological and molecular approaches to assess transmission correlates and clusters
• To describe the outcomes of partner notification of persons with PHI
• To describe antiretroviral resistance in persons with PHI
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Study Collaborators• Florida Department of Health:
Marlene LaLota, Tony Falvo, Joanna Bentley
• Florida Bureau of Laboratories:Berry Bennett
• Los Angeles Department of Health Services:Peter Kerndt, Lisa Smith, Apurva Uniyal
• New York State Department of Health Wadsworth Center, Diagnostic HIV Laboratory:Judith Wethers, Joe Schwendemann, Tim Sullivan
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MethodsHealth Department: Los AngelesLaboratory: New York State
• Collect specimens from: – 14 STD clinics– STD mobile testing unit – LA Gay and Lesbian Center
• Routine HIV screening performed at LA Public Health Laboratory
• 28,000 specimens for pooled NAAT• Further testing at the NYS lab• 50 persons with PHI
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Methods
Health Department: FloridaLaboratory: Florida
• 4 counties: Hillsborough, Duval, Orange, & Pinellas
• Specimens from public health clinics• All testing at the Florida Public Health
Laboratory in Jacksonville• 39,000 specimens for pooled NAAT• 35 persons with PHI
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Methods• All specimens will be tested with 2nd and 3rd
generation antibody assays• Sero-negative specimens will be pooled for NAAT• NAAT positive specimens will be tested with
rapid tests and p24 antigen• Outcomes:
• Number of persons with PHI identified • Cost-effectiveness of testing strategy:
incremental cost of adding NAAT to antibody screening with either 2nd or 3rd generation EIAs
• Effectiveness of NAAT relative to rapid tests and p24 antigen
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Methods
Sub-study of seroconverters• Persons with PHI followed through
seroconversion – Laboratory documentation of
seroconversion– Antiretroviral resistance testing– Phylogenetic analysis– Interview to assess recent risk behaviors,
factors that may affect seroconversion, and HIV testing history
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Timeline
• Study design, IRB approval – Present to June 2005
• Study enrollment, data collection & analysis– June 2005 to June 2006
• Longitudinal follow-up, data analysis, project close-out – June 2006 to December 2006
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Discussion Points• How can we simultaneously promote rapid
testing and screening for PHI?
• To which type of EIA should public laboratories switch?
• Which is the best HIV RNA test for NAAT screening?
• How do we identify which populations should be screened with NAAT?
• Can laboratories easily incorporate pooled NAAT to standard testing algorithms?