normalising hiv testing: cdc’s revised recommendations for ... · divisions of hiv/aids...
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Bernard M. Branson, M.D.Associate Director for Laboratory Diagnostics
Divisions of HIV/AIDS PreventionNational Center for HIV, STD, and TB Prevention
Centers for Disease Control and Prevention
Normalising HIV Testing:CDC’s Revised Recommendations forHIV Screening in Health Care Settings
The findings and conclusions in this presentation are those ofthe authors and do not necessarily represent the views of the
Centers for Disease Control and Prevention
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Presentation Outline
Epidemiologic background Current testing Current recommendations and their effects The case for increased HIV testing Considerations for revising recommendations Summary
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Number HIV infected 1,039,000 – 1,185,000
Number unaware of their HIV infection 252,000 - 312,000 (24%-27%)
Estimated new infections 40,000 annually
Awareness of HIV Status amongPersons with HIV, United States
Glynn M, Rhodes P. 2005 HIV Prevention Conference
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HIV Prevalence, NHANES 1999-2002
00.51
1.52
2.53
3.54
4.55
White M
White F
Black M
Black F
Hispanic F
Hispanic M
White M
White F
Black M
Black F
Hispanic M
Hispanic F
Age 18-39 years Age 40-49 years
- McQuillan et al, NCHS: JAIDS April 2006
Pre
vale
nce
of H
IV A
ntib
ody
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Total Tested
HIVPrevalence
No. %
Unrecognized HIV Infection
No. %Age Group (yrs)18-24 410 57 (14) 45 (79)25-29 303 53 (17) 37 (70)30-39 585 171 (29) 83 (49)40-49 367 137 (37) 41 (30) ≥ 50 102 32 (31) 11 (34)Race/EthnicityWhite 616 127 (21) 23 (18)Black 444 206 (46) 139 (67)Hispanic 466 80 (17) 38 (48)Multiracial 86 16 (19) 8 (50)Other 139 18 (13) 9 (50)
Total 1,767 450 (25) 217 (48)
HIV Prevalence and Proportion of Unrecognized HIV InfectionAmong 1,767 MSM, by Age Group and Race/Ethnicity
NHBS, Baltimore, LA, Miami, NYC, San Francisco
MMWR June 24, 2005
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Terminology
Diagnostic testing: HIV testing based on clinical signs orsymptoms
Screening: HIV testing for all persons in a definedpopulation
Targeted testing: offering testing to subgroups at higherrisk based on behavioral, clinical or demographiccharacteristics
Opt-out testing: HIV testing after notifying the patient thatthe test will be done; consent is inferred unless the patientdeclines
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Current Testing
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Source of HIV Tests and Positive Tests
HIV+ tests**HIV tests*
17%44%Private doctor/HMO27%22%Hospital, ED, Outpatient
2%6%5%9%
21%
0.7%Drug treatment clinic0.1%STD clinic0.6%Correctional facility5%HIV counseling/testing9%Community clinic (public)
*National Health Interview Survey, 2002**Suppl. to HIV/AIDS surveillance, 2000-2003
• 38% - 44% of adults age 18-64 have been tested• 16-22 million persons age 18-64 tested annually in U.S.
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Late HIV Testing is CommonSupplement to HIV/AIDS Surveillance, 2000-2003
Among 4,127 persons with AIDS*, 45% were firstdiagnosed HIV-positive within 12 months of AIDSdiagnosis (“late testers”)
Late testers, compared to those tested early (>5yrs before AIDS diagnosis) were more likely to be:• Younger (18-29 yrs)• Heterosexual• Less educated• African American or Hispanic
MMWR June 27, 2003 *16 states
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0%
20%
40%
60%
80%
100%
Illness Self/partnerat risk
Wanted toknow
Routinecheck up
Required Other
Late (Tested < 1 yr before AIDS dx)
Early (Tested >5 yrs before AIDS dx)
Reasons for testing: late versus early testersSupplement to HIV/AIDS Surveillance, 2000-2003
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Current Recommendationsand their Effects
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Recommendations for TestingPregnant Women
Routine, voluntary HIV testing as a part ofprenatal care, as early as possible, for allpregnant women
Simplified pretest counseling
Flexible consent process
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N u m b e r o f c a s e s
0
200
400
600
800
1000
Num
ber o
f cas
es
19861985 1987 1988 1989 1990 1991 1992 19941993 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004
Estimated Number of Perinatally Acquired AIDSCases, by Year of Diagnosis, 1985-2004 – United States
PACTG 076 &USPHS ZDV Recs
~95%reduction
CDCHIV
screeningRecs
Year of Diagnosis
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Existing CDC RecommendationsAdults and Adolescents
Routinely recommend HIV counseling and testingin settings with HIV prevalence >1%
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Recommendations Are Not Having TheirIntended Effect in Acute Care Settings
163,000201,000215,000HIV serology69.6 million69.4 million68.3 millionAge 15-64110 million107 million108 millionED visits
200220012000
Emergency Departments (EDs) account for 10% ofall ambulatory care visits
U.S. National Center for Health StatisticsNational Hospital Ambulatory Medical Care Survey
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Rapid HIV Screening in Acute Care Settings
Cook County ED, Chicago 2.3%Grady ED, Atlanta 2.7%Johns Hopkins ED, Baltimore 3.2%King-Drew Med Center ED, Los Angeles1.3%Inpatients, Boston Medical Center 3.8%
New HIV+Study site
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Existing CDC RecommendationsAdults and Adolescents
Routinely recommend HIV counseling and testingin settings with HIV prevalence >1%
Targeted counseling and testing based on riskassessment
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Characteristics, HIV-Positive PatientsIdentified in ED Screening
42 (51%) No identified risk 3 (4%) High risk hetero partner 8 (10%) IDU30 (34%) MSM
Risk factors47 (57%)No previous testN= 83
- Cook County Bureau of Health Services, 2003
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Existing CDC RecommendationsAdults and Adolescents
Routinely recommend HIV counseling and testingin settings with HIV prevalence >1%
Targeted counseling and testing based on riskassessment
Routinely recommend HIV counseling and testingfor patients seeking treatment for STDs
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HIV Testing Practices in EmergencyDepartments
Survey of 95 Academic EDs
For patients with suspected STDs:– 93% screen for gonorrhea– 88% screen for chlamydia– 58% screen for syphilis– 3% screen for HIV
- Wilson et al, 1999: Am J Emerg Med
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The Case for HIV Screening
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Criteria that Justify Routine Screening
Serious health disorder that can be detectedbefore symptoms develop
Reliable, inexpensive, acceptable screening testTreatment is more beneficial when begun before
symptoms developFacilities for diagnosis and treatment should be
availableCosts of screening are reasonable in relation to
anticipated benefits
-WHO Public Health Paper, 1968Principles and Practice of Screening for Disease
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Making HIV Screening a Routine Part ofMedical Care
Cook County Hospital ED,Chicago, Illinois
Rapid testing since Oct 02• 62% accept HIV testing• 98% receive test results• 3,802 patients screened• 93 (2.4%) new HIV positive• 80% entered HIV care
(median 18 days)
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Rapid HIV Screening in Medical Settings
6 (0.34%)1,763Wisconsin 3 clinics
45 (0.75%)5,994Massachusetts 1 outpatient, 1 inpatient, 1 clinic
84 (1.3%)6,283Alameda County (Oakland) 1 ED
75 (1.1%)6,909Los Angeles 2 clinics, 1 ED
61 (2%)3,039New York City Bronx- Lebanon: 2 clinics, 1 ED
No. (%) HIV+No. testedDemonstration Project
CDC, preliminary data - Dec 2005
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Lessons Learned
• Difficult to obtain separate written consent andprovide counseling, yet still screen the largenumbers of patients in health care settings.
• Sustainability will depend on streamlinedsystems, additional staff, or both.
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Rationale for Revising Recommendations
Many HIV-infected persons access health care butare not tested for HIV until symptomatic
Effective treatment available
Awareness of HIV infection leads to substantialreductions in high-risk sexual behavior
Great deal of experience with HIV testing, includingrapid tests
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Mortality and HAART Use Over TimeHIV Outpatient Study, CDC, 1994-2003
02468
101214
1994 1995 1996 1997 1998 1999 2000 2001 2002 2003
Year
Dea
ths
per 1
00 P
Y
00.10.20.30.40.50.60.70.80.9
Patie
nts
on H
AAR
T
Patients on HAARTDeaths per 100 PY
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Knowledge of HIV Infection and Behavior
Meta-analysis of high-risk sexual behavior in personsaware and unaware they are infected with HIV in the U.S. Marks G, et al. JAIDS. 2005;39:446
After people become aware they are HIV-positive,the prevalence of high-risk sexual behavior isreduced substantially.
Reduction in Unprotected Anal orVaginal Intercourse with HIV-neg partners:HIV-pos Aware vs. HIV-pos Unaware
68%
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Cost Effectiveness
Cost-effectiveness of screening for HIV in theera of HAART. Sanders G, et al. NEJM 2005. “The cost-effectiveness of routine HIV screening in
health care settings, even in relatively low-prevalence populations, is similar to that ofcommonly accepted interventions, and suchprograms should be expanded.”
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Proposed RecommendationsAdults and Adolescents - I
Routine, voluntary HIV screening for all persons 13-64 in health care settings, not based on risk orprevalence
Opt-out HIV testing with the opportunity to askquestions and the option to decline
Include HIV consent with general consent for care;separate signed informed consent is not required
Prevention counseling in conjunction with HIVscreening in health care settings is not required
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Proposed RecommendationsAdults and Adolescents - II
Communicate test results in same manner asother diagnostic/screening tests
Provide clinical HIV care or establish reliablereferral to qualified providers
Repeat HIV screening of persons with knownrisk at least annually
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Proposed RevisionsAdults and Adolescents - III
Intended for all health care settings, includinginpatient services, EDs, urgent care clinics, STDclinics, TB clinics, public health clinics, communityclinics, substance abuse treatment centers,correctional health facilities, primary care settings
Low prevalence settings:• Initiate screening• If HIV prevalence shown to be <0.1%, screening is
no longer be warranted
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Summary
There is an urgent need to increase the proportionof persons who are aware of their HIV-infectionstatus
Expanded, routine, voluntary, opt-out screening inhealth care settings is needed
Such screening is cost-effective Revised recommendations: September 2006