Universal HIV Testing Closing the Gap

1
Universal HIV Testing Closing the Gap

• Peter A. Leone, MD
• Associate Professor of Medicine
• University of North Carolina
• Medical Director,
• NC HIV/STD Prevention and Care, NCDHHS

2
Awareness of HIV Status among Persons with HIV,
United States

• Number Infected
• Number unaware of their HIV infection
• Estimated new infections annually

• 1,039,000-1,185,000
• 252,000-312,000 (24-27)
• 40,000

Glynn M, Rhodes P. 2005 HIV Prevention Conference
3
Source of HIV tests and Positive Tests

• 38-44 of adults 18-64 yrs. have been tested
• 16-22 million aged 18-64 yrs. tested/yr in U.S.
• HIV
  Tests HIV Tests
• Private MD/HMO 44
  17
• Hospital/ED/Outpt. 22
  27
• Public clinics 9
  21
• HIV CT 5
  9
• Correctional facility 0.6
  5
• STD clinics 0.1
  6
• Drug treatment 0.7
  2

National Health Interview Survey,2002 Suppl to
HIV/AIDS surveillance,2000-2003
4
Former CDC Recommendations Adults and Adolescents

• Routinely recommend HIV screening in settings
  with high HIV prevalence (gt1)
• Targeted testing based on risk assessment
• Routinely recommend HIV Testing for all persons
  seeking treatment for STDs
• Annual testing for sexually active MSM

5
Criteria for Targeted screening among 12,038 STD
Clinic patients

• of of
  HIV
• Patients Patients
  Prev
• tested identified
  tested
• Risk factors in 10
  39 7.5
• patients or partners

Sex Transm Dis, 1998
6
Criteria for Targeted screening among 12,038 STD
Clinic patients

• of of
  HIV
• Patients Patients
  Prev
• tested identified
  tested
• Risk factors in 10
  39 7.5
• patients or partners
• Risk factors and all 40
  79 3.8
• Patients gt 30 yrs

Sex Transm Dis, 1998
7
Criteria for Targeted screening among 12,038 STD
Clinic patients

• of of
  HIV
• Patients Patients
  Prev
• tested identified
  tested
• Risk factors in 10
  39 7.5
• patients or partners
• Risk factors and all 40
  79 3.8
• Patients gt 30 yrs
• All patients 100
  100 1.9

Sex Transm Dis, 1998
8
Texas Targeted Opt-In Testing Prior to 1996

• Clients with high risk behaviors ( e.g. MSM,
  IDU,GUD)
• Clients requesting an HIV test
• Separate consent form required

9
Texas Focus Groups

• Pre-test counseling identified as a deterrent to
  HIV testing
• Many thought they were tested and assumed they
  were HIV negative after their STI clinic
  evaluation
• Focus group participants strongly recommended
  making HIV testing routinely part of STI
  screening

10
Texas Law

• Sec. 81.105 requires informed consent
• Sec.81.106 clarifies that general consent is
  sufficient and specific consent form for HIV
  testing is not required

11
Routine Opt-Out Testing Phased Implementation
1996-1997

• All clients tested unless
• Client known HIV
• Recently tested (30-90 days)
• Client declined test
• General consent for all STD service (includes
  HIV testing)

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Reasons for Changing to Opt-out

• 50 of HIV not tested in some STD clinics
• Only 50 of clients accepted opt-in HIV testing
• Routine opt-out testing historical norm for other
  STD screening
• Opportunity for early diagnosis of HIV and screen
  high risk clients

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Results

• opt-in opt-out
  
• N() N()
  change
• STD visits 31,558 34,533 9
• Eligible 19,184(61) 23,686(69) 23
  
• Pre-test 15,038(78) 11,466(48) -24
• Tested 14,927(78) 23,020(97) 54
• Post-test 6,014(40) 4,406(19) -27
• HIV 168(1.1) 268(1.2) 59

Eligible STD Clients Tested 2003-2005 93-96
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New CDC Recommendations for Screening for HIV
infection

• In all health care settings, screening for HIV
  infection should be routinely performed for all
  patients age 13-64
• Providers should initiate screening unless the
  prevalence of undiagnosed HIV infection in the
  patients they serve has been documented to be
  lt0.1.
• All patients initiating treatment for TB should
  be routinely screened for HIV infection
• All patients seeking treatment for STDs,
  including all patients attending STD clinics,
  should be routinely screened for HIV during each
  visit for a new complaint, regardless of whether
  the patient is known or suspected to have
  specific behavioral risks for HIV infection.

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CDC Recommendations

• Diagnostic testing is performing an HIV test
  based on the presence of clinical signs or
  symptoms.
• Screening is performing an HIV test for all
  persons in a defined population.
• Targeted testing is performing HIV screening on
  subgroups of persons at higher risk
• Opt-out screening is performance of an HIV test
  after notifying the patient that the test will be
  done consent is inferred unless the patient
  declines.

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New CDC Recommendations

• In health care settings
• HIV screening is recommended in all health care
  settings, after notifying the patient that
  testing will be done unless the patient declines
  (opt-out screening)
• Persons at high risk for HIV infection should
  be screened for HIV at least annually
• Separate written consent for HIV testing is not
  required. General consent for medical care is
  sufficient to encompass consent for HIV testing
• Prevention counseling need not be conducted in
  conjunction with HIV testing

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Communicating Test Results

• The central goal of HIV screening in health care
  settings is to maximize the number of persons who
  are aware of their HIV infection and receive care
  and prevention services.
• Definitive mechanisms should be established to
  inform patients of their test results.
• Negative test results may be conveyed without
  direct personal contact between the patient and
  provider.
• Persons known to be at high risk for HIV
  infection should also be advised of the need for
  periodic retesting, and offered or referred for
  prevention counseling.

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Changes to NC Administrative Code

• Providers and Laboratories to report HIV/AIDS
  from 7 days to 24 hrs
• Remove the strict requirement for pretest
  counseling
• HIV testing can be a part of a panel of tests
  without a standalone written consent just for HIV
  testing as long as the consent for testing
  specifies that HIV testing is included.

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CHAPTER 41 HEALTH EPIDEMIOLOGYSUBCHAPTER 41A
COMMUNICABLE DISEASE CONTROLSECTION .0200 -
CONTROL MEASURES FOR COMMUNICABLE DISEASES10A
NCAC 41A .0202

• Testing for HIV may be offered as a part of
  routine laboratory testing panels where a single
  consent for all laboratory tests is obtained so
  long as the patient is notified that they are
  being tested for HIV and given the opportunity to
  refuse testing.

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NC Recommendations for HIV Testing

• Opt-out HIV screening for prenatal and STD visits
• Pretest counseling not required
• Post-test counseling required only for positives
• HIV tests at first prenatal visit and 3rd
  trimester
• HIV test at LD for all women for whom HIV status
  is unknown and in infant if test not obtained
  from mother

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Indirect (but compelling) Evidence for Effect in
Averting Vertical Transmission

• In 1st 2 years, 5 acute cases were pregnant women
  
• 4 of all HIV cases at Prenatal/OB testing sites
• 30 of all female acute cases
• All pregnant, acutely HIV infected women received
  urgent counseling and ART. 5/5 infants have been
  delivered uninfected.
• During this same period, 3 of the 6 infants born
  HIV infected in NC were born to mothers who were
  tested and found to be HIV antibody negative
  early in pregnancy.

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Highlights

• Every pregnant woman shall be given HIV pre-test
  counseling, as described in 1510A NCAC 1941A
  .0202(10), by her attending physician as early in
  the pregnancy as possible at her first prenatal
  visit and either in the third trimester or at
  labor and delivery. At the time this counseling
  is provided, and after informed consent is
  obtained, the attending physician shall test the
  pregnant woman for HIV infection, unless the
  pregnant woman refuses the HIV test.
• (15) Testing for HIV may be offered as a part of
  routine laboratory testing panels where a single
  consent for all laboratory tests is obtained so
  long as the patient is notified that they are
  being tested for HIV and given the opportunity to
  refuse testing.

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Further Modification to Routinize HIV testing
in Medical Care Setings

• "Testing for HIV may be offered as a part of
  routine laboratory testing panels where a single
  consent for all laboratory tests is obtained"
• "Testing for HIV may be offered as part of
  routine laboratory testing panels using a general
  consent which is obtained from the patient for
  treatment and routine laboratory testing,so long
  as the patient is notified that they are being
  tested for HIV and given the opportunity to
  refuse testing."

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General Consent Form

• I hereby voluntarily consent to medical
  and/or dental examinations, treatments and
  procedures including HIV testing, laboratory
  tests and x-rays which are deemed necessary in
  the opinion of my physician and health care
  providers selected by my physician. I understand
  that no guarantees or warranties have been made
  to me concerning the results of the examinations,
  treatments or procedures. My signature
  acknowledges that I have been given the
  opportunity to ask questions about this consent
  form.
• I refuse HIV testing ________________________

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Incorporating AHI Screening in STD clinics

• Screen all STD clients for HIV Ab and AHI
• If offering rapid HIV then offer Rapid Test
  Plus
• -Rapid HIV tests can be offered with
  symptom screen
• Problem Which symptoms (fever?)
• What time period (2-4
  wks)?
• What duration ( 3
  days)?
• Symptoms at best will
  detect 40
• - Targeted screening
• Risk based ( i.e. MSM, anal/vaginal
  sex in past 2 weeks,etc )
• Site based ( prevalence 0.5 or
  type STD,CTS, etc.)
• 3. Bottom line- rapid testing and AHI screening
  are not mutually exclusive
• -Need for further research to define
  symptom screen and develop predictive models for
  AHI screening

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Incorporating AHI Screening

• Screen all STD clients for HIV Ab and AHI
• If offering rapid HIV then offer Rapid Test
  Plus
• -Rapid HIV tests can be offered with
  symptom screen
• Problem Which symptoms (fever?)
• What time period (2-4
  wks)?
• What duration ( 3
  days)?
• Symptoms at best will
  detect 40
• - Targeted screening
• Risk based ( i.e. MSM, anal/vaginal
  sex in past 2 weeks,etc )
• Site based ( prevalence 0.5 or
  type STD,CTS, etc.)
• 3. Bottom line- rapid testing and AHI screening
  are not mutually exclusive
• -Need for further research to define
  symptom screen and develop predictive models for
  AHI screening

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Goals

• Universal testing of HIV for individuals 14-64
  years of age
• Opt-out HIV testing in STD and Prenatal settings
• Disconnect pre- and post-test counseling from HIV
  testing itself
• Add second HIV test in pregnancy and mandate HIV
  testing for pregnant women at LD with unknown
  HIV status