1. HIV Counseling, Testing, Partner Notification
Policy and Regulations for New York State
Presented by David Odegaard, MPH
Director of Training and Education, STAR Program, SUNY DMC

2. True or False
Less than 5% of the US population who are infected with HIV do not know they have HIV.

3. True or False
If you go to your primary health care provider for an annual exam that includes blood tests, you automatically get tested for HIV.

4. True or False
Under New York State HIV testing law, you don’t need to consent – just get the test.

5. True or False
If you test positive, your partners are automatically informed by the New York State that they have been exposed to HIV.

6. US HIV Testing Norms: Then and Now
1986
No effective treatment: HIV care centered on case work
Discrimination against those infected: MSM, IDU, immigrants & sex workers
HIV C&T offered to ‘high risk’ patients (shifting from group to behavior)
Dedicated counseling model:
4-5 day training
Certified counselors for enhanced Medicaid reimbursement
2015
Many effective treatments: HIV managed as chronic disease
HIV discrimination reduced & at-risk populations have changed
HIV C&T offered to all patients
Diversified counseling model: physicians, nurses, nurses aides, dentists, social workers, etc 7

7. US HIV Testing Norms: Then and Now
1986
HIV testing only offered at specialty centers
Long counseling sessions, lengthy risk assessments
Two week results turnaround
Partner notification not emphasized
In NYS: C&T regulations limit testing:
mandated counseling
written consent
2014
NYS 2010 Law: Mandate to offer HIV test PC setting, 13-64
Shorter counseling sessions, minimal risk assessment
Rapid testing encouraged in all settings
HIV prevention for HIV patients emphasized
MAY 2014: NO MORE HIV Specific WRITTEN CONSENT 7

8. HIV Exceptionalism: Impact on HIV testing policy and practice
Should HIV be treated differently than other infectious diseases?

9. HIV Exceptionalism: TB and HIV
# of people infected with TB bacilli:
2 billion
# of people infected with HIV
33.3 million

10. HIV Exceptionalism: TB and HIV
# of new TB cases (2007):
# of new HIV cases (2009):

11. HIV Exceptionalism: TB and HIV
# of new TB cases (2007): 9.77 million
# of new HIV cases (2009): 2.6 million

12. HIV Exceptionalism: TB and HIV
# of deaths attributable to TB (2007)
# of deaths attributable to AIDS (2009)

13. HIV Exceptionalism: TB and HIV
# of deaths attributable to TB (2007):
1.77 million
# of deaths attributable to AIDS (2009):
1.8 million

14. TB vs. HIV TB Screening DOT (quarantine)
No separate consent or confidentiality law
Aggressive, mandatory contact tracing
HIV
Targeted testing
Adherence counseling
Separate consent form
Separate confidentiality law
Voluntary partner notification

15. Driving HIV Policy Then: Now:
Protection of civil liberties of people with HIV
Now:
Treatment as prevention

16. According to the CDC, what percentage of people infected with HIV in the U.S. do not know they are infected?
Answer text will appear upon click as indicated in the Discussion Points box.
Now, let’s take a few minutes to consider why it is that we now have new clinical recommendations and laws addressing HIV screening as a routine part of medical care.
According to the CDC, what percentage of people infected with HIV in the U.S. do not know they are infected?
(Ask audience members to guess before clicking for correct answer).
THEN CLICK TO REVEAL ANSWER: About 25%
About 25%

17. HIV Incidence in the U.S.
Slide content appears automatically.
Convey Discussion Points.
Transmission is higher among people unaware of infection
Risk behavior is reduced with awareness of HIV+ status:
68% reduction in unprotected sex
Marks G, Crepaz N, Janssen RS. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA. 1: AIDS Jun 26;20(10):
We also know that HIV transmission rates are higher among people who do not know they are infected; and, people who become aware they are HIV+ substantially reduce their high-risk sexual behavior.
A study by Marks in JAIDS showed that HIV+ patients aware of their diagnosis versus HIV+ patients who were unaware of their diagnosis had a 68% reduction in unprotected anal or vaginal intercourse with HIV-negative partners.

18. Trends in Annual Rates of Death due to the 9 Leading Causes among Persons 25−44 Years Old, United States, 1987−2010
Focusing on persons 25 to 44 years old emphasizes the importance of HIV infection among causes of death. Compared with rates among other age groups, the rate of death due to HIV infection is relatively high in this age group, but rates of death due to other causes are relatively low.
HIV infection was the leading cause of death among persons 25 to 44 years old in 1994 and In 1995, HIV infection caused about 32,000 deaths, or 20% of all deaths in this age group (based on ICD-10 rules for selecting the underlying cause of death). The rank of HIV infection fell to 5th place from 1997 through 2000, and to 6th place from 2001 through In 2010, HIV fell to 7th place and caused about 3,000 deaths, or 2% of all deaths in this age group.
The data for this slide come from death certificate data compiled by the National Center for Health Statistics.
Note: For comparison with data for 1999 and later years, data for 1987−1998 were modified to account
for ICD-10 rules instead of ICD-9 rules.

20. About (area you serve) E.g. perhaps a map here
Demographics of the population
Summary of Key LTSs
E.g. Morbidity/mortality/prevalence/incidence- maybe a graph

23. Key Provisions in NEW New York State Law
Signed into law September
Providers legally mandated to offer HIV testing to all persons ages 13 – 64.
Specific consent for HIV test is still required. Prior to asking for consent to perform HIV test, providers must make seven points of information about HIV available to patients.
Consent for HIV testing can be incorporated into general consent for medical care.
Transition to what’s new about the 2010 HIV testing law by reviewing the 9 key provisions.

24. Key Provisions in Law (cont.)
Consent for the rapid HIV test can be oral
Test providers are legally required to arrange an appointment for follow-up HIV care to all persons who test positive for HIV
HIV information may be released to medical providers & health insurers without a written disclosure statement from patient

25. Required Offer – Where? In these health care settings:
Inpatient department of hospitals
Emergency departments
Primary care services in outpatient departments of hospitals
Primary care services in diagnostic and treatment centers (includes school-based clinics & family planning sites)
The offer of HIV testing must be done in the following facilities OR with the following providers

26. Which Providers are required to offer HIV screening?
Physicians, physician assistants, nurse practitioners, or midwives providing primary care* regardless of setting
*Primary Care means the medical fields of:
family medicine
general pediatrics
primary care
internal medicine
primary care obstetrics/gynecology

27. Required Offer – Exceptions
When the individual is being treated for a life threatening emergency
When the individual has previously been offered or tested for HIV (unless otherwise indicated due to risk factors)
When the individual lacks capacity to consent (and no other person is available to provide consent)
The law does not require an offer of testing to be made when ….
A person DOES NOT NEED TO HAVE RISK FACTORS TO BE OFFERED AN HIV TEST!

28. Offer vs. Testing
The new law mandates the offer of HIV testing only, not testing itself
In NYS, HIV testing remains voluntary and requires the consent of the person to be tested (or someone authorized to consent for that person)
There are some general exceptions to voluntary testing, but these have not changed
Bullet #2: in some instances of occupational exposure, there are exceptions. This will be discussed later.

29. Exceptions to Voluntary HIV Testing
Newborn screening
Blood, body parts, and organ donations
In order to participate in some federal programs, e.g., Job Corps and the Armed Forces
Under certain conditions, inmates in federal prisons (but not in state or local correctional facilities) are tested for HIV without their consent
Sexual assault defendant testing
For certain types of insurance

30. Why Counsel Prior to HIV Testing?
Opportunity to conduct risk assessment with patient.
Assess patient’s readiness to test
(Is it ever an ‘emergency’ to test?)
Prepare patient and clinician for possible positive results.
Opportunity for risk reduction counseling/ behavioral change intervention*
Provide education on treatment
Helps encourage patient to return for results

31. Post-test Counseling HIV post-test messages must be tailored to status
Post-test messages for negative results do not have to be delivered in person
Providers can hand an information sheet or brochure to patients.
Providers may use “Information on Negative HIV Test Results” (in packet) or Part A (available on DOH website) to satisfy negative post-test counseling requirements.

32. Post-Test Messages for Negative Test Result
Negative post-test messages
Describe meaning of the test result
Discuss possibility of HIV exposure during the last three months
Emphasize risks associated with participating in sexual and needle-sharing activities
May want to refer high-risk clients to intensive prevention programs
Emphasize risks associated with participating in high risk behavior – may be done orally or with written material– Refer participants to “Information on Negative HIV Test Results.” Providers may use this document (available on DOH website) to satisfy negative post-test counseling requirements.

33. Post-Test Counseling for Preliminary Positive Test Result
Positive post-test counseling messages must explain that
ELISA (EIA) screening is NOT diagnostic and must be followed up by:
Confirmatory Western Blot test
Explain the timeframe and location for providing the person with a confirmatory HIV test and the result
Ask the individual if he or she understands the meaning of the ELISA antibody test result
Make sure participants understand the difference between preliminary positive HIV test & confirmed positive HIV test.

34. Window Period (time between exposure and reactive test)
How soon after exposure to HIV can tests detect the virus? “First-generation” and “second-generation” HIV antibody can detect antibodies days after infection.
Fourth-generation tests can simultaneously detect both HIV antibodies and antigens. Tests that look for the p24 antigen can detect it within 14-15 days.
Tests can detect plasma HIV RNA (ribonucleic acid) within about 10 days of infection (recommended in ACUTE infection suspicion or preliminary positive infants).

35. Appointments for Confirmed Positive Test Results Key provision #7
The person ordering the HIV test is legally required to provide or arrange follow-up HIV medical care for all persons who test positive
For legal compliance, the individual’s medical record/client file must reflect name of provider/facility with whom follow-up appointment was made.
If client/patient is pregnant, refer to an appropriate health care provider for a discussion of the risks and benefits of antiretroviral therapy to reduce the risk of maternal-child of HIV and may want to discuss risk of HIV transmission though breast feeding

36. HIV Disclosure and Confidentiality

37. Disclosure Practices Have Not Changed
“HIPAA Compliant Authorization for Release of Medical Information and Confidential HIV Related Information,” still to be used to authorize release of HIV-related information
Show participants HIPAA Compliant Authorization for Release of Medical Information and Confidential HIV Related Information in packet

38. Confidentiality case: Setting: 2005, small community-based clinic
A two clinicians discussed a patient’s HIV negative test results in an exam room with an open door.
An HIV positive patient heard them identify the name and reasons for testing of the patient under discussion.
Patient felt he knew who they were discussing.
Patient complained to the administration that he felt confidentiality at this clinic was not respected.
Patient did not return to the clinic and was lost to follow-up.

40. 1988: New York State enacts Public Health Law, Article 27-F
In the historical context of discrimination, New York State passes Public Health Law specific to HIV.
Protects confidentiality of those tested for HIV, exposed to HIV, infected with HIV.
Requires people who take a voluntary test for HIV sign a consent form: the person understands what the test means and agrees to take it.

41. 1988: New York State enacts Public Health Law, Article 27-F (continued)
Requires that information about a person’s HIV status can only be disclosed if the person signs an HIV release form (with noted exceptions).
Applies to individuals and facilities that provide health and social services to people with HIV or testing for HIV.

42. HIV/AIDS STIGMA
“HIV/AIDS stigma is manifested through discrimination and social ostracism directed against individuals with HIV and AIDS, against groups of people perceived to be or likely to be infected, and against those individuals, groups, and communities with whom these individuals interact.”
Source: Herek, G.M., & Capitanio, J.P Symbolic prejudice or fear of infection?
A functional analysis of AIDS-related stigma among heterosexual adults. Basic Applied Social Psychology, 20(3),

43. Challenges to HIV Confidentiality in New York State
1997: Mandatory unblinding of newborn heelsticks for HIV antibodies (effectively discloses HIV status of all pregnant women)
1997: Nushawn Williams case: 20 yo male infects 16 females with HIV, 9 of whom are from Chautauqua County, NY
2000: Partner notification and mandatory HIV names reporting law enacted

44. Is HIV confidentiality necessary?
Era of HIV exceptionalism over?
HIPPA covers all medical record confidentiality, including HIV
In minority ethnic and rural populations, HIV stigma is thought to be higher than urban MSM communities
Stigma remains: confidentiality law remains.

45. ACTG 076 Reducing Perinatal HIV Transmission
Large randomized double-blind placebo-controlled study
Tested a 3 part regimen of AZT
Orally to 180 women starting at weeks gestation throughout pregnancy
IV during labor and delivery
Orally to infants for 6 weeks
184 women were given placebo

46. ACTG 076 Results Transmission in placebo group= 25.5 %
Transmission in AZT group= 7.6 %
Two thirds reduction in transmission
Findings highly significant

47. When does Mother to Child Transmission Occur?
In utero 25-40%
Intrapartum 60-70%
Breastfeeding: Additional 12-14% risk, highest in the first weeks of life
As this slide illustrates, the majority of mother to child HIV transmissions occur during labor and delivery (60-70%), therefore it is absolutely vital to know the mother’s HIV status prior to labor and delivery. Ideally, there will be a copy of the mother’s HIV test result in her prenatal record. However, if a woman shows up at a facility in labor, with no HIV test result on file, finding out her HIV status as soon as possible will provide the optimal opportunity for clinical treatment to prevent (and lower the risk) of transmission to her infant.

48. Point out that most participants would be familiar with this data from the previous training titled Reducing Perinatal Transmission of HIV. This data was used as the rationale for the existing Maternal-Child Prevention and Care Program, in particular the expedited testing regulations. It demonstrates that the rate of transmission is directly related to early initiation of AZT in accordance with clinical guidelines. It shows that there is a clear clinical benefit to initiating AZT during labor and within 48 hours of birth even if the woman did not receive AZT prenatally.
These data, from August – January 31, were published in the NEJM on Nov 12, 1998 and validated data was published in the same journal on April 1, 1999.
The next slide provides more data about the infants who received AZT within 48 hours and it helps to clarify the importance of starting AZT well before 48 hours after birth.

49. Expedited Testing (ET) Program
Prenatal HIV testing status of all mothers is assessed on admission to site for delivery
If mother’s HIV status is unknown, improperly documented, or undocumented, you must offer expedited testing
(informed consent is required to test the mother)

50. Expedited Testing
If the mother declines test, baby is tested immediately after birth (no consent required)
HIV testing of infant is also done as part of Newborn Screening panel.

51. New York State Expedited Testing Regulations
Effective November 1, 2003
Screening test result must be returned ASAP, and must be received no later than 12 hrs after:
Mother consents to testing
Birth of baby
All preliminary positive results must be reported to DOH regardless of confirmatory result
Key point on this slide:
DOH regulations have changed the time period within which the screening test result must be returned. Old regulations required that the results be returned no later than 48 hrs, revised regulations require that results be received no later than 12 hrs. after the mother consents to testing (intrapartum) or 12 hours from the infant’s birth.
Point out clearly and repeatedly that the goal is to make the test result available in time to offer intrapartum therapy. 12 hours is to be considered the outside limit of availability, not the goal. 12 hour turn around does allow initiation of therapy for the infant in time to result in reduction of transmission rate (9.5) but the goal is to also be able to offer intrapartum therapy which has been shown to reduce the rate to 5.3%.
Note: If Participants have questions regarding the processes for reporting preliminary positive results, refer them to the handout titled Maternal-Pediatric HIV Prevention and Care Program Test History and Assessment form (DOH-4068) and Maternal-Pediatric HIV Prevention and Care Program, Report on Preliminary Positive HIV Test Results (DOH-4159).

52. Primary HIV Infection: Pathogenesis
CD4 Cell Count (cells/mm³)
Symptoms
Plasma RNA Viral Load
1,000
CD4 Cell Count
500
4-8 Weeks
Up to 12 Years
2-3 Years

53. Acute HIV Infection (AHI)
High infectious stage: high viremia. Amplification of transmission with co-existing STIs
Risk of further transmission if diagnosis is missed
Enhanced case finding: Partner Notification and sexual network interventions can lead to more AHI cases or undiagnosed established infections
Public health approach: Screening among high risk populations irrespective of the presence or absence of symptoms
Clinical approach: diagnosis in clinical setting focusing on symptoms and history

54. Planned Public Health Response for detection and f/u of AHI in Pregnancy
Intensify efforts to engage high-risk pregnant women in prenatal care
Educate prenatal providers about acute HIV infection during pregnancy
Advise immediate HIV RNA (viral load) and antibody testing for pregnant woman with symptoms of acute HIV infection
Recommend routine second HIV antibody / 4th generation antigen test in third trimester (resistance to this idea in low seroprevalence areas)
AI Guidelines
“It is important to use both a plasma HIV RNA assay and antibody testing to establish the diagnosis. . . Three available assays to measure plasma HIV RNA include the RT-PCR (Roche Amplicor HIV-1 Monitor and Roche Amplicor HIV-1 Ultrasensitive), the bDNA (branched Chain DNA), and the NASBA (Nucleic Acid Sequence-Based Assay).

55. NYS Partner Notification Regulations
Doctors are required to discuss with HIV-infected patients about their options of letting sexual and needle sharing partners know that they may have been exposed to HIV.
Known contacts of the index case must be reported to the NYSDOH on the required form.

56. Options for Partner Notification
Notification conducted by public health staff from PNAP/CNAP with patient consent (maybe conducted anonymously; requires identifying information.)
Assisted Notification (clinic provider/counselor and/or CNAP notifies partner)
Self-notification (Verification? NYCDOH may f/u)
Non-consented notification of a partner by physician or authorized NP or PA.

57. Options for Partner Notification Using CNAP
CNAP: NYCDOH Contact Notification Assistance Program for NYC providers
PNAP: PartNer Assistance Program for the rest of New York State
CNAP can answer provider’s questions and offer suggestions for specific cases of partner notification.

58. Options for Partner Notification Using CNAP
CNAP can meet HIV + patients to counsel them how to notify partners.
CNAP can meet HIV + patients with partner and assist in notification
CNAP can notify partners without revealing patient’s name or any identifying information.

59. Options for Partner Notification Using CNAP: Anonymous Notification Procedures
Provider or client can call CNAP directly. (If client calls, HIV status is verified).
CNAP counselor obtains identifying information about partner(s).
CNAP counselor informs partner of potential exposure to HIV and provides referrals without revealing name of client. (Counselor does not know client’s name/info.)

60. Options for Partner Notification Non-consensual Notification
Article 27-F NYS Public Health law (unchanged by new regulations).
Physician concludes that notification is medically appropriate and contact has significant risk of infection.
All options have been explored yet provider feels the notification has not occurred.
Physicians have the discretion-but not the legal duty-to notify partner without consent. Name of the index case is not revealed.
Domestic violence screening has occurred.
PAs and NPs may be authorized.
Patient given choice between provider or CNAP to make disclosure; index case’s name will not be revealed.

61. Case from Primary Care Clinic
John has been a HIV patient in the clinic for years; everyone at the clinic thinks he has girlfriend, Marie, who also comes to the clinic.
John’s doctor asked if he has told his girlfriend about his HIV status.
He says that he does not have a girlfriend. He says that Marie is just his friend.
Marie becomes pregnant.
When she is asked to get tested for HIV as part of prenatal care, she refuses. She acknowledges that John is the father.