1. Routine Opt-Out HIV Testing in California
December 15, 2015
Karen E. Mark, MD, PhD
Chief, Office of AIDS
California Department of Public Health 1

2. Why routine testing?
50-ish year old heterosexual gentleman immigrated from HIV-endemic country in Africa to US in mid-1980s
On-going medical care in California for thyroid condition
During recent visit back to his home country, seen in hospital for fatigue and weight loss--diagnosed with HIV
Upon return to California, diagnosis confirmed
CD4 ~50
Started on highly active antiretroviral therapy
Died of AIDS ~2 months after diagnosis

3. Source: HIV/AIDS Surveillance, eHARS data as of Dec 23, 2014.
The Big Picture
Source: HIV/AIDS Surveillance, eHARS data as of Dec 23, 2014.

4. Source: HIV/AIDS Surveillance, eHARS data as of Dec 23, 2014
Demographic Characteristics of Persons Living with HIV/AIDS, California, 2013
Gender
Risk Category
Race/Ethnicity
Source: HIV/AIDS Surveillance, eHARS data as of Dec 23, 2014

5. Source: HIV/AIDS Surveillance, eHARS data as of Dec 23, 2014
Demographic Characteristics of Persons Newly Diagnosed with HIV/AIDS, California, 2013
Gender
Risk Category
Race/Ethnicity
Source: HIV/AIDS Surveillance, eHARS data as of Dec 23, 2014

6. Source: HIV/AIDS Surveillance, eHARS data as of Dec 23, 2014
Age Distribution of Newly Diagnosed HIV Infection and Living HIV/AIDS Cases, California, 2013
Source: HIV/AIDS Surveillance, eHARS data as of Dec 23, 2014

7. States with the Highest Number of Diagnosed PLWH ─ 2012
Percent of all diagnosed PLWH in U.S.
New York
129,987
14.3%
California
116,265
12.8%
Florida
99,209
10.9%
Texas
70,814
7.8%
Georgia
38,357
4.2%
Total (all U.S.)
908,071
100%
* Centers for Disease Control and Prevention. HIV Surveillance Report, 2013; vol Published February Accessed 08/14/2015].

8. States with the Highest Number of New HIV Diagnoses ─ 2013
Percent of all new HIV diagnoses in U.S.
Florida
5,200
12.6%
California
4,636
11.2%
Texas
4,306
10.4%
New York
3,583
8.7%
Georgia
1,877
4.5%
Total (all U.S.)
41,287
100%
* Centers for Disease Control and Prevention. HIV Surveillance Report, 2013; vol Published February Accessed 08/14/2015].

9. California in Context: Number of New Diagnoses

10. Office of AIDS Guiding Documents
National HIV/AIDS Strategy (NHAS)
President’s HIV Care Continuum Initiative
California’s Integrated HIV Surveillance, Prevention, and Care Plan
AMY – frame program presentation here. Karen says consider discussing CDC’s high impact prevention.

11. National HIV/AIDS Strategy
Released July 2010 by President Obama with measurable outcomes to achieve by 2015
Updated in July 2015 with updated outcomes to achieve by 2020
Same vision and 4 goals
Updated with key developments since 2010

12. Vision
The United States will become a place where new HIV infections are rare and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity, or socio-economic circumstance, will have unfettered access to high quality, life-extending care, free from stigma and discrimination.

13. CDPH Office of AIDS Goals Aligned with National HIV/AIDS Strategy
Goal 1: Prevent new HIV infections
Goal 2: Increase access to care and improve health outcomes for PLWHA
Goal 3: Reduce HIV/AIDS-related health disparities
Goal 4: Achieve a coordinated response to the HIV epidemic

14. Developments since 2010 Implementation of the Affordable Care Act
Expanded access to preventive services such as HIV testing without a co-pay or deductible
PLWHA can no longer be discriminated against because of their HIV status and are able to purchase insurance
Increased access to comprehensive health coverage through Medi-Cal Expansion and Covered California
HIV Prevention Trials Network (HPTN) 052 and START (Strategic Timing of Antiretroviral Therapy) trials
Early HIV treatment reduces the risk of onward transmission by 96% while simultaneously improving health outcomes

15. Developments since 2010
FDA approval of HIV Pre-Exposure Prophylaxis (PrEP)
One pill a day of emtricitabine/tenofovir (Truvada®) taken consistently reduces risk of HIV acquisition by over 90%
Adoption of new HIV testing technologies that enhance the ability to diagnose HIV soon after infection
Broaden window of opportunity for effective interventions during acute infection, when HIV most likely to be transmitted to others

16. United States Continuum of HIV Care — 2012
Source: CDC.
This slide presents data on four HIV care continuum outcomes: HIV diagnosis (based on data from the National HIV Surveillance System) and receipt of HIV medical care, antiretroviral prescription, and viral suppression (based on data from the Medical Monitoring Project). The denominator is the estimated number of persons aged ≥13 years with diagnosed or undiagnosed HIV infection (prevalence, based on data from NHSS) in the United States.
Of an estimated 1,218,400 persons living with (diagnosed or undiagnosed) HIV infection in the United States at the end of 2012, 87.2% had been diagnosed, 39.1% received medical care, 36.2% were prescribed antiretroviral therapy, and 30.2% achieved viral suppression.
National HIV Surveillance System: Estimated number of persons aged ≥13 years with diagnosed or undiagnosed HIV infection (denominator) who were alive at the end of the specified year. Estimated number of persons aged ≥13 years with diagnosed HIV infection (numerator) who were alive at the end of the specified year; calculated as part of the overall prevalence estimate.
Medical Monitoring Project: Estimated number of persons aged ≥18 years who received HIV medical care January to April of 2012, whose medical record contained documentation of antiretroviral therapy prescription, or whose most recent VL in the previous 12 months was undetectable or <200 copies/mL—United States and Puerto Rico.
National HIV Surveillance System,: Estimated number of persons aged ≥13 years living with diagnosed or undiagnosed HIV infection (prevalence) in the United States at the end of The estimated number of persons with diagnosed HIV infection was calculated as part of the overall prevalence estimate.
Medical Monitoring Project: Estimated number of persons aged ≥18 years who received HIV medical care during January to April of 2012, were prescribed ART, or whose most recent VL in the previous year was undetectable or <200 copies/mL—United States and Puerto Rico.

17. California’s Continuum of HIV Care – 2013

18. Estimated Transmission of HIV at Each Step of the Care Continuum
61%
30%
2.7%
3.3%
2.5%
Skarbinski et al, JAMA Intern Med, 2015

19. California’s HIV Prevention, Care, and Treatment Strategy
Diagnose the undiagnosed — HIV testing
Targeted Testing
Target clients at highest risk for HIV
Transgender, MSM, IDU, HIV+ sex partner, sex workers
Expanded Testing
Universal HIV testing in medical settings, as recommended by USPHS guidelines
Access to clients who may not know they are at risk 19

20. California’s HIV Prevention, Care, and Treatment Strategy
Link high-risk HIV negative persons to cost-effective HIV prevention services
HIV Pre-Exposure Prophylaxis (PrEP) + Condoms
Emtricitabine/tenofovir (Truvada®) 1 tablet taken daily to prevent HIV infection
Over 90% effective when taken consistently
Provide or provide referrals for PrEP!
Clean syringes for injection drug users
Syringe Exchange Programs
Purchase of syringes in pharmacies without a prescription
Physician syringe prescription for disease prevention 20

21. California’s HIV Prevention, Care, and Treatment Strategy
Link HIV infected persons to care and partner services
Support retention and re-engagement in care
Outreach, case management, housing, transportation, treatment adherence, substance abuse and mental health services
Support comprehensive access to life-saving HIV medical care and treatment
AIDS Drug Assistance Program (ADAP)
Office of AIDS Health Insurance Premium Payment (OA- HIPP) Program
Coordination with DHCS (Medi-Cal), Covered California, and other payers 21

22. California’s HIV Prevention, Care, and Treatment Strategy
Reduce viral load for individual and community, resulting in less HIV transmission
For each HIV infection prevented, $338K in lifetime treatment costs averted 22

23. Diagnose the undiagnosed – HIV testing
Targeted Testing
Target clients at highest risk for HIV
Transgender, MSM, IDU, HIV+ sex partner, sex workers
Expanded Testing
Universal HIV testing in medical settings, as recommended by USPHS guidelines
Access to clients who may not know they are at risk 23

24. Benefits of Targeting Testing
To find 1 newly-identified confirmed positive:
Risk Level
Includes:
No. of Tests Necessary
High
Transgender
MSM/IDU
MSM
IDU
HIV+ Sex Partner
Sex Worker 57
Moderate
IDU Partner
MSM Partner
Sex Worker Partner
Syphilis/Gonorrhea Diagnosis
Stimulant User
395
Low
Everyone else*
582

25. New HIV Diagnoses in California by Source of Testing
Per Val, CY 2014 surveillance numbers are preliminary. KP 12/14/15.
Updated with surveillance numbers from Juliana for all of California. Over the 4-year period, OA-funded = 5.3%. (6.6% 4.2% 4.8% 5.6%) [DLS]
Point – OA-funded targeted testing activities are responsible for detecting less than 5% of new diagnoses in California.
LA/SF account for ~50% of newly diagnosed cases.
Increasing emphasis on routine opt-out testing.

26. New HIV Diagnoses in California Prevention-Funded Counties by Source of Testing
Before we discuss goals and outcomes of OA-funded targeted testing, it may be helpful to see how our program fits into the larger picture of HIV testing in the California Project Area. (reference Karen’s previous mention of these data re: all of California.)
As you can see, OA-funded targeted testing contributes a relatively small proportion of the overall number of NICPs found in the CPA. For the CPA (excludes SF and LA, along with low burden LHJs) our surveillance data show around NICPs per year for 2009 – 2012, and OA-funded targeted testing contributes on average about 11% of those.
CPA OA % % % % % %
(FYI, these data come from Kolbi’s analysis of NICPs reported in Surveillance: NICPs Reported to OA Surveillance vs. Identified with OA Prevention Funds.xlsx. (Look in the Support Docs folder)
Please also review Kolbi’s caveats about these data:
1 California Department of Public Health, Office of AIDS, Program Research and Evaluation Section. CY 2009 and 2010 include data entered into LEO and processed as of October 1, CY 2011 and 2012 include data entered into LEO and processed as of September 2, Data have been de-duplicated and represent the number of unique clients. 2 The Program Announcement Code (e.g. PS Category A, PS , etc.) variable was not collected prior to July 1, Therefore, data from this time frame include all OA funded tests, irrespective of program announcement code. Data collected from July 1, 2010 to December 31, 2010 include only tests funded by the CDC prevention funds granted to OA and The data include only tests funded by the CDC prevention funds granted to OA; Category-B funded tests are excluded.

27. CDC Recommendations for Routine Opt-Out HIV Screening in Healthcare Settings
Performed routinely for all patients aged years
All patients initiating treatment for TB
All patients seeking treatment for STDs should be screened routinely for HIV during each visit for a new complaint, regardless of whether the patient is known or suspected to have specific behavior risks for HIV infection

28. United States Preventative Services Task Force: Routine HIV screening in healthcare settings is Grade A
“The USPSTF recommends that clinicians screen for HIV infection in adolescents and adults ages 15 to 65 years. Younger adolescents and older adults who are at increased risk should also be screened.”
Under Affordable Care Act HIV screening must be provided as a clinical preventive service without patient cost sharing
Medi-Cal and Medicare will reimburse for inclusion of HIV screening as a part of a routine visit
Health and Safety Code requires private insurance to reimburse for HIV testing regardless of primary diagnosis

29. Opt Out: California Assembly Bill (AB) 446
On January 1, 2014, AB 446 became law.
Requires all patients who are having blood drawn at a primary care clinic to be offered a HIV test consistent with recommendations of USPSTF
Opt out: Patient can be told that the test is routinely performed but that the patient may decline or defer testing. Assent is assumed unless the patient declines testing.
On January 1st 2014 in support of this recommendation California put into law that each patient who has blood drawn at a primary care clinic must be offered an HIV test.
The following policies and recommendations have put routine opt out HIV screening in a viable position for expanded implementation.
OA supports routine opt-out HIV testing in health care settings as a critical component in identifying unaware HIV positive individuals, triaging patients into care while reducing stigma and normalizing HIV screening.

30. Acute HIV Infection: A Public Health Priority
Very infectious
More frequently diagnosed using new HIV test algorithm
High probability of finding source and spread partners and interrupting chain of HIV transmission

31. HIV Diagnostic Testing Algorithm I
A1: 3rd or 4th generation
HIV-1/2 immunoassay (EIA)
A1(-)
Negative for HIV-1 and HIV-2 antibodies and p24 Ag (if using 4th gen)
A1(+) A2
HIV-1/HIV-2 differentiation immunoassay (Multispot)
HIV-1 +
HIV-2 –
HIV-1 antibodies detected Initiate care (and viral load)
HIV-1 –
HIV HIV-2 antibodies detected Initiate care
(and viral load)
HIV-1 – or Indeterminate or HIV-2 –
HIV-1 +
HIV-2 +
HIV-2 antibodies detected Initiate care
(and viral load)
RNA
RNA+
Acute HIV-1 Infection Initiate care
RNA (–) Negative for HIV-1

32. California Regulatory Changes: Acute HIV Infection
California regulations now permit use of new HIV testing algorithm
By the end of 2016, regulations will require providers and laboratories to report cases of possible or confirmed acute HIV infection to the local health jurisdiction by telephone WITHIN 1 BUSINESS DAY
Allows local health jurisdiction partner services staff to prioritize these cases for rapid linkage to care and partner services 32

33. Testing Objectives 1. Increase testing in healthcare settings
2. Provide HIV positive results
3. Link to patients to care
4. Link to Partner Services & Prevention Services
These objectives are mirrored by the state office of AIDS. Increased screening with commitment to ushering new patients into care will be the most effective way to access individuals that are unaware of their HIV status.
The domestic response to HIV prevention and testing has been historically grounded in community based organizations (CBO), STD clinics and AIDS Service organizations.
While these organizations work tirelessly to reach at risk populations, test and bring individuals into care, while providing specified culturally competent services there continues to be an estimated 6,000 new cases annually throughout California. This figure has plateaued over the passed xxx years.
In order to see a significant decrease of new infection longitudinally over time, we must diversify and expand our practices of how we find those who are HIV infected.
ASOs and CBOs are known in their communities and are accessed by specific populations however, how does the 40 year old women of ….find case examples from Expanded B….or the 18 year old gay male who just began hooking up and thought HIV left with the 90s….
How do we reach them?

34. Number of CA ET HIV Test Events, CY 2012 - 2014

35. Number of CA ET HIV-Positive Test Events by Positive Type, CY 2012 - 2014
Although the number of HIV test events only increased slightly from CY 2013 to CY 2014 (74,304 vs. 75,205), the number of NICPs increased substantially (57 vs. 74).

36. Percent of CA ET Test Events by Gender, CY 2012-2014 (N=199,570)
Overall, nearly two thirds of test events (65 percent) were provided to females during the last ET grant cycle. Males accounted for the bulk of the remaining test events.
Number of HIV Test Events by CY and Gender
CY 2012 (n=49,541): Other/Unknown=60, Transgender=41, Female=32,865, Male=16,575.
CY 2013 (n=74,304): Other/Unknown=11, Transgender=47, Female=49,633, Male=24,613.
CY 2014 (n=75,725): Other/Unknown=10, Transgender=34, Female=47,278, Male=28,403.

37. CA ET HIV Positivity Yield by Gender and Positive Type, CY 2012-2014 (N=199,570)
NICP (n= 181)
Previously-Identified Confirmed HIV-Positive (n= 107)
Preliminary HIV-Positive (n= 14)
Male
0.21% (145)
0.11% (80)
0.02% (11)
Female
0.02% (31)
0.02% (24)
0.00% (3)
Transgender
6.10% (5)
3.66% (3)
0.00% (0)
Although females accounted for nearly two thirds of test events, the female NICP yield (0.02 percent) was far below the CDC NICP yield target of 0.1 percent. The NICP yield for transgender individuals and males exceeded the CDC NICP yield target.

38. Percent of CA ET Test Events by Race/Ethnicity, CY 2012-2014 (N=199,570)
Number of HIV Test Events by CY and Race/Ethnicity
CY 2012 (n=49,541): Other=10,418, White=9,007, Hispanic/Latino(a)=25,646 , Black/African American= 4,470.
CY 2013 (n=74,304): Other=10,728 , White=13,109, Hispanic/Latino(a)=43,964 , Black/African American=6,503.
CY 2014 (n=75,725): Other=10,625 , White=15,737, Hispanic/Latino(a)=42,544, Black/African American=6,819 .
* Includes: Asian, American Indian, Pacific Islanders, Multiple, Other, and Unknown Race/Ethnicity.

39. CA ET Positivity Yield by Race/Ethnicity, CY 2012-2014 (N=199,570)
Number of HIV Positive Test Events by Positive Type and Race/Ethnicity
NICP (n=181): Black/African American=37, Hispanic/Latino(a)=77, White=49, Other=18.
Previously-Identified Confirmed Positive (n=107): Black/African American=24, Hispanic/Latino(a)=41, White=33, Other=9.
Preliminary Positive (n=14): Black/African American=10, Hispanic/Latino(a)=1, White=3, Other=0.
* Includes: Asian, American Indian, Pacific Islanders, Multiple, Other, and Unknown Race/Ethnicity.

40. CA ET NICP Yield (of HIV Test Events), CY 2012-2014
The overall positivity yield (0.09 percent) was approaching the CDC target of 1 percent. When broken down by CY, CY 2013 was the only period for which the CDC target was not met.

41. Percent of CA ET NICP Test Events Where Client Received Result (of NICP Test Events), CY 2012-2014
CDC Goal (85%)

42. Percent of CA ET NICP Test Events Where Client Linked to Care (LTC) Within 90 Days of Receipt of Result (of NICP Test Events Where Client Received Result), CY
CDC Goal (80%)

43. Percent of CA ET NICP Test Events Where Client Interviewed
Percent of CA ET NICP Test Events Where Client Interviewed* for PS Within 30 Days of Receipt of Result (of NICP Test Events Where Client Received Result), CY
CDC Goal (80%)
The CDC’s PS goal is based on a surveillance-based PS model. Traditionally, OA has followed a venue-based PS model. In a surveillance-based model, newly-identified HIV positive clients are entered into a surveillance system. Once in the surveillance system, the case is referred to a PS agency and then assigned to a DIS worker. Once assigned to a DIS worker, the DIS worker contacts the client to offer PS. (The CDC goal of 80% refers to this contact and conversation.) If the client accepts, PS elicitation occurs.
In the venue-based model, the client is offered PS at the venue where testing occurs, and either accepts or rejects the offer at that time. Only clients who “accept” PS are then contacted by a DIS worker to be interviewed for partner elicitation.
Some clients choose only to receive skill-building for self-notification. The CDC’s definition of interview does not include skill-building, which represents the bulk of our PS activities.
* An interview for partner services only includes records for which the client was interviewed for partner elicitation; skill building is not included.

44. Percent of CA ET NICP Test Events Where Client Offered or Accepted Prevention Services (of NICP Test Events Where Client Received Result), CY
CDC Goal (80%)
Prevention services are defined as generally any service or intervention directly aimed at reducing risk for transmitting or acquiring HIV infection (e.g., prevention counseling, DEBIs, risk-reduction counseling). It excludes services that indirectly impact HIV transmission such as mental health services or housing.

45. Acknowledgments Expanded Testing grantees and test sites
Office of AIDS HIV Prevention Staff
Amy Kile-Puente
Matthew Millspaugh
Clark Marshall
Dennese Neal
Jenny Olsen
Kama Brockman
Office of AIDS Prevention Research and Evaluation Staff
Juliana Grant
Deanna Sykes
Kolbi Parrish

46. Percent of CA ET NICP Test Events Where Client Offered and Accepted
Percent of CA ET NICP Test Events Where Client Offered and Accepted* Partner Services (PS) (of NICP Test Events Where Client Received Result), CY
* Offered and accepted partner services includes skill building and partner elicitation.