The document discusses the FOCUS program's efforts to implement universal HIV and hepatitis C testing in the UCSD emergency departments. Over 15 months, 13,817 patients were tested for HIV, identifying 47 positives and linking 30 of 33 new diagnoses to care. A one-month HCV pilot screened 970 patients, identifying 90 antibody positives and linking 13 of 29 RNA-positive patients to care. The FOCUS team aims to expand HIV and HCV testing, screening 13,000 patients annually for each virus and linking over 90% of new diagnoses to care. Challenges include complex patient disclosures, false positive HIV tests, and ensuring patients understand results and are successfully linked to ongoing medical care.

2. UNIVERSAL HIV AND HEPATITIS C TESTING
IN THE UCSD EMERGENCY DEPARTMENTS:
IT TAKES A SMALL VILLAGE
Jill Blumenthal, Martin Hoenigl, George Lara-Paez, Miriam Zuazo
HIGH Rounds
1/18/19

3. Disclosures
• The FOCUS Program is funded by Gilead Sciences
• Salary support for all team members

4. Outline
• Background
• Program Overview
• Enrollment
• Outcomes
• Unexpected Pitfalls and Lessons Learned
• Future Directions

5. FOCUS Background: a Public Health Program
2010 20132006 2015
CDC releases
HIV testing
guidelines
recommending
routine screening
for everyone aged
13-64 years old
20142012
Developing a model for large scale HIV and HCV screening
FOCUS program
initiated in 3
counties to develop
a systems change
approach that
embodies best
practices in HIV
screening and
linkage to care
300k HIV tests
in 10 counties
encompassing
the regions
most impacted
by HIV
900k HIV tests
in 11 counties
FOCUS begins
integration of
HCV testing
into expansion
of program
2.2M HIV tests &
300k HCV tests
in 21 counties
with routine
screening
program
CDC releases HCV
testing guidelines
recommending Baby
Boomer birth cohort
(born 1945-1965) be
tested at least once
20172016
Projected:
3M HIV tests &
1M HCV tests
in 45 counties
with routine
screening
program

6. Model for Routine Screening: TEST
• Using a systems change approach to integrate routine HIV screening and linkage
to care in healthcare systems, FOCUS’ innovative partnerships successfully
developed a model for routine screening, TEST: Four Pillars of Routine
Screening, which is now being successfully replicated for HCV.

7. 3.2M HIV Tests since 2010, 880K HCV Tests Since 2014
354 Abstracts
accepted at major
conferences
41 Journal Articles
published in peer-
reviewed journals
Dissemination by
FOCUS Partners
165 Current Partnerships
in 65 Cities/Counties
*As of Mar. 2017
**Other includes health departments,
substance use, training, and corrections.
Hospital
(45%)
Community
/Other**
(22%)
Community
Health
Center
(33%)
2010 2011 2012 2013 2014 20162015
24K HIV+, 26K HCV RNA+ Identified
Through Testing
0.7% HIV Seropositivity
6.0% HCV Ab Seropositivity
Strategic Expansion Driven by Opioid Epidemic
and Unmet Need
79% HIV Median LTC
65% HCV Median LTC
2016:
74 New Partners
39 New Cities/Counties
New FOCUS Cities/Counties in
2016Existing FOCUS Cities/Counties (Dec.
2015)Planned Expansion Cities
HCVHIV
FOCUS | Q4 2016

8. MEETING PATIENTS WHERE THEYARE
Kern
San Bernardino
Riverside
Los
Angeles
San
Diego
Orange
Ventura
Imperial
San Luis
Obispo
Santa
Barbara
Current Partnerships Partnerships in Solicitation

9. Southern CA Partners to Date

10. FOCUS: SOUTHERN CALIFORNIA
101K HCV Ab Tests, 2.3K Ab+ and 1K RNA+
diagnosis since 2014
*As of Q1 2/2017
.8% seropositivity
49 Acutes
2.6% RNA
Seropositivity
338K HIV tests and 2.5K positives
diagnosed since 2010
HIV: 338,461 TESTS AND 2,563 POSITIVES (.8%), 49 ACUTES DIAGNOSIS SINCE 2010
HCV: 101,142 HCV Ab TESTS, 2,381 Ab+ (2.6%) and 1K RNA+ (52%) DIAGNOSIS SINCE 2014
HBV: 649 TESTS AND 27 POSITIVES (4% ) SINCE 2016
HCV AB Seropositivity By Site Type HCV LTC
• SoCal FOCUS Partners are linking patients to specialists
for first appointments
• Linkage to care best practices emerging , including for
high risk patients with multiple co-morbidities
• UCLA = 122 patients linked, 90% HCV ALTC
• Venice Family Clinic = 126 patients linked, 79%
HCV LTC
• FHCSD = 40 patients linked, 68% HCV ALTC

11. FOCUS UCSD Program Year 1 (1)
Between July 2017 And October 2018:
HIV Opt-Out Testing for 15 months
q HIV tests at UCSD EDs = 13,817 (eligible patients
[aged 13 -64])
q HIV positives identified through testing: 47
q New HIV diagnoses identified: 33
q HIV LTC (first appointment): 30/33 (90%)

12. FOCUS UCSD Program Year 1 (2)
Between July 2017 And October 2018:
HIV Opt-Out Testing for 15 months
q Emphasis also on Relinkage of Known out of Care
(> 12 months) Positives
q 91 known positives out of care identified
q 42/91 (46%) relinked to care; another 33 still pending
first appointment

13. FOCUS UCSD Program Year 1 (3)
q March-April 2018: One-month pilot EPIC EMR-based
universal HCV screening of birth cohort (i.e.1945 -
1965)
q 970 HCV-Ab tests were ordered with 90 (10.2%)
positive Ab results
q 59/90 (66%) of HCV Ab positive individuals had HCV
RNA testing performed, of which 29/59 (49%) resulted
positive
q 13/29 (45%) were successfully linked to care, (linkage
to care efforts continue in another 34% of individuals)

14. FOCUS UCSD Goals (Year 2)
Beginning July 2017:
q Yearly HIV tests at UCSD EDs = 13,318 (50% of
26,636 unique, eligible patients [aged 13 -64])
q HIV LTC (first appointment following diagnosis): 90%
q Emphasis on Relinkage of Known out of Care Positives
q HCV screening and LTC pilot project: 1 month in 2018
q Yearly HCV tests at UCSD EDs =
TABLE 1
HIV PROPOSED REACH (10/18-
9/19)
PRIOR YEAR’S REACH (7/17-
6/18)
# Eligible Patients 13000 12428
# HIV Tests Conducted 11010 10049
# HIV Positives Identified 27 25
#Known out of Care HIV
Positives
61 57
# Acute HIV Cases
Identified
2 1
# or % HIV+ LTC 90% 88%
HCV PROPOSED REACH PRIOR YEAR’S REACH
(3/18-4/18)
# Eligible Patients 11500 2281
# HCV Tests Conducted 7000 970
# HCV Ab+ Identified 600 84
# HCV RNA + Identified 280 23
# HCV RNA+ LTC 165 13

15. FOCUS Team at UCSD
• Infectious Diseases
• Director: Susan Little
• Co-Director: Martin Hoenigl
• Lead Physician: Jill Blumenthal
• Emergency Department
• Director: Chris Coyne
• Senior Advisor: Gary Vilke
• Data Manager: Jesse Brennan
• FOCUS ID Physicians
• Gabe Wagner, Lucy Horton, Melanie McCauley
• FOCUS Case Managers
• Miriam Zuazo, George Lara-Paez

16. Who gets tested?
ALL INDIVIDUALS presenting to the Hillcrest or
Thornton ED (part of general ED consent) who
are having labs drawn, except:
• <13 years old
• Refusal (i.e. opting out)
• Known HIV positive
• >64 years old
• Negative HIV test within previous 12 months
• Lack of decisional capacity
• Unable to make decisions due to language or
other barriers

17. Epic HIV Testing Prompts (1)
Ø If no/unknown: automated order of 4th Gen HIV test (in the event that the
patient is receiving labs and meets inclusion criteria).
Ø Automated order is then signed off by treating provider.
Ø Discussion of test and opt out option is taking place at the time of blood
draw: “…included in the blood work is a screening test for HIV. This is a CDC
recommendation and is performed on all adult patients unless they refuse”.

18. EMR Testing Algorithm
ryear

19. Genius HIV-1/HIV-2 differentiation immunoassay (PHD)
(Quest send-out)
Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations. June 2014 CDC
(2x Architect until
9/2018, since 9/2018
COBAS at CALM)
HIV Testing Algorithm

20. Changes to HIV Testing Algorithm
ARCHITECT (Cobas) p24 Ag/ HIV-Ab test at CALM
Lab (courier service)
- If positive, confirmed with second ARCHITECT (Cobas)
- If positive, listed in EMR as “pending supplemental testing”
- Same sample automatically sent to County for
confirmatory testing: Will be moved to CALM within
next months
- Genius differential HIV-1/HIV-2 and 3rd Generation CIA
- If these test results are discordant, specimen sent to Quest for
HIV-1 RNA Nucleic Acid Testing

21. Positive Test Result Delivery and Disclosure

22. Hepatitis C Testing (1)
• Goal is to provide one-time screening for hepatitis C for patients born
between 1945 and 1965
• Target patients in the UCSD ED:
• Patients who are having blood drawn anyway
• Patients who don’t already have evidence of hepatitis C diagnosis or prior
testing in Epic, or report such prior diagnosis/testing upon intake/triage
A new question has been added to the Assess section of the ED nurse Full
Triage activity for hepatitis C screening.
This question only appears for patients age 53 (born in 1945) and older.

23. Hepatitis C Testing (2)
If the patient states that they have already been tested
for hepatitis C previously, a second question appears
to document the result of that testing.

24. Hepatitis C Testing
On the physician side, if the patient doesn’t already have
evidence of hepatitis C diagnosis or testing previously in
Epic, and if the patient doesn’t report being hepatitis C
positive or being tested previously, an alert will show to
prompt the ED physician to order the hepatitis C
antibody test.

25. Findings to Date: Year 2 HIV
HIV 10/18 11/18 12/18 Total
HIV Tests Performed 942 894 922 2758
HIV Positive Patients Identified Through Testing 5 3 4 12
New HIV Positive Patients Identified 4 2 2 8
Known out of care HIV Positive Patients
Identified 3 5 7 15
Diagnosed Acute HIV Infections 0 0 0 0
NEW HIV Positive Patients (identified through
testing) Attended First Appointment 2 1 1 4
NOT TESTED - Known out of care HIV Positive
Patients Identified/Pending First Appointment 1 3 3 7
NOT TESTED - Known out of care HIV Positive
Patients Attended First Appointment 1 1 2 4

26. Findings to Date: Hepatitis C
HCV 10/18 11/18 12/18 Total
HCV Ab Tests Performed 17 263 484 764
HCV Ab Positive Patients Identified Through
Testing 1 28 43 72
HCV RNA Tests Performed 0 21 38 59
HCV RNA Positive Patients Identified Through
Testing 0 11 20 31
HCV RNA Positive Patients (identified through
testing) Attended First Appointment 0 3 6 9
NOT TESTED - Known HCV RNA Positive
Patients Pending First Appointment (LTC Only
Clients) 0 0 0 0
NOT TESTED - Known HCV RNA Positive
Patients Attended First Appointment (LTC Only
Clients) 0 0 0 0

27. The Trouble with HIV Results: EMR
• Epic report of screening test result misleading
• Description of “Pending supplemental test” never changes
• Previously “PrelimPos” or “To be confirmed”
• Confirmatory HIV result posted obscurely
• HIV-1 IFA results eventually added
• Variable if can access scanned document located in media from
serology result

28. The Trouble with HIV Results: Provider
• Lack of familiarity
• Program: not aware HIV test performed
• Results: often missed or misinterpreted
• Delay in time to final results
• Can take up to 2 weeks
• Results that don’t return as expected may affect patient care

29. False Positive 4th Generation HIV Ag/Ab
test Results
• 5 false positives out of 3000 Tests in first
3 months of COBAS (recent decline in
false positives)
• 9 false positives out of 12500 Tests in the
14 months before with ARCHITECT

30. Positive Predictive Value of 4th
Generation HIV Ag/Ab test
Low prevalence vs. high prevalence HIV
Population:
Example #1: UCSD Early Test screening
Prevalence of new HIV Dx: 3.8% (in men)
Example #2: UCSD ED FOCUS Opt-out HIV screening
Prevalence of new HIV Dx: 0.27%
PPV with Architect 81%
PPV with COBAS 60%

31. HIV Diagnoses: Demographics and Risk Groups
New HIV+ (n=37) Known HIV+ (n=22)
Age (Median, IQR) 37 (28-47) 44 (34-52)
Gender
Male 27 (73%) 16 (72%)
Female 9 (24%) 5 (23%)
Transfemale 1 (3%) 1 (5%)
Race
White 16 (43%) 11 (50%)
Black 8 (22%) 5 (23%)
Asian 2 (5%) 0 (0%)
Bi-racial 11 (30%) 6 (27%)
Hispanic Ethnicity 13 (35%) 7 (32%)
Risk Group
MSM 19 (51%) 10 (45%)
Heterosexual 12 (32%) 8 (36%)
IDU 1 (3%) 2 (9%)
Other/unknown 5 (14%) 2 (9%)

32. Difficult and Unique Disclosures:
Significant comorbidity
• 48F with advanced metastatic colon adenocarcinoma not
surgically amenable on intermittent chemo
• 4/10/18 presented with abd pain, prelim positive HIV test
• Unclear how to disclose: anxious, no PCP, terminal illness
• Came to AVRC with boyfriend, HIV Ab tests positive in both
• heavy non-injection meth use, boyfriend bisexual
• Despite significant linkage support, both lost to follow up
• Key management issues: Delivering more bad news,
dealing with anxious patients during disclosure

33. Difficult and Unique Disclosures: Dementia (1)
• 76M with Alzheimer’s and recent failure to thrive presented to
ED 6/2/18 after fall, noted to have thrush
• Returned 6/8 with dysphagia, dc’d home; HIV test positive
• Had UCSD geriatrician, brought patient in to disclose 6/19
• Requested that daughter not be told; daughter not happy
• 6/26 sent to ED with weakness and inability to care for self
(CD4 <10), dx with probably PJP pneumonia
• In care at Owen, on FTC/TAF/DTG 12/7 VL UD CD4 92/10%
• Key management issues: testing elderly patients for HIV,
giving HIV results to patient’s with dementia, how to
involve caretakers

34. Difficult and Unique Disclosures:
Severe psychiatric illness
• 36 TGW with meth abuse, schizoaffective disorder, frequent
presentations for suicidal ideation, HIV test positive 10/29/18
• HIV disclosed by ED doc 11/11 after coordinating with social work
• Linked to Owen 11/21/18 for intake but no provider visit, not on ARVs
• Several patients admitted with florid psychosis found to be
HIV+ through FOCUS, ultimately discovered to be known
positives
• Unable to understand dx let alone any aspect of medical care or
continued risk behaviors
• Key management issues: Working with patients who
lack awareness of HIV infection, recognizing restrictions
of management and treatment

35. Linkage to Care Process
• Case Managers (CMs) contacted by the ED.
• CMs contact the patient and gathers relevant
information (e.g., insurance, PCP).
• Patient is linked to Medical Specialist or PCP.

36. Linkage to Care: Comparison of HIV and HCV
HIV
• Structured resources and assistance programs (Medical
Case Management, Counseling Services, Housing)
• Agencies working collectively
• Ability to receive care with no insurance (Ryan
White/ADAP/Blue Shield Open Enrollment)
• The county gets involved, if needed
HCV
• Limited Resources
• Uninsured patients at a major disadvantage
• Patient’s often have co-existing medical conditions that
delay the treatment

37. Linkage to Care Challenges
• HIV and HCV remain largely misunderstood
• Stigma
• Co-existing mental health and substance abuse issues
• Homelessness (no contact information, transient
population)
• Transportation
The good news!
• Make people aware of their status
• Educate patients about treatment options

38. Unexpected Pitfalls and Lessons Learned (1)
• Initial low HIV testing rates
• Education and more education-- must have ED champions!
• Biggest impact: moving the opt-out discussion out of the triage process
and into the blood draw

39. Unexpected Pitfalls and Lessons Learned (2)
• Testing of known positives (many monolingual Spanish)
• Thorough chart review before contacting patients
• Preliminary and final result delays
• Most disclosures done over phone as opposed to while patient in ED
• Testing occasionally repeated at AVRC or clinical settings
• High false positivity rates because of low HIV prevalence
• Caution with disclosure to “low-risk” patients
• Best practice: inform PCP of false positive
• Inability to reach some patients
• Alternative contact methods used; Health Department as back-up

40. Unexpected Pitfalls and Lessons Learned (3)
• Misleading and obscured test results in Epic
• If you can’t beat ‘em, join a different team
• Low awareness of FOCUS program among providers
• Education and more education
• Out of care patients remain a challenge
• Few resources to improve linkage
• Hepatitis C testing/linkage barriers
• Positive Hep C Ab test required urgent Hep C viral load testing order
• ED unable to place referrals to ID Hepatitis C Clinic
• ID Hep C Clinic now closed; Hepatology with 3-4 month wait list

41. Successes!
• First ever universal opt-out HIV and Hep C testing
program at UCSD
• Close working relationship with ED colleagues
• Important changes to laboratory testing (e.g. reflex Hep C
viral load testing with positive Hep C Ab test)
Coming soon…
• HIV laboratory testing through Micro Lab under direction
of Dr. Reed
• HIV confirmatory testing in-house

42. Future Directions
• Expand hepatitis C testing (include risk-based or universal
testing)
• Improve time to positivity to allow for more disclosures in
ED
• Work with Owen Clinic to expand linkage and retention
support for chronically out of care patients
• Bring greater system awareness to the FOCUS program
• Introduce universal testing to ambulatory setting

43. Acknowledgments
• Susan Little
• Gary Vilke
• Chris Coyne
• Jesse Brennan
• Rene Bennett
• Gabe Wagner
• Lucy Horton
• Melanie McCauley
• Sharon Reed
• AVRC Study Staff