Going “Status-Neutral”:

Integrating Prevention and Care

to End the Epidemic
Julie E. Myers, MD, MPH
Director, HIV Prevention
Bureau of HIV/AIDS Prevention and Control
NYC Department of Health and Mental Hygiene
Disclosures
• I have nothing to disclose.

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Outline
• Status-Neutral: A New Paradigm
• Defining status-neutral
• Why do we need a status-neutral approach?
• Where are the implementation gaps?
• Embracing Status-Neutral
• Lessons Learned

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Defining status-neutral

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5
Status-Neutral: Principles
• Positions testing as the “gateway”
• Offer the same approach regardless of status
• Integrates prevention and care programs
• Leverages the same approaches for both prevention and care
• Fully utilizes our “new” tools

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7
8
Why do we need a status-neutral approach?

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 Lifetime Risk of HIV in the US

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Hess et al., CROI 2016.
 Lifetime Risk of HIV in Heterosexuals
MALES FEMALES
“One in n” 95% CI “One in n” 95% CI

Heterosexuals 473 467-480 241 239-244

American 1,116 776-1,458 493 405-583
Indian/Alaska Native
Asian 1,780 1,483-2,013 910 824-991
Black 86 85-88 49 48-50
Latino 390 374-406 242 235-249
Native Hawaiian/API 2,706 111-9,939 395 137-553
White 2,514 2,414-2618 1,083 1,055-1,113

Hess et al., CROI 2016.

 Lifetime Risk of HIV among MSM
“One in n” 95% CI

MSM 6 6-6
American Indian/Alaska Native 12 11-13
Asian 14 13-14
Black 2 2-2
Latino 4 4-5
Native Hawaiian/API 7 4-7
White 11 10-11

This is just an estimate – this doesn’t have to be our reality.

Hess et al., CROI 2016.
Ending the Epidemic:
Jurisdictional Plans

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Ending the Epidemic:
Jurisdictional Plans

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 Ending the Epidemic:
Jurisdictional Plans

EtE Plan:
1. Test
2. Treat
3. PrEP
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16
 Viral Suppression Has Increased Dramatically

17
Nance et al., Ann Int Med 2018.
 PrEP Use Has Increased Dramatically

Stabilization
Rapid Growth

Slow Growth

Mera, et al., IAS 2017.

 Population-Level Data Suggest Impact of
Treatment on New HIV Diagnoses
San Francisco Study

Vancouver Study

New York City

HIV Epidemic,
1981-2016
AS Fauci/NIAID. IAS 2018
Das, et al.
Monatener et al.

Adapted from D. Daskalakis presentation at the 2018 STD Prevention Conference

 Population-Level Data Suggest an Impact of
PrEP on New HIV Diagnoses

PrEP was associated with a

reduction in new diagnoses
independent of state-level
viral load suppression

EAPC, Estimated Annual Percent Change

Sullivan, IAC 2018.
What are the gaps?

21
 Gaps Exist in Sustained Viral Suppression

Fewer Blacks living with diagnosed HIV

infection had sustained viral
suppression compared with Hispanics
and whites.

22
Crepaz N, Dong X, Wang X, Hernandez AL, Hall HI. Racial and Ethnic Disparities in Sustained Viral Suppression and Transmission Risk Potential Among Persons Receiving HIV Care — United States, 2014.
MMWR Morb Mortal Wkly Rep 2018;67:113–118. DOI: http://dx.doi.org/10.15585/mmwr.mm6704a2
 Gaps Exist in Who is Starting PrEP

*Prescription data in this analysis limited to those filled at retail pharmacies or 23

mail order services from Sept 2015- Aug 2016;
racial and ethnic information not available for one-third of the prescription data. https://www.cdc.gov/nchhstp/newsroom/2018/croi-2018.html#Graphics
 Gaps Exist in Who is Starting PrEP

*Prescription data in this analysis limited to those filled at retail pharmacies or 24

mail order services from Sept 2015- Aug 2016;
racial and ethnic information not available for one-third of the prescription data. https://www.cdc.gov/nchhstp/newsroom/2018/croi-2018.html#Graphics
 Gaps Exist in Who is Starting PrEP

*Prescription data in this analysis limited to those filled at retail pharmacies or 25

mail order services from Sept 2015- Aug 2016;
racial and ethnic information not available for one-third of the prescription data. https://www.cdc.gov/nchhstp/newsroom/2018/croi-2018.html#Graphics
 Gaps Exist in Who is Starting PrEP

*Prescription data in this analysis limited to those filled at retail pharmacies or 26

mail order services from Sept 2015- Aug 2016;
racial and ethnic information not available for one-third of the prescription data. https://www.cdc.gov/nchhstp/newsroom/2018/croi-2018.html#Graphics
 Gaps Exist in Who is Starting PrEP

*Prescription data in this analysis limited to those filled at retail pharmacies or 27

mail order services from Sept 2015- Aug 2016;
racial and ethnic information not available for one-third of the prescription data. https://www.cdc.gov/nchhstp/newsroom/2018/croi-2018.html#Graphics
 Gaps Exist Along the PrEP Continuum
• Between engagement and initiation
• Between initiation and persistence

PrEP Retention

Kelley et al., CID 2015.

Perlson et al., IDWeek 2018. 30
Chan et al., J Int. AIDS Soc. 2016.
 Why do these gaps exist?
RACISM STRUCTURAL
FINANCIAL BARRIERS
INEQUITIES
STIGMA UNEMPLOYMENT
TRANSPHOBIA
ACCESSIBILITY HOMOPHOBIA POVERTY
OF SERVICES SOCIAL DETERMINANTS
OF HEALTH
DISTRUST
SEXISM STATIC CARE MODELS
NEGATIVE
LACK OF PAST
EXPERIENCES
AFFIRMING CARE STIGMATIZING MESSAGING
HOMELESSNESS 31
 Why do these gaps exist?
RACISM STRUCTURAL
FINANCIAL BARRIERS
INEQUITIES
STIGMA UNEMPLOYMENT
SOCIAL & TRANSPHOBIA
ACCESSIBILITY
OF SERVICES STRUCTURAL
HOMOPHOBIA
SOCIAL DETERMINANTS
POVERTY

DISTRUST
BARRIERSOF HEALTH
SEXISM STATIC CARE MODELS
NEGATIVE
LACK OF PAST
EXPERIENCES
AFFIRMING CARE STIGMATIZING MESSAGING
HOMELESSNESS 32
What Does This Mean?
• We have embraced our “new” tools…to an extent
• Gaps plague both HIV care and prevention
• Social and structural barriers are playing a role
• We won’t improve engagement unless we fully address these
barriers

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Can embracing a status-neutral
approach help close these gaps?
 Embracing a status-neutral approach

Create navigation programs Reduce the financial burden

Simplifiy eligibility/monitoring
36
for ARVs Innovate Service Delivery
 Embracing a status-neutral approach

Create navigation programs Reduce the financial burden

Simplifiy eligibility/monitoring
37
for ARVs Innovate Service Delivery
Patient Navigation
• An intervention originally designed to help improve poor treatment
outcomes through community health workers, peers
• Recognizes both the complexity of medical care, the difficulty of
engaging in it, and the burden of social issues
• Support for
• Developing a patient-centered care plan
• Obtaining needed social services, including accompaniment
• Coaching to become self-sufficient

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 Comprehensive Navigation for HIV Care

• Recent systematic review of literature

• Modestly positive associations with outcomes suggest that navigation may be
successful in
• Moving PLWH through the medical system
• Keeping them from falling out of care
• Difficult to quantify impact because of different definitions across studies
• Can we use the navigation model to increase access and retention in HIV
prevention?
Mizuno et al. AIDS, 2018. 39
Irvine et al., CID 2015.
 Comprehensive Navigation for PrEP
• Navigation already being implemented around the country but data
of effectiveness, impact are generally lacking
• CDC supports demonstration projects in many cities
• San Francisco: Panel management/patient navigation was associated with
earlier PrEP initiation in primary care clinic
• New York City

Mutchler et al., AIDS Pt Care STDs 2015.

Saleh et al., SYNChronicity Conference 2017. 40
Spinelli et al., JAIDS 2018.
 NYC Ryan White
Care Coordination Program

Social Services
Care
and Benefits
Navigation
Assessment

CLIENT
Treatment
Health
Adherence
Support + DOT
Promotion

Irvine et al., CID 2015.

Nash et al. PLoSOne 2018. Outreach
41
Robertson et al., JAIDS 2018
 PlaySure Network Model: NYC

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https://www1.nyc.gov/site/doh/providers/resources/playsure-network.page
 NYC PlaySure Network Model: The 1 st Yr.
From March 2017-April 2018, across 27 PSN sites focused on PrEP provision:
• 7279 anonymous engagement screens
• 4077 enrollments
• 941 prescribed PrEP
• XXX linked to care

Sites preferentially served Black and Latino MSM:

• 21% of engagement screens conducted
• 26% of enrollments
• 48% of PrEP prescriptions
• XX% linked to care

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From NYC Health Department, unpublished data, 2018
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 Embracing a status-neutral approach

Create navigation programs Reduce the financial burden

Simplifiy eligibility/monitoring
45
for ARVs Innovate Service Delivery
Financial Burden of HIV Medications
Financial Burden of HIV Medications
 Reducing the Financial Burden of HIV Treatment
• AIDS Drug Assistance Programs (ADAPs) have played a crucial role in
reducing socioeconomic disparities in access to HIV medications
• Financial issues, including medication cost or coverage, lead to lapses in ARVs
• Receipt of ADAP is associated with earlier treatment and viral load
suppression
• Can similar financial assistance programs reduce the cost burden of
PrEP and improve access to services?

Hanna et al. PLoS One 2013.

Wohl et al. AIDS Patient Care STDS 2017. 48
Ludema et al. JAIDS 2016.
 Reducing the Financial Burden for PrEP?
• Cost is a major barrier to PrEP uptake
• Insurance status is associated with PrEP use
• Provision of PrEP free of charge is a cited as a facilitator, shapingacceptability
• A patchwork of payment options can help the uninsured
• Pharmaceutical company coverage
• Local PrEP programs
• Charities
• Helping patients navigate these payment options is critical to
equitable uptake

Patel et al., PLoS One 2017.

Whitfield et al., AIDS and Behavior 2018. 49
Golub et al., AIDS Pt Care STDs 2013.
 NYC: Benefits Navigation for PrEP
• Through the PlaySure Network navigation program, clinical and
nonclinical sites can be reimbursed for Benefits Navigation services,
including:
• Providing information on insurance marketplace and PrEP assistance programs
• Applying for PrEP assistance programs
• Requesting explanation of benefits waivers (adolescents)
• Benefits Navigation services are being utilized
• 42% of PlaySure Network enrollees are uninsured
• 51% of uninsured enrollees received Benefits Navigation

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From NYC Health Department, unpublished data, 2018.
NYC: Training on Benefits Navigation

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 Controversy:
Lowering the Price of HIV Medication

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 Controversy:
Lowering the Price of HIV Medication

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 Embracing a status-neutral approach

Create navigation programs Reduce the financial burden

Simplifiy eligibility/monitoring
54
for ARVs Innovate Service Delivery
 Eligibility for Treatment Initiation
A Focus on WHO Guidelines
Typical Course of HIV Infection

HIV RNA Copies per mL Plasma

2015
2013
2010
2002

TIME from INFECTION

Pantaleo et al., NEJM 1993.
Ford et al., Curr Opin HIV/AIDS 2017.
 Eligibility for Treatment Initiation
A Focus on WHO Guidelines
Typical Course of HIV Infection

HIV RNA Copies per mL Plasma

2015
2013
Same-day 2010
initiation? 2002
2018?

TIME from INFECTION

Pantaleo et al., NEJM 1993.
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Ford et al., Curr Opin HIV/AIDS 2017.
 Simplifying Initiation: Clinical Visits, Monitoring

Pilcher et al., JAIDS 2017.

 Same-Day ARV Initiation (vs. Standard of Care)
Improves HIV Treatment Outcomes in Randomized Trials

Ford et al., AIDS 2018.

 Simplifying Initiation: Same-Day PrEP Starts?
• Same-day PrEP initiation is being implemented in some settings
• New York City Sexual Health Clinics
• Metro Denver STD Clinic
• Benefits:
• Avoid missed opportunities
• Ensure that logistical problems don’t complicate initiation
• Controversy: Will we miss acute infections?
• Individuals who could immediately benefit should not be deferred

Daskalakis et al., CROI 2018. 59

Kamis et al., IDWeek 2018.
 Simplifying Monitoring for Care
• Current HIV treatment guidelines propose differential frequency of
monitoring (depending on clinical scenario)
• Usual frequency is every 3-4 mos.
• After 2 yrs., stable PLWH can extend to every 6 mos.
• Less frequent monitoring diminishes burden of care; positive impact on
retention?
• Can simplified monitoring be used in PrEP?

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DHHS HIV Treatment Guidelines, 2018. Available at: https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv/458/plasma-hiv-1-rna--viral-load--and-cd4-count-monitoring
 Simplifying Monitoring for PrEP?
• Less frequent monitoring is already being implemented
• Current protocols, requiring every 3 month labs, are likely too
conservative
• Onerous monitoring schedule likely contributes to low PrEP
persistence
• Controversy: Will we miss new infections?
• It is not logical to require more intensive monitoring of HIV-negative
people than of PLWH

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Spinelli et al. Open Forum Infect Dis. 2018
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 Embracing a status-neutral approach

Create navigation programs Reduce the financial burden

Simplify eligibility/monitoring
63
for ARVs Innovate Service Delivery
Innovate Service Delivery
• Bypass clinical settings – avoid stigma
• Improve/increase accessibility of services – hours, location
• Streamline service delivery – more use of staff, resources
• Increase points of access into the system
• Engage different communities

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Models for Innovation in Service Delivery
(meet consumers where they are)

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Pharmacies Telemedicine/ STD Clinics

Online services (now: Sexual Health Clinics)
 Pharmacies

Tung et al. CROI Abstract. 2016

Bares et al. IDWeek 2018. 2018 66
Keenan et al. IDWeek 2018. 2018
Telemedicine/Online Services

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Sexual Health Clinics
Clinic Access:
• Walk-in basis (Both MD & screening-only
visits)
• 5 days/week at 8 sites; Saturdays at 2 sites;
2 evenings at one site
• Services rendered irrespective of ability to
pay
• Confidential – no documentation needed
• Ages 12 years and up; no parental
notification
• Expand services – contraception, restore
asymptomatic screening
 Sexual Health Clinics
Are the Front Line of HIV
NYC HIV Incidence Studies:
• 1 in 42 MSM attending NYC STD Clinics were diagnosed with HIV within a
year1
• 1 in 20 MSM diagnosed with P&S Syphilis in NYC were diagnosed with HIV
within a year2

• 1 in 15 MSM diagnosed w/ anorectal chlamydia/gonorrhea in NYC STD

Clinics were diagnosed with HIV within a year3
1 Pathela P, AIDS Behav. 2016 [Epub ahead of print]
2 Pathela P, Clin Infect Dis 2015; 61(2)281-7.
3 Pathela P, Clin Infect Dis 2013; 57(8) 1203-9.
 NEW Status-Neutral Services
at NYC Sexual Health Clinics

“JumpstART” Immediate PrEP

PEP (Treatment Initiation) Initiation

Launched Oct. 2016 Launched Nov. 2016 Launched Dec. 2016

2,430 Patients 376 JumpstARTs 2,134 PrEP Starts

60% Black/Latino 72% Black/Latino 55% Black/Latino
1.Navigation
2.Financing
3.Simplification
4.Innovation

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Lessons Learned
Benefits of Status-Neutral Approach
• Reduce institutionalized stigma for people living with HIV
• Recognize that the “serodivide” is already crumbling
• Create efficiencies – improve resource utilization
• Gain insights from parallel service delivery
• People-focused – embrace the person; service delivery is secondary

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Benefits of People-Focused Approach
• Assesses our models of care through a new lens
• Supports self-esteem by normalizing conversations and strategies to
optimize health
• Focuses on sexual health and pleasure – harm reduction
• Respects the individual and their autonomy
Lessons Learned from Implementing
Status-Neutral
• Robust collaboration is needed (internal/external)
• Full integration requires a thorough, deliberate approach
• Messaging has to match programming (and vice versa)

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Promoting Health Through
A Status-Neutral Lens
Beyond Status-Neutral

• Position testing as the gateway

• Break down silos
• Learn from other diseases or prevention paradigms
• Innovate in how we address the social and structural barriers to
engagement

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Ending the Epidemic
NYC
 THANK YOU!

jmyers@health.nyc.gov

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Acknowledgements
• Oni Blackstock
• Maria Ma
• Stephanie Hubbard
• Graham Harriman
• Ben Tsoi
• Paul Kobrak
• Zoe Edelstein
• Demetre Daskalakis

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