NYS SPNS Upper Manhattan Regional Group Collaborative: July 19, 2012 Bruce D. Agins, MD MPH; Principal Investigator, NY-LINKS

Medical Director, AIDS Institute, NYSDOH

LINKAGE AND RETENTION:WHOSE SYSTEM IS IT ANYWAYS?

or Every system is perfectly designed to achieve

exactly the results it achievesor

Why are there holes in Swiss Cheese?

Overview • Why early treatment is important and a community

problem• Why we need to make a maximum effort to focus on

linkage and retention• Why quality improvement is a critical strategy to

improve linkage and retention rates• Why we need to think about ourselves differently as a

system

Rationale for Early Treatment

Benefits of Early ART in Asymptomatic HIV-Infected Patients

Earlier treatment may reduce both HIV-related and non-HIV-related morbidity and mortality

Delay or prevention of immune system compromise

Possible lower risk of antiretroviral resistance

Decreased risk of sexual transmission of HIV

When to Initiate Treatment Guidelines May 2012, NYSDOH AIDS Institute

Key Evidence: Early Initiation

• Deferring ART until a CD4 count of 251-350 cells/mm3 was associated with higher rates of AIDS and death than starting treatment in the range of 351-450 cells/mm3.– Sterne [When to Start Consortium] (2009)

• Initiating ART at CD4 counts <500 cells/mm3 was independently associated with increased mortality.– Kitahata et al. (2009) [NA-ACCORD]

• Cardiovascular risk among HIV-infected individuals could be reduced when ART is initiated at higher nadir CD4 counts.– Ho et al. (2010)

Key Evidence: Community Prevention

• In 2000, Quinn (NEJM) shows that in a community in rural Uganda that viral load suppression prevents transmission (<1500 copies)

• In 2005, Castilla (JAIDS) shows that HAART independently and significantly reduces likelihood of transmission in Madrid.

• In 2010, Das shows that decreasing community viral load in San Francisco is associated with a corresponding decrease in new HIV infections.

Donnell, 2010Partners in Prevention HSV/HIV Transmission

Study• Large multicenter prospective cohort analysis of patients

initiated on ART in 7 African countries involving 3381 couples with 103 genetically linked HIV transmission events

• 349 participants initiated ART

• Only 1/103 transmitted HIV to an uninfected partner

• Use of antiretroviral therapy was accompanied by a 92% reduction in HIV-1 transmission to the uninfected partner

Lancet 375(9731): 2092-2098.

Prevention of HIV-1 Infection with Early Antiretroviral Therapy (HPTN 052)

• 9 countries, 1763 serodiscordant couples; – Infected partners were male or female (50% each)

• Randomly assigned by 1:1 ratio to early therapy (immediate) or delayed therapy (onset of symptoms)

• Ongoing counseling and condoms provided

• 39 HIV Transmission events: 4 in early therapy group – Incidence: 0.3 (early) vs. 2.2(delayed) per 100 person years

• 28 total linked transmissions between couples: 1 linked transmission in the early therapy group– Incidence: 0.1 (early) vs. 0.9 (delayed) per 100 person years

Cohen MS, Chen YQ, McCauley M, et al., HPTN 052 Study Team Prevention of HIV-infection with early antiretroviral therapy. N Engl J Med 2011;365:493-505

HPTN 052: Conclusion

• The early initiation of antiretroviral therapy reduced rates of sexual transmission of HIV-1 and clinical events, indicating both personal and public health benefits from such therapy.

Why Linkage and Retention?

Non-Engager Sporadic User Fully Engaged

[1] Health Resources and Services Administration, HAB. August 2006. Outreach: Engaging People in HIV Care Summary of a HRSA/HAB 2005 Consultation on Linking PLWH Into Care. [2] Eldred L, Malitz F. Introduction [to the supplemental issue on the HRSA SPNS Outreach Initiative]. AIDS Patient Care STDS 2007; 21(Suppl 1):S1–S2.

Engagement in Care Continuum(HRSA)

Ulett et al. AIDS Pt Care STDS 2009;23:41-49, Mugavero et al. Clin Infect Dis 2011;52(S2).

Blueprint for HIV Treatment Success

Adapted from: Gardner et al. Clin Infect Dis 2011;52:793, Greenberg et al. Health Affairs 2009;28:1677, Marks et al. AIDS 2010;24:2665

21% Undiagnosed

31% Not linked

41% Not retained

19% VL<50 c/mL

Health Outcomes

• Early and continued retention in care was associated with VL suppression. The number of missed visits was inversely associated with VL suppression. (Mugavero)

• Analysis of retention among 2197 newly diagnosed patients in SC from 2004-2009 show that poor retention predicted lower VL suppression, poor CD4 improvement and increased risk of mortality. (Tripathi)

• Linkage to to care within 3-9 months in Seattle was correlated with VL suppression and continued engagement in care. (Dombrowski)

National HIV/AIDS Strategy

Increase linkage to care w/in 3 months of

Dx

Increase HIV serostatus awareness

Increase RW clients in continuous

care

Increase proportion of HIV Dx’d persons with

undetectable VL by 20%

Adapted from Mugavero

Why Focus on New Patients?

The first year in outpatient HIV medical care is a dynamic, formative and vulnerable time

Poor early retention in care associated with:– Delayed / failed antiretroviral therapy (ART) receipt– Delayed time to VL suppression and greater cumulative

HIV burden– Increased sexual risk transmission behaviors– Increased risk of clinical events & mortality– Worse ART adherence, CD4 & VL response and increased

long-term mortality following ART start

Adapted from: Mugavero Technical Working Group Presentation 2012.--Ulett et al. AIDS Pt Care STDS 2009;23, Giordano et al. JAIDS 2003;32, Metsch et al. Clin Infect Dis 2008;47, Mugavero et al. Clin Infect Dis 2009;48, Tripathi et al. AIDS Res Hum Retrovirus 2011;e-pub, Giordano et al. Clin Infect Dis 2007;44

Interventions

Adapted from: Mugavero Technical Working Group Presentation, 2012--Ulett et al. AIDS Pt Care STDS 2009;23:41-49 and Mugavero. Top HIV Med 2008;16:156-61. Based upon behavioral Model of Health Services Utilization: Andersen RM. J Health Soc Behav 1995;36:1-10

Supportive/Ancillary Service Interventions

HRSA SPNS & Client Demonstration Projects: 8 studies, largely cross-sectional Ancillary services:

– Case management– Transportation– Housing– Substance abuse services– Mental health services

Association of ancillary service receipt with:– Entry into HIV medical care– Retention in HIV medical care

• Measurement variability– Independent, dependent & mediating variables– How is ‘need’ for ancillary services defined and measured

Demonstrated a need for integrated system- and community-wide databases

AIDS Care 2002;14:Supplement 1

Peer & Outreach Interventions: HRSA SPNS Outreach Initiative Focusing on Linkage & Retention

• Demonstration project supporting heterogeneous approaches & samples:

• Behavioral interventions; Intensive case management• Health literacy and life skills• Outreach in provision of medical services• Supportive services included in 8 of 10 programs

-Structural, financial & personal barriers common, and highly correlated with retention:

Reduction in barriers improved retention

-Tobias et al. AIDS Pt Care STDS 2007;21:S3, Rajabuin et al. AIDS Pt Care STDS 2007;21:S9

What we know about interventions (Mugavero)

Limited RCT evidence available Supportive services & outreach pivotal

– Measurement challenges– Resource intensive

Brief strengths-based intervention efficacious for linkage to care…but early retention a challenge

Intensive outreach for individuals not engaged in care within 6 months of a diagnosis may be effective

Use of peer or paraprofessional patient navigators may be successful

Relatively simple, clinic-based approaches promising…but are they effective for the most vulnerable?

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Bradford. AIDS Pt Care STDS 2007;21:S49

HIV System Navigation

Peer & Outreach Interventions: HRSA SPNS Outreach Initiative Focusing on Linkage & Retention

-Barriers to HIV care can be reduced or removed with

sufficient resources

-Additional resources and system changes needed for

most disadvantaged persons

Tobias et al. AIDS Pt Care STDS 2007;21:S3, Rajabuin et al. AIDS Pt Care STDS 2007;21:S9

Systemic Quality Improvement

Systems, Run Charts and Swiss Cheese

QI Principles & FrameworksFundamental Concept of Improvement:

“Every system is perfectly designed to achieve exactly the results it achieves”

Principles of Improvement:– Understanding work in terms of processes and systems– Developing solutions by teams of providers and

patients– Focusing on patient needs– Testing and measuring effects of changes

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and adapted from a presentation by Sir Liam Donaldson.

Applying the Model to:

• Linkage• Retention in Care

DEFENSES

THE GAPS

HIV DIAGNOSIS

FAILED LINKAG

E

Consumer: competing priorities/ health beliefs/fear of stigma

LINKAGE TO CARE

Counselor does not address linkage

Skilled Counseling StaffAppropriate/Convenient Referral Systems (diverse locations, availability)

Support services available and accessibleNavigation servicesAvailable Transportation ResourcesConsumer education

Not linked to appropriate supportive services (CM, SU, MH, Housing)

No transportation to HIV clinical care

Difficult navigation of clinical environment; Navigators unavailable

No available appointment

DEFENSES

THE GAPS

LINKED CONSUMER

NOT RETAINE

D IN CARE

Consumer priorities/challenges

(Housing, Work, Childcare, Transportation, Insurance,

Financial Concerns)

RETENTION IN CARE

Effective Connection to Ongoing Supportive ServicesFlexible Appointment/Reminder SystemsFriendly and supportive clinical environmentPeer navigation/supportEffective treatment adherence strategiesProvider/patient support

Lack of provider/program follow-up on those lost-to-care

Appointment scheduling and provider availabilityUnfriendly clinic environment or just a bad day today

Lack of supportive services: MH, SU, CM

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We have an opportunity. We have the federal, state and county leaders aligned in support of our mission. We have a National AIDS Strategy driving us. We have a special one-time federal grant. We have the skills. We have the support. We are all working together in one system that determines how linkage and retention happen. If we can all work together, we can change the system for the sake of our patients, for the sake of our clients and for the sake of our community. The time is now. Let us improve together.

ACKNOWLEDGEMENTS

• Meredith Baumgartner• Kathleen Cavolo• Johanne Morne• Cameron Stainken• Andrew Wei

• Michael Mugavero• Sir Liam Donaldson

CONTACT INFORMATION

• Bruce D. Agins, MD MPH• bda01@health.state.ny.us• 212.417.4536

Principal Investigator,SPNS; NY-LINKS

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