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What’s New in HIV Testing, Access and Linkage to Care?. Valerie E. Stone, MD, MPH Massachusetts General Hospital Associate Professor of Medicine Harvard Medical School Boston, MA. Case Presentation. Imagine that you are a primary care provider…

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what s new in hiv testing access and linkage to care

What’s New in HIV Testing, Access and Linkage to Care?

Valerie E. Stone, MD, MPH

Massachusetts General HospitalAssociate Professor of MedicineHarvard Medical SchoolBoston, MA

case presentation
Case Presentation

Imagine that you are a primary care provider…

You are seeing a new 35-year-old female patient for her initial annual physical exam. She feels completely well and has no complaints

She has a history of depression for which she has taken citalopram in the past. Denies history of other medical problems including HTN, DM, asthma, high lipids

Social history is essentially unremarkable – she is an attorney, has a long-term boyfriend with whom she lives, no smoking hx, 5-7 alcoholic drinks per wk, no hx of illicit drug use. FH notable only for breast ca in her mother last year at age 65

You do a complete history and physical including pap/pelvic. Exam is completely normal except that she is a bit overweight (BMI 26.5)

question 1
Question 1

What other screening tests should you order on this patient?

Fasting lipids

HIV antibody test

Both of the above tests

Mammogram

All of the above tests

question 1 response
Question 1 – Response

What other screening tests should you order on this patient?

Fasting lipids

HIV antibody test

Both of the above tests

Mammogram

All of the above tests

question 2
Question 2

If you responded that you should obtain an HIV antibody test…why?

This patient’s sexual history

This patient’s age group

Would suggest routinely for all patients at their annual physical

Given the topic of this presentation, it seemed like the right response!

question 2 response
Question 2 – Response

If you responded that you should obtain an HIV antibody test…why?

This patient’s sexual history

This patient’s age group

Would suggest routinely for all patients at their annual physical

Given the topic of this presentation, it seemed like the right response!

september 22 2006 cdc recommendations routine testing for hiv
September 22, 2006 CDC Recommendations: Routine Testing for HIV

ROUTINE voluntary screening for patients aged 13-64 in health care settings

OPT-OUT testing

NO separate consent

Pretest counseling NOTrequired

Goal is to make HIV testing

Less exceptional

Universal and routine

Not based on RISK

opt out testing has become more feasible legislatively since 2006
Opt-Out Testing Has Become More Feasible Legislatively Since 2006

At the time of CDC’s 2006 recommendations, 20 states had laws or regulations that required written consent for HIV testing

Currently, laws in 40 states and DC are compatible with the CDC recommendations1

States that still have laws requiring signed consent are: Alabama, Hawaii, Massachusetts, Michigan, New York, Nebraska, Pennsylvania, Wisconsin, and Rhode Island

1. Branson BM. 2008 National Summit on HIV Diagnosis, Prevention and Access to Care. November 19-21, 2008; Arlington, VA.

high acceptance of testing and increasing percentage have been tested
High Acceptance of Testing and Increasing Percentage Have Been Tested

HIV testing has a high rate of acceptance in the US

As of 2006 in US, 71 million reported that they had ever had an HIV test -- 40% of target population aged 13-64

Data show modest increase in number tested in 2006 compared with 20021

Most of the testing was done in physicians’ offices (53%) or hospital setting (22% ERs or hospital based clinics)1

PCPs cite many barriers to routine HIV screening2

1. Branson BM. 2008 National Summit on HIV Diagnosis, Prevention and Access to Care. November 19-21, 2008; Arlington, VA.

2. Bashook PG et al. Society of General Internal Medicine Annual Meeting, April 2008.

views on routine hiv testing
Views on Routine HIV Testing

HIV testing should be:

65% say treated just like routine testing for any other disease and should be included as part of regular check-ups

27% say it is different from screening for other diseases and should require written permission from the patient

Don’t know

Neither

27%

65%

Kaiser Family Foundation. Survey of Americans on HIV/AIDS; May 8, 2006. Available at: http://www.kff.org/kaiserpolls/pomr050806pkg.cfm.

trends in hiv testing in the us 2002 2006
Trends in HIV Testing in the US, 2002-2006

Ever tested

Preceding 12 months

Percent

Branson BM. 2008 National Summit on HIV Diagnosis, Prevention and Access to Care. November 19-21, 2008; Arlington, VA.

location of hiv testing
Location of HIV Testing

Summary health statistics for US adults: National Health Interview Survey, 2006.

reasons for hiv testing
Reasons for HIV Testing

100%

Late (Tested <1 y before AIDS dx)

Early (Tested >5 y before AIDS dx)

80%

60%

40%

20%

0%

Illness

Self/partner

Wanted to

Routine

Required

Other

check up

at risk

know

Supplement to HIV/AIDS Surveillance, 2000-2003.

primary care physicians cite many barriers to routine hiv testing
Primary Care Physicians Cite Many Barriers to Routine HIV Testing

Focus groups of primary care physicians regarding routine HIV testing at SGIM Annual Meeting in 2007

Numerous perceived barriers to implementing routine HIV screening cited:

State and local laws and regulations

Concerns about stigma and stereotyping

Belief that pre-test counseling is essential

Time constraints

Concerns about how and when to give results

Reimbursement concerns

Rapid test preferred but not available at their site

Bashook PG et al. Society of General Internal Medicine Annual Meeting, April 2008.

late hiv diagnosis is common
Late HIV Diagnosis Is Common

In 1 state, 45% of patients diagnosed with HIV within 1 year of AIDS diagnosis (“late testers”)

Late testers compared with early testers (>5 y prior to AIDS dx) are more likely to be:

Younger (18-29 y)

Heterosexual

Less educated

African American or Hispanic

CDC. HIV/AIDS Surveillance, 2000-2003. MMWR Morbid Mortal Wkly Rep. 2003;52(25):581-586.

late testing in 34 states 1996 2005
Late Testing in 34 States, 1996-2005

Method: CDC review of AIDS diagnosis within 1 year of first positive test in 34 states with named reporting

Results: 38% of 281,421

1996 – 43% 2001 – 36%

1998 – 42% 2003 – 38%

2000 – 40% 2005 – 36%

CDC. MMWR Morbid Mortal Wkly Rep. 2009;58(24):661-665.

awareness of serostatus among people with hiv and estimates of transmission
Awareness of Serostatus Among People With HIV and Estimates of Transmission

Accounting for

~25% Unaware of Infection

~54% of New Infections

~75% Aware of Infection

~46%of New Infections

People Living with HIV/AIDS: ~1,000,000

New Sexual Infections Each Year: ~32,000

Marks G et al. AIDS. 2006;20(10):1447-1450.

knowledge of hiv infection and behavior
Knowledge of HIV Infection and Behavior

Meta-analysis of 11 HIV risk-behavior studies:

Unprotected anal/vaginal sex with HIV-negative partners was 68% lower in people aware vs unaware they were HIV positive

Marks G et al. J Acquir Immune Defic Syndr. 2005;39(4):446-453.

critical challenge linkage to care
Critical Challenge: Linkage to Care

Mean time from diagnosis to first HIV primary care visit 2.5 years in cohort of 203 consecutive outpatients presenting for HIV care in Boston1

HIV Cost and Services Utilization Study (HCSUS): 1/3 of people delayed >3 months before getting HIV care2

Delay more common in:

African American, Latino

Women (esp children at home)3

Uninsured

Low trust in doctors

1Samet JH. AIDS. 2001;15(1):77-85; 2Turner BJ. Arch Intern Med. 2000;160(17):2614-2622.

3Stein MD. Am J Public Health. 2000;90(7):1138-1140.

hiv provider cited challenges to early linkage to care
HIV Provider-Cited Challenges to Early Linkage to Care

Manpower issues: number of HIV providers is insufficient and decreasing

Productivity is lower in HIV-focused practices than in other primary care practices

Numerous hidden costs of care that negatively impact the cost-effectiveness of HIV care

All of these factors result in each additional patient who is newly “linked to care” contributing further to the challenging financial situation of HIV-focused practices

Saag M, Weddle A, Carmichael JK. National Summit on HIV Diagnosis, Prevention and Access to Care; November 19-21, 2008; Arlington, VA.

interventions to reduce delay
Interventions to Reduce Delay

Rapid testing – more patients get results

Case management

Improve physician training in posttest counseling – Attention to social situation and need for support

Immediate referral and specifics about accessible HIV providers and sites

“No show” follow-up by HIV providers

Address drug, alcohol use, and mood disorders

summary
Summary

3 years have passed since the “new” CDC Recommendations for HIV Testing were released

There has been legislative progress; now 40 states have laws that support opt-out testing

More people have been tested at least once in the US—was 40% as of 2006

Primary care physicians cite numerous barriers to enacting these guidelines

Linkage to care for those found to be HIV positive is critical and remains challenging

testing and access to care

Testing and Access to Care

Harold W. Jaffe, MA, MD, FFPH

Professor of Public HealthUniversity of OxfordOxford, UK

overview of talk
Overview of Talk

HIV rapid tests

Screening for acute infection

Test and treat strategy

hiv rapid tests
HIV Rapid Tests

Point-of-contact testing

Three tests CLIA-waived in the US

Whole blood (finger stick) or oral fluid (OraQuick)

Results in 10 to 20 min

hiv rapid testing of oral fluid
HIV Rapid Testing of Oral Fluid

Reactive Control

Positive HIV-1/2

Positive

Negative

hiv rapid test screening in emergency departments
HIV Rapid Test Screening in Emergency Departments

1Walensky RP, et al. Ann Intern Med. 2008;149:153-160.

2Christopoulos K, et al. CROI 2009, Abstract #1040.

3Lyss SB, et al. J Acquir Immune Defic Syndr. 2007;44:435-442.

confirmation of reactive hiv rapid tests standard algorithm
Confirmation of Reactive HIV Rapid Tests: Standard Algorithm

WB, Western blot; IFA, indirect fluorescent antibody; NAT, nucleic acid test.

*APTIMA RNA Qualitative Assay (Gen-Probe) is only FDA-approved NAT test for confirmation of HIV infection.

confirmation of reactive hiv rapid tests proposed algorithms
Confirmation of Reactive HIV Rapid Tests: Proposed Algorithms

WB, Western blot; IFA, indirect fluorescent antibody; NAAT, nucleic acid amplification test.

*Second manufacturer

†Third manufacturer

From: APHL and CDC. HIV testing algorithms: a status report. April 2009. Available at: http://www.aphl.org/aphlprograms/infectious/hiv/Pages/HIVStatusReport.aspx

screening for early hiv infection by pooled nat testing
Screening for Early HIV Infection by Pooled NAT Testing

A B C D E

F G H I J

100 Individual specimens (HIV antibody negative)

10 Pools of 10

A B C D E

F G H I J

1 Screening Pool

resolution testing
Resolution Testing

A

Individual NAT testing on 10 specimens

10 Pools of 10 tested with NAT

Screening Pools of 100 specimens tested with NAT

screening for early hiv infection
Screening for Early HIV Infection

NAT testing

Detects infection as early as 10 to 12 days

Increases detection rate by 2%-8% in public health settings

Fourth-generation immunoassay*

Simultaneous detection of antibody/p24 antigen in single sample

Detects 60%-90% of EIA-/NAAT+ acute infections

EIA, enzyme immunoassay; NAAT, nucleic acid amplification test.

* ARCHITECT HIV Combo Assay; Abbott Laboratories.Available for sale outside of the United States only.

test and treat strategy
Test and Treat Strategy

“Our model suggests that massive scale-up of universal voluntary HIV testing with immediate initiation of ART could nearly stop transmission and drive HIV into an elimination phase in a high-burden setting within 1-2 years of reaching 90% of programme coverage.”

Granich RM et al. Lancet. 2009;373:48-57.

obstacles to test and treat
Obstacles to Test and Treat

In sub-Saharan Africa, 60%-95% of infected persons have not been diagnosed

Of ~33 million HIV-infected persons worldwide, only ~3 million receiving ART

Primary infection accounts for 9%-31% of sexual transmission of HIV1

Risks and benefits of early treatment unclear

1Hollingsworth TD et al. J Infect Dis. 2008;198:687-693.

a hypothetical conversation
A Hypothetical Conversation

Doctor: You’re doing very well. You’ve had no complications of your HIV infection and your CD4 cell count is high. But I think you should be treated.

Patient: Why?

Doctor: To decrease the likelihood that you’ll infect someone else.

Patient: Will I benefit from the treatment?

Doctor: I don’t know.

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