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• 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

What other screening tests should you order on this patient?

A. Fasting lipids

B. HIV antibody test

C. Both of the above tests

D. Mammogram

E. All of the above tests

Question 1 – Response

What other screening tests should you order on this patient?

A. Fasting lipids

B. HIV antibody test

C. Both of the above tests

D. Mammogram

E. All of the above tests

Question 2

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

A.This patient’s sexual history

B.This patient’s age group

C.Would suggest routinely for all patients at their annual physical

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

Question 2 – Response

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

A.This patient’s sexual history

B.This patient’s age group

C.Would suggest routinely for all patients at their annual physical

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

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 NOT required

• 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

• 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

• 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 TestingHIV 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

65%27%

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

NeitherDon’t know

Trends in HIV Testing in the US, 2002-2006

Per

cen

t

Ever testedPreceding 12 months

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

Location of HIV Testing

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

2002 2006

Private doctor/HMO 44% 53%

Hospital, ED, Outpatient 22% 18%

Community clinic (public) 9% 9%

HIV counseling/testing 5% 5%

Correctional facility 0.6% 0.4%

STD clinic 0.1% 0.1%

Drug treatment clinic 0.7% 0.4%

Reasons for HIV Testing

0%

20%

40%

60%

80%

100%

Illness Self/partnerat risk

Wanted toknow

Routinecheck up

Required Other

Late (Tested <1 y before AIDS dx)

Early (Tested >5 y before AIDS dx)

Supplement to HIV/AIDS Surveillance, 2000-2003.

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

• 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

• 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

~25% Unaware

of Infection

~75% Aware of Infection

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

New Sexual Infections Each Year: ~32,000

Accounting for

~54% of New

Infections

~46% of New

Infections

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

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

• 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

• 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

• 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

• 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 CareHarold W. Jaffe, MA, MD, FFPH

Professor of Public HealthUniversity of OxfordOxford, UK

Overview of Talk

• HIV rapid tests

• Screening for acute infection

• Test and treat strategy

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

Positive Negative

Reactive Control

HIV Rapid Testing of Oral Fluid

Positive HIV-1/2

HIV Rapid Test Screening in Emergency Departments

SiteScreened

(N)HIV Prevalence

(%)

Brigham and Women’s Hospital, Boston1 849 0.6

Columbia University Medical Center, NYC2 2569 0.9

Stroger Hospital, Chicago3 2824 1.2

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

Screening Test Confirmatory Test Tie Breaker

Rapid (oral fluid or blood)

WB None

Rapid (oral fluid or blood)

IFA None

Rapid (oral fluid or blood)

NAT* Additional test

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

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

Confirmation of Reactive HIV Rapid Tests: Proposed Algorithms

Screening Test Confirmatory Test Tie Breaker

Rapid (oral fluid or blood)

Rapid (blood)* WB/IFA/NAAT

Rapid (blood) Rapid (blood)* Rapid (blood)†

*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

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

Screening for Early HIV Infection by Pooled NAT Testing

1 Screening Pool

10 Pools of 10 A B C D E

F G H I J

A B C D E

F G H I J

100 Individual specimens (HIV antibody negative)

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

• 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

“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

• 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

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.