# Presentation: 729041

## Normalizing HIV Testing in Health Care Settings

- Deputy Director for Science
- Divisions of HIV/AIDS Prevention
- National Center for HIV, STD, and TB Prevention
- Centers for Disease Control and Prevention

- Normalizing HIV Testing in Health Care Settings

- Presidential Advisory Council on HIV/AIDS
- March 16, 2006

- The findings and conclusions in this presentation are those of the author and do not necessarily represent the views of CDC.

**Notes:**

	Good morning/afternoon.

	My name is ______ and I am __________ from  ___________ in the Division of HIV/AIDS Prevention at the CDC. 

	Thank you for inviting me to talk with you today about CDC’s new Advancing HIV Prevention initiative, which we refer to as AHP.

## Presentation Outline

- Epidemiologic background
- The case for increased HIV testing
- Current testing
- Current recommendations and their effects
- Considerations for revising recommendations
- Adults and adolescents
- Pregnant women
- Summary

## Estimated Number of AIDS Cases, Deaths, and 

- Year of diagnosis or death

- Estimated Number of AIDS Cases, Deaths, and

- Persons Living with AIDS,1985-2004, United States

- Note. Data adjusted for reporting delays.

- Prevalence (in thousands)

- 0

- 0

- 90

- 400

- 450

- 10

- 20

- 50

- 30

- 100

- 40

- 150

- 50

- 200

- 60

- 250

- 70

- 300

- 80

- 350

- 1985

- 1986

- 1987

- 1988

- 1989

- 1990

- 1991

- 1992

- 1993

- 1994

- 1995

- 1996

- 1997

- 1998

- 1999

- 2000

- 2001

- 2002

- 2003

- 2004

- Deaths

- Prevalence

- AIDS

- 1993 definition

- implementation

## Awareness of HIV Status among 

- Number HIV infected           1,039,000 – 1,185,000
- Number unaware of
-   their HIV infection 	   252,000 - 312,000  (24%-27%)
- Estimated new infections          40,000
-    annually

- Awareness of HIV Status among
- Persons with HIV, United States

*Glynn M, Rhodes P.  2005 HIV Prevention Conference*

## HIV/AIDS Diagnoses among Adults and Adolescents, by Transmission Category — 33 States, 2001–2004 

- MSM
- 61%

- IDU
- 16%

- Heterosexual
- 17%

- MSM/IDU 5%

- Other 1%

- Males
- (n ≈ 112,000)

- Females
- (n ≈ 45,000)

- Heterosexual
- 76%

- IDU
- 21%

- Other 3%

*MMWR, Nov 18, 2005*

## Rates of Estimated HIV/AIDS Cases per 100,000 Population for Adults and Adolescents, by Sex and Race/Ethnicity, 33 States, 2004 

- Rate per 100,000

- Male

- Female

*CDC. HIV/AIDS Surveillance Report, 2004*

##  Estimated Number of Perinatally Acquired AIDS

- Number of cases

- 1986

- 1985

- 1987

- 1988

- 1989

- 1990

- 1991

- 1992

- 1994

- 1993

- 1995

- 1996

- 1997

- 1998

- 1999

- 2000

- 2001

- 2002

- 2003

- 2004

-  Estimated Number of Perinatally Acquired AIDS
- Cases, by Year of Diagnosis, 1985-2004 – United States

**PACTG 076 & USPHS ZDV Recs**

**~****95% reduction**

**CDC **
**HIV screening Recs**

- Year of Diagnosis

## The Case for Increased HIV Testing

## Mortality and HAART Use Over Time

- HIV Outpatient Study, CDC, 1994-2003

## Knowledge of HIV Infection and Behavior

- Meta-analysis of high-risk sexual behavior in persons
- aware and unaware they are infected with HIV in the U.S.
-       *Marks G, et al.  JAIDS.  2005;39:446*

- After people become aware they are HIV-positive, the prevalence of high-risk sexual behavior is reduced substantially.

- Reduction in Unprotected Anal orVaginal Intercourse with HIV-neg partners:
- HIV-pos Aware vs. HIV-pos Unaware

**68%**

## Awareness of Serostatus Among People with HIV and Estimates of Transmission

- ~25% Unaware of Infection

- ~75% Aware of Infection

- People Living with HIV/AIDS: ~1,050,000

- New Infections Each Year: ~40,000

- Accounting for:

**Notes:**
Currently, in the United States, there are an estimated 850,000-950,000 people who are infected with HIV. Of those, the majority of people, an estimated 670,000-770,000 – or 75% – are aware of their status. 

But that leaves 25% – or 180,000 to 280,000 people – unaware they are infected with HIV. 

It has been estimated that infections transmitted from this group account for 27,000, or 2/3, of the 40,000 new infections per year. 

The importance of getting these individuals tested and into treatment that includes prevention interventions is critical.

## 	Total	1,767	450	(25)	217	(48)

- Race/Ethnicity
- White	616	127	(21)		23	(18)
- Black	444	206	(46)	139	(67)
- Hispanic	466	  80	(17)		38	(48)
- Multiracial	  86	  16	(19)	    8	(50)
- Other	139	  18	(13)	    9	(50)

**	****Total****	****1,767****	****450****	****(25)****	****217****	****(48)**

*MMWR June 24, 2005*

## Late HIV Testing is CommonSupplement to HIV/AIDS Surveillance, 2000-2003

- Among 4,127 persons with AIDS*, 45% were first diagnosed HIV-positive within 12 months of AIDS diagnosis (“late testers”)
- Late testers, compared to those tested early (>5 yrs before AIDS diagnosis) were more likely to be:
- Younger (18-29 yrs)
- Heterosexual
- Less educated
- African American or Hispanic

*MMWR   June 27, 2003*

- *16 states

## Reasons for testing: late versus early testers

- Supplement to HIV/AIDS Surveillance, 2000-2003

## Lessons from Kenya

- Six types of HIV testing:
- VCT: initiated by a client
- Routine: initiated by HCW
- Diagnostic: requested by HCW as part of w/u
- Required: without consent (military, immigration)
- Blood and tissue donation
- For medical research

## Lessons from Kenya

- Consent with six types of HIV testing:
- VCT: Consent implicit in seeking test; verbal
- Routine: Inform client, opt-out, option to decline
- Diagnostic: consent implicit, inform patient, opt-out, option to decline
- Required: Inform; no consent
- Blood and tissue donation: Inform; no consent
- For medical research: Special provisions

## Lessons from Kenya

- Five principles:
- Provide information about HIV
- Must know they are being tested
- Opportunity to decline
- Must be offered their test results
- Access to treatment

## President Festus Mogae

- “Next year when you visit a health facility and it becomes necessary to conduct a medical test, the test will include testing for HIV.  Health workers will test for HIV unless you decline to be tested.”

- Botswana
- December 23, 2003

- “I encourage you to accept being tested.  It is in your interest to know.  Knowledge of your HIV status will empower you to take care of your destiny.”

- Routine HIV Testing in Botswana

## Current Testing

## Terminology - I

*Diagnostic testing:* HIV testing based on clinical signs or symptoms
*Screening:* HIV testing for all persons in a defined population
*Targeted testing:* offering testing to subgroups at higher risk based on behavioral, clinical or demographic characteristics
*Opt-out testing:*  HIV testing after notifying the patient that the test will be done; consent is inferred unless the patient declines

## Terminology - II

*Informed consent:* process of communication between patient and provider through which the patient can participate in choosing whether or not to undergo HIV testing
*HIV prevention counseling:* interactive process to assess risk, recognize risky behaviors, and develop a plan to take steps that will reduce risks

## Source of HIV Tests and Positive Tests

|  | HIV tests* | HIV+ tests** |
| --- | --- | --- |
| Private doctor/HMO | 44% | 17% |
| Hospital, ED, Outpatient | 22% | 27% |
| Community clinic (public) | 9% | 21% |
| HIV counseling/testing | 5% | 9% |
| Correctional facility | 0.6% | 5% |
| STD clinic | 0.1% | 6% |
| Drug treatment clinic | 0.7% | 2% |

**National Health Interview Survey, 2002*

***Suppl. to HIV/AIDS surveillance, 2000-2003*

-  38% - 44% of adults age 18-64 have been tested
-  16-22 million persons age 18-64 tested annually in U.S.

## Current Recommendations and their Effects

## Current Recommendations

## Four priorities:
Make voluntary HIV testing a routine part of  medical care
Implement new models for diagnosing HIV infections outside medical settings
Prevent new infections by working with persons diagnosed with HIV and their partners
Further decrease perinatal HIV transmission

**Make voluntary HIV testing a routine part of  medical care**
*Implement new models for diagnosing HIV infections outside medical settings*
*Prevent new infections by working with persons diagnosed with HIV and their partners*
**Further decrease perinatal HIV transmission**

**Advancing HIV Prevention Strategies**

*MMWR  April 18, 2003*

**Notes:**

The primary goal of the new initiative – to reduce HIV transmission – is not new.  AHP emphasizes the use of proven public health approaches to reduce incidence and the spread of disease. The initiative consists of four priority strategies:

Make voluntary testing a routine part of medical care.
Implement new models for diagnosing HIV infections outside medical settings. 
Prevent new infections by working with persons diagnosed with HIV.
Further decrease perinatal HIV transmission.

## Existing CDC RecommendationsAdults and Adolescents

- Routinely recommend HIV screening in settings with high HIV prevalence (_>_1%)
- Targeted testing based on risk assessment
- Annual testing for sexually active MSM

## Are Recommendations Having Their Intended Effect?

## Recommendations Are Not Having Their Intended Effect in Acute Care Settings

|  | 2000 | 2001 | 2002 |
| --- | --- | --- | --- |
| ED visits | 108 million | 107 million | 110 million |
| Age 15-64 | 68.3 million | 69.4 million | 69.6 million |
| HIV serology | 215,000 | 201,000 | 163,000 |

** **EDs account for 10% of all ambulatory care visits

## Rapid HIV Screening in Acute Care Settings

- Cook County ED, Chicago			2.3%
- Grady ED, Atlanta				2.7%
- Johns Hopkins ED, Baltimore		3.2%
- King-Drew Med Center ED, L.A.		1.3%
*           *

_*New HIV+*_

_*Study site*_

## Routine Opt-Out HIV TestingTexas STD Clinics, 1996-97

*Texas Department of State Health Services, 2005*

- 			Opt-In		Opt-Out
- 		_	__    __N (%)__	__     N (%)__	__% change_
- STD Visits		31,558	34,533	     +9	Eligible Clients	19,184 (61)	23,686 (69)	   +23
- Pre-test counsel	15,038 (78)	11,466 (48)	    -24
- Tested		14,927 (78)	23,020 (97)	   +54
- Post-test counsel	  6,014 (40)	  4,406 (19)	    -27
- HIV-positive		     168 (1.1)	     268 (1.2)	   +59

## Routine Opt-Out HIV TestingTexas STD Clinics, 1996-97

*Texas Department of State Health Services, 2005*

- 			Opt-In		Opt-Out
- 		_	__    __N (%)__	__     N (%)__	__% change_
- STD Visits		31,558	34,533	     +9	Eligible Clients	19,184 (61)	23,686 (69)	    +23
- Pre-test counsel	15,038 (78)	11,466 (48)	     -24
- Tested		14,927 **(78)**	23,020 **(97)**	    **+54****	**
- Post-test counsel	  6,014 (40)	  4,406 (19)	     -27
- HIV-positive		     168 (1.1)	     268 (1.2)	    **+59**

## Slide 32

## Existing CDC RecommendationsPregnant Women

- Routine, voluntary HIV testing as a part of prenatal care, as early as possible, for all pregnant women
- Simplified pretest counseling
- Flexible consent process
- HIV rapid testing and treatment during labor and delivery for women without prenatal testing
- Re-screening in third trimester for select, high-risk women

## Opt-Out Consent

- Prenatal HIV testing for pregnant women:
- RCT of 4 counseling models with opt-in consent:
*35% accepted testing*
*Some women felt accepting an HIV test indicated high risk behavior*
- Testing offered as routine, opportunity to decline
*88% accepted testing*
*Significantly less anxious about testing*

*Simpson W, et al, BMJ  June,1999*

## Considerations for Revising Recommendations

## Rationale for Revising Recommendations

- Many HIV-infected persons access health care but are not tested for HIV until symptomatic
- Effective treatment available
- Awareness of HIV infection leads to substantial reductions in high-risk sexual behavior
- The need for pre-test counseling is decreased due to high levels of knowledge about HIV
- Great deal of experience with HIV testing, including rapid tests
- Inconclusive evidence about prevention benefits from typical counseling for persons who test negative

## Cost Effectiveness

- Routine HIV testing: an economic evaluation of current guidelines.  *Walensky RP, et al.  Am J Med  2005;118:292.*
-   “Routine inpatient HIV screening programs are not only cost-effective, but would likely remain so at a prevalence of undiagnosed infection 10 times lower than recommended thresholds.”
- 		   1% HIV prevalence: $35,400 per QALY
- 		0.1% HIV prevalence: $64,500 per QALY

## Cost Effectiveness

- Cost-effectiveness of screening for HIV in the era of HAART.  *Sanders G, et al.  NEJM  2005;352:570.*
-   “The cost-effectiveness of routine HIV screening in health care settings, even in relatively low-prevalence populations, is similar to that of commonly accepted interventions, and such programs should be expanded.”
- 			1% HIV prevalence:   $15,078 per QALY
- 			>0.05% prevalence:  <$50,000 per QALY

## Cost Effectiveness

- Expanded screening for HIV in the U.S. – an analysis of cost effectiveness.  *Paltiel AD, et al.  NEJM  2005;352:586.*
-   “In all but the lowest-risk populations, routine, voluntary screening for HIV once every 3 to 5 years is justified on both clinical and cost-effectiveness grounds. One-time screening in the general population may also be cost-effective.”

## Process for Revising Recommendations

- HIV Prevention Leadership Summit,              San Francisco, August 2005
- Community consultation, Atlanta,        September 2005
- Peer review of “HIV Screening Recommendations for Adults, Adolescents, and Pregnant Women in Health Care Settings,” Atlanta, November 2005
- Revision of draft recommendations in progress

## Considerations for RevisionsAdults and Adolescents - I

- Routine, voluntary HIV screening for all persons 13-64 in health care settings, not based on risk or prevalence
- Repeat HIV screening of persons with known risk at least annually
- Opt-out HIV testing with the opportunity to ask questions and the option to decline; include HIV consent with general consent for care
- Communication of test results
- Prevention counseling in conjunctions with HIV screening in health care settings is not required

## Considerations for RevisionsAdults and Adolescents - II

- Intended for all health care settings, including inpatient services, EDs, urgent care clinics, STD clinics, TB clinics, public health clinics, community clinics
- Corrections facilities: separate recommendations
- Provide clinical HIV care or establish reliable referral to qualified providers

## Considerations for RevisionsAdults and Adolescents - III

- State and local regulations should be reviewed and revised as needed
- Low prevalence settings: consider “sunset” provision
- Initiate screening
- If HIV prevalence shown to be <0.1%, continued screening may be unwarranted

## Considerations for RevisionsPregnant Women

- Universal opt-out HIV screening
- Include HIV in panel of prenatal screening tests
- Consent for prenatal care includes HIV testing
- Notification and option to decline
- Second test in 3rd trimester for pregnant women:
- Known to be at risk for HIV
- In key jurisdictions
- In high HIV prevalence health care facilities
- Opt-out rapid testing for women with undocumented HIV status in L&D
- Initiate ARV prophylaxis on basis of rapid test result
- Opt-out newborn testing if mother’s status unknown

## Remaining Issues

- Who will pay?
- Reimbursement as for other screening
- Public funding
- Assuring access to care
- Continuing work to reduce stigma

## Summary

- There is an urgent need to increase the proportion of persons who are aware of their HIV-infection status
- Expanded, routine, voluntary, opt-out screening in health care settings is needed
- Such screening is cost-effective
- In 2006, CDC will issue revised recommendations for HIV testing of adults, adolescents and pregnant women in health care settings

## Acknowledgments

- CDC
- Bernard Branson
- Margaret Lampe
- Allan Taylor
- Irene Hall
- Jill Clark
- Duncan MacKellar
- Stephanie Sansom
- Sheryl Lyss
- Matt McKenna
- John Brooks
- Anne Moorman
- Peter Kilmarx
- Sherrie Deyette
- Kevin DeCock
- Robert Janssen
- Ron Valdiserri

- Collaborators
- Hunter Handsfield, UWa
- Jim Lee, Texas DSHS
- A. David Paltiel, Yale
- Rochelle Walensky, Harvard
- Gillian Sanders, Duke
- Douglas Owens, Stanford
- Scott Halpern, Penn
- Howard Grossman, AAHM
- FJ Palella, Jr, Northwestern
- Carlos del Rio, Emory
- Yvette Calderon, New York
- Scott Kellerman, New York
- Robert Weinstein, Chicago
- Guthrie Birkhead, New York
- Eve Mokotoff, Michigan