# Presentation: 245483

##  Revised Recommendations for HIV Testing in Health-Care Settings in the United States 

- Deputy Director for Science
- Division of HIV/AIDS Prevention
- Centers for Disease Control and Prevention

** ****Revised Recommendations for HIV Testing in Health-Care Settings in the United States **

**Presidential Advisory Council on HIV/AIDS**
**October 17, 2006**

## Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care SettingsMMWR  2006;55(No. RR-14):1-17Published September 22, 2006

- http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm

## Rationale for Revising Recommendations

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

**Notes:**
This slide summarizes CDC’s rationale for revising the recommendations for HIV testing in health care settings:
 Evidence shows that many HIV-infected persons access health care during the years before they are diagnosed, but they are not tested for HIV.
 Though there is no cure, effective treatment is available.
 Increasing evidence indicates that awareness of HIV infection leads to substantial reductions in high-risk sexual behavior.
 Despite extensive efforts, the evidence is inconclusive about the prevention benefits from “typical” counseling for persons who test negative.  That is not to say that more intensive counseling lacks effectiveness, but that the traditional pre- and post-test counseling usually offered in conjunction with HIV testing does not have lasting effects on risk behavior.
 Finally, in the U.S., there are high levels of knowledge about HIV, and a great deal of experience with HIV testing.

## 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*

**Notes:**
CDC currently estimates that there are 1 to 1.2 million people living with AIDS in the United States.

Of these, approximately one quarter (250,000 to 400,000 persons) do not know they are infected,
and it is estimated that approximately 40,000 new infections continue to occur each year.  

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

- ~25% Unaware of Infection

- ~75% Aware of Infection

- People Living with HIV/AIDS: 1,039,000-1,185,000

- New Sexual Infections Each Year: ~32,000

- Accounting for:

- ~54%      of New Infections

- ~46%      of New Infections

**Marks G, et al**
**AIDS 2006;20:1447-50**

**Notes:**
It is estimated that sexual transmission accounts for 32,000 of the 40,000 new infections each year.

Conservative estimates based on the changes in behavior observed once people find out they are infected with HIV indicate that the 25% of people who are unaware that they are infected account for at least 54%, and potentially as much as 70%, of the new sexually transmitted infections each year.  The transmission rate among those who don’t know they are infected is 3.5 times higher than for people who know about their HIV infection.

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

## 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%**

**Notes:**
In addition to the benefits of treatment for the individual patient, Screening has significant potential prevention benefits.

In a meta-analysis of 11 studies,  after people become aware they are infected with HIV, there is 68% less unprotected anal or vaginal intercourse with HIV-negative partners among people who are aware they are HIV-infected, compared with those who are not.

These studies included people with long-term HIV infection, as well as those who were recently diagnosed; some were conducted before, and others, after the availability of Highly Active Antiretroviral Therapy.  Thus, the finding of reduced risk behavior was not based only on persons who had known of their HIV-positive status for a short time.

## 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*

## 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

## Process for Revising Recommendations

- Strategies announced in 2003 Advancing HIV Prevention Initiative:
- make HIV testing a routine part of medical care
- further decrease perinatal transmission
- Interim technical guidance
- Demonstration projects in health-care settings
- Evidence-based review of literature

**Notes:**
The process for revising CDC’s recommendations for HIV testing in health-care settings spanned several years.

It began with a consultation with Emergency Department providers and public health professionals in March, 2004, followed by a review of the literature
Plans to revise the recommendations were presented at the HIV prevention leadership summit in August 2005.
This was followed by a consultation with community representatives, providers,  and public health professionals in September 2005
A draft of the Recommendations was reviewed during a consultation with diverse professionals in November, 2005, and extensively revised.
The revised draft underwent peer review by recognized experts in the field of HIV, and was circulated for public comment in March 2006.
After revisions based on public comments, the final recommendations were published in the MMWR on September 22, 2006.

## Process for Revising Recommendations

- Affinity session, 2005 HIV Prevention Leadership Summit
- Consultation with medical and public health professionals re: ED screening April 2004
- Community forum, September 2005:
*community-based organizations, people living with HIV/AIDS, health departments, academia*
- Consultation on first draft November 2005:
*professional organizations, state and federal agencies, PLWHA, other stakeholders.*

## Process for Revising Recommendations

- Revised draft circulated for public comment March 2006
- Revised draft submitted for scientific peer review March 2006
- Presented to PACHA, March 16, 2006
- Revisions made on the basis of public and scientific comments
- Final recommendations published September 2006

## Revised RecommendationsAdults and Adolescents - I

- Routine, voluntary HIV screening for all persons 13-64 in health care settings, not based on risk
- All patients with TB or seeking treatment for STDs should be screened for HIV
- Repeat HIV screening of persons with known risk at least annually
- When acute retroviral infection is a possibility, use an RNA test in conjunction with an antibody test

**Notes:**
This is a summary of the revised recommendations for HIV Testing of Adults and Adolescents in Health-Care Settings.
(slide)

## Revised Recommendations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, substance abuse treatment centers, correctional health facilities, primary care settings
- Provide all patients with written or verbal information about HIV and the meaning of test results
- Provide clinical HIV care or establish reliable referral to qualified providers

**Notes:**
(bullets from slide)

## Revised RecommendationsAdults and Adolescents - III

- Low prevalence settings:
- Initiate screening
- If yield from screening is less than 1 per 1000, continued screening is not warranted
- Steps should be considered to resolve conflicts between the recommendations and state or local regulations

**Notes:**
Because providers often do not know what the prevalence of undiagnosed HIV infection might be in their patients, all providers are encouraged to initiate screening.

In very low prevalence settings, providers are encouraged to initiate HIV screening.  If the yield of screening is less than 1 per 1,000, continued screening is not warranted.

Some states have specific laws or regulations with regard to written informed consent or required pretest counseling.  Providers are encouraged to initiate screening within those current parameters, while consideration is given to steps that may be necessary to resolve conflicts with the recommendations.

## Revised RecommendationsAdults and Adolescents - IV

- Opt-out HIV screening with the opportunity to ask questions and the option to decline testing
- Include HIV consent with general consent for care; separate signed informed consent not recommended
- Prevention counseling in conjunctions with HIV screening in health care settings is not required
- Communicate test results in same manner as other diagnostic/screening tests

**Notes:**
This is a summary of additional recommendations for HIV Testing that have been sparked considerable debate.
(slide)

## Revised RecommendationsPregnant Women - I

- Universal opt-out HIV screening during each pregnancy
- Include HIV in routine panel of prenatal screening tests
- Consent for prenatal care includes HIV testing
- Notification and option to decline testing
- Second test in 3rd trimester for pregnant women:
- Known to be at risk for HIV
- In jurisdictions with elevated HIV incidence
- In high HIV prevalence health care facilities

**Notes:**
These are the Recommendations for pregnant women:

Universal, opt-out HIV screening for every pregnant woman during each pregnancy.
Include HIV testing in the routine panel of prenatal screening tests
Consent for prenatal care should include HIV testing
Opt-out screening, after the patient is notified that testing will be done, and that she has the option to decline

A second test during the 3rd trimester is recommended in certain circumstances, where there is an increased likelihood that a pregnant woman might become infected with HIV during pregnancy, after she has had a negative HIV test.  A second test is recommended for women:
- Known to be at high risk for HIV (e.g., injection drug users)
- In jurisdictions with elevated HIV incidence:  these are specified in the Recommendations, and will be revised periodically
- In health care facilities in which prenatal screening identifies at least 1 HIV-infected pregnant woman per 1000 women screened 

## Revised RecommendationsPregnant Women - II

- Opt-out rapid testing with option to decline for women with undocumented HIV status in L&D
- Initiate ARV prophylaxis on basis of rapid test result
- Rapid testing of newborn recommended if mother’s status unknown at delivery
- Initiate ARV prophylaxis within 12 hours of birth on basis of rapid test result

**Notes:**
(slide)

## Review Process for Comments

- All comments reviewed by 4 staff
- Major themes identified and coded
- Entered into Access database
- Comments and responses reviewed and recommendations modified

## Change in Written Informed Consent Requirement

- n=79 Comments

## Change in Prevention Counseling Requirement

- n=80 Comments

## Effect of Counseling in Conjunction with HIV testing

- Meta-analysis of 27 studies of HIV-CT:
- HIV-positive participants reduced unprotected intercourse and increased condom use.
- HIV-negative participants did not modify their behavior more than untested participants.

*- Weinhardt et al, 1999: Am J Public Health*

**Notes:**
[Note:  Second bullet appears on mouse click.]

Another meta-analysis of 27 studies examined the effect of HIV counseling in conjunction with HIV testing.  It found that
HIV-positive participants substantially reduced unprotected intercourse and increased their condom use, but
<click> For HIV-negative study participants, changes in behavior were little different than for persons who had not received HIV counseling and testing at all.

## The Status Quo

- Has brought us a long way, but we are currently stalled
- Late diagnosis is frequent, especially of socio-economically disadvantaged persons
- Numerous missed opportunities for earlier diagnosis, treatment, and prevention

## Missed Opportunities:  South Carolina

- Jan 2001 – Feb 2006
- Confidential matching with registry of health care visits:
- 60 emergency departments
- 62 inpatient facilities
- 63 ambulatory surgery facilities
- 19 free medical clinics

*Courtesy SC Dept of Health and Environmental Control*

## Missed Opportunities:  South Carolina

- 4,345 reported HIV cases
- 3,157 (73%) made 20,271 health-care visits prior to their first positive HIV test
- Diagnosis codes at 15,648 (77%) of prior visits would not have prompted an HIV test

*Courtesy SC Dept of Health and Environmental Control*

## Missed Opportunities:  South Carolina

- 1,316 (42%) developed AIDS within 1 year
- No HIV test was performed during 8,160 prior health care visits (median = 4 per patient)
- Diagnosis codes for 6,127 (75%) of prior visits would not have prompted an HIV test

*Courtesy SC Dept of Health and Environmental Control*

## Moving Forward

## Dissemination of Recommendations

- Published in MMWR, September 22, 2006
- Comprehensive communication and media plan
- Conducted telebriefings to share recommendations with partners and answer questions
- Met with representatives from other DHHS agencies
- Developed web page to post recommendations and resources for clinical settings:
- http://www.cdc.gov/hiv/topics/testing/healthcare/index.htm

## Consultation with National Medical Associations, Atlanta, Oct 16, 2006

- Consulted with key medical organizations and insurers to:
- Identify tools currently available to assist clinicians implement the Recommendations
- Provide comments and proposed modifications to increase utility of tools
- Identify gaps and recommend development of additional tools; and identify organizations that could assist with development of these tools
- Identify process for promotion/dissemination of tools through existing communication networks of partnering organizations
- Identify regulatory/legislative barriers and strategies to address them
- Identify strategies to seek reimbursement for HIV screening
- Provide input on implementation guidance.

## Implementation Guidance

- Develop implementation guidance for various types of settings in collaboration with key stakeholders:
- Emergency departments
- STD clinics
- Community health centers and other primary care settings
- Correctional facilities
- Family planning clinics

## Strengthening Partnerships

- Strengthening partnerships with National organizations to support implementation of recommendations through training and technical assistance:
- National Medical Association
- American Medical Association
- American Academy of Pediatrics
- Society of General Internal Medicine
- HIV Medicine Association
- American Academy of HIV Medicine
- Health Research and Educational Trust of the American Hospital Association
- National Association of Community Health Centers

## Summary

- There is an urgent need to increase the proportion of persons who are know whether they are infected with HIV
- Expanded, routine, voluntary, opt-out screening in health care settings is needed
- Such screening is cost-effective
- Recommendations Revised: September 2006
- Several jurisdictions have already begun
- Efforts underway to support implementation