# Presentation: 756002

## Changes inHIV Testing Practicesand Counseling Recommendations

- Associate Director for Laboratory Diagnostics
- Divisions of HIV/AIDS Prevention
- National Center for HIV, STD, and TB Prevention
- Centers for Disease Control and Prevention

- Changes inHIV Testing Practicesand Counseling Recommendations

- FDA Blood Products Advisory Committee Meeting
- November 3, 2005

**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.

## Outline

- Role of rapid HIV tests in the HHS “Advancing HIV Prevention” Initiative
- Postmarketing surveillance: rapid HIV tests and home sample collection HIV tests
- CDC’s planned revisions of counseling recommendations
- Anticipated value of an OTC vs CLIA-waived test
- Validating HIV tests for home use

## Four priority strategies:
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

*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.

## Awareness of  HIV status among 

- Number HIV infected             1,039,000 – 1,185,000
- Number unaware of
-   their HIV infection 	      252,000 - 312,000
- Estimated number of               40,000
-   new infections annually

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

*Glynn et al*
*2005 HIV Prevention Conference*

## Role for Rapid HIV Tests

- Increase receipt of test results:
*In 2000, 31% did not return for results of HIV-positive conventional tests at publicly funded sites*
- Increase feasibility of testing in acute-care settings with same-day results
- Increase number of venues where testing can be offered to high-risk persons
- Increase identification of HIV-infected pregnant women so they can receive effective prophylaxis

## 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, Los Angeles		1.3%
*           **CDC HIV testing sites:  1.1%*

_*New HIV+*_

_*Study site*_

## Rapid HIV Screening in Medical Settings

| Demonstration Project | No. tested |  % HIV+ |
| --- | --- | --- |
| New York City
   Bronx- Lebanon: 2 clinics, 1 ED | 2,355 | 2% |
| Los Angeles
   2 clinics, 1 ED | 4,816 | 1% |
| Alameda County (Oakland)
   1 ED | 3,746 | 1.2% |
| Massachusetts
   1 outpatient, 1 inpatient, 1 clinic | 5,681 | 0.7% |
| Wisconsin
   3 clinics | 1,555 | 0.4% |

*CDC, preliminary data - Sept 2005*

## Rapid HIV Testing in Non-Clinical Settings

| Community-based organization | No. Tested | % HIV+ |
| --- | --- | --- |
| AIDS Healthcare Foundation, L.A. | 2,318 | 1.6% |
| Bienestar, L.A. | 1,902 | 2.9% |
| CHAG, Detroit | 2,011 | 1.5% |
| Continuum, San Francisco | 1,772 | 1.8% |
| HSP of Dorchester, Boston | 4,618 | 1.1% |
| Kansas City Free Clinic | 1,826 | 1.1% |
| The Night Ministry, Chicago | 1,867 | 1.2% |
| Whitman Walker, Washington DC | 4,245 | 0.7% |
|  | 20,659 | 1.4% |

*CDC, preliminary data - Sept 2005*

## HIV Screening with OraQuick in MIRIAD Mother Infant Rapid Intervention At Delivery

-     Testing of pregnant women in labor for whom no HIV test results are available;  12 hospitals in 5 cities:  Atlanta, Chicago, Miami, New Orleans, New York
- 	7680 women screened
-  54 (0.7%) new HIV infections identified
-  6 false positive OraQuick tests, no false negatives
-  15 false-positive EIAs:  7 p24 only, 8 WB negative
- Specificity:  OraQuick 99.92%; EIA 99.80%
- Positive predictive value: OraQuick  90%;  EIA 76%

*Bulterys et al, JAMA July 2004*

**Notes:**
These are the results of PMTCT with rapid testing in labor and delivery in the U.S.
In this study, conventional EIA testing was performed on all persons, in addition to the rapid test.
The OraQuick rapid test showed no false-negative test results, and fewer false-positive tests than the EIA.

## Performance of OraQuick Rapid HIV Test

- 4 studies comparing OraQuick with whole blood and oral fluid to EIA/Western blot:
- Known HIV+ persons – Los Angeles
- Prospective testing, HIV testing clinic and STD clinics – Los Angeles, Phoenix
- Pregnant women – 5 MIRIAD cities
- Outreach settings – Minneapolis

## Performance of OraQuick:  Known HIV+

|  | N | Whole blood | Oral fluid |
| --- | --- | --- | --- |
| Known HIV+ | 576 | 99.5%  (98.5-99.9) | 98.4%  (97.1-99.3) |
|    - On HAART | 390 | 99.2% (97.8-99.8) | 97.7% (95.6-98.9) |
|    - Not on HAART | 186 | 100% (98.4-100) | 100% (98.4-100) |

- Sensitivity

**Notes:**
All false-negative OraQuick tests were observed in persons receiving HAART therapy, a phenomenon reported by O’Connell et al in J Clin Micro in 2003.  In that study, specimens available before HAART was started were positive by OraQuick, and titers of anti-gp41 antibody (and band intensity on Western blot) were diminished in persons with effective, long-term viral suppression with HAART.

## Performance of OraQuick:  Prospective Testing

|  | 
Sensitivity | 
Specificity |
| --- | --- | --- |
| OraQuick
    - Whole blood 
    - Oral fluid | 
99.7% (98.3-100)
99.1% (97.3-99.8) | 
99.9% (99.8-100)
99.6% (99.4-99.7) |
| Serum EIA | - | 99.7% (99.6-99.8) |

- Combined study population:
- 	     327 HIV-positive by reference tests
- 	12,010 HIV-negative by reference tests

**Notes:**
There was 1 false negative whole blood OraQuick, 3 false-negative oral fluid;
12 false-positive whole blood OraQuick, 54 false-posistive oral fluid, and 35 false-positive EIAs

## Postmarketing Surveillance:  2003

- 20,585 rapid whole blood HIV tests
- 392 (1.9%) confirmed HIV-positive
- 21 (5.4%) reactive OraQuick had negative or indeterminate confirmatory test results
- 10 resolved as true positive on follow-up
- 4  resolved as false-positive on follow-up
- 7 with unsuccessful follow-up

## Postmarketing Surveillance:  2004-2005

|  | 
No. of Tests | HIV Seropositivity 
Median % (range) | Estimated Specificity
  Median % (range) | 
PPV
Median % (range) |
| --- | --- | --- | --- | --- |
| RT whole blood | 83,644 | 0.9 (0.1-2.8) | 99.9 (99.7-100) | 97.3 (76.5-100) |
| RT oral fluid | 17,220 | 1.2 (0.3-2.4) | 99.8 (99.4-100) | 94.5 (66.7-100) |
| Conventional | 31,811 | 1.5 (0.5-5.1) | --- | --- |

- Project-specific median (range) for confirmed HIV seropositivity, specificity and positive predictive value of OraQuick
-  (347 testing sites, 14 project areas)

*CDC, preliminary data - Oct 2005*

## Postmarketing Surveillance:  2004-2005

|  | Received Negative Results
Median % (range) | Received Preliminary Positive Results
Median % (range) | Received Confirmed Positive Results
  Median % (range) |
| --- | --- | --- | --- |
| Rapid | 99.7 (90.6-100) | 100 (87.5-100) | 90.6 (43.7-100) |
| Conventional | 79.9 (29.1-98.9) | --- | 83.3 (44.4-100) |

- Project-specific median (range) of clients who received test results
- (347 testing sites in 14 project areas)

*CDC, preliminary data - Oct 2005*

## Postmarketing Surveillance:  2004-2005

- Quality assurance outcomes, 154 sites, 7 project areas January 1, 2005 to June 30, 2005
- 35,188 persons tested
- 4 (0.01%) invalid test results
- 1,086 controls run
- median 2.7% (range 0.5% - 9.7%) of all tests
- 2 controls reported as “invalid”
- 2 sites each reported testing clients on one day when temperature was out of range
- 1 site reported one day when tests kits were stored outside recommended temperature range

*CDC, preliminary data - Oct 2005*

## Postmarketing Surveillance: Home Sample Collection HIV Testing

- User characteristics, May 1996 – September 1997

|  | All Users | HIV+ Users | HIV Prevalence |
| --- | --- | --- | --- |
| Female | 38% | 15% | 0.4% |
| Male | 62% | 85% | 1.4% |
| African American | 5% | 16% | 2.7% |
| White | 85% | 69% | 0.7% |
| Hispanic | 5% | 12% | 2.6% |
| Heterosexual | 77% | 23% | 0.3% |
| Bisexual male | 8% | 27% | 3.1% |
| MSM | 10% | 38% | 3.5% |
| IDU | 1% | 6% | 4.1% |

*Data available for 76,373 (59%) of 165,194 users*

*-JAMA 1998*

## Postmarketing Surveillance: Home Sample Collection HIV Testing

- 58% of all users and 49% of users who tested HIV positive had never been tested before.
- HIV prevalence:
- 0.8% among those with no previous test
- 0.7% among those with previous negative test

*-JAMA 1998*

## Postmarketing Surveillance: Home Sample Collection HIV Testing

- HIV-positive users:
- 23% had a source of follow-up care
- 65% accepted referrals for care
- 12% were already receiving antiretroviral therapy
- Psychological distress:
- 7% expressed shock at unexpected positive result
- 5% hung up immediately, without counseling
- HIV-negative users:
- 82% received recorded message only
- 29% called more than once
- 12% elected to speak with a counselor

- _Analysis of counselors “call log” and telephone results_

*-JAMA 1998*

## HIV Testing, Persons Age 18-64, 2002 (Excluding Blood Donation)

|  | NHIS | BRFSS |
| --- | --- | --- |
| Ever tested for HIV | 37.8% | 43.5% |
| Tested in past year | 10.0% | 12.2% |
|     - One or more risk factors | 21.5% | 26.8% |
|      - Pregnant women | 48.4% | 54.0% |
| Estimated no. persons tested
during preceding 12 months | 16-18 million | 21-22 million |

- NHIS: National Health Interview Survey
- BRFSS: Behavioral Risk Factor Surveillance System

*- MMWR December 3, 2004*

## HIV Testing, Persons Age 18-64, 2002 Source of Most Recent Test

| Private doctor/HMO | 43.5% |
| --- | --- |
| Hospital, ED, outpatient clinic | 22.4% |
| Public source | 23.5% |
| At home | 5.1% |
| Other location | 4.8% |

- National Health Interview Survey

*- MMWR December 3, 2004*

## Changes  in Testing and Counseling Recommendations

- Routine HIV screening in health care settings in high prevalence communities or facilities
- Opt-out consent for pregnant women, with written or verbal notification that testing will be done
- Written or verbal information about HIV
- Prevention counseling in conjunction with HIV testing not required in health care settings
- Retesting at least annually for persons at high risk
- Ensure linkage to care for persons who test positive

## Rationale for Proposed Changes

- High levels of knowledge about HIV, availability of effective treatment, experience with HIV testing
- Many HIV-infected persons access health care but are not tested for HIV until symptomatic
- Inconclusive evidence about prevention benefits from typical counseling for persons who test negative
- Substantial reductions in high-risk sexual behavior among persons aware of HIV infection
*68% reduction in unprotected intercourse with partners not known to be HIV-positive*
- Prevention counseling encouraged for high risk persons but does not have to occur in context of HIV testing

## Potential Value of OTC vs CLIA-Waived Test

- Persons unwilling to be tested in other settings
- Persons who retest frequently
- Knowledge of partner’s status as a prevention intervention
- Local requirements for laboratories beyond CLIA requirements that impede HIV testing

## Potential Validation Studies

- Observed self-testing at high risk venues
- Counselor provides client with “OTC” device
- Observes specimen collection and testing
- Documents client reaction to test result
- Verifies client interpretation of test result
- Select 2 to 3 settings serving clients with different characteristics
- Minimum 500 clients in setting with HIV prevalence of 3% to 5%