# Presentation: 474961

## Advancing HIV Prevention inthe United States

**Association of Maternal & Child Health Programs Annual Conference **
**March 1, 2004**
**Washington, DC**

## Overview

- Advancing HIV Prevention: a CDC Initiative
-  Margaret Lampe, CDC
- Prenatal HIV Testing
- Stephanie Sansom, CDC
- Implementing HIV Counseling and Rapid Testing for Women in Labor: The New Jersey Experience
- Carolyn Burr, François-Xavier Bagnoud Center, UMDNJ
- Perinatal HIV Prevention in New York
- Roberta Glaros, AIDS Institute, NYDOH

## Advancing HIV Prevention: New Strategies for a Changing Epidemic

**Margaret A. Lampe**
**Epidemiology Branch**
**Division of HIV/AIDS Prevention**
**Centers for Disease Control & Prevention**

## Why a new initiative?

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## OraQuick HIV-1 Rapid Antibody Test: designed for oral fluid, serum, whole blood

**OraQuick HIV-1 Rapid Antibody Test: designed for oral fluid, serum, whole blood**

## FDA-approved November 7, 2002 for use with finger stick whole blood specimens;  granted CLIA waiver January 31, 2003

**FDA-approved November 7, 2002 for use with finger stick whole blood specimens;  granted CLIA waiver January 31, 2003**

## Obtain finger stick blood specimen

**Obtain finger stick blood specimen**

## Loop collects 5 microliters of whole blood

**Loop collects 5 microliters of whole blood**

## Insert loop into vial and stir

**Insert loop into vial and stir**

## Insert device; test develops in 20 minutes

**Insert device; test develops in 20 minutes**

## Positive

**Positive**

**Negative**

**Reactive Control**

**Positive**

**Read results in 20-40 minutes**

## Confirmatory Testing Required

- For Western blot:
- Venipuncture for whole blood
- Oral fluid specimen
- Immunofluorescence assay

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## Rapid HIV-1 Antibody Testing at Labor & Delivery for Women of Unknown HIV Status: 

**A Practical Guide & Model Protocol**

## Rapid HIV Testing in L&D

- MTCT rates of <2% are possible
- Early identification of HIV infection
- 3 part ART regimen including ZDV (AZT)
- Obstetric interventions
-  Pre-conception is ideal time for HIV testing, prevention/treatment, next best is early in pregnancy
- ~280-370 perinatally HIV-infected infants/yr

**Notes:**
“Good”—reasonable sensitivity/specificity and results in less than 1 hour.

Implementing rapid testing and short-course antiretroviral therapy in labor and delivery settings is feasible, and as with implementing any new screening program and clinical intervention, there are some challenges. 

## Rapid HIV Testing in L&D

- ~40% of infected infants, maternal HIV status unknown to provider prior to L&D
- ART can reduce MTCT up to 50% even when begun during L&D.
- “Good” rapid tests are now available in the U.S.
- L&D Rapid testing logistically feasible, with challenges (MIRIAD & others)

**Notes:**
“Good”—reasonable sensitivity/specificity and results in less than 1 hour.

Implementing rapid testing and short-course antiretroviral therapy in labor and delivery settings is feasible, and as with implementing any new screening program and clinical intervention, there are some challenges. 

## OIG Report

- Office of the Inspector General report: “Reducing Obstetrician Barriers to HIV testing”
- “CDC should facilitate the development and states’ implementation of protocols for HIV testing during labor and delivery in order to promote testing in this setting as the standard of care.”

**Notes:**
congressional mandate of the Ryan White CARE Act Amendments of 2000 was to conduct a study of perinatal HIV transmission in the U.S., the Office of the Inspector General (OIG) issued a report titled: “Reducing Obstetrician Barriers to HIV testing” in 2002. Among the recommendations in the report, the OIG recommended that “CDC should facilitate the development and states’ implementation of protocols for HIV testing during labor and delivery in order to promote testing in this setting as the standard of care.”

## Perinatal HIV Rapid Testing Working Group

- Obstetrics
- Pediatrics
- Nursing
- Public health practice
- Health education and training

- Blood screening
- Laboratory science
- Epidemiology
- Rapid HIV testing technology
- Care and support of HIV- infected pregnant women

**10 individuals with expertise in:**

**Notes:**
In the summer of 2002, CDC convened a working group of 10 individuals with expertise in obstetrics, pediatrics, public health practice, nursing, health education and training, blood screening and laboratory science, epidemiology and rapid HIV testing technology. The working group represents academic institutions and university hospitals, a peer advocacy/support organization for women living with HIV, state and federal health agencies, as well as an internationally recognized HIV training and education organization. Each of them brings unique expertise regarding rapid HIV testing to the document.

## Purpose of this Model Protocol

- Practical guidance to:
- Clinicians
- Laboratorians
- Hospital Administrators
- Public Health Program & Data Professionals
- Policy Makers
- Provide general structure of a rapid HIV testing protocol, can be adapted locally

**Notes:**
Protocol can be adapted by facilities

## Contents Overview:

- Planning: considerations when getting started
- Choosing type of test
- Location (L&D or Lab)
- Key elements of a local protocol
- Eligibility
- Opt-out approach
- Providing results, intrapartum clinical care
- Follow up care of woman and child
- Management Considerations

**Notes:**
Deciding where to conduct rapid HIV testing depends on a number of factors, including:
-logistics in the labor and delivery unit, 
-availability of trained staff, 
-the capacity of the laboratory to consistently convey rapid HIV test results quickly  (optimally in less than 60 minutes)
-and the Clinical Laboratory Improvement Act (CLIA) categorization of the test device. 
The OraQquick® rapid HIV-1 antibody test is CLIA waived and can be performed on the labor and delivery unit, the Reveal® rapid HIV-1 antibody test is designated by CLIA as a moderate-complex test, and must therefore be performed in a laboratory. 
Point-of-care testing (L&D) requires training and continuing supervision to ensure competent and proficient testing.  This can pose a challenge, especially if staff turnover is high. 
With rapid testing in the laboratory, attaining prompt results consistently requires the availability of 24-hour staff responsive to the urgent need for stat HIV test results.  
Choosing the location for rapid testing may be best accomplished after a needs assessment in labor and delivery and consultation with the hospital’s point-of-care testing committee. 

-What does a positive RT actually mean?
	PPV, false positives
	Supplemental Testing

## Rapid HIV testing in L&D

- Until all pregnant women with HIV access screening prenatally, the promise of ACTG 076 and other clinical trials cannot be realized.
- Rapid testing provides a last opportunity to reduce the impact of missed prevention opportunities

## Recommendation

- 	“Hospitals should adopt a policy of routine, rapid HIV testing using an opt-out approach for women who have undocumented HIV test results when presenting to labor & delivery.”

## Acknowledgements:

**Rapid Testing Working Group**:
- 	Margaret Lampe, CDC
- 	Bernard Branson, CDC
- 	Sindy Paul, NJ DOH
- 	Carolyn Burr, FXB (NPHRC)
- 	Elaine Gross, FXB (NPHRC)
- 	Robert Maupin, LSU (Obstetrics, MIRIAD)
- 	Cyndie Eicher, LSU (Laboratory)
- 	Brian Forsyth, Yale (Pediatrics)
- 	Dawn Averitt, The Well Project (peer support)
- 	Mary Glenn Fowler, CDC
**Women **participating in:
- 	focus groups, pilots, research studies & rapid testing programs

**Other support:**
- CDC:
- Ida Onorato
- Marc Bulterys
- Alan Greenberg
- Patrick Sullivan
- Perinatal Executive Committee
- Pat Garcia (Northwestern Univ.)
- Yolanda Olszewski (CORE Center, Chicago, IL)
- Yvette Rivero (Univ. Miami)

## Interested?

- _[www.cdc.gov/hiv/PROJECTS/perinatal/](http://www.cdc.gov/hiv/PROJECTS/perinatal/)_** **
- _[MLampe@cdc.gov](mailto:MLampe@cdc.gov)_
**Thank You**

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## Predictive Value-Single Screening Test: Differing HIV Prevalence

| HIV Prevalence | Calculated Positive Predictive Value (PPV) |  |  |  |
| --- | --- | --- | --- | --- |
|  | OraQuick  | Reveal  | Single EIA  | UniGold |
|  |  |  |  |  |
| 10% | 99% | 92% | 98% | 97% |
| 5% | 98% | 85% | 96% | 95% |
| 2% | 95% | 69% | 91% | 87% |
| 1% | 91% | 53% | 83% | 77% |
| 0.5% | 83% | 36% | 71% | 63% |
| 0.3% | 75% | 25% | 60% | 50% |
| 0.1% | 50% | 10% | 33% | 25% |

- *PPV may differ from these estimates

## MIRIAD Sites and Hospitals

**Chicago**

**New York**

**Miami**

**Louisiana**

**Atlanta**

**MIRIAD Sites and Hospitals**

- Cook County

- Bethany

- St. Bernard

- Provident

- Mt. Sinai

- University of

- Chicago

- Bronx

- -

- Lebanon

- Harlem

- Jacobi

- N. Central Bronx

- Lincoln

- Charity (New Orleans)

- Earl K. Long (Baton

- Rouge)

- Jackson Memorial

- Jackson North

- Jackson South

- Grady

## Bethany Hospital

- Rapid test performed on Labor and Delivery unit.
- Eligible patients are determined here in the Labor and Delivery Triage area.

## The rapid test is done on this counter, extra supplies are stored below. 

OB physicians and Midwives share MIRIAD testing at Provident.

- OB physicians and Midwives share MIRIAD testing at Provident.

**Provident Hospital**

## Cook County Hospital

- Clerks on each shift access HIV results from the computer system.
- Eligible patients are offered rapid testing and consented in the Triage area.

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