# Presentation: 714742

##  Perinatal HIV Screening: Efforts to Monitor Trends and Reduce Transmission

**Stephanie Sansom, PhD, MPP, MPH**
**Margaret Lampe, RN, MPH**
**Epidemiology Branch**
**Division of HIV/AIDS Prevention**
**National Center for HIV, STD and TB Prevention**
**Centers for Disease Control and Prevention**

## Objectives

**CDC’s Advancing HIV Prevention initiative**
**Efforts to eliminate perinatal HIV transmission in the U.S. through**
**Routine prenatal HIV testing using an opt-out approach **
**Rapid, opt-out HIV testing at labor and delivery among women without a documented prenatal test**

## Advancing HIV Prevention

**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**

## Further decrease perinatal HIV transmission

**Work with partners to promote routine, voluntary prenatal testing, using an opt-out approach**
**Develop guidance for using rapid tests during labor and delivery or post partum**
**Provide training in conducting prenatal testing**
**Monitor integration of routine prenatal testing into medical practice**

## Prenatal HIV testing recommendations

**1995: USPHS recommends that all pregnant women be counseled for HIV and encouraged to be tested**
**2001: USPHS strengthens recommendation for routine testing of all pregnant women**
**Simplification of testing process so that pretest counseling is not a barrier**
**More flexible consent process to allow for various type of informed consent**
**Routine retesting in 3****rd**** trimester for facilities serving high HIV prevalence (i.e., >.5%) communities.**

## “Dear Colleague” recommendations, April 22, 2003

**No child should be born in the U.S. whose HIV status (or mother’s status) is unknown**
**Routine, voluntary prenatal HIV testing using an opt-out approach**
**Routine rapid testing at labor and delivery among women without a documented         prenatal test**

## Perinatal HIV Prevention indicator

**CDC HIV Prevention grantees should provide annual assessments of prenatal HIV testing rates.**

## Rationale for universal prenatal HIV testing

**Increasingly effective interventions to prevent perinatal transmission – < 2% v 25%**
**Interventions more effective when initiated earlier in pregnancy**
**Estimates that 280-370 infants are still perinatally infected each year**
** ****38% of their mothers not tested until birth or later**

## Prevalence of Diseases Screened for in Newborns

**Tyrosinemia 1 in >300,000**
**Maple-syrup urine disease          ****	****1 in 175,000**
**Homocystinuria 1 in 100,000**
**Galactosemia 1 in 60,000**
**Phenylketonuria 1 in 14,000**
**Hypothyroidism 1 in 4,000**

**Perinatal HIV exposure, US****	**** ****	****1 in 670**
**Perinatal HIV infection, US**
**	****	****1 in 2,680 **
**         ****to 1 in 33,500****      (according to interventions) **

## Implementation of recommended prenatal screening tests, 1998/1999*

| Test | Frequency (%)
(n=5,144) |
| --- | --- |
| Hepatitis B | 96.5 |
| Syphilis | 98.2 |
| Rubella | 97.3 |
| HIV | 57.2 |

- *Schrag S et al, Prenatal Screening for Infectious Diseases and Opportunities for
- Prevention, Obstet Gynecol 2003;102(4):753-60.

## Perinatal screening assessment review of  maternal charts, 2004

**Boost perinatal HIV testing rates: Ongoing monitoring with feedback appears to improve testing rates**
**Assess compliance with USPHS recommendations and provide technical assistance where perinatal HIV screening rates are suboptimal**
**Provide high HIV prevalence states with data to evaluate the impact of programs designed to boost testing rates.**
**Assess impact of state policies on testing rates**
**Improved collaborations with Maternal and Child Health to protect the health of pregnant women and infants**

## Perinatal HIV testingchart review project: Objectives

**State- or area-wide estimates of perinatal HIV screening rates**
**Delivery hospital-specific estimates of perinatal HIV screening rates**
**Assessment of rates of other recommended        perinatal screening tests (Group B strep, hepatitis B, chlamydia, syphilis, rubella)**
**Improved methods for estimating screening rates in all states**

## Perinatal HIV testingchart review project: Methods

**2002 data from part or all of 8 states**** ****(CT, DE, FL, GA, IL, TN, SC, WDC)**
**100-200 records abstracted from each**
**    ****delivery hospital**
**1,000-2,000 records per state**
**Sampling framework based on**
**     ****state birth records**
**Reports on testing rates to **
**    ****state health departments & delivery hospitals**

## 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 is acceptable & feasible, with some logistical 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

## 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
- *Not commercially available at this time

## 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.”**

## Implementation

**Promote with national partners**
**ACOG, FXB, AMCHP, HRET (AHA), CityMatCH, **
**6-7 regional trainings in ’04 and ’05**
**Developing training materials (web-based and CD-ROM)**
**Technical assistance to state grantees**
**Monitor prenatal and L&D testing (hospital survey, medical chart abstraction)**

## Materials Available

- Prenatal C&T
**ACOG Clinician Folder**
**Patient Brochures**
**Patient prenatal test information sheet (opt-out for HIV) **
**Perinatal HIV fact sheet for clinicians**
**Policy statement**
**Clinician antiretroviral therapy pocket guide (FXB)**
- Rapid HIV Testing in L&D
**CDC model protocol**
**FXB slide set**
- Perinatal HIV Faculty Training Curriculum (FXB)
**slide sets with scripts**
**case studies**

## Resources

**CDC Perinatal HIV Prevention**
**(screening guidelines, protocols, promising practices)    **_**[www.cdc.gov/hiv/projects/perinatal](http://www.cdc.gov/hiv/projects/perinatal)**_
**USPHS Perinatal ARV Prophylaxis Guidelines **_**[www.aidsinfo.nih.gov](http://www.aidsinfo.nih.gov/)**_
**AETC **_**[www.aidsetc.org/aidsetc?page=et-30-19](http://www.aidsetc.org/aidsetc?page=et-30-19)**_** **
**ACOG **_**[www.acog.org](http://www.acog.org/)**_
**Women, Children, HIV Global Resources **_**[www.womenchildrenhiv.org](http://www.womenchildrenhiv.org/)**__**[/](http://www.womenchildrenhiv.org/)**_** **