# Presentation: 474962

## Perinatal HIV Prevention in the United States: Translating Research & Policy into PracticeMargaret A. Lampe, RN, MPHCenters for Disease Control & PreventionDivision of HIV/AIDS Prevention Epidemiology Branch Maternal-Child Transmission Team

**February 22, 2005**

## Perinatally Acquired AIDS Cases by Year of Diagnosis, 1981–2002, United States

## Chain of events leading to an HIV-infected child

**The proportion of women . . .**
-   Who are HIV-infected
-  Who become pregnant
-  Who do not seek prenatal care
-  Who are not offered HIV testing
-    Who refuse testing
- 	  Who are not offered ARV prophylaxis
- 		   Who refuse ARV prophylaxis
-           Who do not complete the ARV prophylaxis
-              Whose child is infected despite treatment

-  IOM, 1998

## Steps to Reducing Perinatal HIV Transmission

-  Primary HIV prevention in women
- Prevention of unwanted pregnancy in HIV+ women
- Pre-conception counseling and care
-  Accessible, affordable, welcoming prenatal care
-  Universal prenatal HIV testing
-     Re-offering testing  to those who declined or at risk
- 	 Providing ARV prophylaxis & C/S to all eligible
- 	     Support for adherence to ARV
-           Rapid testing for women with unknown HIV status
- 		 ARV prophylaxis of exposed newborns 	 			     Comprehensive services for mother 				and infant

- François Xavier Bagnoud Center @  UMDNJ

## AHP Strategy 4 Further Decrease Perinatal HIV Transmission

**Work with partners to promote routine, voluntary prenatal testing, with option to decline (opt-out) **
**Develop guidance for using rapid tests during labor and delivery or postpartum and promote its implementation**
**Monitor integration of routine prenatal testing and rapid testing at labor and delivery into medical practice**
**Case control study to assess why perinatal HIV infections are still occurring**

**Notes:**
Further decrease perinatal HIV transmission. 

Although significant reductions have been made in perinatal transmission, 6,000 to 7,000 HIV-infected women gave birth in the United States during 2000, resulting in an estimated 280-370 HIV-infected infants. For about 40% of these perinatal transmissions, health care providers were unaware of the mother’s HIV infection before delivery.

To further decrease perinatal HIV transmission, the CDC will promote recommendations for routine, voluntary HIV testing of all pregnant women, and, as a safety net, for the routine screening of any infant whose mother was not screened. CDC will work with prevention partners, including the American College of Obstetricians and Gynecologists, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Nurse-Midwives, to disseminate the recommendations and support their implementation. 

CDC also will develop guidance for using rapid tests during labor, delivery, or postpartum if the mother was not screened prenatally, and provide training for health departments and providers in conducting prenatal testing. 

In 2003, CDC will expand its activities to monitor the integration of routine prenatal testing into medical practice. 

## 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 1,500**
**	**

## Prenatal HIV testing policies

- Voluntary approaches
- _Opt-in_: pre-test counseling and written consent specifically for an HIV test
- _Opt-out_: notification of test and the option to decline
- Mandatory approaches
- _Mandatory newborn screening_: infants are tested, with or without mother’s consent, when mother’s HIV status is unknown at delivery

## MMWR data sources

_**Chart reviews**_**:**** **
**	****8 states, 1998-1999, from a random sample of reviews of prenatal and L&D charts. Active Bacterial Core Surveillance/Emerging Infections Program.**
_**PRAMS**_**:**** **
**	****9 states, 1999, surveys of a random sample of recently delivered women**
_**Lab reports**_**:**** **
**	****5 Canadian provinces, 1999-2001, all HIV tests submitted to provincial labs.**

## Prenatal HIV Testing by State and Policy, Medical Record Review, 1998-1999

| State | Policy | N | %Tested |
| --- | --- | --- | --- |
| TN | Opt-out | 623 | 85 |
| NY | Mandatory | 438 | 52 |
|  | Mandatory+ | 112 | 83 |
| CT | Opt-in | 668 | 31 |
|  | Mandatory | 93 | 81 |
| MD | Opt-in | 665 | 69 |
| GA | Opt-in | 866 | 66 |
| MN | Opt-in | 605 | 62 |
| CA | Opt-in | 575 | 39 |
| OR | Opt-in | 498 | 25 |

*S. Sansom MMWR, Nov. 2001*

## 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 |

*MMWR 2002;51:1013-6*

## PRAMS Results, 1999

| State | Policy | N | %Tested |
| --- | --- | --- | --- |
| FL | Opt-in | 1,990 | 81 |
| NY | Mandatory | 758 | 69 |
|  | Mandatory+ | 502 | 93 |
| NC | Opt-in | 1,770 | 75 |
| IL | Opt-in | 1,994 | 72 |
| CO | Opt-in | 2,039 | 72 |
| AK | Opt-out | 1,892 | 71 |
| WV | Opt-in | 1,327 | 67 |
| OK | Opt-in | 1,980 | 62 |
| OH | Opt-in | 1,589 | 61 |

## Prenatal HIV Testing by Canadian Province and Policy, 1999-2001

| Province | Policy | N | %Tested |
| --- | --- | --- | --- |
| Alberta | Opt-out | 37,963 | 98 |
| New&Lab | Opt-out | 4,770 | 94 |
| Quebec | Opt-in | 73,781 | 83 |
| B Columbia | Opt-in | 41,739 | 80 |
| Ontario | Opt-in | 129,758 | 54 |

*S. King*

## Additional conclusions

- Better data needed to assess state perinatal HIV testing rates and timing (ante-, intra-, or post-partum)
- Ongoing, randomized reviews of            medical records may be the most valid approach

## Perinatal HIV TestingBalance Shifting  

- 	Benefits versus risks of testing pregnant women for HIV have shifted over years

- BENEFITS

- RISKS

## CDC/USPHS Guidelines for Perinatal Testing in the U.S.

**First edition, 1985**
- No treatment
- Growing stigma
**Second edition, 1995**
- AZT prophylaxis reduces MTCT
- universal counseling/voluntary testing
- Marked decline in perinatal cases
**Third edition, 2001**
- Maternal treatment advances allows both  mothers and babies to benefit
- “HIV screening should be a routine part of prenatal care for all women.”
- Repeat testing 3rd trimester women at risk and in high prevalence areas
**Rapid HIV testing for women in labor with unknown HIV status**

- BENEFITS

- RISKS

- BENEFITS

- RISKS

- BENEFITS

- RISKS

## CDC Recommendations April 22, 2003

- No child should be born in the U.S. whose HIV status (or mother’s status) is unknown
- Routine, opt-out screen prenatally
- Rapid, opt-out test at labor and delivery
- Newborn testing per state law

*“**Dear Colleague” letter ****www.cdc.gov/hiv/projects/perinatal/***

## Slide 17

## ACOG Recommendations

- Opt-out prenatal HIV testing
- Repeat HIV testing in 3rd trimester to women:
- in areas with high HIV prevalence (_>_0.5%)
- known to be at high risk for HIV-infection
- who declined earlier HIV testing
- Rapid HIV testing for women in labor with undocumented HIV status
- initiate ARV prophylaxis (with consent) for women with positive results without waiting for confirmatory test results

**Why Rapid HIV Testing for Women in Labor?**

## Rationale

- 6,000-7,000 HIV infected women gave birth in 2000

*Office of Inspector General, July 2003*

## Rationale

**L&D is an opportunity—a 48 hr window**
** **
**4 FDA-approved Rapid HIV Tests available**
**Oraquick**** Rapid HIV-1 Antibody Test**
**Reveal G-2**** Rapid HIV-1 Antibody Test**
**Uni-Gold**** Recombigen HIV Test**
**Multispot ****HIV-1/HIV-2**

## Rationale

- An intervention – ARV Prophylaxsis

*Wade,et al. 1998 NEJM 339;1409-14*
*Guay, et al. 1999 Lancet 354;795-802*
*Fiscus, et al. 2002 Ped Inf Dis J 21;664-668*
*Moodley, et al. 2003 JID 167;725-735*

*P. Garcia*

**Estimated**
**Transmission**
**Rate**

## Evidence: Objectives of MIRIADMother Infant Rapid Intervention At Delivery

**To determine the feasibility and performance of rapid HIV testing for women in labor with undocumented HIV status**
**   **
**To provide timely antiretroviral drug prophylaxis to reduce perinatal transmission**
**   **
**To facilitate follow-up care for HIV-infected women and their infants**

## MIRIAD Sites and Hospitals 

**MIRIAD Sites and Hospitals **

## MIRIAD Enrollment (Nov 01-Jun 03)

**91,707**** *****encounters***** evaluated at 16 hospital L&D units**
**7,381 ****women were eligible to participate**
** ****(no HIV results in records & **_**>**_** 24 weeks gestation)**
**5,744 (78%)**** approached and offered MIRIAD**
**	****	**** ****(rapid HIV testing) **
**4,849 (84%)**** consented for participation/testing**

*Bulterys, et al. JAMA, July 2004—Vol 292, No. 2*

## OraQuick Test Performance, MIRIAD(Nov 01- Nov 03)

| # False positives | 4    [ EIA: 11  false positives] |
| --- | --- |
| # False negatives | 0 |
| Sensitivity (95% CI) | 100% (90% – 100%) |
| Specificity (95% CI) | 99.9% (99.78% – 99.98%) |
| Positive Predictive Value | 34/38 (90%) [EIA: 34/45 (76%)] |

*Bulterys, et al. JAMA, July 2004—Vol 292, No. 2*

## *

**Rapid HIV Test**

**Standard EIA Test**

**turn-around time (hours)**

**.1**

**.5**

**1**

**5**

**10**

**24**

**100**

**500**

**-2**

**0**

**2**

**4**

**6**

**log (turn-around time)**

- Bulterys, et al. Abstract #95 11th CROI, Feb 2004

*****

*****Wilcoxon test, p<0.001

## Turnaround Times for Rapid Test Results,Point-of-Care vs Lab Testing: MIRIAD

*MMWR 52:36, Sept 16, 2003*

|  | Median | Range |
| --- | --- | --- |
| Point of Care testing (L&D) | 45 min | 30 – 150 min 
( .5 – 2.5 hrs) |
| Laboratory
based testing | 210 min
(3.5 hrs) | 94 – 960 min
(1.6 – 16 hours) |

## MIRIAD – Lessons Learned

**In laboring women with undocumented HIV status, rapid HIV testing using OraQuick delivered accurate and timely test results**
**Acceptance of HIV testing in labor was high but varied by time and day of the week**
**Testing performed at the point of care delivered more timely results**
** **
**MIRIAD allowed previously unidentified HIV+ women immediate access to intrapartum/neonatal ARV prophylaxis**

## OIG Report: Reducing Obstetrician Barriers to HIV Testing(2002)

-   “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.”

*Office of Inspector General, July 2003*

**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 Protocol TeamConvened by CDC

**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.

## Rapid HIV-1 Antibody Testing During Labor & Delivery for Women of Unknown HIV StatusA Practical Guide and Model ProtocolJanuary 2004

## Purpose of Model Protocol

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

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

## CDC 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.”

*Model Protocol: *_[www.cdc.gov/hiv/projects/perinatal](http://www.cdc.gov/hiv/projects/perinatal)__ _

## Conclusion

- 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

## Resources

**National Model Protocol **
**	****	****www.cdc.gov/hiv/projects/perinatal/ ****	****	**
**CDC Rapid Testing Site**
**www.cdc.gov/hiv/rapid_testing ****	****	**
**USPHS Treatment Guidelines****	**_[www.aidsinfo.nih.gov](http://www.aidsinfo.nih.gov/)_
**FXBC at UMDNJ **_[www.WomenChildrenHIV.org](http://www.womenchildrenhiv.org/)_**  **
**ACOG   ****www.acog.org**
**AETC    ****http://hab.hrsa.gov/educating.htm**