# Presentation: 412726

## Implementation of routine, universal prenatal HIV testing:opt-out strategies

**Sansom S, Fowler MG, CDC;**
**Sharma R, Arkansas Dept. of Health;**
**Killingsworth L, Tennessee Dept. of Health;**
**Seider J, Texas Dept. of Health.**

## Objectives

**Describe process that led to CDC recommendation of opt-out prenatal HIV testing this year**
**Describe actual or recommended opt-out implementation in states, organizations**
**Describe the need for better data on prenatal testing rates and next steps**

## Background

**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**

## Rationale

**Increasingly effective interventions to prevent perinatal transmission – to as low as 1%-2% with early intervention **
**25% transmission rate with no interventions**
**Interventions begun at the labor and delivery or just after birth: 9%-13% **
**6,000-7,000 HIV-infected women give birth each year**
**280-370 infants perinatally infected**
** ****38% of their mothers not tested until birth or later**

## 2002 assessment of prenatal HIV testing rates

**In the United States and Canada.**
**By state or provincial prenatal HIV testing policy.**

## Prenatal HIV testing policies

**Voluntary approaches**
_**Opt-in**_**: pre-test counseling and written consent specifically for an HIV test**
_**Opt-out**_**: notification of testing unless it is refused**
**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 sample of prenatal and labor and delivery charts.**
_**Pregnancy Risk Assessment Monitoring System (PRAMS)**_**: 9 states, 1999, survey of a  sample of recently delivered women**
_**Lab reports**_**: 5 Canadian provinces, 1999-2001, all HIV tests submitted to provincial labs.**

## Chart review results, 1998-1999

| State | Policy | %Tested |
| --- | --- | --- |
| TN | Opt-out | 85 |
| NY | Mandatory | 52 |
|  | Mandatory+ | 83 |
| CT | Opt-in | 31 |
|  | Mandatory | 81 |
| MD | Opt-in | 69 |
| GA | Opt-in | 66 |
| MN | Opt-in | 62 |
| CA | Opt-in | 39 |
| OR | Opt-in | 25 |

## PRAMS results, 1999

| State | Policy | %Tested |
| --- | --- | --- |
| NY | Mandatory | 69 |
|  | Mandatory+ | 93 |
| AK | Opt-out | 71 |
| FL | Opt-in | 81 |
| NC | Opt-in | 75 |
| IL | Opt-in | 72 |
| CO | Opt-in | 72 |
| WV | Opt-in | 67 |
| OK | Opt-in | 62 |
| OH | Opt-in | 61 |

## Canadian results, 1999-2001

| Province | Policy | %Tested |
| --- | --- | --- |
| Alberta | Opt-out | 98 |
| Newfoundland & Labrador | Opt-out | 94 |
| Quebec | Opt-in | 83 |
| B Columbia | Opt-in | 80 |
| Ontario | Opt-in | 54 |

## CDC’s 2003 recommendations on perinatal HIV testing

**Opt-out approach for prenatal HIV testing**
**Opt-out rapid HIV testing at labor and delivery**
- Among women whose serostatus is unknown
**Rapid HIV testing of newborn**
- If mother’s serostatus is unknown after birth

## Endorsers of the opt-out approach to prenatal HIV testing

- 1998: Institute of Medicine. Adopt a national policy of universal HIV testing, with patient notification, as a routine part of prenatal care.
- 1999: American College of Obstetricians & Gynecologists/American Academy of Pediatrics.
- 2002: American Medical Association.

## Opt-out implementation

| Org | Year | Counseling | Documentation |
| --- | --- | --- | --- |
| IOM | 1998 | Notification of testing and that it may be refused. | Document refusal in medical record |
| ACOG/AAP | 1999 | Same as IOM | Same as IOM |
| UAB | 1999/
2000 | Same as IOM + written HIV material | Same as IOM + written consent for HIV |

## Opt-out implementation

| State | Year | Counseling | Documentation |
| --- | --- | --- | --- |
| AK | 1997 | Verbal counseling and  notification that test will be performed & that women may refuse it.  | Documented refusal. |
| TN | 1997 | Verbal or  written counseling, notification & that women may refuse it, written forms may provide information on several tests. | Written, alone or for battery of tests, documented refusal.  |
| TX | 1995 | Written HD materials on prenatal tests, including HIV. Verbal or written notification & right of refusal.  | Same as TN, plus documentation of materials and notification. 
 |

## CDC’s recommendations on implementation of opt-out prenatal testing

**Written material for the patient**
- Facts about HIV transmission and prevention
**Sufficient information to allow women to make an informed choice**
**Notification that HIV test will be performed unless refused**
**Documentation of test refusal**

## Challenges 

**Lack of data on prenatal HIV testing rates**
**Difficult to assess impact of prevention programs**
**Difficult to compare testing strategies**
**Difficult to give timely feedback to areas where testing rates are suboptimal**
**No standardized approach to data collection across states**
**Existing data sources may not indicate if testing status is available to prenatal care providers **
**    ****and at labor and delivery**

## Next steps

**Develop better data collection tools to assess perinatal HIV screening**
**CDC piloting a medical chart review project among a sample of women who have delivered **
**Assess which perinatal HIV testing approaches and programs are most successful at increasing prenatal HIV testing rates**

## Acknowledgements

**CT Health Department**
**A Roome**
**J Hadler**
**NY Health Department**
**G Birkhead**
**Canada**
**S King**
**C Archibald**

**CDC**
**S Schrag**
**A Lansky**
**J Anderson**
**B Branson**
**I Onorato**
**A Greenberg**
**ABC/EIP Network**