# Presentation: 162350

## MIRIAD: Mother Infant Rapid Intervention At Delivery  

**Margaret Lampe**
**February 14, 2002**
**Perinatal Grantees Meeting**
**Round Table Discussion**

## BACKGROUND:Voluntary Intrapartum Rapid HIV Testing for Women with Inadequate Prenatal Care

- Most HIV-positive women in the U.S. deliver in a hospital
- In the absence of adequate prenatal care, rapid testing for HIV during the peripartum period offers a crucial opportunity for health care intervention for both mother and infant
- Such policy appears cost-effective, especially in hospitals with maternal HIV seroprevalence above 0.7% (Am J Ob Gyn 1999;181:1062)
- How best to provide rapid HIV testing and treatment options needs systematic research
- Lessons learned in MIRIAD will assist in formulating best-practice recommendations in the U.S. for women presenting late in pregnancy
- Rapid HIV testing and start of ART prophylaxis during labor may be an important HIV prevention strategy for high-risk perinatal populations elsewhere in the world.

## CDC MIRIAD Project Description

- Limited to institutions with relatively high HIV prevalence   (0.8% - 4%) among child bearing women
- Five primary sites: Atlanta, Chicago, Miami, Louisiana, and New York City
- Funded in October 1999 with pilot phase in Spring 2001. Enrollment to begin in late Summer/Fall of 2001.
- Plans to screen 6,000-8,000 women for HIV late in pregnancy and identify and offer ART to 100-140 HIV-infected women per year.
- The collaboration with PACTG 1031 sites has the potential to screen an additional 5,000-10,000 high-risk women and identify 50-100 HIV-infected women a year at US sites. The international PACTG sites could increase these numbers substantially.

## MIRIAD CDC Sites and Hospitals

**Chicago**

**New York**

**Miami**

**Louisiana**

**Atlanta**

**MIRIAD CDC Sites and Hospitals**

- Cook County
- Bethany
- St. Bernard
- Provident

- Bronx-Lebanon
- Harlem
- Jacobi
- N. Central Bronx

- * Tentative participation in 2002

- Charity (New Orleans)
- Earl K. Long (Baton Rouge)

- Jackson Memorial
- Homestead*
- Deering*
- Parkway Regional*

- Grady

## Objectives of the core CDC MIRIAD protocol to be done in collaboration with PACTG (P1031)

**This protocol will assess:**
**The feasibility and acceptance of voluntary rapid HIV testing among pregnant women with unknown HIV serostatus who present in labor or late to care (**_**>**_** 34 weeks gestation) **
**Rapid ART given in labor and delivery or to the neonate **
**The performance of rapid HIV tests in the perinatal setting **
**Barriers to prenatal care and HIV testing**
**The rate of HIV transmission and the risk relative to the timing of initiation of ART **
**Trends in maternal virologic response and the development of viral resistance after initiation of short-course ART**
**Adherence to post-partum medical care of mother and infant for 6 months. **** **

## Late Presenters

- _HIV+_  _HIV-_  _Decline_

**Peripartum Group**
- _HIV+_   _HIV-_   _Decline/Miss_

**ARV Tx**

**Neonatal Tx**

**Interview and Medical Record Abstraction**

**Mother-Infant Pair Follow-up**
**Differs between the CDC MIRIAD and P1031**

- The MIRIAD Core Rapid Testing and Treatment Protocol

**Re-offer Testing**
- _HIV+_  _HIV-_   _Decline_

**ARV Tx**

**Adherence/ Linkage**

**Interview**

**DELIVERY**

## MIRIAD Peripartum Group: Events Leading to Prevention Success

- Present to L&D with unknown HIV status

- Informed consent using flip charts for comprehension

- Rapid testing
- performed. Results
- in ~20-40 minutes.

- Provide results and
- post-test counseling
- before or after delivery
- (per patient preference)

- If HIV +, ARV treatment ASAP

- Follow-up care
- for both woman and infant

**MIRIAD Peripartum Group: Events Leading to Prevention Success**

## Proposed MIRIAD Tests Based on Current AvailabilityInitiation of therapy will be based on results of the OraQuick assay performed on whole blood. A treatment Investigational Device Exemption (IDE) for OraQuick  is currently pending approval by FDA. Different rapid testing algorithms may be evaluated as other rapid tests become available (either under Treatment IDE or with FDA approval).

**Reactive Control**

**Positive HIV-1/2**

**Positive**
**(+)**

**Negative**
**(-)**

**Read results in 20 Minutes**

**OraQuick **

**Device**

**Loop**

**Vial**

**Stand**

## OraQuick has been shown to perform better than both SUDS and EIA. 

**OraQuick has been shown to perform better than both SUDS and EIA. **

***Ref = Reference;  RT = Rapid test; OraQuick1 = Result of 1****st**** OraQuick test;  SUDS1 = results of 1****st**** SUDS test; **
**EIA1 = results of 1****st**** EIA;  RR = Repeatedly reactive**

| Test | Ref
Positive | RT
Positive | False
Negative | Ref 
Negative | RT
Negative | False
Positive | Sensitivity | Specificity |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| OraQuick1
OraQuick RR | 340
340
 | 340
340 | 0
0 | 464
464 | 463
463 | 1
1 | 1.000
1.000 | 0.998
0.998 |
| SUDS1
SUDS RR | 340
337 | 337
334 | 3
3 | 467
467 | 462
465 | 5
2 | 0.991
0.991 | 0.989
0.996 |
| EIA 1
EIA RR | 340
340 | 340
340 | 0
0 | 467
467 | 442
463 | 25
4 | 1.000
1.000 | 0.947
0.991 |

** ****Test results, specimens collected from 340 known HIV+ and 467 HIV- persons**

- Branson, et al. Unpublished data.

## The Influence of Seroprevalence on Positive Predictive Value (PPV)

**Test Specificity 99.8%**

## Opportunities of a CDC-PACTG Collaboration in MIRIAD

- Explore the feasibility of obtaining informed consent during labor and the impact of interventions to reduce perinatal HIV transmission.
- P1031 sites in the U.S. can gain access to rapid HIV diagnostic tests that are otherwise unavailable for clinical use.
- The speed with which core MIRIAD objectives are met may greatly increase.
- The P1031 team plans specific sub-studies, e.g., prevention of postpartum NVP resistance using maternal HAART