# Presentation: 314271

## Informed Consent Issues in MIRIAD

- Denise J. Jamieson, MD MPH
- Medical Officer
- Mother-Child Transmission & Pediatric and Adolescent Studies Section
- Division of HIV/AIDS Prevention
- Centers for Disease Control & Prevention

## The Challenges of Informed Consent in MIRIAD

**Substantial proportion of women recruited in labor (peripartum group 70%)**** **

## Women enrolled intrapartum may represent particularly vulnerable group

- Pregnant women with no prior prenatal care
- No established relationship with provider or health care system
- Labor physically and emotionally demanding
- Focus of woman on anticipated delivery, alleviation of pain
- Circumstances of labor amplify difficulties of pretest/posttest HIV counseling
- Includes recent immigrants, non-English speakers, poor women, women of color

## Major Aims of MIRIAD 

- To determine the feasibility and acceptance of informed consent for rapid testing
- To evaluate the informed consent process in order to develop a more effective and efficient method for approaching women in labor and delivery

## How to address intrapartum informed consent issues in context of MIRIAD 

**Small focus groups**
**Development of flip-charts**
**Pilot of process**
**On-going evaluation of process**

## Preliminary Focus Groups

- Women may wish to defer receipt of test result until after delivery
- Checkboxes added to informed consent form allowing women to be tested and treated in labor; receive results and post-test counseling after delivery

**I want to participate in MIRIAD****  **
-  	No
-  	Yes
- If you answered “yes above, please fill out the next 2 questions.
- I want to be told the rapid test result as soon as possible, even during labor or delivery.
-  	Yes
-  	No, I **do not **want to be told the rapid HIV test result until **after** **I ****	****give birth**
- If my rapid test result is positive, I want medicine right away to help prevent HIV in the baby.
- 	Yes, medicine for me in labor and to my baby.
-  	Yes, medicine for me only
-  	Yes, medicine for my baby only
- 	No, I do not want medicine and do not want my baby to get 	medicine

## Development of flip charts to supplement informed consent process 

- Outside consultant with expertise in flip-chart development
- Pictures with accompanying text
- Piloted with separate groups of HIV-infected and HIV-uninfected focus groups in 3 cities (Atlanta, Chicago, Miami)
- Simpler, fewer pictures, wanted text, liked “universal” woman, more words rather than fewer in bullets

## Pilot Study 

- “Mock” informed consent process
- Series of open-ended questions
- Subjective reaction to process
- Conducted at 3/5 MIRIAD sites (Miami, New Orleans, Chicago)
- Women in labor with known HIV status asked to participate

## 
HIV-infected							9 (32%)
Substantial pain						17 (61%)
Less than 15 minutes to complete interview	16 (57%)
One or more interruptions during interview	20 (71%)
Able to correctly state in their own words
		Purpose							20 (71%)
		Benefits							19 (68%)
		Risks							7 (25%)
Stated that there were no risks 
	associated with study					12 (43%)
Understood right to withdrawal 
	from study at any time					20 (71%)

- HIV-infected							9 (32%)
- Substantial pain						17 (61%)
- Less than 15 minutes to complete interview	16 (57%)
- One or more interruptions during interview	20 (71%)
- Able to correctly state in their own words
- 		Purpose							20 (71%)
- 		Benefits							19 (68%)
- 		Risks							7 (25%)
- Stated that there were no risks
- 	associated with study					12 (43%)
- Understood right to withdrawal
- 	from study at any time					20 (71%)

**Characteristics of and results from 28 women who participated in informed consent pilot study**

## Intrapartum Consent Process (based on pilot and preliminary information) 

- Presentation of flip-chart
- Ask 4 open-ended questions (Purpose, risks, benefits, withdrawal) and score recorded
- Wrong answers reviewed and rehearsed until correctly answered
- Read and sign informed consent form

## Postpartum Evaluation 

- Postpartum interview (3 HIV-uninfected: 1 HIV-infected), ask same 4 open-ended questions and score recorded
- Women declining rapid testing also offered postpartum interview
- Additional questions – reasons for declining/accepting testing, how strongly providers recommended testing

## Summary 

- Challenges of offering rapid HIV C&T in labor to particularly vulnerable group at particularly vulnerable time
- Major aim of MIRIAD to find out how to best approach these women