Utility of Early Infant Diagnostic (EID)Testing in

Assessing the Impact of PMTCT Program

Kenyan ExperienceIAS Conference, 17 to 20 July 2011,

RomeHellen Muttai

CDC Kenya

Kenya Background

Total population 38.6 million

HIV prevalence 6% (KDHS 08)

Number of people living with HIV 1.4 million

Estimated annual pregnancies 1.5 million

~ 96,000 among HIV positive women

PMTCT Program, 2005-2010

2005 2006 2007 2008 2009 2010 -

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

-

200,000

400,000

600,000

800,000

1,000,000

1,200,000

1,400,000 3

18,3

61

575,3

54

785,8

40

988,7

98

1,0

57,2

41

1,1

77,3

85

19,4

39

34,7

95

50,6

59

61,1

25

59,5

91

70,7

32

926 1,443

2,092

3,661

3,700

4,000 Mothers Tested Mothers given ARVs No. PMTCT Sites

No

. o

f P

MT

CT

Sit

es

Wo

me

n T

este

d/o

n A

RV

s

EID Program Scale Up in Kenya, 2005-2010

Standardized • EID testing

algorithm • Lab request

form

Dried blood spot (DBS) samples collected

Shipped to labs by courier services

EID PCR testing initiated in 2003

Currently in 6 labs

2005200620072008200920100

10000

20000

30000

40000

50000

60000

0

200

400

600

800

1000

1200

1400

1600

1800

Number of EID tests doneNo of sites accessing EID

Num

ber

of E

ID te

sts

done

Num

ber

of

faci

litie

s acc

ess

-in

g E

ID

Objectives

Assess utility of EID testing in assessing the impact of PMTCT program

Study Setting

Retrospective review of Nyanza province EID data • Region has the highest

HIV prevalence - 14%• Estimated 250,000

annual pregnancies• ~40,000 among HIV +

women• First lab to do EID testing• Currently supporting a

third of the national tests• Data readily available

Methods

Study population• HIV exposed children <18 months receiving EID testing

from 2008-2010 at 471 facilities Data collection

• Scannable lab form completed by clinician• DBS sample collected and sent to KEMRI/CDC lab

Data management• Sample tested and lab results placed on form• Results returned to clinical sites• Form scanned and stored in database• Patient IDs stripped from database; new study ID

assigned Descriptive analyses of demographic and clinical variables

• Cochran Armitage trend test and Chi square tests were used to assess trends and differences between groups

*KDHS 2010

Demographic and Clinical Characteristics of HIV-exposed Children, 2008-2010 (n=28,598)

N (%)

Age

0-3 months 17,023 (63)*

4-9 months 7,250 (27)*

10-18 months 2,614 (10)*

Gender Female 13, 703 (48)

Patient source

Maternal Child Health (MCH) 13,704 (48)

HIV Clinic 9,979 (35)

Provider Initiated Testing and Counseling (PITC)

1,265 (4)

Other/not documented 3,650 (13)

Maternal ARV historyARVs for PMTCT 10,777 (38)

Not documented 17,821 (62)

Infant breastfeeding status

Breastfeeding 19,155 (67)

Not documented 9,443 (33)*Cases with missing age omitted

Number of HIV Positive Children

Patient SourceAll

N=28,598 (%)

0-3 months

N=17,023* (%)

4-9 months

N=2,158* (%)

10-18 months N=456*

(%)

All 3,759 (13) 1,731 (10) 1,199 (17) 682 (27)

Patient source

MCH (n=13,704) 1,599 (12) 870 (10) 499 (15) 178 (24)

HIV Clinic (n=9,979) 1,422 (14) 575 (10) 457 (16) 353 (31)

Provider Initiated Testing and Counseling (n=1,265)

311 (25) 101 (20) 117 (27) 84 (29)

Other/Not documented (n=3,650)

427 (12) 185 (9) 126 (20) 67 (21)

Proportion of HIV Positive Infants by Age and Patient Source

*Cases with missing age omitted

Proportion HIV Positive Children by Year & PMTCT History (N=28,598)

N Number of children HIV positive (%) p value

Year

2008 2,380* 358 (15)

0.0092009 11,099* 1,520 (14)

2010 14,093* 1,843 (13)

Maternal ARV history

ARVs for PMTCT 10,777 (38) 942 (9)<0.001

Not documented 17,821 (62) 2,817 (16)

Breastfeeding status

Yes 19,155 (67) 2,513 (13)0.87

Not documented 9,443 (33) 1,246 (13)

*Cases with missing year omitted

Comparing Proportion of HIV Positive Infants Using EID Data and PMTCT Impact Study in

Kenya (MCH, Age 6-16 weeks, 2010)EID data for MCH , age

6-16 weeks (n=3,795)

PMTCT Impact Study (4,248)

Overall Positivity Rate 9% 10%

Mother’s ARV use

Yes 6% 9%

No or not sure _ 10%

Not documented 11% _

Infant breast feeding status

Yes 9% _

Not documented 7% _

Not breastfeeding _ 8%

Exclusive breastfeeding _ 8

Mixed feeding _ 15%

Conclusions

Between 2008 and 2010, 28,598 children received EID testing 13% were HIV positive HIV positivity higher with older age, tested through

PITC, and those without documentation on mothers’ ARV use

Results were comparable to the national survey Limitations:

• EID data use does not capture those not tested, about 40-50% in Kenya

• HIV status outcomes vary by age and patient source, and therefore can bias the results

• Lack or format of documentation on the lab request form was a challenge

For more information please contact CDC-Kenya

E-mail: info@ke.cdc.gov Web: www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Acknowledgement

MOH KenyaPEPAR Team Kenya CDC Kenya

•Lucy Wanjiku•Clement Zeh

CDC Atlanta•Marta Ackers

KEMRI/CDC• Jane Mutegi