the 5th hiv transmission workshop, - welcome | virology education

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To be presented at the 5 th International Workshop on HIV Transmission Evaluation of the Early Infant Diagnosis (EID) protocol in the Prevention of Mother to Child Transmission (PMTCT) program in a resource-limited setting in Rwanda Ali Kwizera 1 , Theogene Habiyambere 1 , Jean Claude Uwimbabazi 2 ,Louiselle LeBlanc, MD 1 ,Cyprien Baribwira, MD 1 : 1. University of Maryland School of Medicine, Institute of Human Virology, AIDSRelief Rwanda, 2. National Reference Laboratory-Kigali Rwanda THE 5 th HIV Transmission Workshop, Vienna Austria

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Page 1: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Evaluation of the Early Infant Diagnosis (EID) protocol in the Prevention of Mother to Child Transmission (PMTCT)

program in a resource-limited setting in Rwanda

Ali Kwizera1, Theogene Habiyambere1, Jean Claude Uwimbabazi2,Louiselle LeBlanc, MD1,Cyprien Baribwira, MD1: 1. University of Maryland School of Medicine, Institute of Human Virology, AIDSRelief Rwanda, 2. National Reference Laboratory-Kigali Rwanda

THE 5th HIV Transmission Workshop, Vienna Austria

Page 2: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

AIDSRelief - Rwanda

PEPFAR-funded implementing partner in Rwanda since 2004

Adult and Pediatric HIV and OI Care and Treatment

Prevention and PMTCT with community component

Laboratory Support: Emphasis on simple laboratory techniques to improve care and reduce mortality

Supporting 19 health facilities in Nyamasheke District and 1 health facility in Burera District

Page 3: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

"

"

"

"

"

PROVINCE DE L'EST

PROVINCE DU SUD

PROVINCE DE L'OUEST

PROVINCE DU NORD

VILLE DE KIGALI

KAYONZA

GATSIBO

KIREHE

NYAGATARE

RUSIZI

RUTSIRO

BUGESERA

NGOMA

KARONGI

HUYE

GICUMBI

NYAMAGABE

NYAMASHEKENYANZA

NYARUGURU

BURERA

GAKENKE

KAMONYI

GISAGARA

MUHANGA

RULINDO

RUHANGO

NYABIHU

MUSANZE

RWAMAGANA

NGORORERO GASABO

RUBAVU

KICUKIRONYARUGENGE

.

Légende" Bureau de la Province

Limite de la région et la Ville de KigaliLimite de DistrictParcLac

PROVINCE DE L'ESTPROVINCE DE L'OUESTPROVINCE DU NORDPROVINCE DU SUDVILLE DE KIGALI

© Institut National de la Statistique du Rwanda, Novembre 2005

CARTE ADMINISTRATIVE DU RWANDA: PROVINCES, DISTRICTS ET LA VILLE DE KIGALI

10 0 105 Km

1. CS Bungwe

WHERE WE WORK LOCALLY in Rwanda

12. CS Bushenge13. CS Karengera14. CS Karambi15. CS Kibingo16. CS Mukoma17. CS Mugera18. CS Gisakura19. CS Hanika20. CS Rangiro

2. HD Bushenge3. HD Kibogora4. CS Gatare5. CS Mwezi6. CS Nyamasheke7. CS Kibogora8. CS Muyange9. CS Ruheru10. CS Kamonyi11. CS Yove

Page 4: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Background: PMTCT in Rwanda before 2010

Mother:

HAART if indicated (CD4 < 350 or WHO 3-4)

If not indicated: Zidovudine (AZT) from 28 weeks + single-dose Nevirapine (NVP) at delivery with AZT/3TC for 7 days

Infant

Single-dose NVP at birth and AZT for 4 weeks

HIV DNA PCR on dried blood spot (DBS) sample at 6 weeks

If DBS negative, final serology at 18 months

Page 5: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Background: Role of laboratory in the PMTCT program in Rwanda

Rwanda Laboratory standards on EID:

Training both on site and centralised

Sampling DBS samples

Storage of DBS samples prior to transportation

Transportation to National reference Laboratory

Collection of Results and reporting

Page 6: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Objectives of this evaluation

Assessing quality and efficacy of PMTCT, EID and care of HIV-exposed infants

The Transmission rate?

The Quality of follow up and testing for exposed children in rural setting?

The Feasibility and laboratory quality aspects of DBS-PCR testing in context of logistical challenges?

Identifying remaining challenges and issues needing to be addressed further

Page 7: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Methods

Cohort retrospective review:

Systematic chart review

721 HIV-exposed infants in 20 AIDSRelief supported LPTFs, born between January 2008 and June 2009

Page 8: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Results

89% (642/721) HIV-exposed infants were enrolled in care and followed

94.7% (608/642) had DBS/PCR at 6 weeks

3.7% (32/721) were found to be HIV-infected

7/32 were on HAART at time of evaluation

Of total 721, 20 were lost-to-follow up and 20 had died (both rates below 3%)

Page 9: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Results: Overall outcomes

0

100

200

300

400

500

600

700

800

Exposedinfants

Infantsfollowed

DBS‐PCR 6wks

HIV +  HIV + onARV

OverallLTFU

Overallmortality

721 642608

32 7 20 20

Page 10: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Results: Laboratory perspective

861 in total DBS samples (including doubles) were sent for testing at the national reference laboratory ( NRL)

4/20 LPTFs respected maximum delay time of 10 days for sending the samples

88.6% (763/861) received results

Average turnaround time: 6 weeks

10.1% (n=89) of samples were rejected

69 for poor sampling quality

18 for labeling errors

1.3% (n=11) were never received by NRL

Page 11: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Discussion

In our resource-limited, rural and isolated setting, rolling out a DBS-PCR based EID protocol allows for early HIV diagnosis with a reasonable delay

Need for improvement in turnaround time

Good HIV-exposed infant follow-up coverage (89%) and testing rate at 6 weeks

Scored good in our setting

Remains room for improvement

Page 12: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Discussions

Having only 21.9% (7/32) of HIV-infected infants on ARVs is suboptimal

Considering recent published data, 2008 WHO guidelines and 2009 Rwanda guidelines

HAART for all infected infants is indicated at diagnosis

Laboratory perspective quality improvement strategies:

Sample Collection, not yet 100% still needs improvement

Transport systems necessitating the need to follow-up all collected DBS samples to NRL to minimize the turnaround time

Page 13: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Interventions and solutions

Coverage, follow-up and testing of all infants still not 100%

Possibility of home-testing/ in immunization setting

Education with community workers

Peri-natal education at health center

Relatively long turnaround time

Advocate for Increased number of tests done

Work more closely with the Rwanda National Reference lab

Adopting the new NRL strategy for DBS/PCR HAART coverage:

Education on pediatric HIV

Page 14: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Conclusions

Implementation and monitoring of pre/peri-natal prevention programs must remain a priority to eliminate mother-to- child transmission, which remains unacceptably high in non-HAART PMTCT

Efforts must be focused on ensuring timely diagnosis to provide treatment early and reduce mortality

The 6 week turn around reinforces the need for laboratory quality systems improvements

Page 15: THE 5th HIV Transmission Workshop, - Welcome | Virology Education

To be presented at the 5th International Workshop on HIV Transmission

Thank you