Present by Dr. Nguyen Van Hung

NRL/ NLH

GeneXpert implementation

in Vietnam

Dr. Nguyen Van Hung/NRL-NLH

4/17/2013 1 Vietnam experience/5th GLI meeting,

France

National policy for GeneXpert implementation Approach principle: apply technique in local condition under NTP

leadership & coordination The way such as:

– Review all WHO recommendations – Follow the National strategy of TB control – Apply step by step with evaluation of effectiveness and

cost effectiveness – Maximizing all resourses with considering suistainabitlity

Objective: Increase diag. of MDR TB, TB/HIV and PTB S(-) Target sites:

• NRLs for training and QA (provided by TB REACH) • PMDT sites • Facilities with TB/HIV diagnosis. • Clusters with testing possibility of increase PTB S(-)

detection • Pediatric hospitals

4/17/2013 2 Vietnam experience/5th GLI meeting,

France

Criteria for selection of GeneXpert sites

• Target groups: • High prevalence of MDR TB (MDR treatment sites)

• HIV positive (HIV clinics)

• Vulnerable groups with low TB case detection (paediatric hospitals)

• Volume of suspects (efficient use of machines) • Sites with workload of 10-20 tests/ day

• Treatment capacity • Providing TB, MDR TB Tx and those be provided on a well supervised

ambulatory or semi-ambulatory basis

• Collaboration between TB and HIV units

4/17/2013 3 Vietnam experience/5th GLI meeting,

France

SOPs of GeneXpert implementation in Vietnam

- Diagnosis algorithm approved

by MoH

- SOPs for XpertMTB/RIF testing

- Storage, supplying and

distribution of Cartridges

- Diagnosis algorithm under TB

CARE1

- reporting and recording forms

and registers

4/17/2013 4 Vietnam experience/5th GLI meeting,

France

MDR TB diagnostic algorithm

MDR TB suspects

With no sputum

Induced Spt

Negative

MDR TB suspects (Previously treated for TB, Other MDR TB risk grroups, Contact of MDR TB pts with cough > 2 weeks)

With sputum

Follow up by NTP guideline

TB+/R++

TB+/R-

Consultation

MDR TB Tx, DST (1.,2)

Cat I/II TB Tx

Xpert MTB/RI

F

Assessment for EPTB

XDR-TB MDR TB continue Cat IV

R+/H-: Continued Cat IV

Separately report

Report to NTP

4/17/2013 5 Vietnam experience/5th GLI meeting,

France

Diagnostic algorithm for HIV positive TB suspects

Improvement after 3

days

Xpert

MTB/RIF

HIV (+)/ TB suspected patient

with severe signs

If can not refer immediately

Broad spectrum antibiotic

PCP treatment

Immediately

Referred to high level

TB+/R+ TB+/R- TB-/R-

TB treatment CAT IV

CPT, ART

DST 1,2

TB treatment CAT I,II

CPT, ART

Still can not be

referred to high level Referred to high level

Clinical signs are worse or no

improvement after 3 days

Clinical sign are worse or no

improvement after 3 days

Exclude TB

•Consider to other

diseases related to HIV.

•Reassessment HIV

treatment

Stop antibiotic

treatment

Start TB treatment

CPT

HIV/TB management

Stop antibiotic treatment

Start TB treatment

CPT, ART

Assessment for extra

pulmonary TB

Assessment for other

diseases

Assessment for HIV

treatment

Algorithm IIa: Xpert MTB/RIF test for HIV (+)/ TB suspected patient with severe signs 4/17/2013 6

Vietnam experience/5th GLI meeting,

France

Diagnostic algorithm for children suspected of TB

TB+/R+

•TB treatment CAT IV.

•DST 2

TB-/R- TB+/R-

•TB treatment CAT I, II.

•DST 1, 2

Children with suspected TB

Assess the risk of MDR TB/TB

Suspected MDR TB

Suspected TB/HIV

MDR TB

algorithm

TB diagnostic

algorithm in children

Xpert

MTB/R

TB/HIV

algorithm

Induce sputum

Gastric aspirates/bronchial

Fluids This pathway should

be followed in case no

sputum can be collected

TB treatment CAT I or II.

Not at risk of MDR TB, TB/HIV

Sputum can be

collected

NO

•R+/ H+ or

R+

Yes

4/17/2013 7 Vietnam experience/5th GLI meeting,

France

Experiences:

- Approval from MoH for algorithms and implementation plan took

long time, almost a year

- Shortage of staff, one person holds several tasks concurrently not only TB CARE1

- Several new registers and forms developed increase workload for local staff

Lessons learned:

- Involve partners working and support NTP

- Workshop with local staff from implementation sites to review and revise SOP and recording & reporting forms and registers

before trainings

- Integrate new information in current R & R system, minimize No

of new forms and registers

- Regular meeting among partners to get consensus on the documents prepared

SOPs and Diagnostic algorithms dev.

4/17/2013 8 Vietnam experience/5th GLI meeting,

France

Current number of Xpert machine from different partners

Partner Currently in use

TB CARE 17

Global Fund

TB REACH 5

WHO-CIDA 2

OUCRU 1

PANTHER 1

FIND 1

UNITAID

Total 27

4/17/2013 9 Vietnam experience/5th GLI meeting,

France

Achievements

Before GeneXpert Impl. After GeneXpert Impl.

- Only 2 MDR TB

diagnosis centers with

DST and LPA

- 6 MDR TB treatment

sites and 14 adjacent

provinces

- Turn-around time ranges

from 7days to months

- 22 sites with Xpert

MTB/RIF can diagnose

MDR TB

- 9 MDR TB treatment

sites and 25 adjacent

provinces

- Turn-around time ranges

from a day to less than a

week

4/17/2013 10 Vietnam experience/5th GLI meeting,

France

Xpert MTB/RIF results from June 2012 to Jan 2013

Types of

TB/MDRTB

suspects

Xpert MTB/RIF test result Total

MTB (-) MTB(+)/R(-) MTB(+)/R(+) Error/Invalid

MDR TB 330 1266

(59.7%)

457

(21.5%)

68

(3.2%)

2121

HIV(+)/TB 327 45

(11.3%)

4

(1%)

22

(5.5%)

398

Pediatric

TB

38 3

(6.5%)

1

(2.2%)

4

(8.7%)

46

Other 16 18

(53%)

0 0 34

Total 711 1332

(51.2%)

462

(17.8%)

94

(3.6%)

2599

4/17/2013 11 Vietnam experience/5th GLI meeting,

France

MDR Patient enrolled/ diagnosed

YEAR

2010 2011 2012

Patients diagnosed

252 697 774

Patients enrolled

97 578 713

% 38 83 92

4/17/2013 12 Vietnam experience/5th GLI meeting,

France

Number of Xpert machine from different partners

in planning

Partner Currently in use In Planning

TB CARE 17

Global Fund 26

TB REACH 5

WHO-CIDA 2

OUCRU 1

PANTHER 1

FIND 1

UNITAID 9

Total 62 Xpert mchines 27 35

4/17/2013 13 Vietnam experience/5th GLI meeting,

France

4/17/2013 14 Vietnam experience/5th GLI meeting,

France

Plan to implement Xpert calibration

Steps Personal/Organization

implement Time

Step 1: buy 17 kits to calibration from Cepheid

KNCV week 1- 2/April 2013

Step 2: procedure to confirm aid to goods to be not duty - free tax following rules.

NTP week 3- 4/April 2013

Step 3: receive 17 kits and distribute 9 kits for Pham Ngoc Thach Hospital

NTP week 1- 2/May 2013

Step 4 (*): calibration for Xpert machines in 17 sites

Technician in sites where install Xpert machine will train on - site 31/5 - 1/11/2013

Support from technician of central level

(*) Training : (1) Pham Ngoc Thach Hospital on 31/05/2013 for 8 Southerm sites and (2) National 74 Hospital on 6/6/2013 for 9 Northerm sites 4/17/2013 15

Vietnam experience/5th GLI meeting,

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Calibration Schedule

Time Lab

1/6/13 BV Phạm Ngọc Thạch

6/6/13 BV 74 Trung ương

15/07/2013 BVL&BP Đà Nẵng

16/07/2013 BVL&BP Bình Định

17/07/2013 BVL&BP Bình Thuận

19/07/2013 BVL&BP Cần Thơ

26/07/2013 Phòng khám lao quận Bình Thạnh (HCM)

31/07/2013 BVL&BP Thanh Hóa

8/8/13 Phòng khám lao quận 6 (HCM)

9/8/13 Phòng khám lao quận 8 (HCM)

11/9/13 BVL&BP Quảng Ninh

12/9/13 BVL&BP Hải Phòng

18/09/2013 BV. Nhi đồng I TP HCM

19/09/2013 BVL&BP Tiền Giang

20/09/2013 TTYTDP An Giang

1/11/13 BVL&BP Điện Biên

4/17/2013 16 Vietnam experience/5th GLI meeting,

France

Challenges:

Poor infrastructure at district level (no AC, no budget for running AC…)

High humidity

Power is not stable and was cut off very often in Summer

Current sputum cup provided by NTP can not be used for GeneXpert

Shortage of human resource at all level

Lessons learned:

Involve local, national and international partners in GeneXpert implementation: this can help fill GAP (support budget for AC running, provide AC, support sample transportation)

Budget allocation for new sputum cups

UPS provided for GeneXpert lab

Challenges, Experiences and lesson learned (1)

4/17/2013 17 Vietnam experience/5th GLI meeting,

France

Challenges, Experiences and lesson learned (2)

Zoning diagnosis coverage for sites with GeneXpert to maximize workload of machines

Sputum specimen refferal system established with support from MSH, MDR TB suspect sputum specimens referred to Xpert Lab from dist. and other provinces (satellite sites)

Referral Xpert test outcome to clinic by email, fax, post or lab staff using result referral form

Zoning treatment coverage to ensure all MDR TB patients would be enrolled in treatment after diagnosis

4/17/2013 18 Vietnam experience/5th GLI meeting,

France

SLD forecast and procurement to ensure adequate drugs for patients

MDR TB Tx sites with qualified staff, well prepared facilities, uninterrupted F and SLDs supply would ensure quality of treatment for patients

4/17/2013 19 Vietnam experience/5th GLI meeting,

France

Challenges, Experiences and lesson learned (3)

Next steps

Collaborate with partners to expand geneXpert

implementation in Vietnam with experience learned

Continue to strengthen TB/MDR services to ensure

TB/MDR TB patients enrolled promptly in treatment after

diagnosis.

Advocate and mobilize participation and support from the

Government and partners to sustain GeneXpert

implementation and to ensure F and SLDs for TB/MDR

TB patients

4/17/2013 20 Vietnam experience/5th GLI meeting,

France

Conclusion

1. GeneXpert implementation under NTP

leadership & coordination greatly contributed

to increase TB/MDRTB case detection in

Vietnam.

2. Further contribution from Government and

partners will be essential to expand and

sustain the project.

4/17/2013 21 Vietnam experience/5th GLI meeting,

France

4/17/2013 22 Vietnam experience/5th GLI meeting,

France