Transcript Successes and Challenges in Scaling Up HIV Early Infant Diagnosis Innovations in the Monitoring and Evaluation (M&E) of Global Elimination of Mother.

Successes and Challenges in Scaling Up HIV Early
Infant Diagnosis
Innovations in the Monitoring and Evaluation (M&E) of Global Elimination of Mother to
Child Transmission (EMTCT) Programs in Resource Constrained Settings
Washington, DC
July 22, 2012
Agenda

Background on Early Infant Diagnosis

Challenges

Laboratory Information Management System
(LIMS)

Loss To Follow Up (LTFU)

Moving Forward – new technologies

Elimination of Mother to Child Transmission
Pediatric HIV Infection – an ongoing problem despite PMTCT
In 2010 there were 390,000
new pediatric infections
Even with current
interventions – the rate of
transmission from mothers to
children is high.
There are over 1000 new
pediatric infections each day
Overall rate =
22% - 25%
3
Survival rates for HIV + children who do not initiate ART
Up to 30% of
children do not
make it to age one.
By age two, 50% of
untreated HIV +
children will have
died.
4
The Early Infant Diagnosis Test – DNA PCR
Maternal antibodies are
transferred through the
placenta.
Standard methods of HIV
diagnosis are not effective
Under 18 months, DNA PCR is
required to determine HIV
status of the child
5
The Early Infant Diagnosis Test – DNA PCR
• DNA testing is complex.
• There are unique infrastructure and equipment requirements
• Testing is a long, complicated multi-step procedure
1. Extraction
HIV DNA is extracted from a dried
blood spot (DBS) sample
2. Amplification
Strands of HIV DNA are
replicated many times over
3. Detection
HIV DNA strands are attached to
gold or other particles and
detected using an ELISA reader
• Testing is typically performed at a few central labs, while samples are collected from
many clinics across the country
6
Dry Blood Spot Collection (DBS)
• Uses whole blood from a
heel/finger stick
• Dried on special filter
paper
• Heat stable
• Non-infectious
• Easily transported
7
Treatment rates indicate gap in coverage
8
Infant Retention is Low
9
Global EID Coverage is Low + Link to Care and Treatment
Fewer than 50% of infants born to HIV-positive women
are tested within 12 months
Fewer than 25% of infants who test HIV-positive are
successfully initiated on ART
WHY?
WHAT IS NEEDED?
10
Agenda

Background on Early Infant Diagnosis

Challenges

Laboratory Information Management System
(LIMS)

Loss To Follow Up (LTFU)

Moving Forward – new technologies

Elimination of Mother to Child Transmission
Needs for continued improvement
Low Quality or
Delayed Data
Evaluation
Planning
Intervention
Improvement
Interpretation
Analysis
Data Collection
Data Quality
Control
Data Pooling
Inability to Pool +
Analyze Data
Low transparency and
accountability
12
Investigating Data
Questions:
What proportion of pregnant women testing HIV+ get their HIVexposed infants tested and at what age?
How long does it take for an EID sample to reach the lab, and for
the result to reach the site? the family?
Among HIV-exposed infants receiving EID testing, what percent of
mothers receive their infant’s result?
Among all HIV-exposed infants, what proportion is enrolled into HIV
care and treatment services?
Among all HIV-exposed infants enrolled in care, what proportion is
retained in care until they receive a definitive diagnosis?
Among HIV-infected infants, what proportion initiates ART and at
what age?
13
Agenda

Background on Early Infant Diagnosis

Challenges

Laboratory Information Management System
(LIMS)

Loss To Follow Up (LTFU)

Moving Forward – new technologies

Elimination of Mother to Child Transmission
Laboratory information and management system (LIMS)
- Model Outline -
Laboratory
2.
3.
5.
6.
8.
Receive samples from
the facility (courier)
Send notification of
sample received (SMS
and @)
Creation of Worksheet
Dispatch sample results
back to the facility (SMS
and @)
Reporting on lab
performance and testing
Health facility
1.
4.
7.
Send samples to the lab
(courier)
Receive notification samples
received by the lab (SMS
and @)
Received sample results
(SMS and @)
LIMS
The LIMS provide a
solution that
streamlines EID
information
management and
testing at the EID
laboratories while
simultaneously
providing increased
visibility into the
National EID Program
for the MOH and other
stakeholders
Lab Technician Tracks Sample Information with key indicators
16
LIMS System
Sample Collection Facility
Notified of Sample Receipt –
accountability
Laboratory generates a bar
code to track sample and batch
17
Laboratory Performance Dashboard
18
Laboratory information and management system (LIMS)
technologies
The LIMS technology improves not only the quality of clinical laboratory diagnosis but also
strengthen the capability to provide epidemic alert and response by recording and analyzing
essential laboratory data (prevalence rate, mother and child’s treatment history, progresses etc)
- LIMS dashboard -
Allows national and
site level data analysis
to highlight needed
interventions
Provides real time
volumes and machine
downtimes
Agenda

Background on Early Infant Diagnosis

Challenges

Laboratory Information Management System
(LIMS)

Loss To Follow Up (LTFU)

Moving Forward – new technologies

Elimination of Mother to Child Transmission
Loss To Follow Up (LTFU)
Because of difficulties in returning results quickly to distant clinical sites, staff and mothers may
lose confidence in a test and thus reduce its acceptability, while allowing results to go unclaimed.
Mother and Child often come back
to health facility to find no result
Examples
Sample
Drawn
Kangemi Health Center
Nairobi, Kenya
Health Facility
Yaoundé, Cameroon
Mother Returns
(30 days)
Results
arrive
at site
Batch Sent Sample Results
to Lab Tested Sent
14 days
8 days
5
days
6 days
15 days
Caregiver
Receives
Result
18 days
4
days
Sample
Sample Batch Sent Arrives
Tested
Drawn to Lab at Lab
(2 days)
Mother Returns
(30 days)
5 days
Results
Sent
Results
arrive
at Site
Caregiver
Receives
Result
Loss To Follow Up (LTFU)
Only 25% of infants born HIV+ are in treatment 1 year later. Results are not communicated to more
than half of all infants tested.
- Retention of Infants Throughout the Care and Treatment Continuum -
74%
Infants lost
Infants in system
48
-51% 51% of loss
119
280
232
113
39
17
74
Positive
Births
Positive
PCR
Mothers
Receive
Results
Infants
Initiate
Treatment
57
Infants still
alive after 1
year
*December 2008 Stocktaking Report, UNICEF. **Data from 16 sites across different African countries. Data from 6 sites are from program inception through 15
June 2009, while the other 11 sites data are from program inception through 15 January 2009
occurs
between a
positive test
and the
return of
results
mHealth solutions: SMS printers
The introduction of SMS printers have help reduce the LTFU rate leading to earlier initiation, better
long term survival and decreased costs of care
Laboratory
Health facility
Test results
Sample collection by DBS
SMS connected printer
•
•
•
•
•
•
GSM modem connected
Automatic sending
Two-way communication
Facilitates direct transmission of laboratory results from reference laboratories to clinics
Results printed instantly at the site the same day as the reference laboratory registers the results
Eliminates the final delay of the circuit: the transport of results from the reference lab back to the site
mHealth solutions: SMS printers
Use of SMS/GSM printers for results return has drastically cut turn around time for infant
diagnosis
- Turnaround Time Before and with SMS/GSM Printers -
Kangemi Clinic, Kenya
Ahmadiyyah Muslim Hospital,
Nigeria
Hasiya Bayero Pediatric Hospital,
Nigeria
Before
With SMS Printers
Federal Medical Centre Azare,
Nigeria
Murtala Mohammed Specialist
Hospital, Nigeria
Days
0
10
20
30
40
Mother Returns
50
60
mHealth solutions: SMS printers
Evaluation/Pilot Pending
Botswana
Zimbabwe
Evaluations/Pilot Started
Ethiopia
Malawi
PNG
Evaluations/Pilot Completed
Cameroon
Panama
Uganda
National Scale-Up Started
Kenya (300+ sites)
Mozambique (400+ sites)
Nigeria (150+ sites)
Tanzania (100+ sites)
Zambia (100+ sites)
All countries have
experienced a
significant reduction in
TAT
Outcomes
of SMS
Program
Outcomes:
SMSPrinter
printer
program
CHAI’s
Impact
CHAI’s
Ongoing
Activities
Faster TAT:
•SMS technology enables results to reach sites prior to 30-day target, if
results are sent upon sample processing completion (8 of 10 pilot sites)
•Results received ~25 days earlier with SMS tech (3 representative sites)
Patient retention: TAT for results is not the primary issue. LTFU continued.
• Consolidated laboratory for national EID testing
•Invest in sample transport nationally: affects more phases of TAT
•Later: scale to “difficult to access” sites with IP assistance
•Integrating SMS delivery into database at new EID national lab
•Potential MTN collaboration including SMS
Agenda

Background on Early Infant Diagnosis

Challenges

Laboratory Information Management System
(LIMS)

Loss To Follow Up (LTFU)

Moving Forward – new technologies

Elimination of Mother to Child Transmission
Moving forward – Building Innovation into the Design
Laboratory
Reminder to give
babies HIV
medication
Communicate
availability of results
Reminder of
appointments
Point of Care
EID
Retention
Adherence
Distribution of M&E
forms
Encourage on
exclusive feeding
Innovative Financing
29
Why This Matters
Keeping the children in mind when driving Elimination Programs
Diagnosis and treatment of HIV in children is different than it is in adults
30
Thank you
www.nascop.org/eid
www.clintonhealthaccess.org
Anisa Ghadrshenas
[email protected]