Early Infant Diagnosis of HIV:
Successes, Challenges, and potential
solutions
Dr. Laura Guay
Vice President for Research
Elizabeth Glaser Pediatric AIDS Foundation
Research Professor, George Washington
University School of Public Health and Health
Services
Provision of Antiretroviral Drugs
50%
55% of pregnant women
not receiving PMTCT drugs
45%
45%
40%
34%
35%
32%
30%
24%
25%
20%
15%
18%
15%
10%
12%
10%
20%
68% of HIV-exposed infants
not receiving PMTCT drugs
5%
6%
0%
2004
2005
2006
2007
2008
Pregnant women living with HIV receiving ARVs
Infants born to pregnant women living with HIV receiving ARVs
WHO, UNAIDS, UNICEF - Towards Universal Access: Progress Report 2009
Pearl Study: Coverage Cascade in HIV+ Women
Coetzee D et al. IAS, Capetown, South Africa, July 2009, Abs. WeLBD101
0
HIV-positive deliveries (100%)
Services documented (92%)
HIV test offered (84%)
HIV tested (81%)
Received positive result (74%)
Mother received NVP (71%)
NVP in cord blood (57%)
Completed prophylaxis (50%)
1000 2000 3000 4000
Testing Status of Infants- 2009-2010
Identification of HIV exposed infants
Low rate of return for 4-6 week postnatal visit
• Tingathe community health workers- Malawi
• Pregnant women introduction to and appointment for
postnatal referral clinic- Uganda
• Community testing days- Lesotho
Failure to identify an infant as HIV exposed
•
•
•
•
Maternal PMTCT status codes on immunization card
Revised maternal/infant health card- PMTCT/EID status
Routine maternal PMTCT history
Screening for HIV exposure at all contacts with HC,
particularly EPI clinics (rapid
DBS)
Testing Status of Infants- 2009-2010
Specimen obtained for HIV testing
 Limited number of laboratories with PCR capacity
• In-country capacity developed- Lesotho, Swazi
• Decentralization of lab capacity
• Hub and spoke regional service system- Kenya,
Uganda
 Low facility coverage of EID services (limited
manpower, time, commodities, transport)
• Rapid roll-out of EID access (training, supplies)
• Strong linkages between sites with and without
testing capacity – Uganda
• Moving specimen collection to MCH rather than lab
Specimen obtained for HIV testing
 Lack of trained HCW (staff attrition, rotation)
• Health system wide training
• Mentorship program (clinical and system) CHAI/MOH Zambia
• Ongoing training, supervision
 Low testing acceptance rate (lack of knowledge,
fear of knowing results, no ART access)
• Training and buy-in from HCW- Zimbabwe
• Focused counseling prior to and after delivery
• Community sensitization
Specimen obtained for HIV testing
 Stock out of testing supplies
• Bundling of supplies- Zimbabwe
• Training in inventory management, forecasting
• Supply chain management
 Inadequate specimen transport system
• Dried blood spot use- significant advantage
• Focused local effort to determine best system
• Creative use of existing (non-health) transport
systems with broad reach – Post, EMS, bus,
newspaper delivery
• Distal access via bikes, motorcycles, personnel
Testing Status of Infants- 2009-2010
Test results returned to clinic from lab
 Extremely long turn around time (months)
• Support for data clerks in lab to process results
• Increased frequency of result collection- Tanzania
• Use of technology to replace paper based system
 email- Lesotho; cell phone- Mozambique
 Insufficient/inadequate sample
• Regular communication between lab and clinic
• QI initiatives involving lab and clinics
• Ongoing HCW training/supervision
Test results returned to clinic from lab
 Poor specimen/result tracking
• Electronic EID/laboratory database- Swaziland
• Use of multiple page laboratory request forms
 Inadequate systems for accurate
documentation in clinic
• Revised clinic registers with places for
documenting “EID cascade”
• Clear systems for managing results when received
• Clear lines of responsibility for handling results
received, recording in medical records
Testing Status of Infants- 2009-2010
Determining HIV Test Result
 Limited availability of well trained laboratory technicians
(technical skills, attrition)
• Laboratory training/mentorship programs
• Incentives to remain in public sector
• Development of technology requiring less technical
skills
 Insufficient lab capacity for volume
• Lab capacity expansion = EID scale-up
• Improved inventory management, forecasting for
commodities, supply chain management
Determining HIV Test Result
 Weak QA/QC systems
• Quality focus not just quantity
 Lack of confirmatory testing
• Minimize specimen contamination risk
• Minimize specimen/labeling mix-up
• Development of an efficient, cost-effective
system for confirmation of infection status
 Indeterminate test results
• SOPs for managing indeterminate/inconsistent
results
Testing Status of Infants- 2009-2010
Test results received by caretaker
 Low rate of return for results
• Improved turn around time will decrease frustration from
multiple return visits without results
• Enhanced counseling on importance of infant diagnosis
• Patient friendly clinic services
 Lack of urgency in responding to positive results
• Sensitization of HCW on impact of delayed diagnosis
• Rapid result review and response system in place
 Disorganized system for documenting results when
returned to the clinic
• SOP for ensuring results accessible when caretaker
returns
Test results received by caretaker
 Lack of active patient tracking system
• Use of peers, support groups, community workers
 Concern about counseling women on infant status- both
for negative and infected infants
• Training, counseling aids to decrease discomfort with
providing infant status while ongoing exposure
• Re-training on implications of new WHO guidelines for
postnatal prophylaxis
• Quality infant feeding counseling to minimize
premature discontinuation of breastfeeding
• System in place for referral of HIV infected infants to
care and treatment
Testing Status of Infants- 2009-2010
Enrollment in HIV Care (infected infants)
Poor linkages between PMTCT and HIV
Care and Treatment Programs (bidirectional)
• ART in MCH for women/infants- Lesotho, Swazi
• Consultation/collaboration between PMTCT
and ART clinics to determine best method for
referral
 Personal Escort between services (staff, peers)
 Referral system with feedback to identify those lost
 System of shared data capture for prospective f/up
 Prioritized services for infants
Enrollment in HIV Care (infected infants)
 Loss to follow-up between service delivery
points
• Active follow-up system in place
 Limited knowledge in community and
families about importance of treating
infants
• Community education/sensitization campaigns
• Community health workers/PMTCT champions
Testing Status of Infants- 2009-2010
Initiation of ART (infected infants < 2)
 Limited facilities providing ART to infants
• Decentralization of pediatric care and treatment
services
• Policy changes allowing non- physician ART prescribing
and provision of HIV care and treatment (including
infants)
• ART integration in MCH using MCH nursing
 Inadequate stocks of ARV formulations appropriate for
infants
• Collaboration with Pharma on identifying priority
needs (IATT, IAS)
• Accurate forecasting, supply chain management to
periphery
Initiation of ART (infected infants < 2)
 Lack of experience/comfort treating infants
• Expanded Pediatric ART training/re-training with new
WHO guidelines
• Clinical mentorship programs with extensive and
prolonged mentor contact
• Exchange visits between experienced and new service
delivery sites
• Comprehensive job aids and decision trees/algorithms
 WHO recommends presumptive treatment in absence
of virologic testing but providers reluctant to initiate
ART in infants without definitive diagnosis
Way Forward
• Maximize efforts at each step of the
cascade(s)
• Identify and address gaps in the health
system (manpower, lab capacity, data
collection, training, logistics)
• Creative use of new technologies
• Point of Care or at least Closer to Care early
infant diagnostics
• Community sensitization/engagement
Conclusion
PMTCT program goal 1 - prevent infant HIV
infections, yet ability to monitor HIV transmission
rates to determine progress remains elusive
PMTCT program goal 2 – identify HIV infected
infants as early as possible to decrease morbidity
and mortality yet universal determination of HIV
status remains elusive
Universal access to rapid, high quality, early
infant diagnosis requires universal commitment,
collaboration, and innovation
Tunaweza: Together, we can…
Eliminate Pediatric HIV