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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. - PowerPoint PPT Presentation
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Dr. Laura GuayVice President for Research
Elizabeth Glaser Pediatric AIDS FoundationResearch Professor, George Washington
University School of Public Health and Health Services
Early Infant Diagnosis of HIV: Successes, Challenges, and potential
solutions
Provision of Antiretroviral Drugs
WHO, UNAIDS, UNICEF - Towards Universal Access: Progress Report 2009
55% of pregnant womennot receiving PMTCT
drugs
68% of HIV-exposed infants
not receiving PMTCT drugs
Pearl Study: Coverage Cascade in HIV+ WomenCoetzee D et al. IAS, Capetown, South Africa, July 2009, Abs. WeLBD101
0 1000 2000 3000 4000
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%)
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 (bi-directional)
• 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
ConclusionPMTCT 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