Dr. Laura Guay Vice President for Research Elizabeth Glaser Pediatric AIDS Foundation

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 55% of pregnant womennot receiving PMTCT drugs 68% of HIV-exposed infantsnot receiving PMTCT drugs WHO, UNAIDS, UNICEF - Towards Universal Access: Progress Report 2009

Pearl Study: Coverage Cascade in HIV+ WomenCoetzee D et al. IAS, Capetown, South Africa, July 2009, Abs. WeLBD101

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)

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

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

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

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

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

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

Dr. Laura Guay Vice President for Research Elizabeth Glaser Pediatric AIDS Foundation