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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
50%
                           55% of pregnant women                       45%
45%
                          not receiving PMTCT drugs
40%
                                                       34%
35%
                                                                          32%
30%
                                      24%
25%


20%
                       15%                              20%
                                            18%
15%
        10%
                                                  68% of HIV-exposed infants
10%                            12%                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     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
 4226
           4099 (97%)




                        2895 (70%)




                                     449 (15%)
                                                 230 (51%)   200 (87%)    178 (89%)


Exposed    EID drawn      Results     Tested     Received    Enrolled in Initiated on
 infants                 returned    positive     results       Care          ARV
                         from lab
Overall , 633 infected children = 71% identified, 28% treated
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
 4226
           4099 (97%)




                        2895 (70%)




                                     449 (15%)
                                                 230 (51%)   200 (87%)    178 (89%)


Exposed    EID drawn      Results     Tested     Received    Enrolled in Initiated on
 infants                 returned    positive     results       Care          ARV
                         from lab
Overall , 633 infected children = 71% identified, 28% treated
 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
 4226
           4099 (97%)




                        2895 (70%)




                                     449 (15%)
                                                 230 (51%)   200 (87%)    178 (89%)


Exposed    EID drawn      Results     Tested     Received    Enrolled in Initiated on
 infants                 returned    positive     results       Care          ARV
                         from lab
Overall , 633 infected children = 71% identified, 28% treated
 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
 4226
           4099 (97%)




                        2895 (70%)




                                     449 (15%)
                                                 230 (51%)   200 (87%)    178 (89%)


Exposed    EID drawn      Results     Tested     Received    Enrolled in Initiated on
 infants                 returned    positive     results       Care          ARV
                         from lab
Overall , 633 infected children = 71% identified, 28% treated
  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
 4226
           4099 (97%)




                        2895 (70%)




                                     449 (15%)
                                                 230 (51%)   200 (87%)    178 (89%)


Exposed    EID drawn      Results     Tested     Received    Enrolled in Initiated on
 infants                 returned    positive     results       Care          ARV
                         from lab
Overall , 633 infected children = 71% identified, 28% treated
 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
 4226
           4099 (97%)




                        2895 (70%)




                                     449 (15%)
                                                 230 (51%)   200 (87%)    178 (89%)


Exposed    EID drawn      Results     Tested     Received    Enrolled in Initiated on
 infants                 returned    positive     results       Care          ARV
                         from lab
Overall , 633 infected children = 71% identified, 28% treated
 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
 4226
           4099 (97%)




                        2895 (70%)




                                     449 (15%)
                                                 230 (51%)   200 (87%)    178 (89%)


Exposed    EID drawn      Results     Tested     Received    Enrolled in Initiated on
 infants                 returned    positive     results       Care          ARV
                         from lab
Overall , 633 infected children = 71% identified, 28% treated
 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

				
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