Group Work Recommendations Testing Group Members-names

PopulationHIV-exposed infants HIV exposure unknown Recommendation Virological testing at 4-6 weeks of age Infant testing at first contact with health system 1 Notes 1 (Including delivery). Antibody testing followed by virological testing if appropriate (+Ab test, age) Identification of symptomatic infants should be improved, especially during neonatal period to enable virological testing at 4-6 weeks StrengthSTRONG When to Test

Evidence –early infant ART EvidenceComment Natural history and mortality data Modelling and sensitivity / specificity data Country programme data Rapid disease progression (esp in early infancy); peak in mortality at 2-4mo; CHER trial data (early diagnosis and treatment reduces mortality) Support 4-6 week timing for single test; earlier testing with repeat at 4-6w not feasible recommendation Data show feasibility and expansion of DBS testing; evidence for good EPI coverage strengthens 6 week visit as current point of contact EVIDENCE: STRONG

Benefits and desired effects: 4-6 week viral testing in HIV exposed Benefit Explanation Early diagnosis Early treatment May clarify choice of feeding Point of entry for other family members Knowledge of child’s status for family and healthcare personnel Dependent on early diagnosis; early treatment reduces morbidity and mortality and reduces loss to follow-up Eg HIV-infected child to continue breastfeeding Maternal health (CTX, ART, family planning); diagnosis of other family members

Risks or undesired effects RisksExplanation Incorrect diagnosis Early cessation of breastfeeding Child is not retested May discourage use of presumptive diagnosis Insufficient programme capacity Diversion of resources Need strategy for repeat testing to rule out false- positive and false-negative test results Mothers may choose to stop BF if child uninfected Breastfeeding infants need to be retested but perception may be that child is definitely uninfected In settings where PCR is not available, may be a reduced emphasis on presumptive diagnosis Infants may be tested but unable to access ART Other aspects of child health programme may suffer

Risks/Benefit assessment: 4-6 week viral testing in HIV exposed DecisionExplanation Benefits > Risks STRONG recommendation

Values and preferences: 4-6 week viral testing in HIV exposed DecisionExplanation Denial and stigma Neglect of child HIV status may prejudice maternal care of child

Feasibility DecisionExplanation Capacity Integration of pMTCT / MCH services Interpretation of results Timing of turnaround Repeat testing Early ART Clinic and lab personnel, PCR kits, lab facilities, transportation, mentorship, QA (massive scale up to 100% coverage!) ‘Run-through’ pathway needs to be strengthened and clarified Clear referral pathways, training, supervision Critical to reduce delays: testing and access to ART Strategy appropriate to setting required Availability, regimens, formulations, willingness to treat

Costs: 4-6 week viral testing in HIV exposed DecisionExplanation Technology costs Programme costs Treatment costs Emotional costs Laboratory equipment, PCR testing kits Training, personnel, counsellors, transport Identification of more HIV-infected infants eligible for ART Families and staff

PopulationHIV-exposed infants HIV exposure unknown Recommendation Virological testing at 4-6 weeks of age HIV exposure status of all infants should be determined at first contact with healthcare system 1 Notes 1 (Including delivery). Antibody testing followed by virological testing if appropriate (+Ab test, age) Identification of symptomatic infants should be improved, especially during neonatal period to enable virological testing at 4-6 weeks StrengthSTRONGCONDITIONAL When to Test

HIV-exposedHIV exposure unknown Standard testing pathway at 4-6w Ab testing at earliest point of healthcare contact Delivery Identification of symptomatic infants Beyond 6 weeks If Ab test positive and age appropriate then confirmatory virological test if available OR

Key outstanding questions IssueResearch or action required Trade-off costs Within HIV programmes: pMTCT vs EID Outwith HIV programmes: Impact on other aspects of child health programme Long-term impact Impact on health systems Presumptive diagnosis How this fits in with EID, can we improve identification in early life of children who miss pMTCT Timing of CTX prophylaxis Could this be earlier?