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AbstractIntroduction: Timely diagnosis is necessary to avert early death in HIV‐infected neonates. Birth PCR testing may improve early identification and facilitate access to care. We implemented a birth HIV diagnosis programme in Johannesburg, South Africa and present successes and challenges of the first two and a half years of operation.Methods: Between June 2014 and December 2016, we sought to identify all HIV‐exposed births and offer newborn HIV PCR testing before discharge after delivery. The programme identified newly delivered women who had tested positive during pregnancy and provided post‐partum HIV antibody testing for women without recent negative results. HIV‐positive women were required to consent for neonatal birth testing and asked to return a week later to obtain their results. Neonatal venous blood was sampled and tested at the national laboratory using Roche COBAS® TaqMan® HIV‐1 Qualitative Test (Version 2.0). Non‐negative results triggered active follow‐up for confirmatory testing and appropriate treatment.Results: Of 30,591 women with live births, 6864 (22.4%) were known to be HIV positive and an additional 221 women (1.4% of those tested) were identified during maternal postnatal testing. Of 7085 HIV‐positive women, 6372 (89.9%) were interviewed and agreed to data collection, 6358 (99.8%) consented to birth testing for 6467 neonates and a blood sample was collected for 6377 (98.6%). If tested, 6210 (97.4%) tested negative, 91 (1.4%) positive, 57 (0.9%) revealed errors and 19 (0.3%) were indeterminate . Seven of the 19 neonates with indeterminate results and one with initial error result were found to be infected on subsequent testing yielding an intrauterine transmission rate of 1.6% (95% CI: 1.3–1.9). Sixteen (16%) of 99 infected infants were born to women (n = 221) identified during postnatal testing. With active outreach, 95/99 (96%) infected infants were initiated on antiretroviral therapy. Of 6261 neonates with negative results, 3251 (52%) returned to receive their test results.Conclusion: Our programme successfully achieved high coverage and uptake of birth PCR testing and was able, with active tracking, to start almost all identified HIV‐infected neonates on antiretroviral therapy. Implementation required additional staff for counselling, quality control and outreach. Return for negative results was low and neonates with indeterminate results required multiple repeat tests.

AbstractIntroductionMaternal viral load monitoring (mVL) and early infant diagnosis (EID) are necessary to achieve elimination of mother‐to‐child transmission of HIV. Point‐of‐care testing can achieve better outcomes compared to centralized laboratory testing (CLT). We describe the first implementation of point‐of‐care (POC) mVL and EID testing around delivery at four high volume tertiary obstetric units (TOUs) in Gauteng, South Africa.MethodsProspective study of pregnant women living with HIV (WLHIV) and their infants. During the period 1 June 2018 to 31 March 2019, routine staff collected blood specimens from women and their infants around delivery. Specimen collection occurred throughout the week while dedicated POC operators, conducted testing during working hours on weekdays. Descriptive statistics and multivariable Poisson regression with robust error variance were used to describe outcomes and associated factors. Outcomes determined were (i) coverage of mVL and EID testing defined as a proportion of live births to WLHIV admitted at each facility (ii) results returned prior to discharge (iii) turn‐around time (TAT) and iv) performance of POC testing compared to CLT.ResultsIn total, 8147 live births to pregnant WLHIV were recorded in the implementation period. Of these, 2912 mVL and 5074 EID specimens were included in the analysis, with 131 (4.5%) mVL and 715 (14.1%) EID specimens having initial invalid/error results. Overall coverage of POC mVL and EID testing was 35.6% (range 20.9% to 60.1%) and 61.9% (range 47.0% to 88.0%) respectively. Proportions of POC tested mothers and infants with results returned prior to discharge were 74.3% (range 39.0% to 95.7%) and 73.0% (range 50.0 to 97.9%). Return of results was independently associated with TOU, after‐hours specimen collection, having an initial invalid or error result and period of implementation. Overall TAT for specimens collected from mother‐infant pairs where both had POC testing, during weekdays was longer for EID compared to mVL testing (median 3.3 hours vs. 2.9 hours, p‐value sign test <0.001). POC results were comparable to those from laboratory testing.ConclusionAccurate and timely POC mVL and EID testing around delivery was implemented with variable success across TOUs. Further scale up would need to address health system factors at facility level and high analytical error rates.

AbstractIntroductionTo date, very little programmatic data has been published regarding serial antiretroviral (ARV) levels in infants exposed to maternal treatment and/or infant prophylaxis during the first months of life. Such data provide the opportunity to describe the proportion of infants exposed to virologically suppressive levels of ARVs and to gauge adherence to the prevention of mother‐to‐child transmission of HIV (PMTCT) programme.MethodsFrom August 2014 to January 2016, HIV‐exposed infants born at Kalafong Provincial Tertiary Hospital in Pretoria, South Africa were enrolled as part of an observational cohort study. Plasma samples from HIV‐exposed uninfected infants were obtained at birth, 6‐weeks, 10‐weeks and 14‐weeks of age and quantitative efavirenz (EFV) and nevirapine (NVP) drug level testing performed using liquid chromatography‐mass spectrometry, irrespective of maternal ARV regimen. Descriptive analysis of EFV and NVP levels in relation to self‐reported maternal and infant ARV exposure was performed. EFV levels >500 ng/mL and NVP levels >100 ng/mL were reported based on studies suggesting that trough levels above these thresholds are associated with virological suppression and PMTCT respectively.ResultsAmong 66 infants exposed to maternal EFVin utero, 29 (44%) had virologically suppressive plasma EFV levels at birth, with a median level of 1665 ng/mL (IQR: 1094 to 3673). Among infants who were exclusively breastfed at 6‐, 10‐ and 14 weeks, 13/48 (27%), 5/25 (25%) and 0/21 (0%) had virologically suppressive EFV levels. Among 64 infants whose mothers reported administering daily infant NVP at time of their 6‐week HIV PCR test, only 45 (70%) had NVP levels above the minimum prophylactic trough level.ConclusionsDuring the first 10‐weeks after delivery, a quarter of breastfed infants born to women on an EFV‐containing treatment regimen maintained virologically suppressive EFV plasma levels. This finding highlights the importance of both careful monitoring of ARV side effects and repeat HIV PCR after the first few months of life among HIV‐exposed uninfected infants. As 30% of infants had inadequate NVP plasma levels at 6‐weeks of age, adherence counselling to caregivers regarding infant prophylaxis needs to be enhanced to further reduce mother‐to‐child transmission of HIV.

AbstractIntroductionAdolescent girls and young women (AGYW) living with HIV experience poor HIV outcomes and high rates of unintended pregnancy. Little is known about which healthcare provisions can optimize their HIV‐related outcomes, particularly among AGYW mothers.MethodsEligible 12‐ to 24‐year‐old AGYW living with HIV from 61 health facilities in a South African district completed a survey in 2018–2019 (90% recruited). Analysing surveys and medical records from n = 774 participants, we investigated associations of multiple HIV‐related outcomes (past‐week adherence, consistent clinic attendance, uninterrupted treatment, no tuberculosis [TB] and viral suppression) with seven healthcare provisions: no antiretroviral therapy (ART) stockouts, kind and respectful providers, support groups, short travel time, short waiting time, confidentiality, and safe and affordable facilities. Further, we compared HIV‐related outcomes and healthcare provisions between mothers (n = 336) and nulliparous participants (n = 438). Analyses used multivariable regression models, accounting for multiple outcomes.ResultsHIV‐related outcomes were poor, especially among mothers. In multivariable analyses, two healthcare provisions were "accelerators," associated with multiple improved outcomes, with similar results among mothers. Safe and affordable facilities, and kind and respectful staff were associated with higher predicted probabilities of HIV‐related outcomes (p<0.001): past‐week adherence (62% when neither accelerator was reported to 87% with both accelerators reported), clinic attendance (71%−89%), uninterrupted ART treatment (57%−85%), no TB symptoms (49%−70%) and viral suppression (60%−77%).ConclusionsAccessible and adolescent‐responsive healthcare is critical to improving HIV‐related outcomes, reducing morbidity, mortality and onward HIV transmission among AGYW. Combining these provisions can maximize benefits, especially for AGYW mothers.

AbstractIntroduction: HIV‐1 polymerase chain reaction (PCR) testing at birth aims to facilitate earlier initiation of antiretroviral therapy (ART) for HIV‐infected neonates. Data from two years of universal birth testing implementation in a high‐burden South African urban setting are presented to demonstrate the prevalence and outcomes of diagnostic challenges in this context.Methods: HIV‐exposed neonates born at Rahima Moosa Mother and Child Hospital between 5 June 2014 and 31 August 2016 were routinely screened at birth for HIV‐1 on whole blood samples using the COBAS® AmpliPrep/COBAS® TaqMan (CAP/CTM) HIV‐1 Qualitative Test, version 2.0 (Roche Molecular Systems, Inc., Branchburg, NJ, USA). Virological results were interpreted according to standard operating procedures with the South African National Health Laboratory Service. All neonates with non‐negative results were actively followed‐up and categorized according to HIV infection status as positive, negative, uncertain and lost to follow‐up (LTFU).Results: 104 (1.8%) of 5743 HIV‐exposed neonates received a non‐negative birth PCR result, for which laboratory data were available for 102 (98%) cases – 78 (76%) tested positive and 24 (24%) indeterminate. HIV infection status was confirmed positive in 83 (81%) infants, negative in 8 (8%), uncertain in 5 (5%) and LTFU in 6 (6%) cases. The positive predictive value (excluding cases of uncertain diagnosis and inadequate testing) following a non‐negative HIV‐1 PCR screening test at birth was 0.91 (83/91; 95% confidence interval: 0.85–0.96). Neonates testing positive at birth had significantly higher viral load (VL) results than those testing indeterminate at birth of 4.5 and 3.0 log copies/ml (p = 0.0007), respectively. Similarly, mothers of neonates with positive as compared to indeterminate birth test results had higher VLs of 4.5 and 2.7 log copies/ml (p = 0.0013), respectively. Half of neonates with an indeterminate birth test were shown to be HIV‐infected on subsequent confirmatory testing, with time to final diagnosis 30 days longer for these neonates (p < 0.0001).Conclusion: Indeterminate HIV‐1 PCR results accounted for a quarter of non‐negative results at birth and were associated with a high risk of infection in comparison to the risk of in utero transmission. Indeterminate birth results with positive HIV PCR results on repeat testing were associated with later final diagnosis. The HIV‐1 status remains uncertain in a minority of cases because of repeatedly indeterminate results, highlighting the need for more sensitive and specific virological tests.