CROI 2020 Abstract eBook

Abstract eBook

Poster Abstracts

varied for different individual screening questions. A ‘yes’ response to starting ART after 32 weeks’ gestation had the highest sensitivity in predicting HIV infection 58.6%, (95%CI: 40.7—76.5) and a ‘yes’ to non-adherence to ART had the lowest sensitivity 7.1% (95%CI: -2.4%—16.7%). Conclusion: Although there was a significant association of maternal risk stratification with risk of infant infection and the negative predictive value of the risk screening tool was relatively high, the sensitivity was relatively low, and 38% of infants infected at birth would be missed if birth testing was based solely on a positive risk screen.

784 EVALUATION OF PERFORMANCE AND USABILITY OF CEPHEID XPERT HIV -1 QUAL ASSAY IN MALAWI Maggie N. Nyang'Wa 1 , Augustine Choko 2 , Angela Obasi 3 , Chisomo Msefula 4 , Maganizo Chagomerana 5 , Sarah Watters 1 , Kevin Mortimer 3 , Neil Kennedy 6 , Derek Fairley 6 , Nigel Klein 1 , Dagmar Alber 1 1 University College London, London, UK, 2 Malawi–Liverpool–Wellcome Trust Clinical Rsr Prog, Blantyre, Malawi, 3 Liverpool School of Tropical Medicine, Liverpool, UK, 4 University of Malawi, Blantyre, Malawi, 5 University of North Carolina Project– Malawi, Lilongwe, Malawi, 6 Queen's University Belfast, Belfast, United Kingdom Background: As countries work towards attaining UNAIDS 90-90-90 targets, challenges related to Early Infant Diagnosis (EID) of HIV should be addressed. In Malawi, EID programmes use dried blood spot (DBS) and HIV PCR with turn- around-times (TAT) of 2-3 months with 33% of exposed infants lost to follow- up. There is an urgent need for point-of-care tests (POCTs) which can improve TAT and reduce loss to follow-up. We evaluated the feasibility, sensitivity and specificity, turn-around-time, acceptability and usability of Cepheid Xpert HIV-1 Qual assay (Xpert HIV) whole blood protocol in a rural district hospital compared to HIV PCR. Methods: This prospective diagnostic study consecutively recruited children aged 0-14 years attending Mulanje District Hospital (MDH) in Malawi between July-September 2018. All POCT were done on site using Xpert HIV. DBS were prepared for HIV PCR testing at a central facility, Queen Elizabeth Central Hospital (QECH). As a standard procedure for EID testing DBS were also sent to Thyolo District Hospital (TDH) for testing by PCR. We compared the sensitivity and specificity between Xpert HIV and PCR. We also compared the median TAT between Xpert HIV fromMDH and PCR from QECH and TDH. Acceptability of Xpert HIV was evaluated among caregivers and nurses. Results: Of 600 participants, 324 (54%) were female. 272 (45.3%) were aged over 5 years, 227 (37.83) between 1-5 years and 101 (16.83%) <1 year. Most of the participants 585 (97.5%) were HIV non-infected. A total of 15 participants were diagnosed with HIV. Most HIV positives aged >1 year (11/13 (85%)) started antiretroviral therapy in 1 day and 4/15 (26%) of all HIV positives were lost to follow up. Sensitivity and specificity of Xpert HIV versus PCR at QECH were 100% (95% CI: 78.2 - 100%) and 100% (95% CI: 99.4 - 100%), respectively. Xpert HIV had the shortest median TAT from time of blood test (median = 5.34 hours (interquartile range: 2.45–10.19) compared to PCR performed at QECH (median = 3 days (IQR: 1.05–4.19)), p<0.001 and PCR performed at TDH (median = 24 days (IQR: 20–28)), p<0.001. Results for only 17 of the 32 samples sent to TDH were received. Xpert HIV was well accepted by caregivers and nurses; and was deemed easy to use by laboratory technicians in comparison to PCR. Conclusion: These results suggest that implementing Xpert HIV may improve EID and linkage into HIV care. 785 EARLY INFANT DIAGNOSIS: STRENGTHEN EXISTING SYSTEMS OR INVEST IN POINT-OF-CARE? Nicole McCann 1 , Jennifer Cohn 2 , Clare Flanagan 1 , Emma Sacks 3 , Sushant Mukherjee 3 , Addmore Chadambuka 4 , Haurovi Mafaune 4 , Rochelle P. Walensky 1 , Collins O. Odhiambo 5 , Kenneth Freedberg 1 , Oluwarantimi Adetunji 3 , Christopher Panella 1 , Andrea L. Ciaranello 1 1 Massachusetts General Hospital, Boston, MA, USA, 2 Elizabeth Glaser Pediatric AIDS Foundation, Geneva, Switzerland, 3 Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC, USA, 4 Elizabeth Glaser Pediatric AIDS Foundation, Harare, Zimbabwe, 5 University of Nairobi, Nairobi, Kenya Background: To improve early infant HIV diagnosis (EID) programs, options include replacing lab-based tests with point-of-care (POC) assays or investing in strengthened systems for sample transport and return of results. We projected the clinical benefits and cost-effectiveness of these approaches. Methods: We used the Cost-Effectiveness of Preventing AIDS Complications- Pediatric model, with programmatic and published data, to examine

783 POINT-OF-CARE TESTING IMPROVES EARLY INFANT DIAGNOSIS IN THE PUBLIC HEALTH SECTOR Jessica Joseph 1 , Melody Wang 1 , Caroline E. Boeke 1 , ZelalemM. Abate 2 , Charles Atem 3 , Adisu Kebede 4 , Phibeon M. Mangwendeza 5 , Ellen Munemo 5 , Divine Nzuobontane 3 , Shaukat Khan 1 , Trevor Peter 1 , Jilian Sacks 1 1 Clinton Health Access Initiative, Boston, MA, USA, 2 Clinton Health Access Initiative, Addis Ababa, Ethiopia, 3 Clinton Health Access Initiative, Yaounde, Cameroon, 4 Ethiopian Public Health Institute, Addis Ababa, Ethiopia, 5 Clinton Health Access Initiative, Harare, Zimbabwe Background: Despite progress in the scale-up of early infant diagnosis (EID) programs in the last decade, in 2018 only 51% of HIV-exposed infants received a diagnostic nucleic-acid test within the recommended two months of birth. Point-of-care (POC) testing has been shown to dramatically increase rates of early diagnosis and initiation of ART for HIV-positive infants. As national programs in sub-Saharan Africa incorporate POC EID technologies, it is critical to document the impact of POC EID within routine public sector programs and understand implications for national scale-up. Methods: A 6-month pre-/post-evaluation comparing conventional laboratory (pre) to POC (post) EID testing using either Cepheid GeneXpert or Abbott mPima devices was conducted in 36 facilities across three countries, Cameroon, Ethiopia and Zimbabwe, between 2018-2019. On-site trainings for POC devices were held for facility and laboratory staff prior to implementation. Data were retrospectively extracted from routine records at health facilities for all infants (aged 0-2 years) tested. The primary outcome was the proportion of infants tested in which the infant’s caregiver received the test results within 28 days of sample collection (WHO recommendation, 2010). ART initiation within 28 days of sample collection was also analyzed for HIV-positive infants. Results: Before POC introduction, 2465 EID tests were conducted, of which 123 (5.0%) were HIV-positive. After POC implementation, 4288 tests were conducted, 189 (4.4%) of which were HIV-positive. POC EID resulted in faster turnaround times [median of 0 days (POC) vs. 40 days (conventional)] and POC EID results were more than four times as likely to be received by a caregiver within 28 days of sample collection (19.5% for conventional vs. 86.1% for POC; RR: 4.67; 95% CI: 1.51-7.83). The proportion of caregivers receiving results within 28 days of POC sample collection varied from 76.0% in Cameroon to 96.2% in Ethiopia (Table 1). Infants tested on POC had a much greater probabilty of initiating ART within 28 days (9.8% for conventional vs. 67.2% for POC; RR: 6.72; 95% CI 2.13-11.32). Conclusion: POC EID significantly improved rates of test result returned to caregiver and ART initiation within routine care at public health facilities. However, in some settings gaps remained in timely results return and treatment initiation. To maximize the impact of faster testing through POC, programs must focus on ensuring test results are used and follow-on care is provided.

Poster Abstracts

CROI 2020 290