CROI 2019 Abstract eBook

Abstract eBook

Poster Abstracts

782 DIAGNOSTIC ACCURACY OF HIV ORAL RAPID TESTS VS BLOOD-BASED RAPID TESTS AMONG CHILDREN Chido Dziva Chikwari 1 , Irene Njuguna 2 , Crissi Rainer 3 , Belinda V. Chihota 4 , Jill Neary 2 , Jennifer Slyker 2 , David A. Katz 2 , Dalton Wamalwa 5 , Laura Oyiengo 6 , Grace McHugh 1 , Ethel Dauya 1 , Grace John-Stewart 2 , Rashida Ferrand 7 , Anjuli D. Wagner 2 1 Biomedical Research and Training Institute, Harare, Zimbabwe, 2 University of Washington, Seattle, WA, USA, 3 Duke University, Durham, NC, USA, 4 Centre for Infectious Disease Research in Zambia, Lusaka, Zambia, 5 University of Nairobi, Nairobi, Kenya, 6 Ministry of Health, Homa Bay, Kenya, 7 London School of Hygiene & Tropical Medicine, London, UK Background: Gaps persist in HIV testing globally for children who missed testing in prevention of mother to child transmission of HIV programs. Oral mucosal transudate rapid HIV tests (OMT) have been shown to be highly sensitive in adults but their performance has not been established in children. We validated the OraQuick ADVANCE Rapid HIV-1/2 Antibody test against blood based rapid diagnostic testing (BBT) in children aged 18 months to 18 years in Kenya and Zimbabwe. Methods: ART naïve children were tested for HIV using a series of rapid OMT and BBT. BBT followed the Kenyan and Zimbabwean national algorithms (Determine, followed by First Response [3rd generation] if Determine was reactive). The Determine test used in Zimbabwe was 4th generation, detecting antibodies and antigen; the Determine test used in Kenya was 3rd generation, detecting antibodies only. OMT samples were collected and interpreted by research staff; BBT were performed and interpreted by clinic or research staff. Sensitivity and specificity were calculated using the national algorithms as gold standard; secondary analysis excluded 2 cases where OMT was positive but national algorithmwas initially falsely negative. Binomial distribution was used for 95% confidence intervals [95%CI]. Results: A total of 1,622 children were enrolled, median age was 7 years (IQR: 4,12); 2 (0.1%) were 18-24 months; 1310 (80.8%) were 2-12 years; 301 (18.6%) were 13-18 years. Among the 56 children positive by BBT, 56 (sensitivity: 100% [97.5%CI: 93.7-100%]) were positive by OMT. Among the 1566 children negative by BBT, 1564 (specificity: 99.9% [95%CI: 99.5-100.0%]) were negative by OMT. Due to clinical presentation and OMT results, the 2 children who initially tested BBT negative and OMT positive were subsequently confirmed positive within 1 week by further tests; one (9 years) by ELISA and the second (2 years) by First Response and a third test, INSTI. Excluding these 2 children, the sensitivity and specificity of OMT compared to BBT were each 100% (97.5%CI: 93.7-100% and 99.8-100%, respectively). Conclusion: When compared to the national algorithms, OMT did not miss any positive children. This data suggests that OMT tests are valid in this age range and may be useful for facility or community-based use. Future research should explore the acceptability and uptake of OMT use by caregivers and health care workers in diverse settings to improve pediatric HIV testing coverage globally.

1 Biomedical Research and Training Institute, Harare, Zimbabwe, 2 London School of Hygiene & Tropical Medicine, London, UK, 3 Bulawayo City Council, Bulawayo, Zimbabwe, 4 Ministry of Health and Child Welfare, Harare, Zimbabwe, 5 Population Services International, Harare, Zimbabwe, 6 Organization for Public Health Interventions and Development, Harare, Zimbabwe Background: HIV prevalence is much lower in children than in other age groups but the proportion undiagnosed is significantly higher. Therefore, innovative and targeted strategies are required to improve uptake and yield of HIV testing among children. We evaluated the effectiveness of index-linked HIV testing implemented in clinic and community-based settings in children aged 2-18 years living in the household of an HIV-infected individual in urban and rural settings in Zimbabwe. Methods: Individuals attending for HIV care at 3 urban and 3 rural primary care clinics in western Zimbabwe who had children (2-18 years) of unknown HIV status living in their households were offered 3 options for their children to access HIV testing and counselling (HTC): 1) Clinic-based HTC 2) Home-based HTC by community health workers 3) Testing performed by caregivers using an oral mucosal test (assisted self-testing) Demographic data was collected from consenting caregivers who were followed up over 2 months to ascertain testing outcomes. Results: We recruited 2813 people living with HIV (median age 38, IQR 32-46 years) who had 3431 children eligible for testing (median age 9, IQR 6-13 years). HTC was accepted for 2757 (80.4%) eligible children. Overall, 74.7% selected clinic-based testing, 19.2% opted for community-based testing and 6.1% for assisted self-testing, with no difference in trend by rural or urban setting. Among the 2757 children for whom HTC was accepted, 1977 (71.7%) completed testing. Those who selected community-based testing were more likely to complete the test than those who selected clinic-based testing (OR=1.69 95%CI:1.3-2.2, p<0.001) or assisted self-testing (OR=2.38 95%CI:1.0-2.3, p=0.04). Overall HIV prevalence was 1.4% but the prevalence among 12-18 year olds was 2.5% and 81% of those diagnosed were >7 years. HIV yield was 0.8% overall. Previously undiagnosed HIV was strongly associated with older age (OR=3.54, 95%CI:1.1-11.1, p=0.03) comparing 13-18 years to 2-5year olds and with single or double orphanhood (OR=3.10, 95%CI:1.4-6.9, p=0.005). All 28 HIV positive children were linked to care within 2 weeks. Conclusion: Index-linked testing is a feasible HTC strategy for children in Zimbabwe. However, while clinic-based testing has the highest uptake, children were more likely to be tested in community settings. Older children and orphans are at increased risk of undiagnosed HIV. Strengthening of HTC strategies to target this age group are required. 784 EARLY CHILD DEVELOPMENT OF HIV-EXPOSED UNINFECTED CHILDREN IN RURAL ZIMBABWE Jaya Chandna 1 , Ceri Evans 2 , Bernard Chasekwa 1 , Gwendoline Kandawasvika 3 , Naume Tavengwa 1 , Batsirai Mutasa 1 , Florence D. Majo 1 , Kuda Mutasa 1 , Lawrence Moulton 4 , Robert Ntozini 1 , Andrew Prendergast 1 , Jean Humphrey 4 , Melissa Gladstone 5 , for the SHINE Trial Team 1 Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe, 2 Queen Mary University of London, London, UK, 3 University of Zimbabwe, Harare, Zimbabwe, 4 Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, 5 University of Liverpool, Liverpool, UK Background: Maternal HIV exposure may affect early child development (ECD), but studies comparing developmental outcomes between HIV-exposed uninfected (HEU) and HIV-unexposed children have had heterogeneous findings. We compared ECD outcomes between HEU and HIV-unexposed children recruited to the SHINE trial in rural Zimbabwe. Methods: SHINE was a community-based cluster-randomized trial of infant and young child feeding (IYCF) and water, sanitation and hygiene (WASH) interventions in two rural Zimbabwean districts (ClinicalTrials.gov/ NCT01824940). We assessed ECD outcomes at 24 months of age using the Malawi Developmental Assessment Tool (MDAT, assessing motor, cognitive, language and social development); MacArthur-Bates Communication Development Inventory (CDI) (assessing vocabulary and grammar); A-not-B test (assessing object permanence); and a self-control task. All tools were designed for use in sub-Saharan Africa, and specifically adapted for Shona-speaking households. We used generalized estimating equations to compare ECD scores between HEU and HIV-unexposed children. We included only those randomized to the standard-of-care arm to evaluate children in the absence of trial interventions.

Poster Abstracts

783 FINDING THE MISSING CHILDREN WITH HIV: INDEX-LINKED TESTING IN CLINICS & COMMUNITIES Chido Dziva Chikwari 1 , Tsitsi Bandason 1 , Victoria Simms 2 , Stefanie Dringus 2 , Ethel Dauya 1 , Grace McHugh 1 , Edwin Sibanda 3 , Rudo Chikodzore 4 , Miriam N. Mutseta 5 , Getrude Ncube 4 , Sara Page-Mtongwiza 6 , Elizabeth L. Corbett 2 , Helen A. Weiss 2 , Rashida Ferrand 2

CROI 2019 303