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Introduction: Despite notable progress towards PMTCT, only 50% of HIV-exposed infants in sub-Saharan Africa were tested within the first 2 months of life and only 30% of HIV-infected infants are on antiretroviral treatment. This study assessed HIV prevalence in infants and children receiving care at various service entry points in primary healthcare facilities in Uganda. Methods: A total of 3600 infants up to 24 months of age were systematically enrolled and tested at four regional hospitals across Uganda. Six hundred infants were included and tested from six facility entry points: PMTCT, immunization, inpatient, nutrition, outpatient and community outreach services. Findings: The traditional EID entry point, PMTCT, had a prevalence of 3.8%, representing 19.6% of the total HIV-positive infants identified in the study. Fifty percent of the 117 identified HIV-positive infants were found in the nutrition wards, which had a prevalence of 9.8% (p < 0.001 compared to PMTCT). Inpatient wards had a prevalence of 3.5% and yielded 17.9% of the HIV-positive infants identified. Infants tested at immunization wards and through outreach services identified 0.8% and 1.7% of the HIV-positive infants respectively, and had a prevalence of less than 0.3%. Conclusions: Expanding routine early infant diagnosis screening beyond the traditional PMTCT setting to nutrition and inpatient entry points will increase the identification of HIV-infected infants. Careful reflection for appropriate testing strategies, such as maternal re-testing to identify new HIV infections and HIV-exposed infants in need of follow-up testing and care, at immunization and outreach services should be considered given the expectedly low prevalence rates. These findings may help HIV care programmes significantly expand testing to improve access to early infant diagnosis and paediatric treatment.
This was a cross‐sectional prospective study of infants below the age of 2 years presenting at the primary healthcare facility entry points at four hospitals in Uganda. The four healthcare facilities included in this study were: Mulago National Referral Hospital; St. Mary's Hospital, Lacor; Mbale Regional Referral Hospital; and Mbarara Regional Referral Hospital. Infants were recruited from six entry points at each healthcare facility: Immunization (Expanded Programme on Immunization)/well‐child clinic, paediatric outpatient, paediatric inpatient, nutrition, outreach and PMTCT, which is the traditional setting for EID testing. A total of 3600 infants less than 2 years of age were included in the study. One hundred and fifty infants were enrolled at each of the six entry points per hospital. Data collection occurred between September 2014 and August 2015. Patients were systematically sampled and enrolled at each entry point. Due to low daily volumes (<16 infants/day), consecutive enrolment was employed at the nutrition and PMTCT entry points. Systematic sampling across all attending patients was used within the immunization, paediatric outpatient, paediatric inpatient and outreach settings due to high patient volume, to ensure unbiased patient selection. It was predicted that each entry point could enrol 15 infants per day per study nurse; therefore, if an entry point typically had 16 to 30, 31 to 45, or 46 to 60 eligible infants per day each study nurse would enrol every other, third, or fourth infant respectively. Study systems were put in place to ensure no infant was enrolled at multiple entry points. The study objectives and study enrolment processes, including pre‐HIV test counselling, were explained to the mother or guardian of each infant invited to participate in the study at non‐PMTCT entry points before they signed a letter of informed consent. Demographic and clinical data were collected for each infant and mother (if present) using standardized study‐specific forms and study‐specific identification numbers. All enrolled infants underwent both serological and virological testing to determine HIV exposure and HIV infection status respectively. Dried blood spot specimens (DBS) were collected for virological testing and rapid serological diagnostic tests were conducted on each patient. Both tests were conducted on each enrolled infant regardless of the respective results, except for infants at the PMTCT entry point who did not receive a serological screen as their exposure status was already known. Healthcare facility staff, including nurses, clinical officers and laboratory technicians, were trained on study procedures, how to conduct DBS specimen collection and rapid diagnostic testing, and demonstrated proficiency before study commencement. Finally, maternal HIV status was determined if she provided verbal identification or by confirmation from facility records, if her infant included in the study was HIV‐positive, or if her infant was positive by RDT. All mothers were offered HIV testing per the national guidelines. Rapid diagnostic testing was performed using the Alere Determine™ HIV‐1/2 (Waltham, MA, USA). One drop of whole blood was collected using a lancet heel stick, applied to the test strip, and tested per manufacturer's instructions. Either that same lancet heel stick or a fresh draw was used to collect an additional 3 to 5 drops of whole blood that were applied to a filter paper card (Whatman 903, GE Healthcare Biosciences, Pittsburgh, PA). Specimens were dried overnight at room temperature and shipped weekly for testing to the Central Public Health Laboratories in Kampala, Uganda. Dried blood spot specimens were processed and tested with the Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM 96) HIV‐1 Qualitative Test (Roche Molecular Diagnostics, Branchburg, NJ, USA) according to the manufacturer's instructions. Any infants with positive rapid diagnostic test or virological test result were referred to PMTCT for post‐test counselling and inclusion in care and treatment per the national standard of care guidelines. This study was approved by the Mildmay Uganda Research Ethics Committee, Uganda National Council for Science and Technology, Mulago Hospital Research and Ethics Committee, Institutional Review Committee at St. Mary's Hospital, Lacor, and the Chesapeake Institutional Review Board in the USA. Statistical analysis was performed with the R statistical software (Version 3.3.2, Free Software Foundation, Boston, MA, USA) and GraphPad Prism (Version 6.0, La Jolla, CA, USA). Infants from like entry points were pooled across hospitals for primary analyses. Two‐sample and multi‐sample comparisons were done using the nonparametric rank‐based Wilcoxon‐Mann–Whitney and Kruskal–Wallis tests respectively. Multi‐testing p‐value adjustment for the p values from logistic regression models was performed according to Hothorn et al. 14 and controls family‐wise error rate. Binomial probability confidence interval was computed using the Wilson method 15.
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