Laboratory Data Timeliness and Completeness Improves Following Implementation of an Electronic Laboratory Information System in Côte d'Ivoire: Quasi-Experimental Study on 21 Clinical Laboratories From 2014 to 2020.

BACKGROUND: The Ministry of Health in Côte d'Ivoire and the International Training and Education Center for Health at the University of Washington, funded by the United States President's Emergency Plan for AIDS Relief, have been collaborating to develop and implement the Open-Source Enterprise-Level Laboratory Information System (OpenELIS). The system is designed to improve HIV-related laboratory data management and strengthen quality management and capacity at clinical laboratories across the nation. OBJECTIVE: This evaluation aimed to quantify the effects of implementing OpenELIS on data quality for laboratory tests related to HIV care and treatment. METHODS: This evaluation used a quasi-experimental design to perform an interrupted time-series analysis to estimate the changes in the level and slope of 3 data quality indicators (timeliness, completeness, and validity) after OpenELIS implementation. We collected paper and electronic records on clusters of differentiation 4 (CD4) testing for 48 weeks before OpenELIS adoption until 72 weeks after. Data collection took place at 21 laboratories in 13 health regions that started using OpenELIS between 2014 and 2020. We analyzed the data at the laboratory level. We estimated odds ratios (ORs) by comparing the observed outcomes with modeled counterfactual ones when the laboratories did not adopt OpenELIS. RESULTS: There was an immediate 5-fold increase in timeliness (OR 5.27, 95% CI 4.33-6.41; P<.001) and an immediate 3.6-fold increase in completeness (OR 3.59, 95% CI 2.40-5.37; P<.001). These immediate improvements were observed starting after OpenELIS installation and then maintained until 72 weeks after OpenELIS adoption. The weekly improvement in the postimplementation trend of completeness was significant (OR 1.03, 95% CI 1.02-1.05; P<.001). The improvement in validity was not statistically significant (OR 1.34, 95% CI 0.69-2.60; P=.38), but validity did not fall below pre-OpenELIS levels. CONCLUSIONS: These results demonstrate the value of electronic laboratory information systems in improving laboratory data quality and supporting evidence-based decision-making in health care. These findings highlight the importance of OpenELIS in Côte d'Ivoire and the potential for adoption in other low- and middle-income countries with similar health systems.

Development and national scale implementation of an open-source electronic laboratory information system (OpenELIS) in Côte d'Ivoire: Sustainability lessons from the first 13 years.

PURPOSE: Côte d'Ivoire has a tiered public health laboratory system of 9 reference laboratories, 77 laboratories at regional and general hospitals, and 100 laboratories among 1,486 district health centers. Prior to 2009, nearly all of these laboratories used paper registers and reports to collect and report laboratory data to clinicians and national disease monitoring programs. PROJECT: Since 2009 the Ministry of Health (MOH) in Côte d'Ivoire has sought to implement a comprehensive set of activities aimed at strengthening the laboratory system. One of these activities is the sustainable development, expansion, and technical support of an open-source electronic laboratory information system (OpenELIS), with the long-term goal of Ivorian technical support and managerial sustainment of the system. This project has addressed the need for a comprehensive, customizable, low- to no-cost, open-source LIS to serve the public health systems with initial attention to HIV clients and later expansion to cover the general population. This descriptive case study presents the first published summary of original work which has been ongoing since 2009 in Côte d'Ivoire to transform the laboratory information management systems and processes nationally. IMPACT: OpenELIS is now in use at 106 laboratories across Côte d'Ivoire. This article describes the iterative planning, design, and implementation process of OpenELIS in Côte d'Ivoire, and the evolving leadership, ownership, and capacity of the Ivorian MOH in sustaining the system. This original work synthesizes lessons learned from this 13-year experience towards strengthening laboratory information systems in other low resource settings.

Adaptation of an electronic dashboard to monitor HIV viral load testing in Côte d'Ivoire.

BACKGROUND: The Ministère de le Santé et de l'Hygiène Publique in Côte d'Ivoire and the international community have invested in health information systems in Côte d'Ivoire since 2009, including electronic laboratory information systems. These systems have been implemented in more than 80 laboratories to date and capture all test results produced from these laboratories, including HIV viral load (VL) testing. In 2018 the national HIV programme in Côte d'Ivoire requested international support to develop real-time tools such as dashboards to aggregate and display test-specific data such as HIV VL testing to support the country's programmatic response to HIV. INTERVENTION: The VL dashboard was adapted in 2018 using source software code obtained from the Kenyan Ministry of Health and modified for the Ivorian context. The dashboard enables users to assess relevant clinical data from all Ivoirians living with HIV who undergo VL testing through dashboard data visualisations, including the number of VL tests, kinds of samples tested, and VL levels stratified by demographics and geographic location. LESSONS LEARNT: The VL dashboard enables rapid analysis of VL testing data from across the country and enables the national HIV programme, donors and partners to respond rapidly to issues pertaining to access, turn-around times and others. RECOMMENDATIONS: Adapting existing open-source software is an effective and efficient way to implement transformative tools such as dashboards. The VL dashboard will likely be an essential tool for Côte d'Ivoire to meet the United Nations Programme on HIV/AIDS 90-90-90 targets.

Implementation of broad screening with Ebola rapid diagnostic tests in Forécariah, Guinea.

BACKGROUND: Laboratory-enhanced surveillance is critical for rapidly detecting the potential re-emergence of Ebola virus disease. Rapid diagnostic tests (RDT) for Ebola antigens could expand diagnostic capacity for Ebola virus disease. OBJECTIVES: The Guinean National Coordination for Ebola Response conducted a pilot implementation to determine the feasibility of broad screening of patients and corpses with the OraQuick® Ebola RDT. METHODS: The implementation team developed protocols and trained healthcare workers to screen patients and corpses in Forécariah prefecture, Guinea, from 15 October to 30 November 2015. Data collected included number of consultations, number of fevers reported or measured, number of tests performed for patients or corpses and results of confirmatory RT-PCR testing. Data on malaria RDT results were collected for comparison. Feedback from Ebola RDT users was collected informally during supervision visits and forums. RESULTS: There were 3738 consultations at the 15 selected healthcare facilities; 74.6% of consultations were for febrile illness. Among 2787 eligible febrile patients, 2633 were tested for malaria and 1628 OraQuick® Ebola RDTs were performed. A total of 322 OraQuick® Ebola RDTs were conducted on corpses. All Ebola tests on eligible patients were negative. CONCLUSIONS: Access to Ebola testing was expanded by the implementation of RDTs in an emergency situation. Feedback from Ebola RDT users and lessons learned will contribute to improving quality for RDT expansion.

Early Diagnosis of HIV Infection in Infants - One Caribbean and Six Sub-Saharan African Countries, 2011-2015.

Pediatric human immunodeficiency virus (HIV) infection remains an important public health issue in resource-limited settings. In 2015, 1.4 million children aged <15 years were estimated to be living with HIV (including 170,000 infants born in 2015), with the vast majority living in sub-Saharan Africa (1). In 2014, 150,000 children died from HIV-related causes worldwide (2). Access to timely HIV diagnosis and treatment for HIV-infected infants reduces HIV-associated mortality, which is approximately 50% by age 2 years without treatment (3). Since 2011, the annual number of HIV-infected children has declined by 50%. Despite this gain, in 2014, only 42% of HIV-exposed infants received a diagnostic test for HIV (2), and in 2015, only 51% of children living with HIV received antiretroviral therapy (1). Access to services for early infant diagnosis of HIV (which includes access to testing for HIV-exposed infants and clinical diagnosis of HIV-infected infants) is critical for reducing HIV-associated mortality in children aged <15 years. Using data collected from seven countries supported by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), progress in the provision of HIV testing services for early infant diagnosis was assessed. During 2011-2015, the total number of HIV diagnostic tests performed among HIV-exposed infants within 6 weeks after birth (tests for early infant diagnosis of HIV), as recommended by the World Health Organization (WHO) increased in all seven countries (Cote d'Ivoire, the Democratic Republic of the Congo, Haiti, Malawi, South Africa, Uganda, and Zambia); however, in 2015, the rate of testing for early infant diagnosis among HIV-exposed infants was <50% in five countries. HIV positivity among those tested declined in all seven countries, with three countries (Cote d'Ivoire, the Democratic Republic of the Congo, and Uganda) reporting >50% decline. The most common challenges for access to testing for early infant diagnosis included difficulties in specimen transport, long turnaround time between specimen collection and receipt of results, and limitations in supply chain management. Further reductions in HIV mortality in children can be achieved through continued expansion and improvement of services for early infant diagnosis in PEPFAR-supported countries, including initiatives targeted to reach HIV-exposed infants, ensure access to programs for early infant diagnosis of HIV, and facilitate prompt linkage to treatment for children diagnosed with HIV infection.

Factors contributing to outbreaks of wild poliovirus type 1 infection involving persons aged ≥15 years in the Democratic Republic of the Congo, 2010-2011, informed by a pre-outbreak poliovirus immunity assessment.

BACKGROUND: The Democratic Republic of the Congo (DRC) experienced atypical outbreaks of wild poliovirus type 1 (WPV1) infection during 2010-2011 in that they affected persons aged ≥15 years in 4 (Bandundu, Bas Congo, Kasaï Occidental, and Kinshasa provinces) of the 6 provinces with outbreaks. METHODS: Analyses of cases of WPV1 infection with onset during 2010-2011 by province, age, polio vaccination status, and sex were conducted. The prevalence of antibodies to poliovirus (PV) types 1, 2, and 3 was assessed in sera collected before the outbreaks from women attending antenatal clinics in 3 of the 4 above-mentioned provinces. RESULTS: Of 193 cases of WPV1 infection during 2010-2011, 32 (17%) occurred in individuals aged ≥15 years. Of these 32 cases, 31 (97%) occurred in individuals aged 16-29 years; 9 (28%) were notified in Bandundu, 17 (53%) were notified in Kinshasa, and 22 (69%) had an unknown polio vaccination status. In the seroprevalence assessment, PV type 1 and 3 seroprevalence was lower among women aged 15-29 years in Bandundu and Kinshasa, compared with those in Kasaï Occidental. Seropositivity to PVs was associated with increasing age, more pregnancies, and a younger age at first pregnancy. CONCLUSIONS: This spatiotemporal analysis strongly suggests that the 2010-2011 outbreaks of WPV1 infection affecting young adults were caused by a PV type 1 immunity gap in Kinshasa and Bandundu due to insufficient exposure to PV type 1 through natural infection or vaccination. Poliovirus immunity gaps in this age group likely persist in DRC.

Correlates of syphilis seropositivity and risk for syphilis-associated adverse pregnancy outcomes among women attending antenatal care clinics in the Democratic Republic of Congo.

Screening and treatment for syphilis among pregnant women is the primary means of prevention of congenital syphilis. Sentinel surveillance for syphilis can inform these prevention efforts. We reviewed antenatal syphilis screening results to assess trends and to identify correlates of seropositivity among women attending antenatal care clinics in the Democratic Republic of Congo during 2011. Syphilis seropositivity among the 17,669 women attending the antenatal care clinics during 2011 was 4.2% (range 0.4%-16.9%). Syphilis seropositivity was significantly higher among women attending rural clinics (5.0%) as compared to urban clinics (3.0%) and those tested in antenatal care clinics in the provinces of Equateur (7.6%) and Orientale (7.7%) as compared to other provinces (p < 0.001). Based on the antenatal care syphilis seroprevalence and national pregnancy estimates, we estimate that approximately 128,591 pregnant women countrywide would have tested seropositive for syphilis during 2011. Over 85,000 adverse pregnancy outcomes would have resulted from these maternal infections, assuming prenatal syphilis diagnosis and treatment were not available. The prevalence of syphilis was highest in rural areas, but exceeded 1% in every area, indicating a need to assure screening and treatment throughout Democratic Republic of Congo. These sentinel surveillance estimates can be used to guide national congenital syphilis prevention efforts.

Quantification of HIV-1 p24 by a highly improved ELISA: an alternative to HIV-1 RNA based treatment monitoring in patients from Abidjan, Côte d'Ivoire.

BACKGROUND: Quantification of HIV-1 RNA remains difficult to implement in Africa. Simple and inexpensive tests for antiretroviral treatment (ART) monitoring are needed. OBJECTIVE: To evaluate an HIV-1 p24 ELISA, which combines efficient virus disruption, heat-denaturation and signal amplification, in a West African setting. STUDY DESIGN: Eighty-six HIV-1 infected patients from Abidjan, Côte d'Ivoire, were tested for p24, HIV-1 RNA, and CD4+ count at baseline, and twice within 8 months after ART initiation. RESULTS: All patients responded to ART with a minimal HIV-1 RNA drop of 0.5 log(10) at first follow-up. Forty-one (47.7%) then rebounded >0.5 log(10) or persisted above 1000 copies/mL by week 24. The predicted baseline concentration of p24 corresponding to 100,000 copies/mL of HIV-1 RNA, above which ART is recommended, was 4546 fg/mL (95% confidence interval 3148-6566). A prediction model of virologic failure, occurring after an initial response to ART, correctly classified 84% of patients using baseline p24, p24 change on therapy, and achievement of undetectable p24 as explanatory variables. The model and further bootstrap evaluation suggested a good ability to discriminate between sustained or failing virologic response to ART. CONCLUSION: HIV-1 p24 and RNA based-ART monitoring in a low-resource country dominated by HIV-1 CRF02 AG appeared comparable.