Leveraging PEPFAR-Supported Health Information Systems for COVID-19 Pandemic Response.

Since 2003, the US President's Emergency Plan for AIDS Relief (PEPFAR) has supported implementation and maintenance of health information systems for HIV/AIDS and related diseases, such as tuberculosis, in numerous countries. As the COVID-19 pandemic emerged, several countries conducted rapid assessments and enhanced existing PEPFAR-funded HIV and national health information systems to support COVID-19 surveillance data collection, analysis, visualization, and reporting needs. We describe efforts at the US Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia, USA, and CDC country offices that enhanced existing health information systems in support COVID-19 pandemic response. We describe CDC activities in Haiti as an illustration of efforts in PEPFAR countries. We also describe how investments used to establish and maintain standards-based health information systems in resource-constrained settings can have positive effects on health systems beyond their original scope.

Circulating biomarkers of immune activation distinguish viral suppression from nonsuppression in HAART-treated patients with advanced HIV-1 subtype C infection.

Few studies have examined immune activation profiles in patients with advanced HIV-1 subtype C infection or assessed their potential to predict responsiveness to HAART. BioPlex, ELISA, and nephelometric procedures were used to measure plasma levels of inflammatory biomarkers in HIV-1 subtype C-infected patients sampled before and after 6 months of successful HAART (n = 20); in patients failing HAART (n = 30); and in uninfected controls (n = 8). Prior to HAART, CXCL9, CXCL10, ß 2M, sTNF-R1, TGF- ß 1, IFN- γ , IL-6, TNF, and sCD14 were significantly elevated in HIV-1-infected patients compared to controls (P < 0.01). All of these markers, with the exception of sTNF-R1, were also elevated in patients failing HAART (P < 0.05). The persistently elevated levels of CXCL9, CXCL10, and ß 2M in patients failing therapy in the setting of a marked reduction in these markers in patients on successful HAART suggest that they may be useful not only to monitor immune activation during HAART, but also to distinguish between good and poor responders. In the case of sCD14 and TGF- ß 1, the levels of these biomarkers remained persistently elevated despite HAART-induced virological suppression, a finding that is consistent with ongoing monocyte-macrophage activation, underscoring a potential role for adjuvant anti-inflammatory therapy.

Factors Influencing Data Quality in Electronic Health Record Systems in 50 Health Facilities in Rwanda and the Role of Clinical Alerts: Cross-Sectional Observational Study.

BACKGROUND: Electronic health records (EHRs) play an increasingly important role in delivering HIV care in low- and middle-income countries. The data collected are used for direct clinical care, quality improvement, program monitoring, public health interventions, and research. Despite widespread EHR use for HIV care in African countries, challenges remain, especially in collecting high-quality data. OBJECTIVE: We aimed to assess data completeness, accuracy, and timeliness compared to paper-based records, and factors influencing data quality in a large-scale EHR deployment in Rwanda. METHODS: We randomly selected 50 health facilities (HFs) using OpenMRS, an EHR system that supports HIV care in Rwanda, and performed a data quality evaluation. All HFs were part of a larger randomized controlled trial, with 25 HFs receiving an enhanced EHR with clinical decision support systems. Trained data collectors visited the 50 HFs to collect 28 variables from the paper charts and the EHR system using the Open Data Kit app. We measured data completeness, timeliness, and the degree of matching of the data in paper and EHR records, and calculated concordance scores. Factors potentially affecting data quality were drawn from a previous survey of users in the 50 HFs. RESULTS: We randomly selected 3467 patient records, reviewing both paper and EHR copies (194,152 total data items). Data completeness was >85% threshold for all data elements except viral load (VL) results, second-line, and third-line drug regimens. Matching scores for data values were close to or >85% threshold, except for dates, particularly for drug pickups and VL. The mean data concordance was 10.2 (SD 1.28) for 15 (68%) variables. HF and user factors (eg, years of EHR use, technology experience, EHR availability and uptime, and intervention status) were tested for correlation with data quality measures. EHR system availability and uptime was positively correlated with concordance, whereas users' experience with technology was negatively correlated with concordance. The alerts for missing VL results implemented at 11 intervention HFs showed clear evidence of improving timeliness and completeness of initially low matching of VL results in the EHRs and paper records (11.9%-26.7%; P<.001). Similar effects were seen on the completeness of the recording of medication pickups (18.7%-32.6%; P<.001). CONCLUSIONS: The EHR records in the 50 HFs generally had high levels of completeness except for VL results. Matching results were close to or >85% threshold for nondate variables. Higher EHR stability and uptime, and alerts for entering VL both strongly improved data quality. Most data were considered fit for purpose, but more regular data quality assessments, training, and technical improvements in EHR forms, data reports, and alerts are recommended. The application of quality improvement techniques described in this study should benefit a wide range of HFs and data uses for clinical care, public health, and disease surveillance.

User Perceptions and Use of an Enhanced Electronic Health Record in Rwanda With and Without Clinical Alerts: Cross-sectional Survey.

BACKGROUND: Electronic health records (EHRs) have been implemented in many low-resource settings but lack strong evidence for usability, use, user confidence, scalability, and sustainability. OBJECTIVE: This study aimed to evaluate staff use and perceptions of an EHR widely used for HIV care in >300 health facilities in Rwanda, providing evidence on factors influencing current performance, scalability, and sustainability. METHODS: A randomized, cross-sectional, structured interview survey of health center staff was designed to assess functionality, use, and attitudes toward the EHR and clinical alerts. This study used the associated randomized clinical trial study sample (56/112, 50% sites received an enhanced EHR), pulling 27 (50%) sites from each group. Free-text comments were analyzed thematically using inductive coding. RESULTS: Of the 100 participants, 90 (90% response rate) were interviewed at 54 health centers: 44 (49%) participants were clinical and 46 (51%) were technical. The EHR top uses were to access client data easily or quickly (62/90, 69%), update patient records (56/89, 63%), create new patient records (49/88, 56%), generate various reports (38/85, 45%), and review previous records (43/89, 48%). In addition, >90% (81/90) of respondents agreed that the EHR made it easier to make informed decisions, was worth using, and has improved patient information quality. Regarding availability, (66/88) 75% said they could always or almost always count on the EHR being available, whereas (6/88) 7% said never/almost never. In intervention sites, staff were significantly more likely to update existing records (P=.04), generate summaries before (P<.001) or during visits (P=.01), and agree that "the EHR provides useful alerts, and reminders" (P<.01). CONCLUSIONS: Most users perceived the EHR as well accepted, appropriate, and effective for use in low-resource settings despite infrastructure limitation in 25% (22/88) of the sites. The implementation of EHR enhancements can improve the perceived usefulness and use of key functions. Successful scale-up and use of EHRs in small health facilities could improve clinical documentation, care, reporting, and disease surveillance in low- and middle-income countries.

CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa.

BACKGROUND: South Africa is home to the world's largest antiretroviral therapy program but sustaining engagement along the HIV care continuum has proven challenging in the country and throughout the wider region. Population mobility is common in South Africa, but there are important research gaps in describing this mobility and its impact on engagement in HIV care. Postpartum women and their infants in South Africa are known to be at high risk of dropping out of HIV care after delivery and are frequently mobile. METHODS: In 2017, we developed a beta version of a smartphone application (app) - CareConekta - that detects a user's smartphone location to allow for prospective characterization of mobility. Now we will adapt and test CareConekta to conduct essential formative work on mobility and evaluate an intervention - the CareConekta app plus text notifications and phone calls and/or WhatsApp messages - to facilitate engagement in HIV care during times of mobility. During the 3-year project period, our first objective is to evaluate the feasibility, acceptability, and initial efficacy of using CareConekta as an intervention to improve engagement in HIV care. Our second objective is to characterize mobility among South African women during the peripartum period and its impact on engagement in HIV care. We will enroll 200 eligible pregnant women living with HIV and receiving care at the Gugulethu Midwife Obstetric Unit in Cape Town, South Africa. DISCUSSION: This work will provide critical information about mobility during the peripartum period and the impact on engagement in HIV care. Simultaneously, we will pilot test an intervention to improve engagement with rigorously assessed outcomes. If successful, CareConekta offers tremendous potential as a research and service tool that can be adapted and evaluated in multiple geographic regions, study contexts, and patient populations. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03836625. Registered on 8 February 2019.

Designing for scale: optimising the health information system architecture for mobile maternal health messaging in South Africa (MomConnect).

MomConnect is a national initiative coordinated by the South African National Department of Health that sends text-based mobile phone messages free of charge to pregnant women who voluntarily register at any public healthcare facility in South Africa. We describe the system design and architecture of the MomConnect technical platform, planned as a nationally scalable and extensible initiative. It uses a health information exchange that can connect any standards-compliant electronic front-end application to any standards-compliant electronic back-end database. The implementation of the MomConnect technical platform, in turn, is a national reference application for electronic interoperability in line with the South African National Health Normative Standards Framework. The use of open content and messaging standards enables the architecture to include any application adhering to the selected standards. Its national implementation at scale demonstrates both the use of this technology and a key objective of global health information systems, which is to achieve implementation scale. The system's limited clinical information, initially, allowed the architecture to focus on the base standards and profiles for interoperability in a resource-constrained environment with limited connectivity and infrastructural capacity. Maintenance of the system requires mobilisation of national resources. Future work aims to use the standard interfaces to include data from additional applications as well as to extend and interface the framework with other public health information systems in South Africa. The development of this platform has also shown the benefits of interoperability at both an organisational and technical level in South Africa.

Unpacking the performance of a mobile health information messaging program for mothers (MomConnect) in South Africa: evidence on program reach and messaging exposure.

Despite calls to address broader evidence gaps in linking digital technologies to outcome and impact level health indicators, limited attention has been paid to measuring processes pertaining to the performance of programs. In this paper, we assess the program reach and message exposure of a mobile health information messaging program for mothers (MomConnect) in South Africa. In this descriptive study, we draw from system generated data to measure exposure to the program through registration attempts and conversions, message delivery, opt-outs and drop-outs. Using a logit model, we additionally explore determinants for early registration, opt-outs and drop-outs. From August 2014 to April 2017, 1 159 431 women were registered to MomConnect; corresponding to half of women attending antenatal care 1 (ANC1) and nearly 60% of those attending ANC1 estimated to own a mobile phone. In 2016, 26% of registrations started to get women onto MomConnect did not succeed. If registration attempts were converted to successful registrations, coverage of ANC1 attendees would have been 74% in 2016 and 86% in 2017. When considered as percentage of ANC1 attendees with access to a mobile phone, addressing conversion challenges bring registration coverage to an estimated 83%-89% in 2016 and 97%-100% in 2017. Among women registered, nearly 80% of expected short messaging service messages were received. While registration coverage and message delivery success rates exceed those observed for mobile messaging programs elsewhere, study findings highlight opportunities for program improvement and reinforce the need for rigorous and continuous monitoring of delivery systems.

An ontology for factors affecting tuberculosis treatment adherence behavior in sub-Saharan Africa.

PURPOSE: Adherence behavior is a complex phenomenon influenced by diverse personal, cultural, and socioeconomic factors that may vary between communities in different regions. Understanding the factors that influence adherence behavior is essential in predicting which individuals and communities are at risk of nonadherence. This is necessary for supporting resource allocation and intervention planning in disease control programs. Currently, there is no known concrete and unambiguous computational representation of factors that influence tuberculosis (TB) treatment adherence behavior that is useful for prediction. This study developed a computer-based conceptual model for capturing and structuring knowledge about the factors that influence TB treatment adherence behavior in sub-Saharan Africa (SSA). METHODS: An extensive review of existing categorization systems in the literature was used to develop a conceptual model that captured scientific knowledge about TB adherence behavior in SSA. The model was formalized as an ontology using the web ontology language. The ontology was then evaluated for its comprehensiveness and applicability in building predictive models. CONCLUSION: The outcome of the study is a novel ontology-based approach for curating and structuring scientific knowledge of adherence behavior in patients with TB in SSA. The ontology takes an evidence-based approach by explicitly linking factors to published clinical studies. Factors are structured around five dimensions: factor type, type of effect, regional variation, cross-dependencies between factors, and treatment phase. The ontology is flexible and extendable and provides new insights into the nature of and interrelationship between factors that influence TB adherence.

An affordable HIV-1 drug resistance monitoring method for resource limited settings.

HIV-1 drug resistance has the potential to seriously compromise the effectiveness and impact of antiretroviral therapy (ART). As ART programs in sub-Saharan Africa continue to expand, individuals on ART should be closely monitored for the emergence of drug resistance. Surveillance of transmitted drug resistance to track transmission of viral strains already resistant to ART is also critical. Unfortunately, drug resistance testing is still not readily accessible in resource limited settings, because genotyping is expensive and requires sophisticated laboratory and data management infrastructure. An open access genotypic drug resistance monitoring method to manage individuals and assess transmitted drug resistance is described. The method uses free open source software for the interpretation of drug resistance patterns and the generation of individual patient reports. The genotyping protocol has an amplification rate of greater than 95% for plasma samples with a viral load >1,000 HIV-1 RNA copies/ml. The sensitivity decreases significantly for viral loads <1,000 HIV-1 RNA copies/ml. The method described here was validated against a method of HIV-1 drug resistance testing approved by the United States Food and Drug Administration (FDA), the Viroseq genotyping method. Limitations of the method described here include the fact that it is not automated and that it also failed to amplify the circulating recombinant form CRF02_AG from a validation panel of samples, although it amplified subtypes A and B from the same panel.

Southern African Treatment Resistance Network (SATuRN) RegaDB HIV drug resistance and clinical management database: supporting patient management, surveillance and research in southern Africa.

Substantial amounts of data have been generated from patient management and academic exercises designed to better understand the human immunodeficiency virus (HIV) epidemic and design interventions to control it. A number of specialized databases have been designed to manage huge data sets from HIV cohort, vaccine, host genomic and drug resistance studies. Besides databases from cohort studies, most of the online databases contain limited curated data and are thus sequence repositories. HIV drug resistance has been shown to have a great potential to derail the progress made thus far through antiretroviral therapy. Thus, a lot of resources have been invested in generating drug resistance data for patient management and surveillance purposes. Unfortunately, most of the data currently available relate to subtype B even though >60% of the epidemic is caused by HIV-1 subtype C. A consortium of clinicians, scientists, public health experts and policy markers working in southern Africa came together and formed a network, the Southern African Treatment and Resistance Network (SATuRN), with the aim of increasing curated HIV-1 subtype C and tuberculosis drug resistance data. This article describes the HIV-1 data curation process using the SATuRN Rega database. The data curation is a manual and time-consuming process done by clinical, laboratory and data curation specialists. Access to the highly curated data sets is through applications that are reviewed by the SATuRN executive committee. Examples of research outputs from the analysis of the curated data include trends in the level of transmitted drug resistance in South Africa, analysis of the levels of acquired resistance among patients failing therapy and factors associated with the absence of genotypic evidence of drug resistance among patients failing therapy. All these studies have been important for informing first- and second-line therapy. This database is a free password-protected open source database available on www.bioafrica.net. Database URL: http://www.bioafrica.net/regadb/

Comprehensive yet scalable health information systems for low resource settings: a collaborative effort in sierra leone.

We address the problem of how to integrate health information systems in low-income African countries in which technical infrastructure and human resources vary wildly within countries. We describe a set of tools to meet the needs of different service areas including managing aggregate indicators, patient level record systems, and mobile tools for community outreach. We present the case of Sierra Leone and use this case to motivate and illustrate an architecture that allows us to provide services at each level of the health system (national, regional, facility and community) and provide different configurations of the tools as appropriate for the individual area. Finally, we present a, collaborative implementation of this approach in Sierra Leone.

Handheld computers for survey and trial data collection in resource-poor settings: development and evaluation of PDACT, a Palm Pilot interviewing system.

OBJECTIVE: Handheld computers (personal digital assistant, PDA) have the potential to reduce the logistic burden, cost, and error rate of paper-based health research data collection, but there is a lack of appropriate software. The present work describes the development and evaluation of PDACT, a Personal Data Collection Toolset (www.healthware.org/pdact/index.htm) for the Palm Pilot handheld computer for interviewer-administered and respondent-administered data collection. METHODS: We developed Personal Data Collection Toolkit (PDACT) software to enable questionnaires developed in QDS Design Studio, a Windows application, to be compiled and completed on Palm Pilot devices and evaluated in several representative field survey settings. RESULTS: The software has been used in seven separate studies and in over 90,000 interviews. Five interviewer-administered studies were completed in rural settings with poor communications infrastructure, following one day of interviewer training. Two respondent-administered questionnaire studies were completed by learners, in urban secondary schools, after 15min training. Questionnaires were available on each handheld in up to 11 languages, ranged from 20 to 580 questions, and took between 15 and 90min to complete. Up to 200 Palm Pilot devices were in use on a single day and, in about 50 device-years of use, very few technical problems were found. Compared with paper-based collection, data validation and cleaning times were reduced, and fewer errors were found. PDA data collection is easy to use and preferred by interviewers and respondents (both respondent-administered and interviewer-administered) over paper. Data are compiled and available within hours of collection facilitating data quality assurance. Although hardware increases the setup cost of the first study, the cumulative cost falls thereafter, and converges on the cumulative cost of paper-based studies (four, in the case of our interviewer-administered studies). Handheld data collection is an appropriate, affordable and convenient technology for health data collection, in diverse settings.

The OpenMRS Implementers Network.

OBJECTIVE: OpenMRS (www.openmrs.org) is a configurable open source electronic medical record application developed and maintained by a large network of open source developers coordinated by the Regenstrief Institute and Partners in Health and mainly used for HIV patient and treatment information management in Africa. Our objective is to develop an open Implementers Network for OpenMRS to provide regional support for the growing number of OpenMRS implementations in Africa and to include African developers and implementers in the future growth of OpenMRS. METHODS: We have developed the OpenMRS Implementers Network using a dedicated Wiki site and e-mail server. We have also organized annual meetings in South Africa and regional training courses at African locations where OpenMRS is being implemented. An OpenMRS Internship program has been initiated and we have started collaborating with similar networks and projects working in Africa. To evaluate its potential, OpenMRS was implemented initially at one site in South Africa by a single implementer using a downloadable OpenMRS application and only the OpenMRS Implementers Network for support. RESULTS: The OpenMRS Implementers Network Wiki and list server have grown into effective means of providing implementation support and forums for exchange of implementation experiences. The annual OpenMRS Implementers meeting has been held in South Africa for the past three years and is attracting successively larger numbers of participants with almost 200 implementers and developers attending the 2008 meeting in Durban, South Africa. Six African developers are presently registered on the first intake of the OpenMRS Internship program. Successful collaborations have been started with several African developer groups and projects initiated to develop interoperability between OpenMRS and various applications. The South African OpenMRS Implementer group successfully configured, installed and maintained an integrated HIV/TB OpenMRS application without significant programming support. Since then, this model has been replicated in several other African sites. The OpenMRS Implementers Network has contributed substantially to the growth and sustainability of OpenMRS in Africa and has become a useful way of including Africans in the development and implementation of OpenMRS in developing countries. The Network provides valuable support and enables a basic OpenMRS application to be implemented in the absence of onsite programmers.