Supporting the Enhancement of the Viral Load & Early Infant Diagnosis System

Introduction

The World Health Organization (WHO) recommends that all HIV-exposed infants are virologically tested within 4 to 6 weeks after birth, this is referred to as Early Infant Diagnosis (EID). Initiating antiretroviral therapy (ART) in HIV-infected infants as early as 6-8 weeks (as soon as their infection status can be determined) reduces their risk of early death, it also reduces mother-to-child transmission and mortalities. Effective Viral load testing is the recommended monitoring tool for diagnosing and confirming the success/failure of antiretroviral therapy. Viral load (VL) and early infant diagnosis (EID) testing is geared towards the attainment of 95-95-95 UNAIDS goals – by 2030, 95% of all people living with HIV know their status, 95% of all people with diagnosed HIV infection are on antiretroviral therapy and 95% of all people receiving antiretroviral therapy are virally suppressed.

In Kenya, the National AIDS and STI Control Programme (NASCOP) was set up in 1987 to lead in the fight against HIV/AIDS and its sustainable monitoring for epidemic control. HealthIT is a USAID-funded project that supports the Government of Kenya, the Ministry of Health (MOH), and NASCOP to sustain Digital Health Systems evolution and interoperability to meet current and emerging program needs. One such system is the EID/VL system.

Background

The early infant diagnosis and viral load system is an electronic surveillance system set up in Kenya by the Ministry of Health in 2006 under the stewardship of NASCOP to ensure early screening and linkage of infected newborns to care and treatment in an effort towards decreasing HIV-related infant mortality as well as managing viral load testing in the country. HIV testing and viral load data collection is a continuous and ongoing process. Reasons that necessitated the creation of the system included:

  • Electronic Medical Records (EMRs) are more reliable to store and share patient data. The EMR’s have historical information about the patient and this facilitates logistical monitoring of clients on care and better health outcomes.
  • The system also allows ease in sample tracking and storage i.e., for both pre-analysis and post- analysis- Allows for comparisons of the before they are analyzed and after they are analyzed.
  • There was a need for a quick way to access information on inventory commodity logistics, use and also workload management.

EID VL Business Process

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  • Means of sample transportation includes; contracted couriers, motor riders, and county partners.
  • Types of samples; Plasma (from facilities close to testing labs), Dried Blood Spots (DBS) (from hard-to-reach areas)
  • Remote log-in function has helped reduce paperwork in the testing labs.

There are over 3,500 sites for sample collection and 10 central testing laboratories serving all the health facilities in different regions in Kenya. Testing has also been decentralized through Point of Care (POC) testing in some facilities to reduce turnaround time. The testing laboratory network sends data to the national database (The labs are linked to the National database with data being shared and synchronized every hour with the lab’s database. Data in the database is then displayed on the National NASCOP dashboards(https://nascop.org/).) The synchronization ensures that the data being displayed on the dashboard is current.

Reference Laboratories

Hosted at NASCOP Data Center (UoN) Hosted on Lab Premise
KEMRI Nairobi AMPATH
KEMRI Kisumu Walter Reed
KEMRI Alupe Nyumbani
Coast Provincial General Hospital EDARP
Kenyatta National Hospital NHRL
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EID /VL SYSTEM INFORMATION FLOW

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The scope of support that HealthIT offers NASCOP include the following areas :

  • EID /VL System Hosting.
  • Electronic Patient file/ records.
  • Sample processing and results relay.
  • Data aggregation to NASCOP data center
  • Dashboard review and analysis,
  • NASCOP data center support and maintenance (internet, cooling, power maintenance)

EID/VL System Enhancement Process

Challenge

According to World Health Organization (WHO), regular and reliable data from health facilities and the resource systems that support care and treatment are central to ensuring the availability and quality of health services. This can only be achieved by enhancing the already available Electronic Health Records. In Kenya, the EID/VL system users-the lab users and lab managers over time experienced challenges. In 2022, there was an initiative to upgrade and enhance the EID/VL system to cater to the needs and requirements of the system users so as to strengthen sample testing, results relay, and the availability of quality data for decision-making as well as training of the system users to efficiently use the system. Although each lab had unique challenges, some were also cross-cutting e.g., completeness of data, functionality, and efficiency of the system in terms of supporting the lab processes, for example, remote logging of samples to the various reference labs.

Process/Methodology

(a) Stakeholder Engagement

The enhancement process started with requirements gathering. In 2022, HealthIT supported National HIV Reference Lab (NHRL and NASCOP to hold a regional lab meeting to document system improvement requirements and review system updates).

Issues and Challenges by the labs on EID included:

Challenges included: samples from the same facilities being scattered in the worksheet making sorting difficult; laboratories not able to confirm receipt of results by the facility; critical alerts not sent to the facilities; SMS queries to the facilities are not available; double entry for facility and the labs-entering CCC with a digit missing; reason for rejection not captured in the results summary and individual print outs, and documentation of breakdown longer than one month.

Issues and Challenges by the labs on VL included:

Samples awaiting testing URL returns an error; excel downloads do not have the names of all patients; delayed shipments are treated as rejections when knocked out of the system automatically; entries done at some laboratories show as pending upload (samples were not received, and remote logged VL samples sometimes do not appear in the system real-time among others).

(b) Systems Upgrade Plan

The EID/VL system upgrade plan for all eight labs was then developed jointly with the labs. HealthIT working with the County Proximate Universities (CPUs) by way of hackathons under the leadership of NASCOP and NHRL was able to address the requirements and enhance the system.

Results

The upgraded Early Infant Diagnosis and Viral Load Dashboard was rolled out in July and August 2022. Below are some of the enhancements supported by HealthIT in 2022

(a) Harmonization of validation processes

USAID HealthIT working with NHRL and NASCOP harmonized and enhanced the system code base for the EID/VL and Implemented validation rules on the data entry forms to address data quality issues. For example, dates were validated for consistency and some fields were made mandatory to enhance data completeness.

(b) Enhancement of the Critical Results Notification Systems

As part of the upgrade process, HealthIT worked with the USAID program team and stakeholders to improve EID/VL system critical results email, SMS alerts, and notifications. These alerts are sent to partners and stakeholders informing them of any results that are considered critical and need follow-up. HealthIT also Implemented a user management feature for the recipient of critical results alerts. This allows the function to be cascaded to the respective laboratories. Working with USAID partners, the project gathered requirements for the notifications module for EID/VL system to enable notification of partners and other users that do not have accounts in the system. This feature enables partners to receive relevant summaries of tests done as deemed appropriate by NASCOP. The Critical Alert System also supports the linkage of infants to care and recently diagnosed clients, to get initiated into treatment immediately.

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(c) System Integration/Interoperability

HealthIT engaged Palladium Kenya and UCSF on systems integration to exchange EID/VL data for different purposes including recency study and case-based surveillance. The purpose was to enhance data exchange between the various players within the national public health space e.g.,

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(d) Strengthened Recency Samples Testing

A recency test according to UNAIDS is a laboratory-based test that detects whether an HIV infection is recent (less than six months) or not. In June 2022, the recency team comprising HealthIT, NASCOP and the HIV reference labs held a meeting to agree on how recency samples are to be collected, tested (to ensure accuracy and minimal duplication or errors) and captured on the EID/ VL system. This is expected to harmonize the process of testing and capturing data for recency samples as EID/VL system is able to exchange recency sample results and trends with the case-based surveillance team. The system was updated to conform to the Recency Surveillance Sample Request Form and validation made to capture mandatory fields..

(e) Improving the Remote log-in Function

Each reference lab has health facilities within a region that are linked to it. The concern was logging samples from these sites before was not efficient hence the need for remote logging from the facilities. HealthIT’s focus in 2022 was also on providing a seamless workflow within the system for logging samples to the reference labs. Remote logging is necessary to improve data quality and improve sample and results tracking by clinicians to improve Turnaround Time (TAT) leading to prompt interventions

(f) Other Achievements

  • HealthIT also supported two workshops with lab managers to sensitize them on the new system improvements.
  • EID/VL Results Transmission – HealthIT continued to support the transmission of results to facilities and patients by providing SMS, email, and short code services
  • System Hosting and Data Center Support - HealthIT continued to support most of the regional labs with system hosting, maintenance, and management at UoN Data Centre and NASCOP Afya Annex Data Centre with the installation of a new server and power generator. The project also procured batteries for the UPS, and maintenance of the backup generator and has ensured continuous service provision of both the internet and NASCOP GSuite.

Roll Out of the Upgraded System

The upgraded software was tested and rolled out to six (6) of the eight (8) regional reference laboratories in August 2022. The use of this system is expected to enhance data quality and consistency for improved programming and decision-making.

Roll Out Process

  • Testing and Deployment – - For each lab, the system was deployed, HealthIT provided a one-week period of thorough testing by the lab managers and lab users. The testing was done off-site at the UoN Data Center before being deployed to the live environment in the labs. The testing process began in late March 2022 to August 2022.
  • Capacity Building -- During the testing process, HealthIT carried out capacity building and sensitization of the Lab users on the use of the upgraded lab system.
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Next Steps

(a) Counties and Health facilities Reached

There have been efforts to harmonize the laboratories’ business process where EID/VL team engaged NASCOP and the Lab team to refine the business process repeatedly i.e., how samples should be processed right from the facility to the lab. Most facilities were encouraged to do logging of samples to the NASCOP portal before shipment starts because at the facility level, transcription errors are minimal compared to the lab level. There are plans to engage the regional laboratories to document a harmonized business process for EID/VL system. This will inform system evolution and management in subsequent periods. HealthIT will continue to provide technical assistance to the Ministry of Health to support the continuous evolution of the EID VL system as we support the Government in the fight against HIV/AIDS and the attainment of the UNAIDS 95-95-95 goals

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