Kenya is a HIV ‘high burden’ county in Africa with both a generalised and a concentrated epidemic within its population of 47 million.
For adults, counselling services and HIV testing using rapid test strips are widely available.
Following the ‘Test and Treat’ guidelines released by the World Health Organization in 2014,
Early infant diagnosis (EID) testing began in 2006 and is offered at seven national laboratories.
To help improve access to viral load and EID testing, the Ministry of Health encouraged evaluations of new technologies as they become available. It has also developed a point-of-care (POC) testing policy to guide the implementation of POC testing to support laboratory practice and bring services closer to patients. A POC technical working group comprising several stakeholders, including the Elizabeth Glaser Pediatric AIDS Foundation, the Clinton Health Access Initiative and the United Nations Children’s Fund, is overseeing the implementation.
Currently, the National Public Health Laboratories Services, in collaboration with key stakeholders, is putting together a national POC roadmap that addresses the introduction and scale-up of POC testing in the existing landscape. The Kenya Medical Research Institute has been evaluating technologies as they become available in order to determine their suitability for use in Kenya.
Guidelines for POC technology evaluation and adoption were developed and launched in 2014. The national coordinator for POC evaluations is the National Public Health Laboratories Services, but there are sub-coordinators in all 47 counties of Kenya (
Kenya point-of-care quality assurance programme management structure.
Kenya has a national quality assurance programme that has been pursuing laboratory accreditation through the Strengthening Laboratory Management Towards Accreditation approach.
EQA occurs three times a year in Kenya through an intermediate model involving both local and international EQA providers. International panels are sourced from Human Quality Assessment Services, Public Health Agency of Canada (QASI), the US Centers for Disease Control and Prevention, and the World Health Organization, depending on the test. The EQA panels are distributed to county hubs for redistribution to the testing sites. National panels, including dried tube specimens, split samples, rechecking and internal controls, are procured centrally. The national programme also supports validation of new tests/equipment, certification of personnel and routine maintenance of equipment. Routine supervision is decentralised.
All seven central molecular testing laboratories participate in the US Centers for Disease Control and Prevention, Atlanta, proficiency testing for viral load, EID and HIV drug resistance testing. Additionally, a subset (4/7) of the central testing labs participate in a quarterly inter-laboratory EQA programme, with all expected to participate during 2016. Samples are processed between the participating laboratories and results are discussed every quarter to enhance quality. It is conceivable that there will be three cycles of EQA annually for EID and viral load when the appropriate POC testing devices become available.
The POC testing pipeline has only had a few technologies that have reached clinical evaluation, and of those, the Alere Pima™ and BD FACSPresto™ have shown the biggest potential for use. Following satisfactory evaluation findings,
CD4 device mapping in Kenya. A total of 298 functioning CD4 instruments were clustered across 47 counties.
Site selection was based on a national map of existing CD4 sites and extensive discussion between regional implementing partners and individual County Health Management teams who oversee all health-related issues in the county. This process led to the generation of a list of 150 facilities that fit the site selection criteria agreed upon by the POC Technical Working Group, such as total patient volumes per health facility, distance travelled to central testing hubs, and the total throughput of the Pima device. These criteria were used to generate a score for each site that was eligible for Pima placement. In addition, qualitative criteria, such as security and availability of personnel, were considered when selecting placements for the initial 44 devices from the 150 sites generated. The same site selection methodology was applied for the 62 additional Pima devices that were deployed in early 2015.
The Ministry of Health has enacted a law passed by parliament that recommends device leasing (as opposed to purchase) for all medical diagnostic services in the country. In this model, the device belongs to the manufacturer during its usage period. The manufacturer is responsible for the maintenance of the device. The cost of the cartridge, service and maintenance is bundled and packaged together with the cost per test.
In 2014, trainings were conducted using the super-user training model and included the training of County Laboratory Coordinators, implementing partners, and a team from the National HIV Reference Laboratory. However, the quality of training that cascaded down through training-of-trainers was poor and therefore required follow-up for on-site re-training by the Ministry of Health, supported by implementation partners. In 2015, trainings focused on an end-user training model.
While most facilities were able to begin testing within one to two weeks after the super-user training, there was delayed end-user/facility-based training in some facilities due to conflicting commitments by either the County Laboratory Coordinator or the implementing partner. The lessons learned from 2014 have been applied to the 2015 training curriculum, such as the switch from super-user training to end-user training.
Follow-up visits after the initial training and implementation of the 44 Pima devices showed that most POC testing sites adapted their clinical workflow around the availability of onsite CD4 testing. Nearby satellite sites are now redirecting their samples to Pima POC testing sites. Using this approach, the 119 Pima devices performed an average of 2432 tests per month, or 6.5% of all CD4 tests done in the country. The BD FACSPresto was rolled out at 13 sites, for an average of 818 tests a month.
At POC testing sites, 71.5% of patients received same day results, while post-implementation assessments have shown a reduction in time to initiation on antiretroviral therapy from two months
The first phase of implementation of POC CD4 testing devices in Kenya revealed a number of challenges:
Testing errors resulted in wastage of a significant number of test cartridges for the Pima device. In 2014, the error rate was 7.6% of all tests done, while in 2015, this rate increased to 13.6% in the first two quarters of the year. The maximum pass rate for the EQA system over 40 rounds was only 82.0%.
Lack of reporting on commodity consumption resulted in stock-outs at some sites and the delay in issuing new control beads for the Pima machines. Machine downtimes reduced overall access to the service.
Movement of staff within counties while organisational structures were finalised meant that some of the staff trained as super-users were transferred to new regions and could no longer provide support to the Pima POC testing sites in the region in which they were trained.
Other competing engagements of some county super-users meant that they were unable to provide consistent mentorship or support to the users they trained.
Lack of internet in remote regions meant data transmission to the national database was erratic.
POC technologies for HIV have the potential to improve access to diagnosis and to reduce time to result or to initiation of treatment. Kenya, being a high HIV burden country, is keen to adopt technologies that offer the most promise and is therefore constantly evaluating them.
During the rollout of the Alere Pima and BD FACSPresto systems, some lessons have been learnt that can guide future adoption of POC testing for viral load and EID. The rate of testing errors, and the causes, does not differ markedly from what others have reported.
The POC CD4 testing programme was hampered by poor reporting on commodity consumption. The net effect was a lack of supplies, leading to avoidable machine downtime. In our experience, supportive supervision improves reporting. An even more effective solution is automating the reporting by means of digital transmission systems.
After each EQA cycle, the National HIV Reference Laboratory and supporting partners need to conduct intervention meetings with participating sites with unsatisfactory reports to support improvement of performance and enhance quality service delivery (
(a) CD4 Pima™ POC testing trends 2014–2015 error rates; (b) Drill down to sites with high error rates: top 36 sites in Kenya contributing to 75% of the total error rates.
Kenya has been very engaged with the evaluation and implementation of POC testing and pursues the highest quality of care for Kenyans through quality diagnostics. The MOH is continuously expanding quality assurance programmes with an emphasis on the accreditation of laboratories and plans for local production of external quality assurance panels.
Implementing partners can continue to work with the Ministry of Health to mitigate further risk and to address the various challenges raised above in some of the following ways: including different end-users in trainings to address the turnover of staff and support trained super-users; and leveraging resources across relevant partners and organisations to ensure that an internet connection is available at every facility to enable online reporting of monthly consumption.
The lessons learned through the implementation of PIMA are guiding the planning for EID and viral load POC; primarily site selection and continuous quality assurance for monitoring and evaluation. The collaboration between implementing partners and Ministry of Health is an important aspect to planning for sustainable quality POC testing.
The authors are grateful to POC testing implementing partners, including the Clinton Health Access Initiative, who supported Pima implementation in Kenya. We also thank the London School of Hygiene and Tropical Medicine for invitation and support towards the development of a quality assurance framework for Kenya.
The authors declare that they have no financial or personal relationships which may have inappropriately influenced them in writing this article.
None.