Scale-up of Kenya's national HIV viral load program: Findings and lessons learned.

OBJECTIVES: Kenya is one of the first African countries to scale up a national HIV viral load monitoring program. We sought to assess program scale up using the national database and identify areas for systems strengthening. METHODS: Data from January 2012 to March 2016 were extracted from Kenya's national viral load database. Characteristics of 1,108,356 tests were assessed over time, including reason for testing, turnaround times, test results, treatment regimens, and socio-demographic information. RESULTS: The number of facilities offering viral load testing increased to ~2,000 with >40,000 tests being conducted per month by 2016. By March 2016, most (84.2%) tests were conducted for routine monitoring purposes and the turnaround time from facility-level sample collection to result dispatch from the lab was 21(24) [median (IQR)] days. Although the proportions of repeat viral load tests increased over time, the volumes were lower than expected. Elevated viral load was much more common in pediatric and adolescent patients (0-<3 years: 43.1%, 3-<10 years: 34.5%, 10-<20 years: 36.6%) than in adults (30-<60 years: 13.3%; p<0.001). CONCLUSIONS: Coverage of viral load testing dramatically increased in Kenya to >50% of patients on antiretroviral therapy (ART) by early 2016 and represents a relatively efficient laboratory system. However, strengthening of patient tracking mechanisms and viral load result utilization may be necessary to further improve the system. Additional focus is needed on paediatric/adolescent patients to improve viral suppression in these groups. Kenya's national viral load database has demonstrated its usefulness in assessing laboratory programs, tracking trends in patient characteristics, monitoring scale-up of new policies and programs, and identifying problem areas for further investigation.

Correction: The BD FACSPresto Point of Care CD4 Test accurately enumerates CD4+ T cell counts.

[This corrects the article DOI: 10.1371/journal.pone.0145586.].

The BD FACSPresto Point of Care CD4 Test Accurately Enumerates CD4+ T Cell Counts.

OBJECTIVE: Currently 50% of ART eligible patients are not yet receiving life-saving antiretroviral therapy (ART). Financial constraints do not allow most developing countries to adopt a universal test and offer ART strategy. Decentralizing CD4+ T cell testing may, therefore, provide greater access to testing, ART, and better patient management. We evaluated the technical performance of a new point-of-care CD4+ T cell technology, the BD FACSPresto, in a field methods comparison study. METHODS: 264 HIV-positive patients were consecutively enrolled and included in the study. The BD FACSPresto POC CD4+ T cell technology was placed in two rural health care facilities and operated by health care facility staff. We compared paired finger-prick and venous samples using the BD FACSPresto and several existing reference technologies, respectively. RESULTS: The BD FACSPresto had a mean bias of 67.29 cells/ul and an r(2) of 0.9203 compared to the BD FACSCalibur. At ART eligibility thresholds of 350 and 500 cells/ul, the sensitivity to define treatment eligibility were 81.5% and 77.2% and the specificities were 98.9% and 100%, respectively. Similar results were observed when the BD FACSPresto was compared to the BD FACSCount and Alere Pima. The coefficient of variation (CV) was less than 7% for both the BD FACSCalibur and BD FACSPresto. CD4+ T cell testing by nurses using the BD FACSPresto at rural health care facilities showed high technical similarity to test results generated by laboratory technicians using the BD FACSPresto in a high functioning laboratory. CONCLUSIONS: The BD FACSPresto performed favorably in the laboratory setting compared to the conventional reference standard technologies; however, the lower sensitivities indicated that up to 20% of patients tested in the field in need of treatment would be missed. The BD FACSPresto is a technology that can allow for greater decentralization and wider access to CD4+ T cell testing and ART.

Technical performance evaluation of the MyT4 point of care technology for CD4+ T cell enumeration.

OBJECTIVE: Though absolute CD4+ T cell enumeration is the primary gateway to antiretroviral therapy initiation for HIV-positive patients in all developing countries, patient access to this critical diagnostic test is relatively poor. We technically evaluated the performance of a newly developed point-of-care CD4+ T cell technology, the MyT4, compared with conventional CD4+ T cell testing technologies. DESIGN: Over 250 HIV-positive patients were consecutively enrolled and their blood tested on the MyT4, BD FACSCalibur, and BD FACSCount. RESULTS: Compared with the BD FACSCount, the MyT4 had an r2 of 0.7269 and a mean bias of -23.37 cells/µl. Compared with the BD FACSCalibur, the MyT4 had an r2 of 0.5825 and a mean bias of -46.58 cells/µl. Kenya currently uses a CD4+ T cell test threshold of 350 cells/µl to determine patient eligibility for antiretroviral therapy. At this threshold, the MyT4 had a sensitivity of 95.3% (95% CI: 88.4-98.7%) and a specificity of 87.9% (95% CI: 82.3-92.3%) compared with the BD FACSCount and sensitivity and specificity of 88.2% (95% CI: 79.4-94.2%) and 84.2% (95% CI: 78.2-89.2%), respectively, compared with the BD FACSCalibur. Finally, the MyT4 had a coefficient of variation of 12.80% compared with 14.03% for the BD FACSCalibur. CONCLUSIONS: We conclude that the MyT4 performed well at the current 350 cells/µl ART initiation eligibility threshold when used by lower cadres of health care facility staff in rural clinics compared to conventional CD4+ T cell technologies.