Mother-to-child transmission of HIV in Kenya: A cross-sectional analysis of the national database over nine years.

OBJECTIVE: To describe factors associated with mother-to-child HIV transmission (MTCT) in Kenya and identify opportunities to increase testing/care coverage. DESIGN: Cross-sectional analysis of national early infant diagnosis (EID) database. METHODS: 365,841 Kenyan infants were tested for HIV from January 2007-July 2015 and results, demographics, and treatment information were entered into a national database. HIV risk factors were assessed using multivariable logistic regression. RESULTS: 11.1% of infants tested HIV positive in 2007-2010 and 6.9% in 2014-2015. Greater odds of infection were observed in females (OR: 1.08; 95% CI:1.05-1.11), older children (18-24 months vs. 6 weeks-2 months: 4.26; 95% CI:3.87-4.69), infants whose mothers received no PMTCT intervention (vs. HAART OR: 1.92; 95% CI:1.79-2.06), infants receiving no prophylaxis (vs. nevirapine for 6 weeks OR: 2.76; 95% CI:2.51-3.05), and infants mixed breastfed (vs. exclusive breastfeeding OR: 1.39; 95% CI:1.30-1.49). In 2014-2015, 9.1% of infants had mothers who were not on treatment during pregnancy, 9.8% were not on prophylaxis, and 7.0% were mixed breastfed. Infants exposed to all three risky practices had a seven-fold higher odds of HIV infection compared to those exposed to recommended practices. The highest yield of HIV-positive infants were found through targeted testing of symptomatic infants in pediatric/outpatient departments (>15%); still, most infected infants were identified through PMTCT programs. CONCLUSION: Despite impressive gains in Kenya's PMTCT program, some HIV-infected infants present late and are not benefitting from PMTCT best practices. Efforts to identify these early and enforce evidence-based practice for PMTCT should be scaled up. Infant testing should be expanded in pediatric/outpatient departments, given high yields in these portals.

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.