Introduction: Point-of-care (POC) early infant diagnosis (EID) testing has been shown to dramatically decrease turnaround times from sample collection to caregiver result receipt and time to ART initiation for HIV-positive infants compared to centralized laboratory testing. As governments in sub-Saharan Africa implement POC EID technologies, we report on the feasibility and effectiveness of POC EID testing and the impact of same-day result delivery on rapid ART initiation within national programmes across six countries. Methods: This pre-/post-evaluation compared centralized laboratory-based (pre) with POC (post) EID testing in 52 facilities across Cameroon, Democratic Republic of Congo, Ethiopia, Kenya, Senegal and Zimbabwe between April 2017 and October 2019 (country-dependent). Data were collected retrospectively from routine records at health facilities for all infants tested under two years of age. Hazard ratios and 95% confidence intervals were calculated to compare time-to-event outcomes, visualized with Kaplan-Meier curves, and the Somers' D test was used to compare continuous outcomes. Results: Data were collected for 2892 EID tests conducted on centralized laboratory-based platforms and 4610 EID tests on POC devices with 127 (4%) and 192 (4%) HIV-positive infants identified, respectively. POC EID significantly reduced the time from sample collection to caregiver result receipt (POC median: 0 days, IQR: 0 to 0 vs. centralized: 35 days, IQR: 26 to 56) and time from sample collection to ART initiation for HIV-positive infants (POC median: 1 day, IQR: 0 to 7 vs. centralized: 39 days, IQR: 26 to 57). With POC testing, 72% of infants received results on the same day as sample collection; HIV-positive infants with a same-day diagnosis had six times the rate of ART initiation compared to those diagnosed one or more days after sample collection (HR: 6.39; 95% CI: 3.44 to 11.85). Conclusions: Same-day diagnosis and treatment initiation for infants is possible with POC EID within routine government-led and-supported public sector healthcare facilities in resource-limited settings. Given that POC EID allows for rapid ART initiation, aligning to the World Health Organization's recommendation of ART initiation within seven days, its use in public sector programmes has the potential to reduce overall mortality for infants with HIV through early treatment initiation.
Introduction In many low‐ and middle‐income countries, HIV viral load (VL) testing occurs at centralized laboratories and time‐to‐result‐delivery is lengthy, preventing timely monitoring of HIV treatment adherence. Near point‐of‐care (POC) devices, which are placed within health facility laboratories rather than clinics themselves (i.e. “true” POC), can offer VL in conjunction with centralized laboratories to expedite clinical decision making and improve outcomes, especially for patients at high risk of treatment failure. We assessed impacts of near‐POC VL testing on result receipt and clinical action in public sector programmes in Cameroon, Democratic Republic of Congo, Kenya, Malawi, Senegal, Tanzania and Zimbabwe. Methods Routine health data were collected retrospectively after introducing near‐POC VL testing at 57 public sector health facilities (2017 to 2019, country‐dependent). Where possible, key indicators were compared to data from patients receiving centralized laboratory testing using hazard ratios and the Somers’ D test. Results Data were collected from 6795 tests conducted on near‐POC and 17614 tests on centralized laboratory‐based platforms. Thirty‐one percent (2062/6694) of near‐POC tests were conducted for high‐risk populations: pregnant and breastfeeding women, children and those with suspected failure. Compared to conventional testing, near‐POC improved the median time from sample collection to return of results to patient [six vs. sixty‐eight days, effect size: −32.2%; 95% CI: −41.0% to −23.4%] and to clinical action for individuals with an elevated HIV VL [three vs. fourty‐nine days, effect size: −35.4%; 95% CI: −46.0% to −24.8%]. Near‐POC VL results were two times more likely to be returned to the patient within 90 days compared to centralized tests [50% (1781/3594) vs. 27% (4172/15271); aHR: 2.22, 95% CI: 2.05 to 2.39]. Thirty‐seven percent (340/925) of patients with an elevated near‐POC HIV VL result had documented clinical follow‐up actions within 30 days compared to 7% (167/2276) for centralized testing. Conclusions Near‐POC VL testing enabled rapid test result delivery for high‐risk populations and led to significant improvements in the timeliness of patient result receipt compared to centralized testing. While there was some improvement in time‐to‐clinical action with near‐POC VL testing, major gaps remained. Strengthening of systems supporting the utilization of results for patient management are needed to truly capitalize on the benefits of decentralized testing.
Background: The number of people living with HIV (PLHIV) in need of treatment monitoring in low-and-middle-income countries is rapidly expanding, straining existing laboratory capacity. Point-of-care viral load (POC VL) testing can alleviate the burden on centralized laboratories and enable faster delivery of results, improving clinical outcomes. However, implementation costs are uncertain and will depend on clinic testing volume. We sought to estimate the costs of decentralized POC VL testing compared to centralized laboratory testing for adults and children receiving HIV care in Kenya. Methods: We conducted microcosting to estimate the per-patient costs of POC VL testing compared to known costs of centralized laboratory testing. We completed time-and-motion observations and stakeholder interviews to assess personnel structures, staff time, equipment costs, and laboratory processes associated with POC VL administration. Capital costs were estimated using a 5 year lifespan and a 3% annual discount rate. Results: We estimated that POC VL testing cost USD $24.25 per test, assuming a clinic is conducting 100 VL tests per month. Test cartridge and laboratory equipment costs accounted for most of the cost (62% and 28%, respectively). Costs varied by number of VL tests conducted at the clinic, ranging from $54.93 to $18.12 per test assuming 20 to 500 VL tests per month, respectively. A VL test processed at a centralized laboratory was estimated to cost USD $25.65. Conclusion: POC VL testing for HIV treatment monitoring can be feasibly implemented in clinics within Kenya and costs declined with higher testing volumes. Our cost estimates are useful to policymakers in planning resource allocation and can inform cost-effectiveness analyses evaluating POC VL testing.
The geographic and evolutionary origins of the SARS-CoV-2 Omicron variant (BA.1), which was first detected mid-November 2021 in Southern Africa, remain unknown. We tested 13,097 COVID-19 patients sampled between mid-2021 to early 2022 from 22 African countries for BA.1 by real-time RT-PCR. By November-December 2021, BA.1 had replaced the Delta variant in all African sub-regions following a South-North gradient, with a peak Rt of 4.1. Polymerase chain reaction and near-full genome sequencing data revealed genetically diverse Omicron ancestors already existed across Africa by August 2021. Mutations, altering viral tropism, replication and immune escape, gradually accumulated in the spike gene. Omicron ancestors were therefore present in several African countries months before Omicron dominated transmission. These data also indicate that travel bans are ineffective in the face of undetected and widespread infection.
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