Near-point-of-care viral load testing during pregnancy and viremia at delivery.

OBJECTIVES: Assess whether near-point-of-care (POC) viral load testing at the first antenatal care visit (ANC1) increased the proportion of women taking antiretroviral therapy who were virally suppressed at delivery through expedited clinical action. DESIGN: Difference-in-difference analysis. METHODS: At 20 public sector facilities in Zimbabwe, 10 implemented near-POC viral load testing at ANC1 (August 2019 to November 2020) and 10 used centralized viral load testing at ANC1. Study endpoints included time to result received, clinical action, and unsuppressed viral load (UVL; >1000 copies/ml) at delivery. RESULTS: Of 1782 women, only 46% came for ANC1 before their third trimester. Preimplementation, 28% of women received viral load testing at ANC1, increasing to 86% during implementation. In the near-POC viral load arm, women were more likely to receive their result within 30 days of ANC1 sample collection compared with the centralized laboratory arm [54 versus 14%, relative risk (RR): 4.17, 95% confidence interval (CI) 1.82-9.55], as well as receive clinical action among those with UVL (63 versus 8%, RR 7.88; 95% CI 1.53-40.47). However, we did not observe significant changes in risk of UVL at delivery with near-POC viral load (RR 1.02, 95% CI 0.95-1.10). CONCLUSION: ANC1 viral load coverage was initially low. Near-POC viral load testing at ANC1 dramatically improved the timeliness of result receipt by patients and clinical action for those with an UVL. Although we did not observe a significant impact of provision of near-POC viral load at ANC1 on re-suppression at delivery, potentially because of late presentation for ANC1, continued near-POC viral load testing during pregnancy and delivery may reduce UVL and mother-to-child transmission risk.

Feasibility and impact of near-point-of-care integrated tuberculosis/HIV testing in Malawi and Zimbabwe.

OBJECTIVES: Near-point-of-care (POC) testing for early infant diagnosis (EID) and viral load expedites clinical action and improves outcomes but requires capital investment. We assessed whether excess capacity on existing near-POC devices used for TB diagnosis could be leveraged to increase near-POC HIV molecular testing, termed integrated testing, without compromising TB services. DESIGN: Preimplementation/postimplementation studies in 10 health facilities in Malawi and 8 in Zimbabwe. METHODS: Timeliness of EID and viral load test results and clinical action were compared between centralized and near-POC testing using Somers' D tests (continuous indicators) and risk ratios (RR, binary indicators); TB testing/treatment rates and timeliness were analyzed preintegration/postintegration. RESULTS: With integration, average device utilization increased but did not exceed 55%. Despite the addition of HIV testing, TB test volumes, timeliness, and treatment initiations were maintained. Although few HIV-positive infants were identified, near-POC EID testing improved treatment initiation within 1 month by 57% compared with centralized EID [Malawi RR: 1.57, 95% confidence interval (CI) 0.98-2.52], and near-POC viral load testing significantly increased the proportion of patients with elevated viral load receiving clinical action within 1 month (Zimbabwe RR: 5.26, 95% CI 3.38-8.20; Malawi RR: 3.90, 95% CI 2.58-5.91). CONCLUSION: Integrating TB/HIV testing using existing multidisease platforms is feasible and enables increased access to rapid diagnostics without disrupting existing TB services. Our results serve as an example of a novel, efficient implementation model that can increase access to critical testing services across disease silos and should be considered for additional clinical applications.

Point-of-care CD4 technology invalid result rates in public health care settings across five countries.

BACKGROUND: Since 2010, point-of-care (POC) CD4 testing platforms have been introduced in both urban and rural settings to expand access to testing by bringing diagnostic services closer to patients. We conducted an analysis of routinely collected CD4 testing data to determine the invalid result rates associated with POC CD4 testing. METHODS: We analyzed 981,152 CD4 testing records collected from Alere Pima Analyzers between January 2011 and December 2016 across five countries in sub-Saharan Africa. Routinely collected data and programmatic records were used to determine the rate of invalid test results per month, by facility type, and by operator based on cumulative usage during the study period. In addition, frequency of invalid test types and utilization of control beads were assessed. RESULTS: Across the five countries, 75,530 invalid messages were returned, resulting in an overall invalid result rate of 7.7%. The invalid result rate by country ranged from 6.6% to 11.2%. Invalid result rates were consistent across facility types. Invalid result rates were inversely correlated with operator usage: low volume operators (<50 tests over study period) experienced an invalid result rate of 10.2%, while high volume operators (>500 tests over study period) experienced an invalid result rate of 5.5%. Two invalid result types (exposure position control and reagent control) accounted for nearly 50% of invalid results. Routine data showed that control beads were run on 88.3% of days that the device was used. CONCLUSIONS: Our analysis found that the rate of invalid results was consistent across all types of health facilities, indicating that decentralization of POC CD4 testing to lower level health facilities did not exhibit high invalid result rates or increase cartridge wastage. Additionally, invalid result rates were inversely correlated to operator usage, with high-volume operators experiencing lower invalid result rates than low-volume operators. POC CD4 testing can, therefore, be performed in decentralized national testing programs; however, adequate training, quality assurance, routine monitoring, and ongoing mentorship should also be implemented for success.