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

OBJECTIVES Near-point-of-care (POC) testing for early infant diagnosis (EID) and viral load (VL) 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 Pre/post implementation studies in 10 health facilities in Malawi and 8 in Zimbabwe. METHODS Timeliness of EID and VL test results and clinical action were compared between centralized and near-POC testing using Somers' D tests (continuous indicators) and risk ratios (binary indicators); TB testing/treatment rates and timeliness were analyzed pre/post integration. 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 one month by 57% compared to centralized EID (Malawi RR:1.57, 95% CI:0.98-2.52), and near-POC VL testing significantly increased the proportion of patients with elevated VL receiving clinical action within one month (Zimbabwe RR:5.26, 95% CI:3.38-8.20; Malawi RR:3.90, 95% CI:2.58-5.91). CONCLUSIONS Integrating TB/HIV testing using existing multi-disease 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 servicing across disease silos and should be considered for additional clinical applications.