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Supplemental Digital Content is Available in the Text., Background: To improve early infant HIV diagnosis (EID) programs, options include replacing laboratory-based tests with point-of-care (POC) assays or investing in strengthened systems for sample transport and result return. Setting: We used the CEPAC-Pediatric model to examine clinical benefits and costs of 3 EID strategies in Zimbabwe for infants 6 weeks of age. Methods: We examined (1) laboratory-based EID (LAB), (2) strengthened laboratory-based EID (S-LAB), and (3) POC EID (POC). LAB/S-LAB and POC assays differed in sensitivity (LAB/S-LAB 100%, POC 96.9%) and specificity (LAB/S-LAB 99.6%, POC 99.9%). LAB/S-LAB/POC algorithms also differed in: probability of result return (79%/91%/98%), time until result return (61/53/1 days), probability of initiating antiretroviral therapy (ART) after positive result (52%/71%/86%), and total cost/test ($18.10/$30.47/$30.71). We projected life expectancy (LE) and average lifetime per-person cost for all HIV-exposed infants. We calculated incremental cost-effectiveness ratios (ICERs) from discounted (3%/year) LE and costs in $/year-of-life saved (YLS), defining cost effective as an ICER

RESEARCH OBJECTIVE: Point‐of‐care (POC) assays for early infant diagnosis of HIV (EID) increase access to testing, shorten time to results, and expedite initiation of antiretroviral therapy when compared with laboratory‐based (centralized) assays. However, there is a significant gap in our understanding of its human resource impact at the facility‐level. This study evaluated the human resource labor time associated with the use of EID platforms by facility‐based health workers (HWs). STUDY DESIGN: Using time‐motion methodology, we collected direct observation and self‐reported time‐use data on EID tasks performed by HWs at health facilities in Zimbabwe. Data collection occurred at three EID facility types in Zimbabwe—five POC hubs (test samples from the hub and lower‐volume, nearby facilities), nine POC spokes (lower‐volume), and eleven facilities that use centralized laboratories. EID activities were grouped into pre‐result (counseling, administrative, blood sampling, and preparation) and total EID time (counseling to result communication). Total EID time was observed in POC hub facilities. Since EID tests were not performed on‐site at facilities using centralized laboratories and POC spoke facilities, tasks related to logging and communicating results were not observed. Instead, direct observation data were complemented with HW surveys at those facilities. Mean difference comparisons between centralized and POC EID services were performed with a two‐sample t test with allowance for unequal variances. Bootstrapping with 10 000 replicates was used to estimate the bias‐corrected and accelerated 95% confidence intervals for each measure and difference in means test. To assess whether results were robust, group comparison was performed with two‐sided permutation tests with 10 000 replicates, with same inference to those from the bootstrapped two‐sample t tests. A P‐value of

Background Point-of-care early infant diagnosis (POC EID) increases access to HIV test results and shortens time to result-return and antiretroviral therapy initiation, as compared to central laboratory-based EID. However, to scale-up POC EID, governments need more information about programmatic costs. Methods We evaluated POC EID costs from a health systems perspective. Our primary analysis assessed the Abbott m-PIMA and 2 versions of the Cepheid GeneXpert IV platforms-with a solar battery or gel battery-used in Zimbabwe, with instrument purchase. We also included the following 2 scenarios with zero upfront equipment purchase: (1) m-PIMA using a reagent rental model, with an all-inclusive price when the buyer commits to an average testing volume, and (2) GeneXpert IV, reflecting contexts where GeneXpert is already in place for tuberculosis diagnosis or HIV viral load monitoring. We collected data from project expenditures, observations of health workers, and from government salary scales. We calculated cost per EID test based on number of EID tests performed on each machine per day. Results The cost per successfully completed test was $44.55 for m-PIMA with platform purchase and $25.89 for m-PIMA reagent rental. Costs for GeneXpert IV with platform purchase were $25.70 using a solar battery, $25.29 using a gel battery, and $23.85 under a scenario assuming no equipment costs. In our primary analyses, materials costs comprised 73%-74% total costs, equipment 14%-20%, labor 5%-8%, training 1%, facility upgrades 1%, and monitoring 1%. Conclusions As countries consider scaling up POC EID, these data are important for budgeting and planning.

Background Point-of-care (POC) assays for early infant diagnosis of HIV (EID) increase access to testing, shorten time to results, and expedite initiation of antiretroviral therapy when compared with laboratory-based assays. However, there is a significant gap in our understanding of its human resource impact at the facility level. This study evaluates front-line health workers' (HWs') time associated with EID. Setting Using time-motion methodology, we collected time-use data on EID tasks performed by HWs at 3 EID facility types in Zimbabwe-5 POC hubs, 9 POC spokes, and 11 facilities that used centralized laboratories. Methods Data collectors observed 30 EID processes and 30 HWs' provided self-reported time. Comparisons of mean differences of HWs' time-use between centralized and POC EID were performed with a 2-sample t test with unequal variances. Results Observed average total labor time per EID test at POC facilities was 28 minutes, 22 seconds [95% confidence interval (CI): 22:51 to 35:48], which was equivalent to the average preresult time at facilities using centralized EID. HWs performed other tasks while the machine processed samples. Observed average preresult time (counseling to sample preparation) was 18 minutes, 6 Supported by seconds (95% CI: 13:00 to 23:42) for POC compared with 27 minutes, 48 seconds (95% CI: 23:48 to 32:50) for facilities using centralized laboratories. The mean difference of 9 minutes, 42 seconds (95% CI: 03:04 to 16:18) was statistically significant. The differences in self-reported average total labor time per EID test between HWs at facilities using centralized laboratories or POC were not statistically significant. Conclusion Use of POC assays did not incur additional human resource time compared with sending dried blood spots to a centralized laboratory for EID.