CLINICAL RESEARCH UPDATE

by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer

January 14, 2025


Featured Literature:

Moore Jr. K, Le Tourneau N, Alavarez J, et al.  Feasibility and staff acceptability of implementing Xpert HIV-1 viral load point-of-care testing: a pilot study in San Francisco.  BMC Infect Dis.  2025 Jan 6;25(1):26.  doi: 10.1186/s12879-024-10384-2.

This study describes operational feasibility, staff acceptability, and test performance of the point-of-care Xpert® HIV-1 Viral Load assay, as part of a broader evaluation of rapid ART on linkage to care and viral suppression in a high-volume, community-based sexual health center. Standard of care testing involved HIV-1/2 Ab screening followed by supplemental testing for initial reactive results. For people with elevated risk for acute HIV, pooled RNA testing was conducted via the health department; quantitative RNA testing was also performed using COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, V 2.0 as indicated (this was used as the standard-of-care virologic testing comparator). Remnant specimens from routine HIV/STI testing or PrEP/PEP/HIV services were used; information including other testing results were extracted from health records. Clinical staff observations, document review, and interviews with the research coordinator and one clinician were conducted. Over four months, Xpert testing was performed on 113 samples from 111 individuals; median run-time was 89.9 minutes. HIV-1 RNA was detected in 5 samples, one of which yielded < 40 copies/mL. The Xpert assay showed close agreement with COBAS (mean log10 copies/mL difference: 0.148±0.235). Identified benefits included faster turnaround time for results, theoretical facilitation of immediate care and treatment (including decision making/care engagement regarding acute HIV as well as ART initiation and treatment response), and decreased reliance on outside laboratories. Identified challenges related to staff workload, training, testing logistics, and wait time.

Author’s Commentary:

Point-of-care testing for HIV and associated conditions can greatly enhance low-barrier services and programs serving populations who might not regularly engage with traditional medical settings due to stigma, mistrust, or other factors. Results of this pilot study demonstrate that incorporation of POC quantitative virologic testing for HIV prevention/testing and treatment services is feasible, and that staff are generally supportive given identified benefits. Further work is needed to validate test performance given the limited sample size of this study. Importantly, further evaluation is also needed to determine how to implement POC quantitative virologic testing into clinic operations and workflows, given several key logistical and access considerations including cost and regulatory/certification requirements.

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