Evaluating the impact of point-of-care HIV viral load assessment on linkage to care in Baltimore, MD: a randomized controlled trial.

Autor: Bayan MH; Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA., Smalls T; Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA., Boudreau A; Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA., Mirza AW; Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA., Pasco C; Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA., Demko ZO; Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA., Rothman RE; Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA.; Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA., Hsieh YH; Department of Emergency Medicine, Johns Hopkins University, Baltimore, MD, USA., Eshleman SH; Department of Pathology, Johns Hopkins University, Baltimore, MD, USA., Mostafa HH; Department of Pathology, Johns Hopkins University, Baltimore, MD, USA., Gonzalez-Jimenez N; Centers for Disease Control and Prevention, Atlanta, GA, USA., Chavez PR; Centers for Disease Control and Prevention, Atlanta, GA, USA., Emerson B; Centers for Disease Control and Prevention, Atlanta, GA, USA., Delaney KP; Centers for Disease Control and Prevention, Atlanta, GA, USA., Daugherty D; DLH Corporation, Atlanta, GA, USA., MacGowan RJ; Centers for Disease Control and Prevention, Atlanta, GA, USA., Manabe YC; Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA., Hamill MM; Division of Infectious Diseases, Johns Hopkins University, Baltimore, MD, USA. mhamill6@jhu.edu.
Jazyk: angličtina
Zdroj: BMC infectious diseases [BMC Infect Dis] 2023 Sep 01; Vol. 23 (1), pp. 570. Date of Electronic Publication: 2023 Sep 01.
DOI: 10.1186/s12879-023-08459-7
Abstrakt: Background: Integration of a sensitive point-of-care (POC) HIV viral load (VL) test into screening algorithms may help detect acute HIV infection earlier, identify people with HIV (PWH) who are not virally suppressed, and facilitate earlier referral to antiretroviral therapy (ART), or evaluation for pre-exposure prophylaxis (PrEP). This report describes a randomized clinical trial sponsored by the Centers for Disease Control and Prevention (CDC): "Ending the HIV Epidemic Through Point-of-Care Technologies" (EHPOC). The study's primary aim is to evaluate the use of a POC HIV VL test as part of a testing approach and assess the impact on time to linkage to ART or PrEP. The study will recruit people in Baltimore, Maryland, including patients attending a hospital emergency department, patients attending an infectious disease clinic, and people recruited via community outreach. The secondary aim is to evaluate the performance characteristics of two rapid HIV antibody tests approved by the United States Food and Drug Administration (FDA).
Methods: The study will recruit people 18 years or older who have risk factors for HIV acquisition and are not on PrEP, or PWH who are not taking ART. Participants will be randomly assigned to either the control arm or the intervention arm. Participants randomized to the control arm will only receive the standard-of-care (SOC) HIV screening tests. Intervention arm participants will receive a POC HIV VL test in addition to the SOC HIV diagnostic screening tests. Follow up will consist of an interim phone survey conducted at week-4 and an in-person week-12 visit. Demographic and behavioral information, and oral fluid and blood specimens will be collected at enrollment and at week-12. Survey data will be captured in a Research Electronic Data Capture (REDCap) database. Participants in both arms will be referred for either ART or PrEP based on their HIV test results.
Discussion: The EHPOC trial will explore a novel HIV diagnostic technology that can be performed at the POC and provide viral assessment. The study may help inform HIV testing algorithms and contribute to the evidence to support same day ART and PrEP recommendations.
Trial Registration: NIH ClinicalTrials.gov NCT04793750. Date: 11 March 2021.
(© 2023. BioMed Central Ltd., part of Springer Nature.)
Databáze: MEDLINE
Externí odkaz: