{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T00:13:40Z","timestamp":1790208820499,"version":"4.1.0"},"reference-count":40,"publisher":"American Medical Association (AMA)","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n HIV viral load (VL) testing is essential for monitoring responses to antiretroviral therapy (ART) among people with HIV (PWH) and prior to the initiation of HIV preexposure prophylaxis (PrEP). In the US, the potential benefit of implementing HIV VL testing in these scenarios on linkage to care (LTC) has not been evaluated.<\/jats:p>\n <\/jats:sec>\n \n Objectives<\/jats:title>\n To investigate whether providing laboratory-based HIV VL test results changed LTC rates or time to linkage for ART or PrEP across 12 weeks.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This randomized clinical trial was conducted from August 18, 2021, to February 2, 2023, with 12 weeks of follow-up. Participants were a convenience sample of adults with risk factors for HIV acquisition or PWH not taking daily ART, all of whom were recruited from an academic center emergency department in Baltimore, Maryland, and via social media advertising.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Participants were randomized 1:1 to receive a laboratory-based plasma HIV VL test with next-day results in addition to the standard of care HIV antigen\/antibody test result (intervention) or to receive the standard of care HIV antigen\/antibody assay alone (control).<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcome was LTC for ART or PrEP within 12 weeks of enrollment. Secondary outcomes included time to LTC and differences in LTC by HIV status. Analyses were conducted using the intention-to-treat population.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 1105 potential participants screened, 195 (17.6%) were enrolled (median [IQR] age 36, [27-47] years; 119 [61.0%) male; 112 [57.4%] Black or African American, 51 (26.2%) White, and 32 (16.4%) other race and ethnicity; and 34 [17.4%] PWH). By week 12, 93 participants (47.7%) completed follow-up, and 69 (35.4%) were linked to care (38 of 69 [55.1%] in the intervention group vs 31 of 69 [44.9%] in the control group). Overall, there was no statistically significant difference in LTC between the intervention and control group (hazard ratio, 1.28 [95% CI, 0.80-2.05];\n P<\/jats:italic>\n \u2009=\u2009.31]). In a modified intention-to-treat analysis, time to LTC was significantly less for PWH in the intervention group (log-rank\n P<\/jats:italic>\n \u2009=\u2009.03).\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this randomized clinical trial assessing the effects of HIV VL test results on LTC, providing a next-day HIV VL test result did not change LTC overall. More data are required to ascertain whether a rapid point-of-care HIV VL test would improve LTC.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT04793750<\/jats:ext-link>\n https:\/\/clinicaltrials.gov\/study\/NCT04793750<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2025.48380","type":"journal-article","created":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T16:00:24Z","timestamp":1765900824000},"page":"e2548380","source":"Crossref","is-referenced-by-count":1,"title":["Next-Day HIV Viral Load Test Result and Linkage to Care Among Persons Living With or at Risk of HIV"],"prefix":"10.1001","volume":"8","author":[{"given":"Matthew M.","family":"Hamill","sequence":"first","affiliation":[{"name":"Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Harris","family":"Bayan","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alec","family":"Boudreau","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nisha","family":"Ramdeep","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Rothman","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan H.","family":"Eshleman","sequence":"additional","affiliation":[{"name":"Department of Pathology, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tanique","family":"Bennett","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thelio","family":"Sewell","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zoe O.","family":"Demko","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agha","family":"Mirza","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Travis J.","family":"Smalls","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nyah","family":"Johnson","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benji","family":"Riggan","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Nielsen","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robin J.","family":"MacGowan","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Gonzalez-Jimenez","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pollyanna R.","family":"Chavez","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin P.","family":"Delaney","sequence":"additional","affiliation":[{"name":"Centers for Disease Control and Prevention, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu-Hsiang","family":"Hsieh","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukari C.","family":"Manabe","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Johns Hopkins School of Medicine, Baltimore, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2025,12,16]]},"reference":[{"issue":"8","key":"zoi251301r1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0272405","article-title":"Achieving the 95 95 95 targets for all: a pathway to ending AIDS.","volume":"17","author":"Frescura","year":"2022","journal-title":"PLoS One"},{"issue":"1","key":"zoi251301r3","doi-asserted-by":"publisher","first-page":"53","DOI":"10.1093\/cid\/ciw666","article-title":"Time until emergence of HIV test reactivity following infection with HIV-1: implications for interpreting test results and retesting after exposure.","volume":"64","author":"Delaney","year":"2017","journal-title":"Clin Infect Dis"},{"key":"zoi251301r9","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2023.114872","article-title":"m-PIMA\u2122 HIV1\/2 VL: a suitable tool for HIV-1 and HIV-2 viral load quantification in West Africa.","volume":"324","author":"Diop-Ndiaye","year":"2024","journal-title":"J Virol Methods"},{"issue":"3","key":"zoi251301r10","doi-asserted-by":"publisher","first-page":"e671","DOI":"10.1093\/cid\/ciac609","article-title":"Timeliness of point-of-care viral load results improves human immunodeficiency virus monitoring in Nigeria.","volume":"76","author":"Chaplin","year":"2023","journal-title":"Clin Infect Dis"},{"issue":"4","key":"zoi251301r11","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0272673","article-title":"Near point-of-care HIV viral load testing: cascade after high viral load in suburban Yangon, Myanmar.","volume":"18","author":"Tun","year":"2023","journal-title":"PLoS One"},{"issue":"12","key":"zoi251301r12","doi-asserted-by":"publisher","first-page":"4716","DOI":"10.1021\/acssensors.3c01819","article-title":"Compact point-of-care device for self-administered HIV viral load tests from whole blood.","volume":"8","author":"Liu","year":"2023","journal-title":"ACS Sens"},{"issue":"1","key":"zoi251301r13","doi-asserted-by":"publisher","first-page":"570","DOI":"10.1186\/s12879-023-08459-7","article-title":"Evaluating the impact of point-of-care HIV viral load assessment on linkage to care in Baltimore, MD: a randomized controlled trial.","volume":"23","author":"Bayan","year":"2023","journal-title":"BMC Infect Dis"},{"issue":"20","key":"zoi251301r14","doi-asserted-by":"publisher","first-page":"2191","DOI":"10.1001\/jama.2013.281053","article-title":"World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.","volume":"310","year":"2013","journal-title":"JAMA"},{"issue":"7","key":"zoi251301r15","doi-asserted-by":"publisher","first-page":"985","DOI":"10.2105\/AJPH.2022.306835","article-title":"Rapid uptake of testing for chlamydia, gonorrhea, and HIV from an online platform, April-October 2020.","volume":"112","author":"Melendez","year":"2022","journal-title":"Am J Public Health"},{"issue":"6","key":"zoi251301r16","doi-asserted-by":"publisher","first-page":"1760","DOI":"10.1093\/jac\/dkx062","article-title":"Randomized controlled trial of the tolerability and completion of maraviroc compared with Kaletra\u00ae in combination with Truvada\u00ae for HIV post-exposure prophylaxis (MiPEP Trial).","volume":"72","author":"Milinkovic","year":"2017","journal-title":"J Antimicrob Chemother"},{"issue":"2","key":"zoi251301r17","doi-asserted-by":"publisher","first-page":"191","DOI":"10.1097\/QAI.0000000000002548","article-title":"Embedding a linkage to preexposure prophylaxis care intervention in social network strategy and partner notification services: results from a pilot randomized controlled trial.","volume":"86","author":"Teixeira da Silva","year":"2021","journal-title":"J Acquir Immune Defic Syndr"},{"issue":"4","key":"zoi251301r18","doi-asserted-by":"publisher","first-page":"468","DOI":"10.1016\/j.annemergmed.2022.07.015","article-title":"HIV pre-exposure prophylaxis in the emergency department: a systematic review.","volume":"81","author":"Gormley","year":"2023","journal-title":"Ann Emerg Med"},{"issue":"8","key":"zoi251301r21","doi-asserted-by":"publisher","first-page":"913","DOI":"10.1111\/acem.14194","article-title":"HIV screening in emergency departments: linkage works but what about retention?","volume":"28","author":"Mathur","year":"2021","journal-title":"Acad Emerg Med"},{"issue":"5","key":"zoi251301r22","doi-asserted-by":"publisher","first-page":"621","DOI":"10.1016\/j.annemergmed.2018.07.001","article-title":"Linkage to care, antiretroviral treatment initiation, and viral suppression of acute HIV-infected individuals identified from an emergency department-based HIV screening and linkage-to-care program.","volume":"72","author":"Negoita","year":"2018","journal-title":"Ann Emerg Med"},{"issue":"5","key":"zoi251301r23","doi-asserted-by":"publisher","first-page":"678","DOI":"10.1093\/cid\/ciw322","article-title":"A randomized trial to test a peer mentor intervention to improve outcomes in persons hospitalized with HIV infection.","volume":"63","author":"Giordano","year":"2016","journal-title":"Clin Infect Dis"},{"issue":"6","key":"zoi251301r24","doi-asserted-by":"publisher","first-page":"361","DOI":"10.1097\/OLQ.0000000000000760","article-title":"A cluster randomized evaluation of a health department data to care intervention designed to increase engagement in HIV care and antiretroviral use.","volume":"45","author":"Dombrowski","year":"2018","journal-title":"Sex Transm Dis"},{"issue":"1","key":"zoi251301r25","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1080\/15381501.2019.1699485","article-title":"An HIV health plan patient navigation program: engaging HIV positive individuals in primary medical care.","volume":"19","author":"Messeri","year":"2019","journal-title":"J HIV AIDS Soc Serv"},{"key":"zoi251301r26","doi-asserted-by":"publisher","DOI":"10.1016\/j.lana.2021.100057","article-title":"The Cooperative Re-Engagement Controlled trial (CoRECT): a randomised trial to assess a collaborative data to care model to improve HIV care continuum outcomes.","volume":"3","author":"Fanfair","year":"2021","journal-title":"Lancet Reg Health Am"},{"issue":"3","key":"zoi251301r27","doi-asserted-by":"publisher","first-page":"e140","DOI":"10.1016\/S2352-3018(16)00007-2","article-title":"Effect of the US National HIV\/AIDS Strategy targets for improved HIV care engagement: a modelling study.","volume":"3","author":"Shah","year":"2016","journal-title":"Lancet HIV"},{"issue":"1","key":"zoi251301r28","doi-asserted-by":"publisher","first-page":"2003","DOI":"10.1186\/s12889-021-12077-w","article-title":"A socio-ecological analysis of factors influencing HIV treatment initiation and adherence among key populations in Papua New Guinea.","volume":"21","author":"Mitchell","year":"2021","journal-title":"BMC Public Health"},{"issue":"4","key":"zoi251301r29","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pgph.0001024","article-title":"Patient reported experience measures on HIV viral load testing at public health facilities in Dar es Salaam, Tanzania: a convergent mixed method study.","volume":"3","author":"Karoli","year":"2023","journal-title":"PLOS Glob Public Health"},{"issue":"1","key":"zoi251301r30","doi-asserted-by":"publisher","first-page":"1540","DOI":"10.1186\/s12913-022-08593-z","article-title":"\u201cAfter viral load testing, I get my results so I get to know which path my life is taking me\u201d: qualitative insights on routine centralized and point-of-care viral load testing in western Kenya from the Opt4Kids and Opt4Mamas studies.","volume":"22","author":"Qian","year":"2022","journal-title":"BMC Health Serv Res"},{"issue":"1","key":"zoi251301r31","doi-asserted-by":"publisher","first-page":"72","DOI":"10.3390\/diagnostics14010072","article-title":"\u201cIt soothes your heart\u201d: a multimethod study exploring acceptability of point-of-care viral load testing among Ugandan pregnant and postpartum women living with HIV.","volume":"14","author":"Nakyanzi","year":"2023","journal-title":"Diagnostics (Basel)"},{"issue":"1","key":"zoi251301r32","doi-asserted-by":"publisher","DOI":"10.1002\/jia2.25220","article-title":"\u201cIs it making any difference?\u201d a qualitative study examining the treatment-taking experiences of asymptomatic people living with HIV in the context of Treat-all in Eswatini.","volume":"22","author":"Horter","year":"2019","journal-title":"J Int AIDS Soc"},{"issue":"7","key":"zoi251301r33","doi-asserted-by":"publisher","first-page":"509","DOI":"10.1089\/apc.2006.0201","article-title":"Experiences and perceptions of patients with 100% adherence to highly active antiretroviral therapy: a qualitative study.","volume":"21","author":"Sidat","year":"2007","journal-title":"AIDS Patient Care STDS"},{"issue":"9","key":"zoi251301r34","doi-asserted-by":"publisher","first-page":"1191","DOI":"10.1080\/09540121.2019.1687831","article-title":"I wanted it as soon as possible: a qualitative exploration of reactions to access to same-day ART start among participants in San Diego\u2019s ART-NET project.","volume":"32","author":"Amico","year":"2020","journal-title":"AIDS Care"},{"issue":"10","key":"zoi251301r35","doi-asserted-by":"publisher","DOI":"10.1002\/jia2.26153","article-title":"\u201cThey test my blood to know how much blood is in my body\u201d: the untapped potential of promoting viral load literacy to support adherence and viral suppression among adolescents living with HIV.","volume":"26","author":"Bernays","year":"2023","journal-title":"J Int AIDS Soc"},{"key":"zoi251301r36","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2022.861431","article-title":"Hearing from men living with HIV: experiences with HIV testing, treatment, and viral load suppression in four high-prevalence countries in Sub-Saharan Africa.","volume":"10","author":"Wiginton","year":"2022","journal-title":"Front Public Health"},{"issue":"2","key":"zoi251301r37","doi-asserted-by":"publisher","first-page":"288","DOI":"10.1080\/17441692.2020.1805785","article-title":"Influence of evolving HIV treatment guidance on CD4 counts and viral load monitoring: a mixed-methods study in three African countries.","volume":"16","author":"Renju","year":"2021","journal-title":"Glob Public Health"},{"issue":"6","key":"zoi251301r38","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0218364","article-title":"\u201cI take my pills every day, but then it goes up, goes down. I don\u2019t know what\u2019s going on\u201d: perceptions of HIV virological failure in a rural context in Mozambique: a qualitative research study.","volume":"14","author":"Pulido Tarquino","year":"2019","journal-title":"PLoS One"},{"issue":"3","key":"zoi251301r39","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00097-18","article-title":"Point-of-care HIV viral load testing: an essential tool for a sustainable global HIV\/AIDS response.","volume":"32","author":"Drain","year":"2019","journal-title":"Clin Microbiol Rev"},{"issue":"4","key":"zoi251301r40","doi-asserted-by":"publisher","first-page":"e229","DOI":"10.1016\/S2352-3018(19)30402-3","article-title":"Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial.","volume":"7","author":"Drain","year":"2020","journal-title":"Lancet HIV"},{"key":"zoi251301r4","author":"Delaney","year":"2018"},{"key":"zoi251301r2","unstructured":"Ending the HIV epidemic overview. United States Department of Health and Human Services. 2025. Accessed October 29, 2025. https:\/\/www.hiv.gov\/federal-response\/ending-the-hiv-epidemic\/overview"},{"key":"zoi251301r5","unstructured":"Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. World Health Organization. June 1, 2016. Accessed October 29, 2025. https:\/\/www.who.int\/publications\/i\/item\/9789241549684"},{"key":"zoi251301r6","unstructured":"Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Panel on Antiretroviral Guidelines for Adults and Adolescents. Department of Health and Human Services. Accessed December 18, 2024. https:\/\/clinicalinfo.hiv.gov\/en\/guidelines\/adult-and-adolescent-arv. Accessed 12\/18\/2024"},{"key":"zoi251301r7","unstructured":"HIV-1 nucleic acid testing. U.S. Food and Drug Administration. 2019. Accessed October 29, 2025. https:\/\/www.fda.gov\/vaccines-blood-biologics\/hiv-1"},{"key":"zoi251301r8","unstructured":"Preexposure prophylaxis for the prevention of HIV infection in the United States\u20142021 Update: a clinical practice guideline. Centers for Disease Control and Prevention. Accessed October 29, 2025. https:\/\/stacks.cdc.gov\/view\/cdc\/112360"},{"key":"zoi251301r19","unstructured":"Ending the HIV epidemic: HIV treatment is prevention. Centers for Disease Control and Prevention: Vital Signs. Updated March 18, 2019. Accessed October 29, 2025. https:\/\/www.cdc.gov\/vitalsigns\/end-hiv\/index.html"},{"key":"zoi251301r20","unstructured":"HIV surveillance supplemental report: monitoring selected national HIV prevention and care objectives by using HIV surveillance data United States and 6 territories and freely associated states, 2022. Centers for Disease Control and Prevention: Stacks. 2024 Accessed October 29, 2025. https:\/\/stacks.cdc.gov\/view\/cdc\/156511"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2842845\/hamill_2025_oi_251301_1765293633.02782.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T16:00:27Z","timestamp":1765900827000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2842845"}},"subtitle":["A Randomized Clinical Trial"],"short-title":[],"issued":{"date-parts":[[2025,12,16]]},"references-count":40,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2025,12,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2025.48380","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,12,16]]}}}