{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T07:56:25Z","timestamp":1771487785655,"version":"3.50.1"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2021,10,29]],"date-time":"2021-10-29T00:00:00Z","timestamp":1635465600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["U01AI100053"],"award-info":[{"award-number":["U01AI100053"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["P30AI050410"],"award-info":[{"award-number":["P30AI050410"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["K24AI120796"],"award-info":[{"award-number":["K24AI120796"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["T32HD075731"],"award-info":[{"award-number":["T32HD075731"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["D43TW009340"],"award-info":[{"award-number":["D43TW009340"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,8,25]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Point-of-care (POC) early infant diagnosis (EID) provides same-day results and the potential for immediate initiation of antiretroviral therapy (ART).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We conducted a pragmatic trial at 6 public clinics in Zambia. HIV-exposed infants were individually randomized to either (1) POC EID (onsite testing with the Alere q HIV-1\/2 Detect) or (2) enhanced standard of care (SOC) EID (off-site testing at a public laboratory). Infants with HIV were referred for ART and followed for 12 months. Our primary outcome was defined as alive, in care, and virally suppressed at 12 months.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Between March 2016 and November 2018, we randomized 4000 HIV-exposed infants to POC (n=1989) or SOC (n=2011). All but 2 infants in the POC group received same-day results, while the median time to result in the SOC group was 27 (interquartile range: 22\u201330) days. Eighty-one (2%; 95% confidence interval [CI]: 1.6\u20132.5%) infants were diagnosed with HIV. Although ART initiation was high, there were 15 (19%) deaths, 15 (19%) follow-up losses, and 31 (38%) virologic failures. By 12 months, only 20 of 81 (25%; 95% CI: 15\u201334%) infants with HIV were alive, in care, and virally suppressed: 13 (30%; 16\u201343%) infants in the POC group vs 7 (19%; 6\u201332%) in the SOC group (RR: 1.56; .7\u20133.50).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>POC EID eliminated diagnostic delays and accelerated ART initiation but did not translate into definitive improvement in 12-month outcomes. In settings where centralized EID is well functioning, POC EID is unlikely to improve pediatric HIV outcomes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>This trial is registered at https:\/\/clinicaltrials.gov (NCT02682810).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciab923","type":"journal-article","created":{"date-parts":[[2021,10,28]],"date-time":"2021-10-28T11:10:38Z","timestamp":1635419438000},"page":"260-268","source":"Crossref","is-referenced-by-count":8,"title":["A Randomized Trial of Point-of-Care Early Infant Human Immunodeficiency Virus (HIV) Diagnosis in Zambia"],"prefix":"10.1093","volume":"75","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0397-2994","authenticated-orcid":false,"given":"Carla J","family":"Chibwesha","sequence":"first","affiliation":[{"name":"Division of Global Women\u2019s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina , USA"},{"name":"UNC Global Projects\u2013Zambia , Lusaka , Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katie R","family":"Mollan","sequence":"additional","affiliation":[{"name":"Biostatistics Core, Center for AIDS Research, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine E","family":"Ford","sequence":"additional","affiliation":[{"name":"Division of Global Women\u2019s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina , USA"},{"name":"UNC Global Projects\u2013Zambia , Lusaka , Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aaron","family":"Shibemba","sequence":"additional","affiliation":[{"name":"Department of Pathology and Microbiology, University Teaching Hospital , Lusaka , Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pooja T","family":"Saha","sequence":"additional","affiliation":[{"name":"Biostatistics Core, Center for AIDS Research, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mildred","family":"Lusaka","sequence":"additional","affiliation":[{"name":"UNC Global Projects\u2013Zambia , Lusaka , Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Felistas","family":"Mbewe","sequence":"additional","affiliation":[{"name":"UNC Global Projects\u2013Zambia , Lusaka , Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew G","family":"Allmon","sequence":"additional","affiliation":[{"name":"Biostatistics Core, Center for AIDS Research, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina , USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rose","family":"Lungu","sequence":"additional","affiliation":[{"name":"UNC Global Projects\u2013Zambia , Lusaka , Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans M L","family":"Spiegel","sequence":"additional","affiliation":[{"name":"Kelly Services , Rockville, Maryland , USA and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emmanuel","family":"Mweni","sequence":"additional","affiliation":[{"name":"UNC Global Projects\u2013Zambia , Lusaka , Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Humphrey","family":"Mwape","sequence":"additional","affiliation":[{"name":"UNC Global Projects\u2013Zambia , Lusaka , Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chipepo","family":"Kankasa","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and Child Health, University Teaching Hospital , Lusaka , Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin H","family":"Chi","sequence":"additional","affiliation":[{"name":"Division of Global Women\u2019s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina , USA"},{"name":"UNC Global Projects\u2013Zambia , Lusaka , Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey S A","family":"Stringer","sequence":"additional","affiliation":[{"name":"Division of Global Women\u2019s Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill , Chapel Hill, North Carolina , USA"},{"name":"UNC Global Projects\u2013Zambia , Lusaka , Zambia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2021,10,29]]},"reference":[{"key":"2022082520474998800_CIT0001","author":"Joint United Nations Programme on HIV\/AIDS 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