{"doi":"10.1093/cid/ciab923","title":"A Randomized Trial of Point-of-Care Early Infant Human Immunodeficiency Virus (HIV) Diagnosis in Zambia","abstract":"BACKGROUND: Point-of-care (POC) early infant diagnosis (EID) provides same-day results and the potential for immediate initiation of antiretroviral therapy (ART). METHODS: 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. RESULTS: 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: 22-30) days. Eighty-one (2%; 95% confidence interval [CI]: 1.6-2.5%) 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: 15-34%) infants with HIV were alive, in care, and virally suppressed: 13 (30%; 16-43%) infants in the POC group vs 7 (19%; 6-32%) in the SOC group (RR: 1.56; .7-3.50). CONCLUSIONS: 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. CLINICAL TRIALS REGISTRATION: This trial is registered at https://clinicaltrials.gov (NCT02682810).","journal":"Clinical Infectious Diseases","year":2021,"id":198053,"datarank":0.7794583609654511,"base_score":2.4849066497880004,"endowment":2.4849066497880004,"self_citation_contribution":0.37273599746820013,"citation_network_contribution":0.4067223634972509,"self_endowment_contribution":0.37273599746820013,"citer_contribution":0.4067223634972509,"corpus_percentile":null,"corpus_rank":null,"citation_count":11,"citer_count":9,"citers_with_citation_signal":7,"citers_with_endowment":7,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9442,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02682810"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":334763,"name":"Katie R. Mollan","orcid":"0000-0002-8592-5154","position":1,"is_corresponding":false},{"id":605482,"name":"Catherine E. Ford","orcid":"0000-0001-8646-2078","position":2,"is_corresponding":false},{"id":494704,"name":"Aaron Shibemba","orcid":null,"position":3,"is_corresponding":false},{"id":611892,"name":"Pooja T. Saha","orcid":"0000-0002-2317-6311","position":4,"is_corresponding":false},{"id":772636,"name":"Mildred Lusaka","orcid":"0000-0002-9152-973X","position":5,"is_corresponding":false},{"id":597088,"name":"Felistas Mbewe","orcid":null,"position":6,"is_corresponding":false},{"id":720218,"name":"Andrew G. Allmon","orcid":null,"position":7,"is_corresponding":false},{"id":664321,"name":"Rose Lungu","orcid":null,"position":8,"is_corresponding":false},{"id":314442,"name":"Hans Spiegel","orcid":"0000-0001-9552-789X","position":9,"is_corresponding":false},{"id":773166,"name":"Emmanuel Mweni","orcid":null,"position":10,"is_corresponding":false},{"id":403358,"name":"Humphrey Mwape","orcid":null,"position":11,"is_corresponding":false},{"id":448359,"name":"Chipepo Kankasa","orcid":null,"position":12,"is_corresponding":false},{"id":300372,"name":"Benjamin H Chi","orcid":null,"position":13,"is_corresponding":false},{"id":248972,"name":"Jeffrey S. A. Stringer","orcid":"0000-0002-9590-7216","position":14,"is_corresponding":false},{"id":340368,"name":"Carla J. Chibwesha","orcid":"0000-0002-0397-2994","position":0,"is_corresponding":true}],"reference_count":28,"raw_metadata":null,"created_at":"2026-07-18T23:50:27.616568Z","pmid":"34718462","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}