{"doi":"10.1093/cid/ciaf230","title":"Limited Utility of HIV RNA Testing to Monitor Oral Preexposure Prophylaxis Use: A Real-World Cohort Study—United States, 2019–2023","abstract":"BACKGROUND: The 2021 update of the Centers for Disease Control and Prevention clinical guidelines for human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) recommended both antigen-antibody (Ag/Ab) and RNA testing at PrEP initiation and routine follow-up. We assessed the real-world use and performance of HIV tests among oral PrEP users. METHODS: An oral PrEP user cohort was constructed using the HealthVerity database that included linked diagnoses, laboratory tests, and prescriptions from December 2018 to August 2023. Data were stratified by pre-guideline update (2019-2021) and post-guideline update (2022-2023) periods. For each period, we assessed the agreement between same-day HIV Ag/Ab and RNA results and calculated the false-positive rates and positive predictive values of HIV Ag/Ab and RNA tests compared with the adjudicated HIV status. RESULTS: The HIV RNA testing rate for follow-up, per 100 person-years, increased from 16 before to 123 after the guideline update. The positivity rate of HIV RNA tests decreased from 1.39% to 0.22%. Overall agreement between Ag/Ab and RNA results remained high. The false-positive rates of HIV Ag/Ab and RNA testing remained similar, but the positive predictive value of HIV RNA testing for PrEP follow-up decreased from 100% to 67%. We estimated that 8226-9900 RNA tests would be needed for 1 HIV diagnosis earlier than would be detected with Ag/Ab testing alone. DISCUSSION: HIV RNA testing did not provide additional value to Ag/Ab testing during routine follow-up of oral PrEP users. Considering the cost and logistical complexity of HIV RNA testing, its use as a routine test during follow-up of oral PrEP users warrants reconsideration.","journal":"Clinical Infectious Diseases","year":2025,"id":541099,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":2,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.7757,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2025-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":379410,"name":"Kevin P. Delaney","orcid":"0000-0002-7562-7647","position":1,"is_corresponding":false},{"id":351446,"name":"Ya-Lin A. Huang","orcid":"0000-0003-3137-8594","position":2,"is_corresponding":false},{"id":305154,"name":"Rupa Patel","orcid":"0000-0002-0329-7036","position":3,"is_corresponding":false},{"id":91694,"name":"Athena P. Kourtis","orcid":"0000-0003-1585-1310","position":4,"is_corresponding":false},{"id":342935,"name":"Karen W. Hoover","orcid":"0000-0003-4942-7905","position":5,"is_corresponding":false},{"id":351447,"name":"Weiming Zhu","orcid":"0000-0002-9042-6202","position":0,"is_corresponding":true}],"reference_count":8,"raw_metadata":null,"created_at":"2026-07-19T02:52:42.901627Z","pmid":"40323767","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":[]}