{"doi":"10.17615/615f-x798","title":"Brief Report: Impact of Early Antiretroviral Therapy on the Performance of HIV Rapid Tests and HIV Incidence Assays","abstract":"Background: Antiretroviral therapy (ART) can downregulate antibody responses to HIV infection. We evaluated the impact of early vs. delayed ART on the performance of HIV diagnostic and incidence assays. Methods: Samples were obtained from 207 participants in the HPTN 052 trial, who were stably suppressed on ART for ≥4 years [Malawi sites; pre-ART CD4 cell count 350-550 cells/mm3 (early ART arm, N = 180) or <250 cells/mm3 or an AIDS-defining illness (delayed ART arm, N = 27)]. Samples were tested with 2 HIV rapid tests and 2 HIV incidence assays; selected samples were also tested with two fourth-generation immunoassays and a Western blot (WB) assay. A pre-ART sample was analyzed if the follow-up sample had a false-negative or weakly-reactive rapid test result, or had an incidence assay result indicative of recent infection (false-recent result). Results: Ten (4.8%) samples had a nonreactive or weakly-reactive rapid test result (7/180 early ART arm, 3/27 delayed ART arm, P = 0.13); one sample had nonreactive fourth-generation assay results and 3 had indeterminate WBs. Forty (18.9%) samples had a false-recent incidence assay result; 16 (7.8%) had false-recent results with both incidence assays. Baseline samples had stronger rapid test and WB bands, higher fourth-generation assay signal-to-cutoff values, and fewer HIV incidence assay results indicative of recent infection. Conclusions: False-negative/weakly-reactive HIV rapid tests and false-recent HIV incidence assay results were observed in virally-suppressed individuals, regardless of pre-ART CD4 cell count. Downregulation of the antibody response to HIV infection in the setting of ART may impact population-level surveys of HIV prevalence and incidence.","journal":"UNC Libraries","year":2023,"id":415756,"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":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.6522,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":607136,"name":"Katherine Schlusser","orcid":null,"position":1,"is_corresponding":false},{"id":1197886,"name":"Tamara Walsky","orcid":"0000-0002-3889-4404","position":2,"is_corresponding":false},{"id":1198147,"name":"D. Soko","orcid":null,"position":3,"is_corresponding":false},{"id":1198060,"name":"E.A. Wilson","orcid":null,"position":4,"is_corresponding":false},{"id":547657,"name":"S.H. Eshleman","orcid":null,"position":5,"is_corresponding":false},{"id":1198148,"name":"J. Kumwenda","orcid":null,"position":6,"is_corresponding":false},{"id":1198149,"name":"Barbara Debevec","orcid":null,"position":7,"is_corresponding":false},{"id":609584,"name":"M. McCauley","orcid":null,"position":8,"is_corresponding":false},{"id":547654,"name":"J.M. Fogel","orcid":null,"position":9,"is_corresponding":false},{"id":1090218,"name":"T. Gamble","orcid":null,"position":10,"is_corresponding":false},{"id":533758,"name":"M.C. Hosseinipour","orcid":null,"position":11,"is_corresponding":false},{"id":108425,"name":"Oliver Laeyendecker","orcid":"0000-0002-6429-4760","position":12,"is_corresponding":false},{"id":547659,"name":"E. Piwowar-Manning","orcid":null,"position":13,"is_corresponding":false},{"id":406121,"name":"Gerald Tegha","orcid":"0000-0002-7744-5564","position":14,"is_corresponding":false},{"id":597931,"name":"M.S. Cohen","orcid":null,"position":15,"is_corresponding":false},{"id":1197859,"name":"Y.Q. Chen","orcid":"0009-0009-9964-5901","position":0,"is_corresponding":true}],"reference_count":0,"raw_metadata":null,"created_at":"2026-07-19T01:22:15.958504Z","pmid":null,"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":[]}