{"doi":"10.1371/journal.pone.0281279","title":"Clinic-based SAMBA-II vs centralized laboratory viral load assays among HIV-1 infected children, adolescents and young adults in rural Zimbabwe: A randomized controlled trial","abstract":"BACKGROUND: In Zimbabwe, children, adolescents and young adults living with HIV (CALWH) who are on public health antiretroviral therapy (ART) have inadequate viral load (VL) suppression. We assessed whether a clinic-based VL monitoring could decrease 12-month virologic failure rates among these CALWH. METHODS: The study was registered on ClinicalTrials.gov: NCT03986099. CALWH in care at Chidamoyo Christian Hospital (CCH) and 8 rural outreach sites (ROS) on long-term community-based ART were randomized (1:1) to 6 monthly VL monitoring by COBAS®Ampliprep®/Taqman48® HIV-1 at the provincial referral laboratory (PRL) as per standard of care (SOC) or by the clinic-based SAMBA II assay, Diagnostics for the Real World, at CCH. VL suppression, turn-around-time (TAT) for VL results, drug switching and drug resistance in second-line failure were assessed at 12 months. RESULTS: Of 390 CALWH enrolled 347 (89%) completed 12 months follow-up. Median (IQR) age and ART duration were 14.1 (9.7-18.2) and 6.4 (3.7-7.9) years, respectively. Over half (57%) of the participants were female. At enrolment, 78 (20%) had VL ≥1,000 copies/ml and VL suppression of 80% was unchanged after 12 months, with no significant difference between the SOC (81%) and the clinic-based (80%) arms (p = 0.528). Median (IQR) months to confirmatory VL result at CCH vs PRL was 4.0 (2.1-4.4) vs 4.5 (3.5-6.3) respectively; p = 0.027 at 12 months. Drug switching was documented among 26/347 (7%) participants with no difference between the median (IQR) time to switch in SOC vs clinic-based arms (5.1 (3.9-10.0) months vs 4.4 (2.5-8.4) respectively; p = 0.569). Out of 24 confirmed second-line failures, only 4/19 (21%) had protease inhibitor resistance. CONCLUSION: In rural Zimbabwe, the clinic-based SAMBA II assay was able to provide confirmatory VL results faster than the SOC VL assay at the PRL. However, this rapid TAT did not allow for a more efficient drug switch among these CALWH.","journal":"PLoS ONE","year":2023,"id":378383,"datarank":0.2146407039707269,"base_score":1.0986122886681096,"endowment":1.0986122886681096,"self_citation_contribution":0.16479184330021646,"citation_network_contribution":0.04984886067051044,"self_endowment_contribution":0.16479184330021646,"citer_contribution":0.04984886067051044,"corpus_percentile":null,"corpus_rank":null,"citation_count":2,"citer_count":2,"citers_with_citation_signal":1,"citers_with_endowment":1,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9459,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT03986099"]},"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":271212,"name":"Rhoderick Machekano","orcid":"0000-0002-3433-2551","position":1,"is_corresponding":false},{"id":1142314,"name":"Tichaona Mapangisana","orcid":"0000-0003-4027-6901","position":2,"is_corresponding":false},{"id":1142703,"name":"Caroline Maposhere","orcid":null,"position":3,"is_corresponding":false},{"id":1142704,"name":"Reggie Mutetwa","orcid":null,"position":4,"is_corresponding":false},{"id":423646,"name":"Justen Manasa","orcid":"0000-0002-8874-907X","position":5,"is_corresponding":false},{"id":769460,"name":"Tinei Shamu","orcid":"0000-0001-8931-4484","position":6,"is_corresponding":false},{"id":492989,"name":"Kathy McCarty","orcid":null,"position":7,"is_corresponding":false},{"id":421305,"name":"Shungu Munyati","orcid":null,"position":8,"is_corresponding":false},{"id":1142705,"name":"Junior Mutsvangwa","orcid":null,"position":9,"is_corresponding":false},{"id":1142706,"name":"Mampedi Bogoshi","orcid":null,"position":10,"is_corresponding":false},{"id":973623,"name":"Dennis Israelski","orcid":null,"position":11,"is_corresponding":false},{"id":36861,"name":"David Katzenstein","orcid":"0000-0002-8593-4560","position":12,"is_corresponding":false},{"id":69663,"name":"Vinie Kouamou","orcid":"0000-0003-3531-7780","position":0,"is_corresponding":true}],"reference_count":38,"raw_metadata":null,"created_at":"2026-07-19T01:16:44.708019Z","pmid":"36787296","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":[]}