{"doi":"10.1007/s10461-018-2261-8","title":"Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE","abstract":null,"journal":"AIDS and Behavior","year":2019,"id":611037,"datarank":0.3958585994422889,"base_score":2.639057329615259,"endowment":2.639057329615259,"self_citation_contribution":0.3958585994422889,"citation_network_contribution":0.0,"self_endowment_contribution":0.3958585994422889,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":13,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":407491,"name":"Barbra A. Richardson","orcid":"0000-0001-9564-1828","position":1,"is_corresponding":false},{"id":612970,"name":"Marla Husnik","orcid":"0000-0001-7032-6944","position":2,"is_corresponding":false},{"id":32390,"name":"Elizabeth R. Brown","orcid":"0000-0003-4286-2111","position":3,"is_corresponding":false},{"id":459398,"name":"Flavia Matovu Kiweewa","orcid":"0000-0002-0046-4353","position":4,"is_corresponding":false},{"id":1571278,"name":"Ashley J. Mayo","orcid":null,"position":5,"is_corresponding":false},{"id":299060,"name":"Jared M. Baeten","orcid":"0000-0001-8242-8438","position":6,"is_corresponding":false},{"id":460379,"name":"Thesla Palanee-Phillips","orcid":null,"position":7,"is_corresponding":false},{"id":473720,"name":"Ariane van der Straten","orcid":"0000-0001-8536-648X","position":8,"is_corresponding":false},{"id":1571277,"name":"Barbara S. Mensch","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Vaginal Ring Use in a Phase 3 Microbicide Trial: A Comparison of Objective Measures and Self-reports of Non-adherence in ASPIRE","abstract":"This analysis compares self-reports of product use with objective measures of non-adherence-quarterly plasma dapivirine levels and monthly residual dapivirine (DPV) levels in used rings-in MTN-020/ASPIRE, a phase 3 trial of a monthly DPV vaginal ring among women aged 18-45 years in Malawi, South Africa, Uganda and Zimbabwe. For participants on active product (N = 1211) we assessed self-reported monthly non-adherence, as measured by (1) whether the ring was ever out, and out for ≥ 12 h in the previous month and, (2) by a self-rating scale assessing ability to keep the vaginal ring inserted, and compared the self-reports to two biomarkers of non-use separately and as a composite measure. For this analysis, a plasma DPV value ≤ 95 pg/ml and residual ring ≥ 23.5 mg were used to classify non-adherence (i.e. the ring never being in the vagina the previous month). Compared to self-reports, non-adherence was found to be substantially higher for the composite measure as well as its two components, an indication that ring removal was likely underreported in the trial. The discrepancy between the self-report measure of ring outage and the composite indicator was greater for those aged 18-21 than for those older, evidence that younger women are more likely to underreport non-adherence. Despite underreporting of non-adherence, self-reports of the ring never being out were significant in predicting the composite objective measure. Furthermore, the association between the self-rating scale and the objective measure was in the expected direction and significant, although 11% of those 18-21 and 7% of those 22+ who rated their ability to keep the ring inserted as good, very good or excellent in the 4 weeks prior to exit were considered non-adherent according to the objective measure. This analysis indicates that while self-reports are significantly associated with objective measures of adherence in the ASPIRE trial, they were inflated-more so by those younger-and therefore may have limited utility identifying those who have challenges using products as directed. ClinicalTrials.gov number NCT01617096.","is_dataset_classified":null,"base_score":2.639057329615259,"endowment":2.639057329615259,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"30218318","pmcid":"PMC6374159","openalex_id":"https://openalex.org/W2890947317","authors":[],"funders":[{"funder_name":"National Institute of Allergy and Infectious Diseases","grant_id":"UM1AI068633","title":null},{"funder_name":"National Institute of Allergy and Infectious Diseases","grant_id":"UM1AI068615","title":null},{"funder_name":"National Institute of Allergy and Infectious Diseases","grant_id":"UM1AI106707","title":null},{"funder_name":"NIAID NIH HHS","grant_id":"UM1 AI069463","title":null},{"funder_name":"NIAID NIH HHS","grant_id":"U01 AI068633","title":null},{"funder_name":"NIAID NIH HHS","grant_id":"UM1 AI069530","title":null},{"funder_name":"NIAID NIH HHS","grant_id":"P30 AI027757","title":null},{"funder_name":"NIAID NIH HHS","grant_id":"U01 AI069463","title":null},{"funder_name":"National Institutes of Health","grant_id":"5UM1AI068615-12","title":"Statistical and Data Management Center (SDMC): Microbicide Trials Network"},{"funder_name":"National Institutes of Health","grant_id":"5UM1AI106707-04","title":"Laboratory Center (LC):  Microbicide Trials Network"},{"funder_name":"National Institutes of Health","grant_id":"4UM1AI068633-15","title":"Leadership and Operations Center (LOC): Microbicide Trials Network"},{"funder_name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","grant_id":"","title":null}],"total_grants":12,"fwci":1.4998,"citation_percentile":0.81674291,"influential_citations":0,"citation_trend":[{"year":2019,"count":5},{"year":2020,"count":1},{"year":2021,"count":5},{"year":2022,"count":1},{"year":2024,"count":1}],"oa_status":"green","license":"Springer TDM","oa_locations":[{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/6374159","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/6374159","host_type":"repository"},{"url":"https://link.springer.com/article/10.1007/s10461-018-2261-8/fulltext.html","host_type":"publisher"},{"url":"https://link.springer.com/content/pdf/10.1007/s10461-018-2261-8.pdf","host_type":"publisher"},{"url":"https://doi.org/10.1007/s10461-018-2261-8","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/30218318","host_type":"repository"},{"url":"https://europepmc.org/articles/pmc6374159?pdf=render","host_type":""},{"url":"https://dx.doi.org/10.1007/s10461-018-2261-8","host_type":""}],"fields_of_study":["HIV/AIDS Research and Interventions","Adolescent Sexual and Reproductive Health","HIV, Drug Use, Sexual Risk","03 medical and health sciences","0302 clinical medicine","0305 other medical science"],"mesh_terms":["Administration, Intravaginal","Adult","Contraceptive Devices, Female","Female","Humans","Malawi","Patient Compliance","Pyrimidines","South Africa","Uganda","Zimbabwe","HIV Infections","Anti-HIV Agents","Young Adult","Self Report"],"keywords":["Vaginal ring","Medicine","Vagina","Rating scale","Microbicide","Clinical psychology","Gynecology","Demography","Obstetrics","Psychology","Environmental health","Family medicine","Surgery","Family planning","Population","Developmental psychology","Research methodology","Sub-Saharan Africa","Hiv Prevention","Objective Measures","Non-adherence","Microbicides","Self-reports","Adult","Zimbabwe","Malawi","Anti-HIV Agents","Contraceptive Devices, Female","HIV Infections","Administration, Intravaginal","South Africa","Young Adult","Pyrimidines","Humans","Patient Compliance","Female","Uganda","Self Report"],"sdg_mappings":[{"sdg_number":3,"sdg_label":"3. 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