Abstract
Original language | English |
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Article number | CD013080 |
Journal | Cochrane Database of Systematic Reviews |
Volume | 2022 |
Issue number | 7 |
DOIs | |
Publication status | Published - 25 Jul 2022 |
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In: Cochrane Database of Systematic Reviews, Vol. 2022, No. 7, CD013080, 25.07.2022.
Research output: Contribution to journal › Review article › Academic › peer-review
TY - JOUR
T1 - Accuracy of measures for antiretroviral adherence in people living with HIV
AU - Smith, Rhodine
AU - Villanueva, Gemma
AU - Probyn, Katrin
AU - Sguassero, Yanina
AU - Ford, Nathan
AU - Orrell, Catherine
AU - Cohen, Karen
AU - Chaplin, Marty
AU - Leeflang, Mariska M. G.
AU - Hine, Paul
N1 - Funding Information: Funding source: this study was funded, in part, by grants from the Fogarty International Center AIDS International Training and Research Program (TW00011) and the Centers For AIDS Research (AI36219). Funding Information: Funding source: supported by NICHD Contracts N01-HD-3-3345 (2002–2007), HHSN267200800001C (2007–2012), and HHSN275201300003C (2012–2017) Funding Information: Funding source: grant R01MH067513 from the National Institute of Mental Health (NIMH) (Bethesda, MD, USA). (from refID 5045 Ekstrand 2011) Funding Information: Funding source: the American People and the President’s Emergency Plan for AIDS Relief (PEPFAR) through US Agency for International Development (USAID) under the terms of Cooperative Agreements AID-674-A-12-00029 and 72067419CA00004 to HE2RO. The contents are the responsibility of the authors and do not necessarily reflect the views of PEPFAR, USAID or the United States Government. DE was supported by funding from NIH/CFAR/IAS Creative and Novel Ideas in HIV Research (CNIHR) program (sub-award with UAB Center for AIDS Research: P30AI027767) and National Research Foundation (not reported) of South Africa Thuthuka program (post-PhD track 500 TTK1206261680 Grant number 84331). Funding Information: The CIDG editorial base is funded by UK aid from the UK government for the benefit of low-and middle-income countries (project number 300342-104). The views expressed do not necessarily reflect the official policies of the UK government. Funding Information: Funding source: this publication was made possible by UMB AITRP Fogarty Grant Number 5-D43 TWO 10441 from the United States’ National Institutes of Health’s Forgarty International Center awarded to Dr. William Blattner of the Institute of Human Virology, University of Maryland, Baltimore. Funding Information: C.J.C. has received research funding from Janssen, Gilead Sciences, Bristol-Myers Squibb (BMS), Merck, Tobira and ViiV Healthcare. He is on advisory boards for Gilead Sciences, Janssen, Merck, Tobira and BMS. He has received speaker honoraria from Janssen, Gilead Sciences, BMS and Merck prior to January 2011. Funding Information: Funding source: the Swiss Foundation for Excellence and Talent in Biomedical Research through a grant to ND Labhardt Funding Information: The ESPOIR cohort was supported by an Abbott Laboratories unrestricted grant (to Caen Côte de Nacre University hospital). The REACH cohort was supported by the National Institute of Mental Health (grant RO-54907) and the National Institute on Alcohol Abuse and Alcoholism (grant K-24 015287). Funding Information: FP is the recipient of a BAE grant from the Instituto de Salud Carlos III, Spanish Ministry of Health. Funding Information: Funding source: CHAPAS-1 is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP 2004.01.H.d2.33011). Cipla Ltd donated the first-line drugs. Drs. Haberer and Bangsberg are support- Funding Information: Funding source: donations to fund the programme were received from Syfrets Trust Ltd, Merck (Pty) Ltd, Bristol-Myers Squibb Foundation, Durbanville High School, and the University of Cape Town. Mary-Ann Davies and Andrew Boulle receive support from the International Epidemiological Databases to Evaluate AIDS in Southern Africa (IeDEASA) collaboration which is funded by the National Institutes for Health (NIH; U01 AI069924-01). Funding Information: Funding source: partially funded by the RD12/0017/0003 project as part of the Plan Nacional I +D+ i, Investigation Cientifica, Desarrollo e Innovación, and co-financed by ISCIII-Subdirección General de Evaluación y el Fondo Europeo de Desarrollo Regional (FEDER) Funding Information: Funding source: Abbott Laboratories provided financial support Funding Information: Funding source: the laboratory costs were financed, in part, by the companies Abbott, Boehringer-Ingelheim, GlaxoSmithKline and Hoffmann La Roche. Funding Information: Funding source: The President’s Emergency Plan for AIDS Relief (PPFAR) through the National Institute of Child Health and Human Development (NICHD), grant number 1R01HD074558 and 1R01HD080465. The University of Cape Town (UCT) Clinical PK Laboratory is supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health under award numbers UM1 AI068634, UM1 AI068636, and UM1 AI106701. Overall support for the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT) at UCT Funding Information: We acknowledge Ms Anel Schoonees, Researcher at the Centre for Evidence-based Health Care (CEBHC) in South Africa and Cochrane Infectious Diseases Group (CIDG) Information Specialist; and Vittoria Lutje, CIDG Information Specialist. We acknowledge the following members of the Cochrane Response team for their help with screening and data extraction: Brian Buckley, Elise Cogo, Hanna Bergman, Jennifer Petkovic, and Nicholas Henschke. We thank the following individuals for their kind assistance: Karen Ma, Richard James, Shahista Jaffer, Vera Unwin, Karina Mondragon-Shem, and Gala Garrod with title and abstract screening, via Cochrane Crowd. The CIDG supported the authors in the development of this Cochrane Diagnostic Test Accuracy (DTA) Review. The following people conducted the editorial process for this review update. CIDG Contact Editor: Dr Lawrence Mbuagbaw; DTA Contact Editor: Ms Marta Roqué Sign-off Editor (final editorial decision): Professor Paul Garner Managing Editor (collated comments, provided editorial guidance to authors, edited the article): Dr Deirdre Walshe Copy Editor (copy editing and production): Anne Lethaby, Cochrane Copy Edit Support Peer reviewers (review stage; provided comments and recommended an editorial decision): Dr Michael McCaul, Division of Epidemiology and Biostatistics, Department of Global Health, Stellenbosch University, South Africa (clinical/content peer review); Dr Rebecca Kuehn, Liverpool School of Tropical Medicine, UK (clinical/content peer review); Dr Jantjie Taljaard. Division of Infectious Diseases, Department of Medicine, Tygerberg Hospital and Stellenbosch University, South Africa (clinical/content peer review). Three additional peer reviewers from the DTA editorial team provided search, statistical, and general methods peer review, but chose not to be publicly acknowledged. Sign-off Editor (final editorial decision): Professor Paul Garner Managing Editor (collated comments, provided editorial guidance to authors, edited the article): Dr Deirdre Walshe Copy Editor (copy editing and production): Anne Lethaby, Cochrane Copy Edit Support Peer reviewers (review stage; provided comments and recommended an editorial decision): Dr Michael McCaul, Division of Epidemiology and Biostatistics, Department of Global Health, Stellenbosch University, South Africa (clinical/content peer review); Dr Rebecca Kuehn, Liverpool School of Tropical Medicine, UK (clinical/content peer review); Dr Jantjie Taljaard. Division of Infectious Diseases, Department of Medicine, Tygerberg Hospital and Stellenbosch University, South Africa (clinical/content peer review). Three additional peer reviewers from the DTA editorial team provided search, statistical, and general methods peer review, but chose not to be publicly acknowledged. Dr Rebecca Kuehn is a member of CIDG, and provided peer-review comments on this article, but was not otherwise involved in the editorial process or decision making for this article. Dr Marty Chaplin, Dr Nathan Ford, and Dr Paul Hine are CIDG Editors, and Dr Mariska Leeflang is a DTA Editor, but were not involved in the editorial process of this article. The CIDG editorial base is funded by UK aid from the UK government for the benefit of low- and middle-income countries (project number 300342-104). The views expressed do not necessarily reflect the official policies of the UK government. Rhodine Smith is partly supported by, and Marty Chaplin is supported by the Research, Evidence and Development Initiative (READ-It). READ-It (project number 300342-104) is funded by UK aid from the UK government; however, the views expressed do not necessarily reflect the UK government’s official policies Funding Information: Funding source: the current work was supported by Duke University Center for AIDS Research, an NIH-funded program; International Research Scientist Development Award funded by the Fogarty International Center and the National Institute of Mental Health; the Global Health Fellows Program of the National Institutes of Health funded by the Fogarty International Center and the National Institute of Mental Health; the Infectious Diseases Society of America Medical Scholars Program. The National Institute of Allergy and Infectious Diseases at the National Institutes of Health funded analyses of hair samples. Funding Information: Funding source: JM was supported by a fellowship from TuXs Medical Center Department of Geographic Medicine and Infectious Diseases, and an Australian National Health and Medical Research Council (NHM-RC) Postgraduate Scholarship. The study was supported by a Lifespan/TuXs/Brown Center for AIDS Research NIH grant (1P30A142853-12). AM was supported by a Fogarty International Center training grant (5D43TW000237-15). MRJ was supported by an NIH Career Development Award (5K23AI074423-04). SRL is an NHMRC Practitioner Fellow. Funding Information: Funding source: Wellcome Trust foundation (grant number WT089351MA). ASH and JAB were funded by Wellcome Trust fellowships (WT089351MA and WT083579MA, respectively). SM and HN were employees of the KEMRI/Wellcome Trust research programme while CAO was an employee of the Kenyan Ministry of Health. EJS was funded by the International AIDS Vaccine Initiative while PAC was financially supported by the Health Protection Agency, UK. TFRW was a member of the Phar-mAccess African studies to Evaluate Resistance (PASER), which received financial support from the Ministry of Foreign Affairs of the Netherlands. Funding Information: Funding source: National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH; AI042006, AI068636, AI069481 and UM1AI068634) and the Harvard University Center for AIDS Research, an NIH-funded program (P30 AI060354) Funding Information: Funding source: the Discovery Foundation supported CO through an Academic Fellowship Award in 2013 and EDCTP awarded CO a senior fellowship from 2012 to 2014: TA.2011.40200.015. Funding Information: Funding source: the TREAT Asia Studies to Evaluate Resistance (TASER) is an initiative of TREAT Asia, a program of amfAR, The Foundation for AIDS Research, with major support provided by the Dutch Ministry of Foreign Affairs through a partnership with Stichting Aids Fonds, and with additional support from amfAR and the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH) and the National Cancer Institute (NCI) as part of the International Epidemiologic Databases to Evaluate AIDS (IeDEA) (grant no. U01AI069907). Queen Elizabeth Hospital and the Integrated Treatment Centre are supported by the Hong Kong Council for AIDS Trust Fund. The Kirby Institute is funded by the Australian Government Department of Health and Ageing and is affiliated with the Faculty of Medicine, UNSW Australia (the University of New South Wales) Funding Information: Rhodine Smith is partly supported by, and Marty Chaplin is supported by the Research, Evidence and Development Initiative (READ-It). READ-It (project number 300342-104) is funded by UK aid from the UK government; however, the views expressed do not necessarily reflect the UK government’s official policies Funding Information: Funding source: M. B. was partially funded by a grant from the BMS ‘Secure-The-Future’ fund. D. B. received funding from The Doris Duke Charitable Foundation. Funding Information: Funding source: Thammasat University Infectious Diseases and Infection Control Research Fund Funding Information: Funding source: this study was supported in part by the Thai American Physician Foundation (to A.A.) and Thammasat University Fund to Infectious Disease and Hospital Epidemiology Research Unit (to A.A.). Funding Information: Funding source: the research infrastructure for conducting the SAPiT trial, including data management, laboratory and pharmacy cores were established through the Comprehensive International Program of Research on AIDS grant (CIPRA, grant # AI51794). The US President’s Emergency Plan for AIDS Relief (PEPfAR) funded the care of all the SAPiT patients; the Global Fund to fight AIDS, Tuberculosis and Malaria funded the cost for drugs used in the SAPiT trial. The TRUTH study was supported by the Howard Hughes Medical Institute, Chevy Chase, MD, USA (grant # 55007065) and the Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) Cooperative Agreement Number UY2G/ PS001350–02. Patient care was supported by the KwaZulu-Natal Department of Health and the US President’s Emergency Plan for AIDS Relief (PEPFAR; Washington DC, USA). KN and TG were supported by the Columbia University-South Africa Fogarty AIDS International Training and Research Program (AITRP) funded by the Fogarty International Center, National Institutes of Health (grant # D43TW00231). No funding was received for this retrospective study. Funding Information: ed by the US National Institute of Mental Health (K23–87228 and K24–87227, respectively) and the Mark and Lisa Schwartz Foundation. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Funding Information: Funding source: supported by the US Government Centers for Disease Control and Prevention Cooperative Agreement Number: PS000651. Chuka Anude was funded by the US National Institutes of Health Fogarty AIDS International Training Research Program (AITRP, NIH 2-D43-TW001041-11) Funding Information: was provided by the National Institute of Allergy and Infectious Diseases (U01 AI068632), The Eunice Kennedy Shriver National Institute of Child Health and Human Development, and National Institute of Mental Health grant AI068632. Ms Phillips receives partial funding from the South African Department of Science and Technology/National Research Foundation (DST - not reported), Centre of Excellence in Epidemiological Modelling and Analysis (SACEMA), Stellenbosch University, Stellenbosch, South Africa. Dr Orrell is partially supported through DAIDS grants (1R01AI122300–01, 1R34MH108393-01 and 2UM1AI0695-08). Funding Information: Funding source: AbbVie Spain (ACA-SPAI-08-16). The study was sponsored by the Spciedad Andaluza de Enfermedades Infecciosas (SAEI). AbbVie had a role in the study design, preparation of the final report and manuscript writing. Publisher Copyright: Copyright © 2022 The Authors. Cochrane Database of Systematic Reviews published by John Wiley & Sons, Ltd. on behalf of The Cochrane Collaboration.
PY - 2022/7/25
Y1 - 2022/7/25
N2 - Background: Good patient adherence to antiretroviral (ART) medication determines effective HIV viral suppression, and thus reduces the risk of progression and transmission of HIV. With accurate methods to monitor treatment adherence, we could use simple triage to target adherence support interventions that could help in the community or at health centres in resource-limited settings. Objectives: To determine the accuracy of simple measures of ART adherence (including patient self-report, tablet counts, pharmacy records, electronic monitoring, or composite methods) for detecting non-suppressed viral load in people living with HIV and receiving ART treatment. Search methods: The Cochrane Infectious Diseases Group Information Specialists searched CENTRAL, MEDLINE, Embase, LILACS, CINAHL, African-Wide information, and Web of Science up to 22 April 2021. They also searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for ongoing studies. No restrictions were placed on the language or date of publication when searching the electronic databases. Selection criteria: We included studies of all designs that evaluated a simple measure of adherence (index test) such as self-report, tablet counts, pharmacy records or secondary database analysis, or both, electronic monitoring or composite measures of any of those tests, in people living with HIV and receiving ART treatment. We used a viral load assay with a limit of detection ranging from 10 copies/mL to 400 copies/mL as the reference standard. We created 2 × 2 tables to calculate sensitivity and specificity. Data collection and analysis: We screened studies, extracted data, and assessed risk of bias using QUADAS-2 independently and in duplicate. We assessed the certainty of evidence using the GRADE method. The results of estimated sensitivity and specificity were presented using paired forest plots and tabulated summaries. We encountered a high level of variation among studies which precluded a meaningful meta-analysis or comparison of adherence measures. We explored heterogeneity using pre-defined subgroup analysis. Main results: We included 51 studies involving children and adults with HIV, mostly living in low- and middle-income settings, conducted between 2003 and 2021. Several studies assessed more than one index test, and the most common measure of adherence to ART was self-report. - Self-report questionnaires (25 studies, 9211 participants; very low-certainty): sensitivity ranged from 10% to 85% and specificity ranged from 10% to 99%. - Self-report using a visual analogue scale (VAS) (11 studies, 4235 participants; very low-certainty): sensitivity ranged from 0% to 58% and specificity ranged from 55% to 100%. - Tablet counts (12 studies, 3466 participants; very low-certainty): sensitivity ranged from 0% to 100% and specificity ranged from 5% to 99%. - Electronic monitoring devices (3 studies, 186 participants; very low-certainty): sensitivity ranged from 60% to 88% and the specificity ranged from 27% to 67%. - Pharmacy records or secondary databases (6 studies, 2254 participants; very low-certainty): sensitivity ranged from 17% to 88% and the specificity ranged from 9% to 95%. - Composite measures (9 studies, 1513 participants; very low-certainty): sensitivity ranged from 10% to 100% and specificity ranged from 49% to 100%. Across all included studies, the ability of adherence measures to detect viral non-suppression showed a large variation in both sensitivity and specificity that could not be explained by subgroup analysis. We assessed the overall certainty of the evidence as very low due to risk of bias, indirectness, inconsistency, and imprecision. The risk of bias and the applicability concerns for patient selection, index test, and reference standard domains were generally low or unclear due to unclear reporting. The main methodological issues identified were related to flow and timing due to high numbers of missing data. For all index tests, we assessed the certainty of the evidence as very low due to limitations in the design and conduct of the studies, applicability concerns and inconsistency of results. Authors' conclusions: We encountered high variability for all index tests, and the overall certainty of evidence in all areas was very low. No measure consistently offered either a sufficiently high sensitivity or specificity to detect viral non-suppression. These concerns limit their value in triaging patients for viral load monitoring or enhanced adherence support interventions.
AB - Background: Good patient adherence to antiretroviral (ART) medication determines effective HIV viral suppression, and thus reduces the risk of progression and transmission of HIV. With accurate methods to monitor treatment adherence, we could use simple triage to target adherence support interventions that could help in the community or at health centres in resource-limited settings. Objectives: To determine the accuracy of simple measures of ART adherence (including patient self-report, tablet counts, pharmacy records, electronic monitoring, or composite methods) for detecting non-suppressed viral load in people living with HIV and receiving ART treatment. Search methods: The Cochrane Infectious Diseases Group Information Specialists searched CENTRAL, MEDLINE, Embase, LILACS, CINAHL, African-Wide information, and Web of Science up to 22 April 2021. They also searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov for ongoing studies. No restrictions were placed on the language or date of publication when searching the electronic databases. Selection criteria: We included studies of all designs that evaluated a simple measure of adherence (index test) such as self-report, tablet counts, pharmacy records or secondary database analysis, or both, electronic monitoring or composite measures of any of those tests, in people living with HIV and receiving ART treatment. We used a viral load assay with a limit of detection ranging from 10 copies/mL to 400 copies/mL as the reference standard. We created 2 × 2 tables to calculate sensitivity and specificity. Data collection and analysis: We screened studies, extracted data, and assessed risk of bias using QUADAS-2 independently and in duplicate. We assessed the certainty of evidence using the GRADE method. The results of estimated sensitivity and specificity were presented using paired forest plots and tabulated summaries. We encountered a high level of variation among studies which precluded a meaningful meta-analysis or comparison of adherence measures. We explored heterogeneity using pre-defined subgroup analysis. Main results: We included 51 studies involving children and adults with HIV, mostly living in low- and middle-income settings, conducted between 2003 and 2021. Several studies assessed more than one index test, and the most common measure of adherence to ART was self-report. - Self-report questionnaires (25 studies, 9211 participants; very low-certainty): sensitivity ranged from 10% to 85% and specificity ranged from 10% to 99%. - Self-report using a visual analogue scale (VAS) (11 studies, 4235 participants; very low-certainty): sensitivity ranged from 0% to 58% and specificity ranged from 55% to 100%. - Tablet counts (12 studies, 3466 participants; very low-certainty): sensitivity ranged from 0% to 100% and specificity ranged from 5% to 99%. - Electronic monitoring devices (3 studies, 186 participants; very low-certainty): sensitivity ranged from 60% to 88% and the specificity ranged from 27% to 67%. - Pharmacy records or secondary databases (6 studies, 2254 participants; very low-certainty): sensitivity ranged from 17% to 88% and the specificity ranged from 9% to 95%. - Composite measures (9 studies, 1513 participants; very low-certainty): sensitivity ranged from 10% to 100% and specificity ranged from 49% to 100%. Across all included studies, the ability of adherence measures to detect viral non-suppression showed a large variation in both sensitivity and specificity that could not be explained by subgroup analysis. We assessed the overall certainty of the evidence as very low due to risk of bias, indirectness, inconsistency, and imprecision. The risk of bias and the applicability concerns for patient selection, index test, and reference standard domains were generally low or unclear due to unclear reporting. The main methodological issues identified were related to flow and timing due to high numbers of missing data. For all index tests, we assessed the certainty of the evidence as very low due to limitations in the design and conduct of the studies, applicability concerns and inconsistency of results. Authors' conclusions: We encountered high variability for all index tests, and the overall certainty of evidence in all areas was very low. No measure consistently offered either a sufficiently high sensitivity or specificity to detect viral non-suppression. These concerns limit their value in triaging patients for viral load monitoring or enhanced adherence support interventions.
UR - http://www.scopus.com/inward/record.url?scp=85134910731&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/14651858.CD013080.pub2
DO - https://doi.org/10.1002/14651858.CD013080.pub2
M3 - Review article
C2 - 35871531
SN - 1465-1858
VL - 2022
JO - Cochrane Database of Systematic Reviews
JF - Cochrane Database of Systematic Reviews
IS - 7
M1 - CD013080
ER -