Evidence map›Paper›PMID 35352097›Full record

Observational studyClinical infectious diseases : an official publication of the Infectious Diseases Society of America2022

Adherence Measured Using Electronic Dose Monitoring is Associated with Emergent Antiretroviral Resistance and Poor Outcomes in People with Human Immunodeficiency Virus/AIDS and Multidrug-Resistant Tuberculosis.

Mark Bateman, Allison Wolf, Benjamin Chimukangara, James C M Brust, Richard Lessells, Rivet Amico, Resha Boodhram, Nalini Singh, Catherine Orrell, Gerald Friedland and 3 more

Registry-linked trialOpen access · greenAbstract readObservational Study
In one paragraph

Observational study in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03162107 (Promoting Engagement in the Drug Resistant TB/HIV Care Continuum in South Africa PRAXIS Study), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.9field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03162107 completednot on this map

Promoting Engagement in the Drug Resistant TB/HIV Care Continuum in South Africa PRAXIS Study (PRospective Study of Adherence in M/XDR-TB Implementation Science)

TypeobservationalSponsorCentre for the AIDS Programme of Research in South AfricaRan2016 to 2021Enrolled199ConditionsPatient Non-compliance
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 20 citations in OpenAlex.

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  7. Experiences of key populations in multidrug-resistant TB and HIV.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 2 countries.

Mark BatemanDepartment of Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Allison WolfDivision of Pulmonary, Allergy, and Critical Care Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Benjamin ChimukangaraCritical Care Medicine Department, National Institutes of Health Clinical Center, Bethesda, Maryland, USA.
James C M BrustDepartment of Medicine, Albert Einstein College of Medicine, New York, New York, USA.
Richard LessellsKwaZulu-Natal Research Innovation and Sequencing Platform, School of Laboratory Medicine & Medical Sciences, University of KwaZulu-Natal, Durban, South Africa.
Rivet AmicoDepartment of Health Behavior & Health Education, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.
Resha BoodhramCentre for the AIDS Programme of Research in South Africa Medical Reseach Council - Human Immunodeficiency Virus - Tuberculosis Pathogenesis and Treatment Research Unit, Durban, South Africa.
Nalini SinghKing Dinuzulu Hospital Complex, Durban, South Africa.
Catherine OrrellDesmond Tutu Health Foundation, Cape Town, South Africa.
Gerald FriedlandYale University School of Medicine, New Haven, Connecticut, USA.
Kogieleum NaidooCentre for the AIDS Programme of Research in South Africa Medical Reseach Council - Human Immunodeficiency Virus - Tuberculosis Pathogenesis and Treatment Research Unit, Durban, South Africa.
Nesri PadayatchiCentre for the AIDS Programme of Research in South Africa Medical Reseach Council - Human Immunodeficiency Virus - Tuberculosis Pathogenesis and Treatment Research Unit, Durban, South Africa.
Max R O'DonnellDivision of Pulmonary, Allergy, and Critical Care Medicine, Columbia University Irving Medical Center, New York, New York, USA.
Centre for the AIDS Programme of Research in South Africa · ZAColumbia University Irving Medical Center · USAlbert Einstein College of Medicine · USDesmond Tutu HIV Foundation · ZAR. K. Khan Hospital · ZAUniversity of KwaZulu-Natal · ZAUniversity of Michigan–Ann Arbor · USYale University · US

Funding

Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
Patient and Population Health Outcomes Research SWGP30AI124414 · NIAID · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI Kathryn M. Anastos · 2017 to 2026
$28.3M
Novel Reporter Phages to Detect Complex TB Drug Resistance and PersistenceR01AI114900 · NIAID · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI Michelle H Larsen, Max O'Donnell · 2015 to 2026
$7.2M
Emergence of bedaquiline and clofazimine resistance after interruption of drug-resistant TB therapy in a high HIV prevalence settingR01AI145679 · NIAID · ALBERT EINSTEIN COLLEGE OF MEDICINE · PI BRUST, JAMES C M · 2020 to 2025
$3.6M
Promoting Engagement in the Drug Resistant TB/HIV Care Continuum in South AfricaR01AI124413 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI O'DONNELL, MAX, PADAYATCHI, NESRI · 2016 to 2020
$2.7M
Mentoring of multidisciplinary global health research in tuberculosis and HIVK24AI155045 · NIAID · ALBERT EINSTEIN COLLEGE OF MEDICINE · PI BRUST, JAMES C M · 2020 to 2025
$889k
NCATS NIH HHS UL1 TR001873NCATS NIH HHS UL1TR001873NIAID NIH HHS K24 AI155045NIAID NIH HHS P30 AI124414NIAID NIH HHS R01 AI114900NIAID NIH HHS R01 AI124413NIAID NIH HHS R01 AI145679
6 · The paper itself

Abstract

backgroundMedication adherence is known to challenge treatment of human immunodeficiency virus (HIV)/AIDS and multidrug-resistant tuberculosis (MDR-TB). We hypothesized that adherence using electronic dose monitoring (EDM) would identify an antiretroviral therapy (ART) adherence threshold for emergent ART resistance and predict treatment outcomes in patients with MDR-TB and HIV on ART and bedaquiline-containing TB regimens.

methodsA prospective cohort of adults with MDR-TB and HIV on ART and initiating MDR-TB treatment with bedaquiline were enrolled at a public hospital in KwaZulu-Natal, South Africa (PRAXIS Study). Participants received separate EDM devices that measure adherence to bedaquiline and ART (nevirapine or lopinavir/ritonavir). Adherence was calculated cumulatively over 6 months. Participants were followed through completion of MDR-TB treatment. HIV genome sequencing was performed at baseline and 2 and 6 months on samples with HIV RNA ≥1000 copies/mL.

resultsFrom November 2016 through February 2018, 198 persons with MDR-TB and HIV were enrolled and followed (median, 17.2 months; interquartile range, 12.2-19.6). Eleven percent had baseline ART resistance mutations, and 7.5% developed emergent ART resistance at 6 months. ART adherence was independently associated with ART resistance and mortality. Modeling identified a significant (P < .001), linear association between ART adherence and emergent resistance, suggesting a strong association without a specific threshold.

conclusionsOur findings highlight the need for ART resistance testing, especially in patients with MDR-TB and HIV, which is currently not the standard of care in resource-limited settings. Despite short follow-up duration, reduced ART adherence was significantly associated with emergent resistance and increased mortality. CLINICAL TRIALS REGISTRATION: NCT03162107.

Indexed as

Acquired Immunodeficiency SyndromeHIV InfectionsTuberculosis, Multidrug-ResistantAdultAnti-Retroviral AgentsAntitubercular AgentsElectronicsHIVHumansProspective StudiesSouth AfricaAnti-Retroviral AgentsAntitubercular Agentsantiretroviral adherenceelectronic dose monitoringemergent resistancepatients with HIV/AIDS and multidrug-resistant tuberculosisSouth Africa

Identifiers

PMID35352097
PMCPMC9617578
OpenAlexW4220780832

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.