Evidence map›Paper›PMID 25153084›Full record

Trial reportPloS one2014

Psychosocial predictors of non-adherence and treatment failure in a large scale multi-national trial of antiretroviral therapy for HIV: data from the ACTG A5175/PEARLS trial.

Steven A Safren, Katie B Biello, Laura Smeaton, Matthew J Mimiaga, Ann Walawander, Javier R Lama, Aadia Rana, Mulinda Nyirenda, Virginia M Kayoyo, Wadzanai Samaneka and 10 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 1 synthesis or guideline pooled it.

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  6. Concurrent Anemia and Elevated C-Reactive Protein Predicts HIV Clinical Treatment Failure, Including Tuberculosis, After Antiretroviral Therapy Initiation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015
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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

20 authors.

Steven A SafrenMassachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; The Fenway Institute, Fenway Health, Boston, MA, United States of America.
Katie B BielloThe Fenway Institute, Fenway Health, Boston, MA, United States of America; Harvard School of Public Health, Boston, MA, United States of America.
Laura SmeatonHarvard School of Public Health, Boston, MA, United States of America.
Matthew J MimiagaMassachusetts General Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; The Fenway Institute, Fenway Health, Boston, MA, United States of America; Harvard School of Public Health, Boston, MA, United States of America.
Ann WalawanderFrontier Science and Technology Research Foundation, Amherst, NY, United States of America.
Javier R LamaAsociacion Civil Impacta Salud y Educacion, Lima, Peru.
Aadia RanaAlpert Medical School/The Miriam Hospital, Providence, RI, United States of America.
Mulinda NyirendaCollege of Medicine - Johns Hopkins Research Project, Blantyre, Malawi.
Virginia M KayoyoUniversity of North Carolina Project, Lilongwe, Malawi.
Wadzanai SamanekaUniversity of Zimbabwe-University of California San Francisco Collaborative Research Program, Harare, Zimbabwe.
Anjali JoglekarNational AIDS Research Institute, Pune, India.
David CelentanoJohns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America.
Ana MartinezNIH/NIAD/DAIDS Pharmaceutical Affairs, Bethesda, MD, United States of America.
Jocelyn E RemmertMassachusetts General Hospital, Boston, MA, United States of America.
Aspara NairFrontier Science and Technology Research Foundation, Amherst, NY, United States of America.
Umesh G LallooNelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, S. Africa.
Nagalingeswaran KumarasamyYRGCARE Medical Centre, Chennai, India.
James HakimUniversity of Zimbabwe, Harare, Zimbabwe, Africa.
Thomas B CampbellUniversity of Colorado Denver, Aurora, CO, United States of America.
PEARLS (ACTG A5175) Study Team

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
WOMEN'S HEALTH AGENDAU01AI038858 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI BENSON, CONSTANCE ANN · 1996 to 2008
$157.5M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI ROBERT GROSS · 1999 to 2026
$78.6M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024156 · NCRR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2006 to 2011
$53.0M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
NCATS NIH HHS UL1 TR000042NCATS NIH HHS UL1 TR000457NCATS NIH HHS UL1 TR001082NCRR NIH HHS M01 RR000865NCRR NIH HHS M0I-RR00865NCRR NIH HHS RR00424NCRR NIH HHS RR024996NCRR NIH HHS RR025780NCRR NIH HHS UL1 RR024156NCRR NIH HHS UL1RR024156NCRR NIH HHS UL1 RR024996NCRR NIH HHS #UL 1RR 025747NCRR NIH HHS UL1 RR025780NIAID NIH HHS 001-AI069467-04NIAID NIH HHS 1U01AI069426-01NIAID NIH HHS 1U01AI069436-01NIAID NIH HHS 1U01AI069513-01NIAID NIH HHS 1U01AI069518-01NIAID NIH HHS 3U01AI046376-05S4NIAID NIH HHS 5 U01 AI069399-04NIAID NIH HHS 5U01AI069401NIAID NIH HHS 5U01AI069417-04NIAID NIH HHS 5U01AI069438NIAID NIH HHS 5U01 AI069484-02NIAID NIH HHS 5 U01 AI069518-04NIAID NIH HHS AI032782NIAID NIH HHS AI050410NIAID NIH HHS AI069423-03NIAID NIH HHS AI069424NIAID NIH HHS AI069428NIAID NIH HHS AI-069439NIAID NIH HHS AI069463NIAID NIH HHS AI069470NIAID NIH HHS AI069471NIAID NIH HHS AI069472NIAID NIH HHS AI069474NIAID NIH HHS AI069532NIAID NIH HHS AI25915NIAID NIH HHS AI27661NIAID NIH HHS AI-27665NIAID NIH HHS AI34853NIAID NIH HHS AI38858-09S1NIAID NIH HHS AI46370NIAID NIH HHS AI68634NIAID NIH HHS AI68636NIAID NIH HHS AI-69419NIAID NIH HHS AI69450NIAID NIH HHS P30 AI045008NIAID NIH HHS P30-AI045008-11NIAID NIH HHS P30 AI050410NIAID NIH HHS U01 AI025915NIAID NIH HHS U01 AI027661NIAID NIH HHS U01 AI027665NIAID NIH HHS U01 AI032782NIAID NIH HHS U01 AI034853NIAID NIH HHS U01 AI038858NIAID NIH HHS U01 AI046370NIAID NIH HHS U01 AI046376NIAID NIH HHS U01 AI068634NIAID NIH HHS U01 AI068636NIAID NIH HHS U01AI068636NIAID NIH HHS U01 AI069399NIAID NIH HHS U01 AI069401NIAID NIH HHS U01 AI069417NIAID NIH HHS U01 AI069419NIAID NIH HHS U01 AI069421NIAID NIH HHS U01 AI069421-05NIAID NIH HHS U01 AI069423NIAID NIH HHS U01 AI069424NIAID NIH HHS U01 AI069426NIAID NIH HHS U01 AI069428NIAID NIH HHS U01 AI069436NIAID NIH HHS U01 AI069438NIAID NIH HHS U01 AI069439NIAID NIH HHS U01 AI069450NIAID NIH HHS U01 AI069463NIAID NIH HHS U01 AI069467NIAID NIH HHS U01 AI069470NIAID NIH HHS U01 AI069471NIAID NIH HHS U01 AI069472NIAID NIH HHS U01 AI069474NIAID NIH HHS U01 AI069476NIAID NIH HHS U01AI069476NIAID NIH HHS U01 AI069495NIAID NIH HHS U01AI069495NIAID NIH HHS U01 AI069511NIAID NIH HHS U01AI069511-02NIAID NIH HHS U01 AI069513NIAID NIH HHS U01 AI069518NIAID NIH HHS U01 AI069532NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069399NIAID NIH HHS UM1 AI069419NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069428NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069450NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069471NIAID NIH HHS UM1 AI069472NIAID NIH HHS UM1 AI069474NIAID NIH HHS UM1 AI069532NIMH NIH HHS K24 MH094214PHS HHS U01A1069432
6 · The paper itself

Abstract

backgroundPEARLS, a large scale trial of antiretroviral therapy (ART) for HIV (n = 1,571, 9 countries, 4 continents), found that a once-daily protease inhibitor (PI) based regimen (ATV+DDI+FTC), but not a once-daily non-nucleoside reverse transcriptase inhibitor/nucleoside reverse transcriptase inhibitor (NNRTI/NRTI) regimen (EFV+FTC/TDF), had inferior efficacy compared to a standard of care twice-daily NNRTI/NRTI regimen (EFV+3TC/ZDV). The present study examined non-adherence in PEARLS.

methodsOutcomes: non-adherence assessed by pill count and by self-report, and time to treatment failure. Longitudinal predictors: regimen, quality of life (general health perceptions  =  QOL-health, mental health  =  QOL-mental health), social support, substance use, binge drinking, and sexual behaviors. "Life-Steps" adherence counseling was provided.

resultsIn both pill-count and self-report multivariable models, both once-a-day regimens had lower levels of non-adherence than the twice-a-day standard of care regimen; although these associations attenuated with time in the self-report model. In both multivariable models, hard-drug use was associated with non-adherence, living in Africa and better QOL-health were associated with less non-adherence. According to pill-count, unprotected sex was associated with non-adherence. According to self-report, soft-drug use was associated with non-adherence and living in Asia was associated with less non-adherence. Both pill-count (HR = 1.55, 95% CI: 1.15, 2.09, p<.01) and self-report (HR = 1.13, 95% CI: 1.08, 1.13, p<.01) non-adherence were significant predictors of treatment failure over 72 weeks. In multivariable models (including pill-count or self-report nonadherence), worse QOL-health, age group (younger), and region were also significant predictors of treatment failure.

conclusionIn the context of a large, multi-national, multi-continent, clinical trial there were variations in adherence over time, with more simplified regimens generally being associated with better adherence. Additionally, variables such as QOL-health, regimen, drug-use, and region play a role. Self-report and pill-count adherence, as well as additional psychosocial variables, such QOL-health, age, and region, were, in turn, associated with treatment failure.

Indexed as

AdultAnti-Retroviral AgentsFemaleHIV InfectionsHumansMaleMiddle AgedModels, TheoreticalPatient CompliancePsychologyQuality of LifeSocial SupportTreatment OutcomeAnti-Retroviral Agents

Identifiers

PMID25153084
PMCPMC4143224

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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.