Evidence map›Paper›PMID 27760126›Full record

Trial reportPloS one2016

Self-Reported Side Effects and Adherence to Antiretroviral Therapy in HIV-Infected Pregnant Women under Option B+: A Prospective Study.

Tamsin Phillips, Annibale Cois, Robert H Remien, Claude A Mellins, James A McIntyre, Greg Petro, Elaine J Abrams, Landon Myer

Abstract readClinical Trial
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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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

8 authors.

Tamsin PhillipsDivision of Epidemiology & Biostatistics, University of Cape Town, Cape Town, South Africa.ORCID http://orcid.org/0000-0003-4554-2922
Annibale CoisDivision of Epidemiology & Biostatistics, University of Cape Town, Cape Town, South Africa.
Robert H RemienHIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute, Columbia University, New York, NY, United States of America.
Claude A MellinsHIV Center for Clinical and Behavioral Studies, New York State Psychiatric Institute, Columbia University, New York, NY, United States of America.
James A McIntyreDivision of Epidemiology & Biostatistics, University of Cape Town, Cape Town, South Africa.
Greg PetroDepartment of Obstetrics & Gynaecology, University of Cape Town, Cape Town, South Africa.
Elaine J AbramsICAP, Columbia University, Mailman School of Public Health, New York, NY, United States of America.
Landon MyerDivision of Epidemiology & Biostatistics, University of Cape Town, Cape Town, South Africa.

Funding

The Statistics, Data Science, and Data Management (SDM) CoreP30MH043520 · NIMH · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI Claude Ann Mellins · 2003 to 2026
$48.2M
Strategies to optimize ART services for maternal&child health: the MCH-ART studyR01HD074558 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI ABRAMS, ELAINE JANINE, MYER, BENJAMIN LANDON · 2012 to 2014
$2.9M
NICHD NIH HHS R01 HD074558NIMH NIH HHS P30 MH043520
6 · The paper itself

Abstract

backgroundAntiretroviral therapy (ART) regimens containing efavirenz (EFV) are recommended as part of universal ART for pregnant and breastfeeding women. EFV may have appreciable side effects (SE), and ART adherence in pregnancy is a major concern, but little is known about ART SE and associations with adherence in pregnancy.

methodsWe investigated the distribution of patient-reported SE (based on Division of AIDS categories) and the association of SE with missed ART doses in a cohort of 517 women starting EFV+3TC/FTC+TDF during pregnancy. In analysis, SE were considered in terms of their overall frequency, by systems category, and by latent classes.

resultsOverall 97% of women reported experiencing at least one SE after ART initiation, with 48% experiencing more than five SE. Gastrointestinal, central nervous system, systemic and skin SE were reported by 81%, 85%, 79% and 31% of women, respectively, with considerable overlap across groups. At least one missed dose was reported by 32% of women. In multivariable models, ART non-adherence was associated with systemic SE compared to other systems categories, and measures of the overall burden of SE experienced were most strongly associated with missed ART doses.

conclusionThese data demonstrate very high levels of SE in pregnant women initiating EFV-based ART and a strong association between SE burden and ART adherence. ART regimens with reduced SE profiles may enhance adherence, and as countries expand universal ART for all adult patients, counseling must include preparation for ART SE.

Indexed as

Self ReportAdultAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesFemaleHIV InfectionsHumansPatient CompliancePregnancyPregnancy Complications, InfectiousProspective StudiesYoung AdultAlkynesAnti-HIV AgentsBenzoxazinesCyclopropanesefavirenz

Identifiers

PMID27760126
PMCPMC5070813

What OpenQuestion holds

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Registered trials

None linked

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.