Evidence map›Paper›PMID 36650479›Full record

Trial reportBMC pregnancy and childbirth2023

Prevalence of neurotoxicity symptoms among postpartum women on isoniazid preventive therapy and efavirenz-based treatment for HIV: an exploratory objective of the IMPAACT P1078 randomized trial.

Patricia Mandima, Kristin Baltrusaitis, Grace Montepiedra, Lisa Aaron, Jyoti Mathad, Carolyne Onyango-Makumbi, Mandisa Nyati, James Ngocho, Gift Chareka, Ponego Ponatshego and 6 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 33% 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.

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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Review
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

16 authors at 10 institutions in 6 countries.

Patricia Mandima *University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe. pmandima@uz-ctrc.org.
Kristin Baltrusaitis *Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Grace MontepiedraCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Lisa AaronCenter for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Jyoti MathadWeill Cornell Medical College, New York, NY, USA.
Carolyne Onyango-MakumbiMakerere University-John Hopkins University Research Collaboration, Kampala, Uganda.
Mandisa NyatiChris Hani Baragwanath Hospital, Johannesburg, Soweto, South Africa.
James NgochoKilimanjaro Christian Medical University College, Moshi, Tanzania.
Gift CharekaUniversity of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe.
Ponego PonatshegoHarvard AIDS Institute, Gaborone, Botswana.
Gaerolwe MashetoHarvard AIDS Institute, Gaborone, Botswana.
Katie McCarthy, FHI 360, Durham, NC, USA.
Patrick Jean-PhilippeNational Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Amita GuptaDivision of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, USA.
Lynda Stranix-ChibandaUniversity of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe.
IMPAACT P1078 T. B. APPRISE study team
Cancer Research And Biostatistics · USUniversity of Zimbabwe · ZWBotswana Harvard AIDS Institute Partnership · BWChris Hani Baragwanath Hospital · ZACornell University · USFamily Health International 360 · USJohns Hopkins University · USKilimanjaro Christian Medical Centre · TZMUJHU Research Collaboration · UGNational Institute of Allergy and Infectious Diseases · US

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
UZ-UCSF CTUUM1AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ZVAVAHERA MIKE CHIRENJE, LYNDA STRANIX-CHIBANDA · 2012 to 2026
$75.9M
UZ-UCSF Clinical Trials UnitU01AI069436 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI CHIRENJE, ZVAVAHERA MIKE · 2007 to 2011
$49.3M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
Botswana-Harvard T.H. Chan School of Public Health AIDS Initiative Partnership CTU Y18 SupplementUM1AI069456 · NIAID · THE BOTSWANA HARVARD HEALTH PARTNERSHIP · PI SHAHIN LOCKMAN, Joseph Moeketsi Makhema · 2012 to 2026
$29.4M
NIAID NIH HHS U01 AI069436NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI069436NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069456
6 · The paper itself

Abstract

backgroundThis exploratory analysis investigates the prevalence and risk factors of neurocognitive toxicity in postpartum women on HIV treatment in response to a concern of an Isoniazid Preventive Therapy (IPT)/Efavirenz interaction. TRIAL

designPregnant women on HIV treatment from countries with high TB prevalence were randomized in IMPAACT P1078 to 28 weeks of IPT started either during pregnancy or at 12 weeks postpartum. Partway through study implementation, the Patient Health Questionnaire 9, the cognitive complaint questionnaire, and the Pittsburg Sleep Quality Index were added to evaluate depression, cognitive function, and sleep quality at postpartum weeks. Screening for peripheral neuropathy was conducted throughout the study.

methodsWe summarized percentages of women with depression symptoms, cognitive dysfunction, poor sleep quality and peripheral neuropathy and assessed the association of 11 baseline risk factors of neurotoxicity using logistic regression, adjusted for gestational age stratum.

resultsOf 956 women enrolled, 749 (78%) had at least one neurocognitive evaluation. During the postpartum period, the percentage of women reporting at least mild depression symptoms, cognitive complaint and poor sleep quality peaked at 13%, 8% and 10%, respectively, at 12 weeks, and the percentage of women reporting peripheral neuropathy peaked at 13% at 24 weeks. There was no evidence of study arm differences in odds of all four neurotoxic symptoms.

conclusionsTiming of IPT initiation and EFV use were not associated with symptoms of neurotoxicity. Further study is advised to formally assess risk factors of neurotoxicity.

Indexed as

HIV InfectionsTuberculosisAlkynesAntitubercular AgentsBenzoxazinesCyclopropanesFemaleHumansIsoniazidPostpartum PeriodPregnancyPrevalenceAlkynesAntitubercular AgentsBenzoxazinesCyclopropanesefavirenzIsoniazidDepressionEfavirenzIsoniazid preventive therapyPHQ-9Pregnant and Breastfeeding Women

Identifiers

PMID36650479
PMCPMC9847058
OpenAlexW4316814854

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.