Evidence map›Paper›PMID 28498184›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2017

Viral Suppression and HIV Drug Resistance at 6 Months Among Women in Malawi's Option B+ Program: Results From the PURE Malawi Study.

Mina Hosseinipour, Julie A E Nelson, Clement Trapence, Sarah E Rutstein, Florence Kasende, Virginia Kayoyo, Blessings Kaunda-Khangamwa, Kara Compliment, Christopher Stanley, Fabian Cataldo and 12 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% 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

36 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.

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  6. Predictors of Viremia in Postpartum Women on Antiretroviral Therapy.Journal of acquired immune deficiency syndromes (1999) · 2020
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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

22 authors at 7 institutions in 4 countries.

Mina Hosseinipour*University of North Carolina Project, Lilongwe, Malawi; †Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC; ‡Department of Microbiology, University of North Carolina School of Medicine, Chapel Hill, NC; §Lighthouse Trust, Lilongwe, Malawi; ‖Dignitas International, Zomba, Malawi; ¶Malaria Alert Centre, College of Medicine, University of Malawi, Blantyre, Malawi; #Lineberger Cancer Center, University of North Carolina School of Medicine, Chapel Hill, NC; **Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada; ††The International Union Against Tuberculosis and Lung Disease, Paris, France; ‡‡Mothers2Mothers, Lilongwe, Malawi; §§Management Sciences for Health, Lilongwe, Malawi; ‖‖Department of HIV and AIDS, Ministry of Health, Lilongwe, Malawi; ¶¶Department of Economics, Chancellor College, University of Malawi, Zomba, Malawi; and ##Department of Public Health, School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.
Julie A E Nelson
Clement Trapence
Sarah E Rutstein
Florence Kasende
Virginia Kayoyo
Blessings Kaunda-Khangamwa
Kara Compliment
Christopher Stanley
Fabian Cataldo
Monique van Lettow
Nora E Rosenberg
Hannock Tweya
Salem Gugsa
Veena Sampathkumar
Erik Schouten
Michael Eliya
Frank Chimbwandira
Levison Chiwaula
Atupele Kapito-Tembo
Sam Phiri
PURE Malawi Consortium
Lighthouse Trust · MWUniversity of North Carolina at Chapel Hill · USDignitas International · MWUniversity of Malawi · MWMinistry of Health · MWChristian Health Association of Malawi · MWPublic Health Institute of Malawi · MW

Funding

Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
Malawi HIV Implementation Research Scientist Training Program (MHIRST)D43TW010060 · FIC · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MINA CHRISTINE HOSSEINIPOUR, Victor Mwapasa · 2015 to 2026
$3.8M
Developing and Assessing a Male Engagement Intervention for Option B+ in MalawiR00MH104154 · NIMH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI ROSENBERG, NORA · 2017 to 2019
$746k
Optimizing HIV Therapy: virological monitoring, adherence & cost-effectivenessF30MH098731 · NIMH · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RUTSTEIN, SARAH E. · 2012 to 2016
$201k
FIC NIH HHS D43 TW010060NIAID NIH HHS P30 AI050410NIMH NIH HHS F30 MH098731NIMH NIH HHS R00 MH104154
6 · The paper itself

Abstract

backgroundIn 2011, Malawi launched Option B+, a program of universal antiretroviral therapy (ART) treatment for pregnant and lactating women to optimize maternal health and prevent pediatric HIV infection. For optimal outcomes, women need to achieve HIVRNA suppression. We report 6-month HIVRNA suppression and HIV drug resistance in the PURE study.

methodsPURE study was a cluster-randomized controlled trial evaluating 3 strategies for promoting uptake and retention; arm 1: Standard of Care, arm 2: Facility Peer Support, and arm 3: Community Peer support. Pregnant and breastfeeding mothers were enrolled and followed according to Malawi ART guidelines. Dried blood spots for HIVRNA testing were collected at 6 months. Samples with ART failure (HIVRNA ≥1000 copies/ml) had resistance testing. We calculated odds ratios for ART failure using generalized estimating equations with a logit link and binomial distribution.

resultsWe enrolled 1269 women across 21 sites in Southern and Central Malawi. Most enrolled while pregnant (86%) and were WHO stage 1 (95%). At 6 months, 950/1269 (75%) were retained; 833/950 (88%) had HIVRNA testing conducted, and 699/833 (84%) were suppressed. Among those with HIVRNA ≥1000 copies/ml with successful amplification (N = 55, 41% of all viral loads > 1000 copies/ml), confirmed HIV resistance was found in 35% (19/55), primarily to the nonnucleoside reverse transcriptase inhibitor class of drugs. ART failure was associated with treatment default but not study arm, age, WHO stage, or breastfeeding status.

conclusionsVirologic suppression at 6 months was <90% target, but the observed confirmed resistance rates suggest that adherence support should be the primary approach for early failure in option B+.

Indexed as

Maternal-Child Health ServicesWorld Health OrganizationAdultAnti-HIV AgentsBreast FeedingCD4 Lymphocyte CountCluster AnalysisDrug MonitoringDrug ResistanceFemaleHIV InfectionsHumansInfant, NewbornInfectious Disease Transmission, VerticalMalawiPregnancyAnti-HIV Agents

Identifiers

PMID28498184
PMCPMC5431274
OpenAlexW2612582782

What OpenQuestion holds

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Read underepoch 390

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.