Evidence map›Paper›PMID 34815285›Full record

ArticleBMJ open2021

Evaluation of the safety and efficacy of dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in HIV-infected pregnant women: protocol of a multicentre, two-arm, randomised, placebo-controlled, superiority clinical trial (MAMAH project).

Raquel González, Tacilta Nhampossa, Ghyslain Mombo-Ngoma, Johannes Mischlinger, Meral Esen, André-Marie Tchouatieu, Clara Pons-Duran, Lia Betty Dimessa, Bertrand Lell, Heimo Lagler and 9 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03671109 (Evaluation of the Safety and Efficacy of Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment of Malaria in HIV-infected Pregnant Women), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 11% 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.

NCT03671109 phase3completednot on this map

Evaluation of the Safety and Efficacy of Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment of Malaria in HIV-infected Pregnant Women

TypeinterventionalSponsorBarcelona Institute for Global HealthRan2019 to 2023Enrolled666ConditionsMalaria, HIV/AIDS, Pregnancy RelatedArmsDihydroartemisinin-piperaquine (DHA-PPQ), Placebo Oral Tablet
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Article
  9. 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

19 authors at 8 institutions in 6 countries.

Raquel GonzálezMaternal, Child and Reproductive Health Initiative, Barcelona Institute for Global Health (ISGlobal), Hospital Clínic- Universitat de Barcelona, Barcelona, Spain raquel.gonzalez@isglobal.org.ORCID 0000-0001-5487-801X
Tacilta NhampossaCentro de Investigação em Saúde de Manhiça, Maputo, Mozambique.
Ghyslain Mombo-NgomaCentre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.
Johannes MischlingerDepartment of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine & I Department of Medicine University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Meral EsenUniversity of Tübingen, Tubingen, Germany.
André-Marie TchouatieuMedicines for Malaria Venture, Geneva, Switzerland.
Clara Pons-DuranMaternal, Child and Reproductive Health Initiative, Barcelona Institute for Global Health (ISGlobal), Hospital Clínic- Universitat de Barcelona, Barcelona, Spain.ORCID 0000-0002-9840-7559
Lia Betty DimessaCentre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.
Bertrand LellCentre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.
Heimo LaglerDepartment of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria.
Laura Garcia-OteroMaternal, Child and Reproductive Health Initiative, Barcelona Institute for Global Health (ISGlobal), Hospital Clínic- Universitat de Barcelona, Barcelona, Spain.
Rella Zoleko ManegoCentre de Recherches Médicales de Lambaréné, Lambaréné, Gabon.
Myriam El GaaloulMedicines for Malaria Venture, Geneva, Switzerland.
Sergi SanzMaternal, Child and Reproductive Health Initiative, Barcelona Institute for Global Health (ISGlobal), Hospital Clínic- Universitat de Barcelona, Barcelona, Spain.
Mireia PiquerasMaternal, Child and Reproductive Health Initiative, Barcelona Institute for Global Health (ISGlobal), Hospital Clínic- Universitat de Barcelona, Barcelona, Spain.
Esperanca SeveneCentro de Investigação em Saúde de Manhiça, Maputo, Mozambique.
Michael RamharterDepartment of Tropical Medicine, Bernhard Nocht Institute for Tropical Medicine & I Department of Medicine University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Francisco SauteCentro de Investigação em Saúde de Manhiça, Maputo, Mozambique.
Clara MenendezMaternal, Child and Reproductive Health Initiative, Barcelona Institute for Global Health (ISGlobal), Hospital Clínic- Universitat de Barcelona, Barcelona, Spain.
Barcelona Institute for Global Health · ESCentre de Recherche Médicales de Lambaréné · GAManhiça Health Research Centre · MZMedicines for Malaria Venture · CHUniversität Hamburg · DEEduardo Mondlane University · MZMedical University of Vienna · ATUniversity of Tübingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMalaria infection during pregnancy is an important driver of maternal and neonatal health especially among HIV-infected women. Intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine is recommended for malaria prevention in HIV-uninfected women, but it is contraindicated in those HIV-infected on cotrimoxazole prophylaxis (CTXp) due to potential adverse effects. Dihydroartemisinin-piperaquine (DHA-PPQ) has been shown to improve antimalarial protection, constituting a promising IPTp candidate. This trial's objective is to determine if monthly 3-day IPTp courses of DHA-PPQ added to daily CTXp are safe and superior to CTXp alone in decreasing the proportion of peripheral malaria parasitaemia at the end of pregnancy. METHODS AND ANALYSIS: This is a multicentre, two-arm, placebo-controlled, individually randomised trial in HIV-infected pregnant women receiving CTXp and antiretroviral treatment. A total of 664 women will be enrolled at the first antenatal care clinic visit in sites from Gabon and Mozambique. Participants will receive an insecticide-treated net, and they will be administered monthly IPTp with DHA-PPQ or placebo (1:1 ratio) as directly observed therapy from the second trimester of pregnancy. Primary study outcome is the prevalence of maternal parasitaemia at delivery. Secondary outcomes include prevalence of malaria-related maternal and infant outcomes and proportion of adverse perinatal outcomes. Participants will be followed until 6 weeks after the end of pregnancy and their infants until 1 year of age to also evaluate the impact of DHA-PPQ on mother-to-child transmission of HIV. The analysis will be done in the intention to treat and according to protocol cohorts, adjusted by gravidity, country, seasonality and other variables associated with malaria. ETHICS AND DISSEMINATION: The protocol was reviewed and approved by the institutional and national ethics committees of Gabon and Mozambique and the Hospital Clinic of Barcelona. Project results will be presented to all stakeholders and published in open-access journals. TRIAL REGISTRATION NUMBER: NCT03671109.

Indexed as

AntimalarialsHIV InfectionsMalariaPregnancy Complications, ParasiticArtemisininsDrug CombinationsEquivalence Trials as TopicFemaleHumansInfantInfant, NewbornInfectious Disease Transmission, VerticalMulticenter Studies as TopicPiperazinesPregnancyPregnant PeopleAntimalarialsArtemisininsartenimolDrug CombinationspiperaquinePiperazinesQuinolinesclinical trialsepidemiologyHIV & AIDSmaternal medicinetropical medicine

Identifiers

PMID34815285
PMCPMC8611429
OpenAlexW3216276831

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

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.