Evidence map›Paper›PMID 33076866›Full record

ArticleBMC infectious diseases2020

Genotype-Informed Versus Empiric Management Of VirEmia (GIVE MOVE): study protocol of an open-label randomised clinical trial in children and adolescents living with HIV in Lesotho and Tanzania.

Jennifer Anne Brown, Isaac Ringera, Ezekiel Luoga, Molisana Cheleboi, Namvua Kimera, Josephine Muhairwe, Buntshi Paulin Kayembe, Mosa Molapo Hlasoa, Lorraine Kabundi, Ching Wey David Yav and 11 more

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

Article in BMC infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04233242 (Genotype-Informed Versus Empiric Management of VirEmia), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.1field-weighted citation impact, top 52% 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.

NCT04233242 nacompletednot on this map

Genotype-Informed Versus Empiric Management of VirEmia (GIVE MOVE) in HIV-Infected Children and Adolescents on Antiretroviral Therapy: An Open-Label Randomised Clinical Trial

TypeinterventionalSponsorSwiss Tropical & Public Health InstituteRan2020 to 2023Enrolled286ConditionsHIV-1-infectionArmsClinical management informed by HIV-1 genotypic resistance testing
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
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

21 authors at 6 institutions in 4 countries.

Jennifer Anne BrownSwiss Tropical and Public Health Institute, Basel, Switzerland.
Isaac RingeraSolidarMed, Partnerships for Health, Maseru, Lesotho.
Ezekiel LuogaIfakara Health Institute, Ifakara, Tanzania.
Molisana CheleboiSeboche Mission Hospital, Seboche, Lesotho.
Namvua KimeraIfakara Health Institute, Ifakara, Tanzania.
Josephine MuhairweSolidarMed, Partnerships for Health, Maseru, Lesotho.
Buntshi Paulin KayembeBaylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.
Mosa Molapo HlasoaBaylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.
Lorraine KabundiBaylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.
Ching Wey David YavBaylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.
Buoang MothobiSolidarMed, Partnerships for Health, Maseru, Lesotho.
Lineo ThahaneBaylor College of Medicine Children's Foundation Lesotho, Maseru, Lesotho.
Alain AmstutzSwiss Tropical and Public Health Institute, Basel, Switzerland.
Nadine BachmannSwiss Tropical and Public Health Institute, Basel, Switzerland.
Getrud Joseph MollelIfakara Health Institute, Ifakara, Tanzania.
Moniek BresserSwiss Tropical and Public Health Institute, Basel, Switzerland.
Tracy Renée GlassSwiss Tropical and Public Health Institute, Basel, Switzerland.
Daniel Henry ParisSwiss Tropical and Public Health Institute, Basel, Switzerland.
Thomas KlimkaitMolecular Virology, Department of Biomedicine, University of Basel, Basel, Switzerland.
Maja WeisserSwiss Tropical and Public Health Institute, Basel, Switzerland.
Niklaus Daniel LabhardtSwiss Tropical and Public Health Institute, Basel, Switzerland. n.labhardt@swisstph.ch.ORCID http://orcid.org/0000-0003-3599-1791
Swiss Tropical and Public Health Institute · CHChildren’s Foundation · GBIfakara Health Institute · TZBaylor College of Medicine · USMission Health · USUniversity of Basel · CH

Funding

Fondation Botnar REG-19-008Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung PCEFP3_181355
6 · The paper itself

Abstract

backgroundGlobally, the majority of people living with HIV have no or only limited access to HIV drug resistance testing to guide the selection of antiretroviral drugs. This is of particular concern for children and adolescents, who experience high rates of treatment failure. The GIVE MOVE trial assesses the clinical impact and cost-effectiveness of routinely providing genotypic resistance testing (GRT) to children and adolescents living with HIV who have an unsuppressed viral load (VL) while taking antiretroviral therapy (ART).

methodsGIVE MOVE is an open-label randomised clinical trial enrolling children and adolescents (≥6 months to <19 years) living with HIV with a VL ≥400 copies/mL (c/mL) while taking first-line ART. Recruitment takes place at sites in Lesotho and Tanzania. Participants are randomised in a 1:1 allocation to a control arm receiving the standard of care (3 sessions of enhanced adherence counselling, a follow-up VL test, continuation of the same regimen upon viral resuppression or empiric selection of a new regimen upon sustained elevated viremia) and an intervention arm (GRT to inform onward treatment). The composite primary endpoint is the occurrence of any one or more of the following events during the 36 weeks of follow-up period: i) death due to any cause; ii) HIV- or ART-related hospital admission of ≥24 h duration; iii) new clinical World Health Organisation stage 4 event (excluding lymph node tuberculosis, stunting, oral or genital herpes simplex infection and oesophageal candidiasis); and iv) no documented VL <50 c/mL at 36 weeks follow-up. Secondary and exploratory endpoints assess additional health-related outcomes, and a nested study will assess the cost-effectiveness of the intervention. Enrolment of a total of 276 participants is planned, with an interim analysis scheduled after the first 138 participants have completed follow-up. DISCUSSION: This randomised clinical trial will assess if the availability of resistance testing improves clinical outcomes in children and adolescents with elevated viremia while taking ART.

trial registrationThis trial is registered with ClinicalTrials.gov ( NCT04233242 ; registered 18.01.2020). More information: www.givemove.org .

Indexed as

Drug Resistance, ViralAdolescentAnti-HIV AgentsChildChild, PreschoolCost-Benefit AnalysisCounselingFemaleGenotypeHerpes GenitalisHIVHIV InfectionsHumansInfantLesothoLongitudinal StudiesAnti-HIV AgentsAdolescentsAntiretroviral therapyChildrenDrug resistanceGenotypic resistance testingHIVRandomised clinical trialSub-Saharan AfricaTreatment failure

Identifiers

PMID33076866
PMCPMC7574572
OpenAlexW3092710727

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.