Evidence map›Paper›PMID 39300364›Full record

Trial reportBMC infectious diseases2024

An optimized strategy triggered at the 2nd immunization visit to prevent HIV acquisition by breastfeeding: a phase 2 trial in Burkina Faso (PREVENIR-PEV).

Anaïs Mennecier, Béninwendé Leticia Delphine Sakana, Morgana D'Ottavi, Souleymane Tassembedo, Jean-Pierre Moles, Dramane Kania, Ajani Ousmane Taofiki, Franck Edgar Kadeba, Ibrahima Diallo, Sabrina Eymard-Duvernay and 6 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03869944 (Elimination of Paediatric HIV-1 Infection), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT03869944 phase2unknown statusnot on this map

Elimination of Paediatric HIV-1 Infection: Evaluation of the Prevention Programme and Rescue Intervention Based on the Expanded Programme on Immunization (EPI). ANRS 12388 PREVENIR-PEV Study.

TypeinterventionalSponsorANRS, Emerging Infectious DiseasesRan2019 to 2022Enrolled97ConditionsHIV-1ArmsLamivudine Oral Solution
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  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.

Anaïs MennecierPathogenesis and Control of Chronic and Emerging Infections, Montpellier University, INSERM, 60 Rue de Navacelles, Montpellier, EFS, 34394, France. anais.mennecier@inserm.fr.
Béninwendé Leticia Delphine SakanaInfectious Disease Research Programme, Centre MURAZ/National Institute of Public Health, Bobo-Dioulasso, Burkina Faso.
Morgana D'OttaviPathogenesis and Control of Chronic and Emerging Infections, Montpellier University, INSERM, 60 Rue de Navacelles, Montpellier, EFS, 34394, France.
Souleymane TassembedoInfectious Disease Research Programme, Centre MURAZ/National Institute of Public Health, Bobo-Dioulasso, Burkina Faso.
Jean-Pierre MolesPathogenesis and Control of Chronic and Emerging Infections, Montpellier University, INSERM, 60 Rue de Navacelles, Montpellier, EFS, 34394, France.
Dramane KaniaInfectious Disease Research Programme, Centre MURAZ/National Institute of Public Health, Bobo-Dioulasso, Burkina Faso.
Ajani Ousmane TaofikiSexual and Reproductive Health Research Programme, Centre MURAZ/National Institute of Public Health, Bobo-Dioulasso, Burkina Faso.
Franck Edgar KadebaInfectious Disease Research Programme, Centre MURAZ/National Institute of Public Health, Bobo-Dioulasso, Burkina Faso.
Ibrahima DialloInfectious Disease Research Programme, Centre MURAZ/National Institute of Public Health, Bobo-Dioulasso, Burkina Faso.
Sabrina Eymard-DuvernayPathogenesis and Control of Chronic and Emerging Infections, Montpellier University, INSERM, 60 Rue de Navacelles, Montpellier, EFS, 34394, France.
Nicolas MedaInfectious Disease Research Programme, Centre MURAZ/National Institute of Public Health, Bobo-Dioulasso, Burkina Faso.
Beatriz MosqueiraPathogenesis and Control of Chronic and Emerging Infections, Montpellier University, INSERM, 60 Rue de Navacelles, Montpellier, EFS, 34394, France.
Paulin FaoInfectious Disease Research Programme, Centre MURAZ/National Institute of Public Health, Bobo-Dioulasso, Burkina Faso.
Nicolas NagotPathogenesis and Control of Chronic and Emerging Infections, Montpellier University, INSERM, 60 Rue de Navacelles, Montpellier, EFS, 34394, France.
PREVENIR-PEV Study Group
Philippe Vande PerrePathogenesis and Control of Chronic and Emerging Infections, Montpellier University, INSERM, 60 Rue de Navacelles, Montpellier, EFS, 34394, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMother-to-child transmission of HIV during breastfeeding remains a challenge in low- and middle-income countries (LMIC). A prevention package was initiated during the highly attended 2nd visit of the Expanded Program of Immunisation (EPI-2) to identify the undiagnosed infants living with HIV and reduce the postnatal transmission of infant exposed to HIV.

methodsPREVENIR-PEV is a non-randomized phase II clinical trial conducted at two health centres in Bobo Dioulasso (Burkina Faso). The study recruited mothers living with HIV aged 15 years and older with their singleton breastfed infants. During EPI-2 (at 8 weeks) and upon signature of the informed consent, a point-of-care early infant diagnosis (EID) was performed. HIV exposed uninfected (HEU) infants were followed-up until 12 months of age. High risk HEU infants (i.e., whose maternal viral load ≥ 1000 cp/mL at EPI-2 or M6) received an extended postnatal prophylaxis (PNP) with lamivudine until end of follow-up or the end of breastfeeding.

resultsBetween 4 December 2019 and 4 December 2020, 118 mothers living with HIV-1 were identified, and 102 eligible mother/infant pairs had their infants tested for HIV EID. Six infants were newly diagnosed with HIV, and 96 HEU infants were followed-up for 10 months. Among the participants followed-up, all mothers were prescribed antiretrovirals. All 18 infants eligible for PNP at either EPI-2 or 6 months (M6) were initiated on lamivudine. No HIV transmission occurred, and no serious adverse events were reported in infants receiving lamivudine.

conclusionsThe PREVENIR-PEV prevention package integrated into existing care is safe and its implementation is feasible in a LMIC with a low HIV prevalence. More research is needed to target mother/infant pairs not adhering to the intervention proposed in this trial.

trial registrationNCT03869944; first registered on 11/03/2019.

Indexed as

Breast FeedingHIV InfectionsInfectious Disease Transmission, VerticalAdolescentAdultAnti-HIV AgentsBurkina FasoFemaleHumansInfantInfant, NewbornLamivudineMaleMothersViral LoadYoung AdultAnti-HIV AgentsLamivudineAfricaBreast feedingClinical trialHIVInfectious disease transmissionPreventionVertical

Identifiers

PMID39300364
PMCPMC11414164

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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.