Design and challenges of a large HIV prevention clinical study on mother-to-child transmission: ANRS 12397 PROMISE-EPI study in Zambia and Burkina Faso.
Adolescent
Adult
Anti-HIV Agents
/ administration & dosage
Breast Feeding
Burkina Faso
COVID-19
/ epidemiology
Cross-Sectional Studies
Female
HIV Infections
/ diagnosis
Humans
Infant
Infectious Disease Transmission, Vertical
/ prevention & control
Lamivudine
/ administration & dosage
Pandemics
Pre-Exposure Prophylaxis
/ methods
Research Design
SARS-CoV-2
Viral Load
Young Adult
Zambia
Africa
Design
HIV
Mother-to-child transmission
Pre-Exposure Prophylaxis
Randomized controlled trial
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
06 2021
06 2021
Historique:
received:
11
02
2021
revised:
08
04
2021
accepted:
09
04
2021
pubmed:
20
4
2021
medline:
16
6
2021
entrez:
19
4
2021
Statut:
ppublish
Résumé
Post-natal HIV infection through breastfeeding remains a challenge in many low and middle-income countries, particularly due to non-availability of alternative infant feeding options and the suboptimal Prevention of Mother to Child Transmission of HIV-1 (PMTCT) cascade implementation and monitoring. The PROMISE-EPI study aims to address the latter by identifying HIV infected mothers during an almost never-missed visit for their infant, the second extended program on immunization visit at 6-8 weeks of age (EPI-2). The study is divided into 3 components inclusive of an open-label randomized controlled trial aiming to assess the efficacy of a responsive preventive intervention compared to routine intervention based on the national PMTCT guidelines for HIV-1 uninfected exposed breastfeeding infants. The preventive intervention includes: a) Point of care testing for early infant HIV diagnosis and maternal viral load; b) infant, single-drug Pre-Exposure Prophylaxis (PrEP) (lamivudine) if mothers are virally unsuppressed. The primary outcome is HIV-transmission rate from EPI-2 to 12 months. The study targets to screen 37,000 mother/infant pairs in Zambia and Burkina Faso to identify 2000 mother/infant pairs for the clinical trial. The study design and challenges faced during study implementation are described, including the COVID-19 pandemic and the amended HIV guidelines in Zambia in 2020 (triple-drug PrEP in HIV exposed infants guided by quarterly maternal viral load). The changes in the Zambian guidelines raised several questions including the equipoise of PrEP options, the standard of care-triple-drug (control arm in Zambia) versus the study-single-drug (intervention arm). Trial registration number (www.clinicaltrials.gov): NCT03869944. Submission category: Study Design, Statistical Design, Study Protocols.
Identifiants
pubmed: 33872801
pii: S1551-7144(21)00138-5
doi: 10.1016/j.cct.2021.106402
pii:
doi:
Substances chimiques
Anti-HIV Agents
0
Lamivudine
2T8Q726O95
Banques de données
ClinicalTrials.gov
['NCT03869944']
Types de publication
Clinical Trial Protocol
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
106402Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.