Including pregnant and breastfeeding people in trials of novel LAED PrEP agents: perspectives from sub‐Saharan Africa community stakeholders

Prior to the implementation of protocol changes, HPTN 084 community working group members hosted a stakeholder consultation to gather community perspectives on proposed pregnancy-related amendments, including relaxation of contraceptive requirements and active CAB dosing during pregnancy and lactati...

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Bibliographic Details
Published in:Journal of the International AIDS Society 2023-07, Vol.26 (S2), p.e26120-n/a
Main Authors: White, Rhonda R., Dyer, Molly C., Hosseinipour, Mina C., Delany‐Moretlwe, Sinead
Format: Article
Language:English
Subjects:
Acquired immune deficiency syndrome
AIDS
Allergies
Breast Feeding
Breast milk
Breastfeeding & lactation
Clinical trials
Data management
Drug abuse
Female
Funding
Health aspects
HIV
HIV infection
HIV Infections - drug therapy
HIV Infections - prevention & control
Human immunodeficiency virus
Humans
Infectious diseases
Management
Pharmacology
Pregnancy
Pregnant women
Prevention
Social aspects
Stakeholders
Viewpoint
Womens health
Working groups
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Summary:Prior to the implementation of protocol changes, HPTN 084 community working group members hosted a stakeholder consultation to gather community perspectives on proposed pregnancy-related amendments, including relaxation of contraceptive requirements and active CAB dosing during pregnancy and lactation. While qualitative in nature, the Zoom polls confirmed that the greatest concerns related to CAB safety during pregnancy (as opposed to lactation despite virtually no available data on CAB in breast milk), and that partners were likely to be extremely influential in participants’ decisions to use CAB in pregnancy. FUNDING This study was made possible through funding support from the National Institute of Allergy and Infectious Diseases, Office of the Director (NIAID), National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD), National Institute on Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH), under award numbers UM1AI068619 (HPTN Leadership and Operations Center), UM1AI068617 (HPTN Statistical and Data Management Center), and UM1AI068613 (HPTN Laboratory Center).
ISSN:1758-2652
1758-2652
DOI:10.1002/jia2.26120