IMPAACT 2046/UPLIFT (Understanding Practices of Lactation and Infant Feeding decisions Together with women with HIV) is a multi-site, mixed-methods, observational cohort study. The purpose of the study is to explore infant feeding preferences, practices, and outcomes among mothers with HIV and their families in the United States. It will employ both qualitative and quantitative research methods to address existing knowledge gaps and to understand the clinical, behavioral, and social factors influencing infant feeding decisions. As part of the study's mixed method approach, a longitudinal cohort study of mothers and their infants will be established. The study also aims to pilot a national registry of breastfeeding women living with HIV in the United States.
Is of legal age or circumstance to provide independent informed consent
Is pregnant with a gestational age of 28 0/7 to 37 6/7 weeks at entry and is considering breastfeeding
Is pregnant with a gestational age of 28 0/7 to 37 6/7 weeks at entry and is not considering breastfeeding
Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, did not breastfeed for any duration and has no intent to breastfeed
Has any condition identified during the screening period that, in the opinion of site investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Pregnant and postpartum women with HIV (PPWH); healthcare providers (HCP) and ancillary healthcare professionals (AHP) who care for PPWH and/or their infants; other influential individuals who contribute to infant feeding decisions. Pilot registry testers who will enter data into the pilot registry.
Cohort
Prospective
No intervention provided in this study
Other interventionNone; No intervention provided in this study
CA 1: Factors influencing infant feeding decision
Qualitative themes from in-depth interviews
CA 1: Infants born to women with HIV who receive any breast milk
Binomial outcome from site level surveys
CA 2: Infant feeding method chosen
Binary outcome
CA 2: Breastfeeding initiation among those who intended to breastfeed
Binary outcome
CA 1: Approaches to support infant feeding decisions and improve quality of care
Qualitative themes from in-depth interviews
CA 1: Descriptive results of current practices, burden, benefits and resources
Site surveys, provider surveys, In-depth Interviews
CA 2: Median cost per postpartum woman with HIV and infant pair
Numerical outcome, by feeding approach
CA 2: Cost effectiveness ratio presented as cost per quality adjusted life year saved in breastfeeding mother/infant pair
Numerical outcome
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International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Lead sponsor
University of Colorado, Denver
Collaborator
Centers for Disease Control and Prevention
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
