Understanding practices of lactation and infant feeding together with women with HIV: the UPLIFT observational study protocol.

INTRODUCTION

There is a limited understanding of infant feeding decisions, practices, and outcomes for women living with HIV (WLHIV) and their infants since U.S. guidelines were updated in 2023 to support breastfeeding for virally suppressed women on antiretroviral treatment.

METHODS AND ANALYSIS: The Understanding Practices of Lactation and Infant Feeding Together with women with HIV (UPLIFT) study is a convergent mixed-methods, multisite, observational study designed to address key knowledge gaps. Twelve US sites will begin enrollment in early 2026 to accomplish three core activities (CA). In CA1, we explore infant feeding decision-making and experiences via in-depth interviews with pregnant/postpartum WLHIV (n = 50), their partners and other influential individuals (n = 25), and a diverse sample of healthcare professionals (n = 45). Site-level surveys assess infant feeding practices and estimate the prevalence of breastfeeding among WLHIV. In CA2, we establish an observational longitudinal cohort of 450 WLHIV-infant dyads to examine infant feeding practices and outcomes. WLHIV will be enrolled during pregnancy and early postpartum, with half intending to breastfeed, and will be followed for ≥48 weeks. Clinical and laboratory data will be collected. Comprehensive surveys collect data on demographics, social determinants of health, mental health, antiretroviral therapy adherence, and infant feeding intentions and experiences. We measure HIV RNA and DNA in breast milk to determine factors associated with detectable HIV. Finally, we estimate the costs and benefits associated with breastfeeding compared to replacement feeding. In CA3, we develop and pilot a voluntary registry of U.S. WLHIV who are breastfeeding and their infants (n = 50-200). Pilot registry testers (n = 30) will provide feedback on the usability, acceptability, appropriateness, and feasibility of the registry.

DISCUSSION: The UPLIFT study will generate critical insights to inform patient-centered care, guide practice and policy, and empower WLHIV in the US to make informed infant feeding decisions.

ETHICS AND DISSEMINATION: The UPLIFT study received approval from Advarra, the institutional review board of record for all UPLIFT sites. Results will be disseminated through conference presentations, peer-reviewed journals, and lay summaries.

CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT07293559, NCT07293559.