Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-18 @ 8:18 PM
Study NCT ID:
NCT07293559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
Sponsor:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Organization:
Study Overview
Official Title:
Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UPLIFT
Brief Summary:
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.
Detailed Description:
This is a convergent mixed-method, multisite study to identify factors in infant feeding decisions and explore infant feeding perspectives, preferences, practices and outcomes among women with HIV in the US. Feasibility and acceptability of developing a national registry of breastfeeding women with HIV in the US will also be assessed. The study sites will enroll women with HIV who are pregnant or postpartum (PPWH), healthcare providers (HCPs) and ancillary healthcare professionals (AHPs), other influential individuals who contribute to infant feeding decisions, and pilot registry testers.
The study will be comprised of three core activities:
* Core Activity 1: Will explore the multifaceted process of infant feeding decision-making, and describe clinical practice, and counseling approaches via in-depth interviews (IDIs) and surveys. IDIs will be completed with PPWH, influential people who contribute to infant feeding decisions, HCPs, and AHPs. HCPs and AHPs will also complete self-administered surveys, and site staff at each site will complete site-level surveys to inform a landscape analysis.
* Core Activity 2: Will establish an observational prospective cohort of PPWH, and their liveborn infants, to examine current infant feeding practices and outcomes and their associated costs and cost benefits.
* Core Activity 3: Will develop and pilot a national registry of breastfeeding women with HIV and assess its feasibility and acceptability among pilot registry testers.
The study will be comprised of three core activities:
* Core Activity 1: Will explore the multifaceted process of infant feeding decision-making, and describe clinical practice, and counseling approaches via in-depth interviews (IDIs) and surveys. IDIs will be completed with PPWH, influential people who contribute to infant feeding decisions, HCPs, and AHPs. HCPs and AHPs will also complete self-administered surveys, and site staff at each site will complete site-level surveys to inform a landscape analysis.
* Core Activity 2: Will establish an observational prospective cohort of PPWH, and their liveborn infants, to examine current infant feeding practices and outcomes and their associated costs and cost benefits.
* Core Activity 3: Will develop and pilot a national registry of breastfeeding women with HIV and assess its feasibility and acceptability among pilot registry testers.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: