Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое No intervention provided in this study
  None; No intervention provided in this study

Первичные конечные точки

• CA 1: Factors influencing infant feeding decision [Срок оценки: Within 28 days and 2 years of Enrollment]
• CA 1: Infants born to women with HIV who receive any breast milk [Срок оценки: Monthly, through study completion, up until 5 years]
• CA 2: Infant feeding method chosen [Срок оценки: At 48 weeks post birth]
• CA 2: Breastfeeding initiation among those who intended to breastfeed [Срок оценки: At 48 weeks post birth]
• CA 2: Duration of breastfeeding among PPWH who breastfeed [Срок оценки: Through 96 weeks post birth]
• CA 2: Completion of intended duration of breastfeeding [Срок оценки: Through 96 weeks post birth]
• CA 2: Mixed method analysis of infant feeding practices from in-depth interviews and survey data [Срок оценки: At 48 weeks post birth]
• CA 2: Breast milk samples with detectable HIV DNA or RNA [Срок оценки: Through 48 weeks post birth; At weaning up to 96 weeks post birth]
• CA 2: Viral load measured in different breast milk compartments [Срок оценки: Through 48 weeks post birth; At weaning up to 96 weeks post birth]
• CA 3: Data completed in registry [Срок оценки: Through study completion, an average of 3 years]

Вторичные конечные точки (12)

• CA 1: Approaches to support infant feeding decisions and improve quality of care [Срок оценки: Within 28 days and 2 years of Enrollment]
• CA 1: Descriptive results of current practices, burden, benefits and resources [Срок оценки: Monthly, through study completion, up to 5 years]
• CA 2: Median cost per postpartum woman with HIV and infant pair [Срок оценки: Through study completion, up to 5 years]
• CA 2: Cost effectiveness ratio presented as cost per quality adjusted life year saved in breastfeeding mother/infant pair [Срок оценки: Through study completion, up to 5 years]
• CA 2: Cost per case of medical condition prevented by breastfeeding [Срок оценки: Through study completion, up to 5 years]
• CA 2: Changes in scores of mental health and quality of life surveys [Срок оценки: At 20 Weeks, At 48 Weeks]
• CA 2: Satisfaction with infant feeding decision and decision regret survey scores [Срок оценки: At 20 weeks, At 48 weeks]
• CA 2: Infant HIV acquisition [Срок оценки: Through study completion, up to 96 weeks post birth]
• CA 2: Infant weight-for-age, length-for-age, head circumference-for-age (by z-score for sex) [Срок оценки: At 20 weeks, At 48 weeks]
• CA 2: Score classification of each Ages and Stages developmental area [Срок оценки: At 20 weeks, At 48 weeks]
• CA 2: Plasma HIV viral load [Срок оценки: Through 48 weeks post birth, At weaning up to 96 weeks post birth]
• CA 2: Number of copies of HIV DNA or RNA per mL of milk [Срок оценки: Through 48 weeks post birth, At weaning up to 96 weeks post birth]

Критерии участия

Core Activity 1 Inclusion Criteria: Pregnant and Postpartum Women with HIV

• Is of legal age or circumstance to provide independent informed consent
• Belongs to one of the following five categories:

• 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
• Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, breastfed for less than four weeks, and has weaned
• Gave birth to a live born infant after 28 February 2023, is over 4 weeks postpartum, and breastfed for four weeks or longer
• Diagnosed with HIV prior to or during the pregnancy
• If preferred language is other than English, is willing to participate in interviews with an available translator.

Core Activity 1 Inclusion Criteria: Healthcare Providers and Ancillary Healthcare Professionals

• Is of legal age or circumstance to provide independent informed consent
• Is a healthcare provider who self-identifies as an obstetrician, midwife, nurse, adult or pediatric infectious disease specialist, or advance practice provider who participated in the care of at least five PPWH and/or their infants over the three years prior to entry OR
• Is an ancillary healthcare professional who self-identifies as a social worker, lactation support provider, patient navigator, pharmacist, doula who participated in the care of at least five PPWH and/or their infants over the three years prior to entry

Core Activity 1 Inclusion Criteria: Influential Individuals

• Has been identified by a PPWH enrolled in Core Activity 1 as aware of her HIV status and contributing to her infant feeding decisions
• Is of legal age or circumstance to provide independent informed consent
• If preferred language is other than English, is willing to participate in interviews with an available translator.

Core Activity 2 Inclusion Criteria: Pregnant and Postpartum Women with HIV and their Infant

• Is of legal age or circumstance to provide independent informed consent
• Is pregnant with singleton fetus with a gestational age of ≥ 28 0/7 weeks at entry OR
• Gave birth to a live born, singleton infant up to 7 days prior to entry
• Diagnosed with HIV prior to or during the pregnancy
• Expected to be available for the duration of follow-up

Core Activity 3 Inclusion Criteria: Breastfeeding Postpartum Women with HIV and their Infant

• Is of legal age or circumstance to provide independent informed consent
• Must be up to 7 days postpartum with live-born infant
• Diagnosed with HIV prior to or during the pregnancy
• Breastfed her infant for any duration

Core Activity 3 Inclusion Criteria: Pilot Registry Testers

• Is of legal age or circumstance to provide independent informed consent
• Working at a healthcare facility that provides care for women with HIV who are breastfeeding and/or their infants

Exclusion Criteria: Core Activities 1-3

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 11 центров

• University of Southern California (CRS 5048) — Los Angeles
• David Geffen School of Medicine at UCLA (CRS 5112) — Los Angeles
• University California, San Diego (CRS 4601) — San Diego
• University of Colorado, Denver (CRS 5052) — Aurora
• University of Florida (5051) — Jacksonville
• Univ of Miami Pediatric/Perinatal HIV/AIDS (5127) — Miami
• 5030, Emory University School of Medicine Clinical Research Site — Atlanta
• Lurie Children's Hospital of Chicago (CRS 4001) — Chicago
• … и ещё 3 центра

Публикации

• Smith C, Barr EA, Hampanda K, Trumbull M, Wu H, McKinney J, Buisson S, Hoffmann C, Brown C, Hutchinson AB, Amico KR, Asiodu IV, McFarland EJ, Lampe MA, Cholli PA, Varechtchouk O, Esber A, Kourtis AP, Abuogi L. Understanding practices of lactation and infant feeding together with women with HIV: the UPLIFT observational study protocol. Front Reprod Health. 2026 Jul 8;8:1856899. doi: 10.3389/frph.20 PMID 42488399

Идентификаторы

NCT: NCT07293559 · IMPAACT 2046

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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