Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
NCT ID: NCT07293559
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1150 participants
OBSERVATIONAL
2026-01-31
2030-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Core Activity 1
This core activity aims to explore current site-level infant feeding practices and infant feeding decision-making and preferences at selected sites in the US.
No intervention provided in this study
None; No intervention provided in this study
Core Activity 2
This core activity aims to examine infant feeding practices and outcomes among women with HIV at selected sites in the US and to describe the financial implications of different infant feeding choices.
No intervention provided in this study
None; No intervention provided in this study
Core Activity 3
This core activity aims to pilot and assess the feasibility and acceptability of a national registry of breastfeeding women with HIV in the US.
No intervention provided in this study
None; No intervention provided in this study
Interventions
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No intervention provided in this study
None; No intervention provided in this study
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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.
* 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
* 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
* 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
ALL
Yes
Sponsors
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University of Colorado, Denver
OTHER
Centers for Disease Control and Prevention
FED
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Lisa Abuogi
Role: STUDY_CHAIR
University of Colorado, Denver
Locations
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University of Southern California (CRS 5048)
Los Angeles, California, United States
David Geffen School of Medicine at UCLA (CRS 5112)
Los Angeles, California, United States
University California, San Diego (CRS 4601)
San Diego, California, United States
University of Colorado, Denver (CRS 5052)
Aurora, Colorado, United States
University of Florida (5051)
Jacksonville, Florida, United States
Univ of Miami Pediatric/Perinatal HIV/AIDS (5127)
Miami, Florida, United States
5030, Emory University School of Medicine Clinical Research Site
Atlanta, Georgia, United States
Lurie Children's Hospital of Chicago (CRS 4001)
Chicago, Illinois, United States
Johns Hopkins University (CRS 5092)
Baltimore, Maryland, United States
Jacobi Med. Ctr. Bronx NICHD CRS (5013)
The Bronx, New York, United States
St. Jude Childrens Research Hosp, Memphis (6501)
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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James Homans, MD
Role: primary
Yvonne Morales, LVN
Role: backup
Other Identifiers
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IMPAACT 2046
Identifier Type: -
Identifier Source: org_study_id