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

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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.

• 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

Locations
United States
California
David Geffen School of Medicine at UCLA (CRS 5112)
NOT_YET_RECRUITING
Los Angeles
University of Southern California (CRS 5048)
NOT_YET_RECRUITING
Los Angeles
University California, San Diego (CRS 4601)
NOT_YET_RECRUITING
San Diego
Colorado
University of Colorado, Denver (CRS 5052)
RECRUITING
Aurora
Florida
University of Florida (5051)
NOT_YET_RECRUITING
Jacksonville
Univ of Miami Pediatric/Perinatal HIV/AIDS (5127)
NOT_YET_RECRUITING
Miami
Georgia
5030, Emory University School of Medicine Clinical Research Site
NOT_YET_RECRUITING
Atlanta
Illinois
Lurie Children's Hospital of Chicago (CRS 4001)
RECRUITING
Chicago
Maryland
Johns Hopkins University (CRS 5092)
NOT_YET_RECRUITING
Baltimore
New York
Jacobi Med. Ctr. Bronx NICHD CRS (5013)
NOT_YET_RECRUITING
The Bronx
Tennessee
St. Jude Childrens Research Hosp, Memphis (6501)
NOT_YET_RECRUITING
Memphis
Contact Information
Primary
Lisa Levy
llevy@fhi360.org
202-884-8480
Time Frame
Start Date: 2026-02-24
Estimated Completion Date: 2031-04-24
Participants
Target number of participants: 1150
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Centers for Disease Control and Prevention, University of Colorado, Denver, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

This content was sourced from clinicaltrials.gov