Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
Recruiting · NCT07293559 · Observational (researchers observe without assigning treatment) · Lead sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
View the official record on ClinicalTrials.gov →Interventions studied
No intervention provided in this study
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
11 locations listed across 8 US states.
- 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