NCT07293559Recruiting
Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1150 (estimated)
- First submitted
- 16 Dec 2025
- Start date
- 24 Feb 2026
- Primary completion date
- 24 Apr 2031
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Diseases
- HIV
- NCT number
- NCT07293559
What you commit to
- Study type: Observational
- Planned participants: 1150
- From 24 Feb 2026 to the primary completion date, 24 Apr 2031
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Criteria the registry did not label
- 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
Sex: All · Accepts healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 5030, Emory University School of Medicine Clinical Research Site Coordinator of this site? Confirm its status | Atlanta | United States | Not yet recruiting |
| University of Colorado, Denver (CRS 5052) Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Johns Hopkins University (CRS 5092) Coordinator of this site? Confirm its status | Baltimore | United States | Not yet recruiting |
| Lurie Children's Hospital of Chicago (CRS 4001) Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Florida (5051) Coordinator of this site? Confirm its status | Jacksonville | United States | Not yet recruiting |
| University of Southern California (CRS 5048) Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| David Geffen School of Medicine at UCLA (CRS 5112) Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| St. Jude Childrens Research Hosp, Memphis (6501) Coordinator of this site? Confirm its status | Memphis | United States | Not yet recruiting |
| Univ of Miami Pediatric/Perinatal HIV/AIDS (5127) Coordinator of this site? Confirm its status | Miami | United States | Not yet recruiting |
| University California, San Diego (CRS 4601) Coordinator of this site? Confirm its status | San Diego | United States | Not yet recruiting |
| Jacobi Med. Ctr. Bronx NICHD CRS (5013) Coordinator of this site? Confirm its status | The Bronx | United States | Not yet recruiting |
Related publications
- Understanding practices of lactation and infant feeding together with women with HIV: the UPLIFT observational study protocol.Front Reprod Health · 2026 · PMID 42488399
This page is information, not medical advice. Discuss any trial with your doctor.